(104 days)
Not Found
No
The device description and performance studies focus on the physical components (LED lamps, stand) and standard engineering verification (electrical, mechanical, safety, reliability). There is no mention of AI, ML, image processing, or data-driven algorithms for diagnosis or treatment adjustment.
Yes
The device is used for the "treatment of indirect hyperbilirubinemia in term and pre-term infants," indicating its therapeutic purpose.
No
The device description states its intended use is for "treatment of indirect hyperbilirubinemia," indicating a therapeutic rather than diagnostic function. It emits blue light for phototherapy, which is a treatment modality.
No
The device description explicitly details hardware components such as a lamp unit with LED lamps, a roll stand, a plastic light enclosure, and a base, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of indirect hyperbilirubinemia (neonatal jaundice) using light therapy. IVD devices are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body (like blood, urine, etc.).
- Device Description: The device is a phototherapy system that emits blue light. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, using reagents, or providing diagnostic information based on biological samples.
The Lullaby LED Phototherapy System is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Lullaby The LED Phototherapy System is used for the treatment of indirect hyper-bilirubinemia 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.
Product codes
LBI
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.
The Lullaby "M LED Phototherapy System is an intensive Phototherapy device with Blue LED light in the range of 400-550nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
term and pre-term infants
Intended User / Care Setting
trained, professional medical staff, on the order of a licensed medical practitioner in a hospital environment - NICUs, PICUs and Well-baby Nurseries
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, LullabyTM LED Phototherapy System, did not require clinical studies to support substantial equivalence.
Verification and Testing activities establish the performance, functionality, usability, safety, and reliability characteristics of Lullaby 11 LED Phototherapy System.
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 demonstrate that the Lullaby TM LED Phototherapy System meets all design requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 2012
Wipro GE Healthcare Private Ltd.
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 |
| 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 Phototherapy
Lullaby™ Phototherapy System (K071828) |
| 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 |
4
1
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
1
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
2
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.
3
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.
4
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
5
Indications for Use
510(k) Number : K120168
20168
Device Name:
LullabyTM LED Phototherapy System
Indications for Use:
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.
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