DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

January 26, 2015

Foshan United Medical Technologies LTD

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NAMSA
4050 Olson Memorial Highway, Suite 450
Minneapolis, Minnesota 55422

Re: K143124
Trade/Device Name: KA01 Chitosan Wound Dressing
Regulatory Class: Unclassified
Product Code: FRO
Dated: October 30, 2014
Received: October 31, 2014

Dear Ms. Palma:

We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act’s requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Page 2 – Ms. Marcia Palma

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, sMisbranding by reference to premarket notifications (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director
Division of Surgical Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
510(k) Summary

1. Submission Sponsor

Foshan United Medical Technologies Ltd

89 Taoyuan East Road,
Shishan,
Nanhai,
Foshan
Guangdong Province,
528225, P.R. China
Office number: +86 (0)757 - 8120 8559
John Cen, Quality Assurance and Regulatory Affairs Manager

2. Submission Correspondent

NAMSA
4050 Olson Memorial Hwy
Suite 450
Minneapolis, MN 55422

Marcia Palma
Senior Principal Consultant
Office: 763-588-9847
Mobile: 612-269-3520
Fax: 763-287-3836
Email: [email protected]

3. Date Prepared

January 22, 2015

4. Device Identification

Trade/Proprietary Name: KA01 Chitosan Wound Dressing

Common/Usual Name: Dressing, Wound, Drug
Classification Name: Unclassified
Classification Regulation: Unclassified
Product Code: FRO
Device Class: Unclassified
Classification Panel: General and Plastic Surgery

5. Predicate Devices

Primary: K070175 MedTrade Products Aquanova Super-Absorbent Dressing

Secondary: K063271 Convatec Aquacel Hydrofibre Wound Dressing

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6. Device Description

The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing

comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly
absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan
forms a gel, which assists in maintaining a moist environment for optimal wound
healing, aids autolytic debridement, and allows intact removal.

The KA01 Chitosan Wound Dressing is intended for use as a primary dressing on a
variety of chronic and acute wounds. It is intended to be secured with a semi
permeable adhesive secondary dressing and to remain in place up to 7 days depending
on the level of exudate. Dressings are individually packed in paper/poly pouches and
terminally sterilized to achieve a SAL 10-6. A range of dressing sizes between 25cm2
and 220cm2 is available.

Flat Dressing Sizes: Flat Rope Dressing Sizes:

5 x 5cm, 7.5 x 12cm, 10 x 10cm, 1.5 x 45cm, 2.5x45 cm, 3 x 45cm,
10 x 12cm, 10 x 20 cm 3 x 30cm, 4x10 cm, 4x20 cm, 4x30 cm

7. Indication for Use

Rx:
The KA01 Chitosan Wound Dressing is indicated for the management of moderately
to heavily exuding chronic wounds and acute wounds. Under medical supervision the
KA01 Chitosan Wound Dressing may be used for management of:

 Pressure sores
 Diabetic ulcers
 Leg ulcers
 Donor sites and graft sites
 Surgical wounds
 Skin abrasions and lacerations
 1st and 2nd degree burns
 Trauma wounds

OTC:
The KA01 Chitosan Wound Dressing may be used for the management of:
 Minor cuts
 Minor scalds and 1st degree burns
 Abrasions
 Lacerations

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8. Comparison to Predicates

The intended use, device design, mechanism of action, material and performance
testing of KA01 Chitosan Wound Dressing, as designed and manufactured, are
determined to be substantially equivalent to the referenced predicate devices. The
differences between the KA01 Chitosan Wound Dressing and the predicate devices
do not raise any questions regarding its safety and effectiveness.

Comparison to Predicate Devices

Primary:
KA01 Chitosan Wound Secondary:
Parameter Aquanova Super-
Dressings Aquacel Dressing
Absorbent Dressing
510(k) Number
TBD K070175 K063271
Decision Date
Foshan United Medical
Manufacturer MedTrade Products Convatec
Technologies Ltd
Classification Unclassified Same Class I
Product Code FRO Same NAC
878.4018
Regulation
Unclassified Same Hydrophilic wound
Number and Name
dressing
Indications for Use Rx: Under the Under the
The KA01 Chitosan Wound supervision of a supervision of a
Dressing is indicated for the healthcare health care
management of moderately to professional professional, Aquacel
heavily exuding chronic AQUANOVA may may be used for
wounds and acute wounds. be used for wounds management of:
Under medical supervision such as leg ulcers - leg ulcers, pressure
the KA01 Chitosan Wound (Stages I-IV), ulcers (Stage II-IV)
Dressing may be used for the diabetic ulcers, and diabetic ulcers
management of: surgical wounds - surgical wounds
 Pressure sores (post-operative, (post-operative,
 Diabetic ulcers donor sites, donor sites,
 Leg ulcers dermatological), dermatological)
 Donor sites and Graft burns (first and - second degree burns
sites second degree) and - surgical or
 Surgical wounds the management of traumatic wounds left
 Skin abrasions and surgical or traumatic to heal by secondary
lacerations wounds which have intention
 1st and 2nd degree burns been left to heal by - local management
 Trauma wounds secondary intention. of wounds that are
AQUANOVA may prone to bleeding,
OTC: also be used for the such as wounds that
The KA01 Chitosan Wound local management of have been
Dressing may be used for the wounds that are mechanically or
management of: prone to bleeding surgically debrided,
• Minor cuts such as wounds that donor sites, and
• Minor scalds and 1st degree have been surgically traumatic wounds
burns or mechanically - the management of
• Abrasions debrided, donor sites, painful wounds
• Lacerations and traumatic

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 Comparison to Predicate Devices
Primary:
KA01 Chitosan Wound Secondary:
Parameter Aquanova Super-
Dressings Aquacel Dressing
Absorbent Dressing
wounds. For Over the Counter
AQUANOVA can Use: Aquacel
also be used in the Hydrofiber Wound
control of minor Dressing may be used
bleeding. for:
-abrasions
AQUANOVA Super- -lacerations
Absorbent OTC is -minor cuts
indicated for minor -minor scalds and
burns, superficial burns
cuts, lacerations and
abrasions, and minor
irritations of the skin.
Intended for prescription use
in the management of chronic
wounds, postoperative
wounds and traumatic
Intended Use Same Same
wounds. Also intended for
over-the-counter use for
minor cuts, burns, abrasions
and lacerations.
Absorbable, single layer,
needle punched non-woven
Device Design Same Same
pad or ribbon dressing that
can be cut or folded
Hydrocolloid fibers
Chitosan, chitosan
(sodium
Material 100% Chitosan fibers derivatives, and
carboxymethyl-
structural material
cellulose)
Conformable, highly
absorbent dressing that forms
a soft clear gel on contact
with wound exudate which
Mechanism of
maintains a moist Same Same
Action
environment for optimal
wound healing, provides
patient comfort and allows
painless intact removal.
Sterility SAL 10-6 Same Same
Single Use Yes Same Same
Biocompatible Yes Same Same

9. Functional and Safety Testing

To verify that device design met its functional performance and safety requirements,

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 representative samples of the device underwent testing including bench testing
(absorbency, gel absorbency retention, moisture content, pH), viral inactivation
testing, biocompatibility testing (cytotoxicity, irritation, sensitization, systemic
toxicity), packaging testing (pouch seal and transportation), sterilization validation
testing, and shelf life stability testing (accelerated aged and real time).

10. Conclusion

Foshan United Medical Technologies Ltd considers the KA01 Chitosan Wound
Dressing to be equivalent to the predicate devices listed above. This conclusion is
based upon the devices’ similarities in intended use, design, mechanisms of action,
technology and materials.