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Premarket Notification 510(k) Summary Se4o27l4

As required by section 807.92

LuhlabyTM Warmer

GENERAL COMPANY INFORMATION as required by 807.92(a)1

Date: May 2012]

[ 101h
Submitter: Wipro GE Healthcare Private Ltd.
4, kadugodi industrial area
bangalore, INDIA 560067

Primar Contact Person: Ms Agata Anthony

GE Healthcare,
Phone - +1410 456 0329
Fax - +1-410-888-0544

Sanjukta DebRoy
Secondary Contact Person: GE Healthcare,
Phone : +91 9632211022
Fax :+9180 28411645
Device: Trade Name: Lullaby' M Warmer

Common/Usual Name: Infant Radiant Warmer

Classification Names: Warmer, Infant Radiant, Class :11
Product Code: FMT, General Hospital and Personal use Theraputic Devices
Regulation No: 21 CFR 880.5130
Predicate Device(s): Ohmeda OhioR Infant Warmer System (K963058)

Device Description: The LullabyTM Warmer is a radiant warmer which provides a micro-
environment for a premature, new born baby which otherwise might
have very little chance of survival as it will not be able to maintain, by
itself, its core body temperature.

The LullabyTM Warmer provides a means for the care giver to monitor
the baby continuously by giving timely feedback via the different alarm
systems and servo controlled thermal feedback mechanism while
maintaining a pre-set temperature and thus ensures that the neonate
slowly develops the internal organs to enable it to maintain its body
temperature.
 K 0/Ao0,5

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Indication for Use: Infant radiant warmers provide infrared heat in a controlled manner to
infants who are unable to maintain thermoregulation based on their own
physiology. Infant radiant warmers may be used to facilitate the
newborn's transition to the external environment or to provide[ a
controlled open microenvironiment.

Technolojzv: Lullaby TM Warmer uses the same fundamental technology as its predicate
Ohmeda Ohiok Infant Warmer System providing radiant heat in a controlled
manner to infants who are unable to maintain thermoregulation based on their
own physiology.

The control system uses a microprocessor and provides both manual and servo
modes of operation. The patient temperature, control temperature, Apgar timer,
Audio and visual alarm system are included on the control panel.

The intended use for both predicate and the proposed device is the same only
minor word phrasing differences are there in order to add more clarity.

The Lullaby'" Warmer uses recliner mechanism for bed tilting which offers a
wider tilting angle as compared to the predicate device.
For more on the predicate device comparison refer to section 12 of this 5 10k
submission.

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Determination of Substantial Summary of Non-Clinical Tests:

Equvlne Verification and Testing activities establish the performance, functionality,
usability, safety, and reliability characteristics of LullabyTM Warmer.

The LullabyTM Warmer comply with voluntary standards as detailed in

Section 09, 15, 16, 17 and 18 of this premarket submission.
The following quality assurance measures were applied to the development of
the system:
* Risk Analysis
* Requirements Reviews
* Design Reviews

Summary of Simulated Use Setting:

The Design verification of LullabyTM Warmer has been divided into several
protocols that include electrical, mechanical, safety Testing, reliability,-and
system design verification protocols.

The performance testing included testing on unit level, system level, as wellI as
usability and safety parameters.

The results of the Design verification testing protocols have been documented
in Section 18 of this 510(k) application.
TM
The results demonstrate that the Lullaby Warmer meets all design
requirements and performance claims.

The subject of this premarket submission, LullabyTM Warmer ,did not

_________________________require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the LullabyTM Warmer to be as safe and as effective

as the predicate device, and the performance to be substantially equivalent to
________________________the predicate device.

3
4DEPARTMENT
"'to
OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 Newv H-ampshire Avenue
Document Control Room -W066-G609
Silver Spring, MD 20993-0002

Wipro GE Healthcare Private Ltd. SEP

C/O Ms. Agata Anthony 71 0
Regulatory Affairs Director
GE Healthcare
8880 Gorman Road
Laurel, Maryland 20723

Re: K121625
Trade/Device Name: Lullaby" Warmer
Regulation Number: 21 CFR 880.5130
Regulation Name: Infant Radiant Warmer
Regulatory Class: 11
Product Code: FMT
Dated: August 14, 2012
Received: August 20, 2012

Dear Ms. Anthony:

We have reviewed your Section 5 10(k) premarket no'tification of intent to market the device
referenced above and have determinied 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 11 (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 2 1, Parts 800 to 898. In
addition, FDA may publish further announcements concerning your device in the Federal
Register.
Page 2- Ms. Anthony

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 forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of
the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please go to
htt):H/ww.w.fda.rzov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 I5809.htm for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also,
please note the regulation entitled, "Misbranding by reference to premarket notification"
(2I1CFR 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.g~ov/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 Small Manufacturers, International and Consumer Assistance at its toll-free
number (800) 638-2041 or (301) 796-7100 or at its Internet address
http)://),rww.fda.jgov/MedicalDevices/ResourcesforYou/ndustry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M4_.S., M.B.A.

Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
 Indications for Use

5 10(k) Number (if knowvn): K-4Ja/(,,

Device Name: Lullabyrm Warmer

Indications for Use:

Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to
maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used
to facilitate the newborn's transition to the external environment or to provide a controlled open
microenvironment.

Prescription Use.L. AND/OR Over-The-Counter Use-

(Part 21 CFRS801 Subpart D) (Part 21 CFRSO01 SubpartC)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft)erl14sb
Division of AnesthGslOY, eelHsia
iftin Control, Dental Devices'
510(k) Number: P4 IAI