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 rrovide a controlled open microenvironment.

Device Description

The Lullaby™ 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 Lullaby™ 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.

AI/ML Overview

The Lullaby™ Warmer is an infant radiant warmer. The provided documents detail its premarket notification (510(k)) summary, indicating that it did not require clinical studies for substantial equivalence. Therefore, the device does not rely on a study demonstrating how it meets acceptance criteria based on human expert performance or clinical outcomes. Instead, its acceptance is based on non-clinical tests and compliance with recognized standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General)	Reported Device Performance
Performance, functionality, usability, safety, and reliability characteristics	The Lullaby™ Warmer meets all design requirements and performance claims based on verification and testing activities.
Compliance with voluntary standards	The Lullaby™ Warmer complies with voluntary standards as detailed in Sections 09, 15, 16, 17, and 18 of the premarket submission.
Meets design requirements	Results of Design verification testing protocols demonstrate that the Lullaby™ Warmer meets all design requirements.
Meets performance claims	Results of Design verification testing protocols demonstrate that the Lullaby™ Warmer meets all performance claims.
Electrical safety	Addressed through specific design verification protocols.
Mechanical safety	Addressed through specific design verification protocols.
Reliability	Addressed through specific design verification protocols.
System design verification	Addressed through specific design verification protocols.

2. Sample size used for the test set and the data provenance

The document explicitly states: "The subject of this premarket submission, Lullaby™ Warmer, did not require clinical studies to support substantial equivalence."
Therefore, there was no "test set" in the context of clinical data, no sample size of patients, and no data provenance from human subjects for this device's 510(k) submission. Acceptance was based on engineering and performance verification testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical studies were required, there was no test set involving human subjects where expert ground truth was established for the device's performance with patients. Ground truth in this context would relate to engineering specifications and performance benchmarks, which are established by design and testing engineers.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Lullaby™ Warmer is an infant radiant warmer, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Lullaby™ Warmer is a physical medical device, not an algorithm. Its performance is demonstrated through its functional capabilities, safety features, and compliance with manufacturing and performance standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Lullaby™ Warmer's acceptance is based on engineering specifications, technical performance benchmarks, and compliance with recognized voluntary standards. This includes verification that the device maintains a pre-set temperature, provides timely feedback via alarm systems, and operates within specified electrical, mechanical, and safety parameters.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning or clinical data. The device's design and manufacturing process would involve internal testing and validation against specifications.

9. How the ground truth for the training set was established

Not applicable. As no training set (in the machine learning sense) was used, no ground truth needed to be established for it. The "ground truth" for the device's functionality is its adherence to its design specifications and the regulatory requirements for infant radiant warmers.

Summary

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2012

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Premarket Notification 510(k) Summary As required by section 807.92

Lullaby™ Warmer

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

[10th May 2012] Date: Wipro GE Healthcare Private Ltd. Submitter: 4, kadugodi industrial area bangalore, INDIA 560067

Primary Contact Person:

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

Secondary Contact Person:

Sanjukta DebRoy GE Healthcare, Phone : +91 9632211022 Fax :+9180 28411645

LullabyTM Warmer Device: Trade Name:

Infant Radiant Warmer Common/Usual Name: Warmer, Infant Radiant, Class : II Classification Names: FMT , General Hospital and Personal use Theraputic Devices Product Code: Regulation No: 21 CFR 880.5130

Predicate Device(s): Ohmeda Ohio8 Infant Warmer System (K963058)

The Lullaby™ Warmer is a radiant warmer which provides a micro-Device Description: 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 Lullaby™ 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.

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Indication for Use:	Infant radiant warmers provide infrared heat in a controlled manner toinfants who are unable to maintain thermoregulation based on their ownphysiology. Infant radiant warmers may be used to facilitate thenewborn's transition to the external environment or to provide acontrolled open microenvironment.
Technology:	Lullaby™ Warmer uses the same fundamental technology as its predicateOhmeda Ohio® Infant Warmer System providing radiant heat in a controlledmanner to infants who are unable to maintain thermoregulation based on theirown physiology.
	The control system uses a microprocessor and provides both manual and servomodes 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 onlyminor word phrasing differences are there in order to add more clarity.
	The Lullaby™ Warmer uses recliner mechanism for bed tilting which offers awider tilting angle as compared to the predicate device.For more on the predicate device comparison refer to section 12 of this 510ksubmission.

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Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:
	Verification and Testing activities establish the performance, functionality,usability, safety, and reliability characteristics of Lullaby™ Warmer.
	The Lullaby™ Warmer comply with voluntary standards as detailed inSection 09, 15, 16, 17 and 18 of this premarket submission.
	The following quality assurance measures were applied to the development ofthe system:
	Risk Analysis Requirements Reviews Design Reviews
	Summary of Simulated Use Setting:
	The Design verification of Lullaby™ Warmer has been divided into severalprotocols that include electrical, mechanical, safety Testing, reliability, andsystem design verification protocols.
	The performance testing included testing on unit level, system level, as well asusability and safety parameters.
	The results of the Design verification testing protocols have been documentedin Section 18 of this 510(k) application.
	The results demonstrate that the Lullaby™ Warmer meets all designrequirements and performance claims.
	The subject of this premarket submission, Lullaby™ Warmer , did notrequire clinical studies to support substantial equivalence.
	Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Wipro GE Healthcare Private Ltd. C/O Ms. Agata Anthony 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: II Product Code: FMT Dated: August 14, 2012 Received: August 20, 2012

Dear Ms. Anthony:

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.

SEP 14 2012

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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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

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Indications for Use

K121625 510(k) Number (if known):

Device Name: Lullaby™ Warmer

Indications for Use:

Prescription Use_

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

fw Richard Chapman

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Infection Control, Dental D

510(k) Number: K121625

Regulation Number and Section

§ 880.5130 Infant radiant warmer.

(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.