The Lullaby The LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner.

The Lullaby 10 LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner.

The Lullaby The LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

Device Description

The Lullaby™ LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. The system can be used for infants in a bassinet, incubator, open bed or radiant warmer. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum range. The Lullaby™ LED Phototherapy System consists of a lamp unit with 10 blue LED lamps mounted on a roll stand. The lamp unit consists of a lightweight plastic light enclosure. It can be adjusted vertically and tilted if required. The light enclosure can be tilted up to approximately 90° from the horizontal about it pivot axis. The height of the pedestal can be adjusted to change the vertical position of the lamp unit. The base of the Lullaby™ LED Phototherapy System is designed to slide conveniently under a bassinet, incubator, open bed, or radiant warmer. The lamp unit is designed as a table top style to place directly on the incubator

AI/ML Overview

This 510(k) premarket notification describes the Lullaby™ LED Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the proposed Lullaby™ LED Phototherapy System with its predicate device, the Lullaby™ Phototherapy System (K071828), to establish substantial equivalence. The performance factors listed act as the de facto acceptance criteria.

Performance Factor	Acceptance Criteria (Predicate Device K071828)	Reported Device Performance (Lullaby™ LED Phototherapy System)
Light Intensity (High Irradiance Mode)	30 µW.cm⁻².nm⁻¹	> 45 µW.cm⁻².nm⁻¹
Light Intensity (Low Irradiance Mode)	20 µW.cm⁻².nm⁻¹	> 22 µW.cm⁻².nm⁻¹
Light Spectrum	450-475 nm	450-465 nm
Surface Area Coverage	50 cm x 30 cm	60 cm x 30 cm
Power Consumption	100W	20W
Lamp Life	1000 hours	50000 hours
Lamp Source	CFL tubes	LEDs
Overheat Protection	Power cutoff for temp > 85° C	Power cutoff for temperature ≥ 90° C

Note on "Acceptance Criteria": In the context of a 510(k) for a substantially equivalent device, the "acceptance criteria" are typically met by demonstrating that the new device performs as well as or better than the predicate device for key performance characteristics, or that any differences do not raise new questions of safety or effectiveness. The table above uses the predicate device's performance as the benchmark for these criteria.

2. Sample Size and Data Provenance

The document states: "The subject of this premarket submission, Lullaby™ LED Phototherapy System, did not require clinical studies to support substantial equivalence." Therefore, there is no patient-specific test set or associated sample size for demonstrating clinical performance. The evaluation was based on non-clinical testing and engineering verification.

The data provenance for the non-clinical tests would be internal to Wipro GE Healthcare Private Ltd. and performed during the device's development and testing phases in India (based on the submitter's address).

3. Number and Qualifications of Experts for Ground Truth

Since no clinical studies were conducted and the device's substantial equivalence was based on non-clinical engineering and performance testing, there were no experts used to establish ground truth for a test set in a clinical context. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation based on the provided technical documentation.

4. Adjudication Method

As there was no clinical test set requiring expert interpretation or consensus, there was no adjudication method used in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not required.

6. Standalone (Algorithm Only) Performance

This device is a physical medical device (phototherapy system), not an algorithm or AI software, therefore, the concept of "standalone (algorithm only) performance" does not apply. The performance evaluation focused on the physical characteristics and functionality of the system itself.

7. Type of Ground Truth Used

The "ground truth" for this submission was established through engineering verification and performance testing. This involved:

Testing of electrical, mechanical, and safety parameters.
Reliability testing.
System design verification protocols.
Compliance with voluntary standards.

The results of these tests demonstrated that the device met all design requirements and performance claims, allowing it to be deemed substantially equivalent to the predicate.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. Therefore, there is no training set sample size to report.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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K-120168

MAY - 2 2012

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

LullabyTM LED Phototherapy System

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

Date:Submitter:	10th January 2012Wipro GE Healthcare Private Ltd.4, kadugodi industrial areabangalore, INDIA 560067
Primary Contact Person:	Ms Agata AnthonyGE Healthcare,Phone - +1410 456 0329Fax - +1-410-888-0544
Secondary Contact Person:	Sanjukta DebRoyGE Healthcare,Phone : +91 9632211022Fax :+9180 28411645
Device:Trade Name:	Lullaby™ LED Phototherapy System
Common/Usual Name:	Phototherapy Device
Classification Names:	Neonatal Phototherapy Unit,General Hospital, LBI,
Product Code:
Regulation No:
Predicate Device(s):	21 CFR 880.5700 Unit, Neonatal PhototherapyLullaby™ Phototherapy System (K071828)
Device Description:	The Lullaby™ LED Phototherapy System is intended for thetreatment of neonatal hyperbilirubinemia, commonly known asneonatal jaundice, in a hospital. The system can be used forinfants in a bassinet, incubator, open bed or radiant warmer. Thelamp unit emits blue light, which falls within the phototherapytherapeutic spectrum range. The Lullaby™ LED PhototherapySystem consists of a lamp unit with 10 blue LED lamps mountedon a roll stand.The lamp unit consists of a lightweight plastic light enclosure. Itcan be adjusted vertically and tilted if required. The lightenclosure can be tilted up to approximately 90° from thehorizontal about it pivot axis. The height of the pedestal can beadjusted to change the vertical position of the lamp unit. The baseof the Lullaby™ LED Phototherapy System is designed to slideconveniently under a bassinet, incubator, open bed, or radiantwarmer. The lamp unit is designed as a table top style to placedirectly on the incubator

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The Lullaby™ LED Phototherapy System is used for the Indication for Use: treatment of indirect hyper-bilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Wellbaby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner. The Lullaby "M LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner. The Lullaby 110 LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities. Lullaby™ LED Phototherapy System is an intensive Technology: Phototherapy device with Blue LED light in the range of 400-550nm. This range corresponds to the spectral absorption of light by bilirubin and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, and so there is no unusual threat of exposure of the infant to UV radiation. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, and so there is no unusual threat of exposure of the infant to IR radiation, or of excessive warming of the infant. As with all phototherapy lights, protective eyeshades must be used to protect the infant's eyes from excessive light exposure during treatment. The Lullaby™ LED Phototherapy System employs the same fundamental scientific technology as its predicate device Lullaby 110 Phototherapy System (K071828) by having the same mode of action for treating neonatal jaundice. But the source of light in Lullaby 110 LED Phototherapy System is from LED source as compared to CFL source in Lullaby TM Phototherapy System. Refer to the comparison table below for more details. Performance Factors LullabyTM Lullaby™ LED Phototherapy System Phototherapy System K071828 Proposed Predicate Light Intensity High Irradiance Mode: High irradiance mode: 30 µW.cm 2.nm 1 > 45 µW.cm -nm -Low Irradiance Mode: Low irradiance mode: 20 µW=cm " . nm " > 22 µW.cm 4.nm " 450-465 nm Light Spectrum 450-475 nm 60 cm X 30 cm 50 cm X 30 cm Surface Area Coverage Power Consumption 100W 20W (Low power consumption because of use of LED lights) Lamp Life 1000 hours 50000 hours Lamp Source CFL tubes LEDs Overheat protection Power cutoff for temp > Power cutoff for temperature ≥ 85° C 90° C

Confidential and Privileged. This document contains confidential and privileged trade secrets and other miermation of General Electrie Co. and as such may not be diselosed to others not employed by General Electric Co. All rights reserved

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Determination of Substantial Equivalence:

い

Summary of Non-Clinical Tests:

Verification and Testing activities establish the performance, functionality, usability, safety, and reliability characteristics of Lullaby 11 LED Phototherapy System.

The Lullaby™ LED Phototherapy System comply with voluntary standards as detailed in Section 09, 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 Lullaby™ LED Phototherapy System 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 well as usability and safety parameters.

The results of the Design verification testing protocols have been documented in Section 18 of this 510(k) application.

The results demonstrate that the Lullaby TM LED Phototherapy System meets all design requirements and performance claims.

The subject of this premarket submission, LullabyTM LED Phototherapy System, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Lullaby TM LED Phototherapy Conclusion: Systems to be as safe and as effective as the predicate device, and the performance to be substantially equivalent to the predicate device.

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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 consists of a stylized caduceus symbol, which features three wavy lines representing the branches of government. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

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

MAY - 2 2012

Wipro GE Healthcare Private Ltd. C/O Ms. Agata Anthony Regulatory Affairs Director Ohmeda Medical 8880 Gorman Road Laurel, Maryland 20723

Re: K120168

Trade/Device Name: Lullaby™ LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: March 3, 2012 Received: March 7, 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.

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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 /ucm 1 1 5809.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.

Anthany D. awaton

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

510(k) Number : K120168

20168

Device Name:

LullabyTM LED Phototherapy System

Indications for Use:

The Lullaby 10 LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner.

The Lullaby The LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for RZe

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

510(k) Number:

8 Confidential and Privileged. This document contidential and privileged trade secrets and other milemation of General Electric Co, and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

Regulation Number and Section

§ 880.5700 Neonatal phototherapy unit.

(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).