(34 days)
Not Found
No
The summary describes a phototherapy system that delivers light and does not mention any AI/ML components or image processing.
Yes
The device is intended for the "treatment of neonatal hyperbilirubinemia," which indicates a therapeutic purpose.
No
Explanation: The device is intended for treatment (phototherapy) of neonatal hyperbilirubinemia, not for diagnosis.
No
The device description explicitly states it consists of a "freestanding lamp," which is a hardware component.
No, the Lullaby™ Phototherapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Lullaby™ Phototherapy System is a therapeutic device. Its purpose is to treat a condition (neonatal hyperbilirubinemia) by applying light directly to the patient's body. It does not analyze any biological samples.
The provided information clearly describes a device that delivers light therapy to a patient, which is a form of treatment, not a diagnostic test performed on a specimen.
N/A
Intended Use / Indications for Use
The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device is intended for professional use only by trained clinicians.
Product codes
LBI
Device Description
The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device consists of a freestanding lamp that delivers specific wavelength light to the patient positioned below the lamp.
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
neonatal
Intended User / Care Setting
professional use only by trained clinicians.
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)
Non-clinical Tests: The device has been evaluated for electrical safety and has been found to conform to applicable medical device safety standards.
Clinical Tests: None required.
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
Traditional 510(K) Premarket Notification GE Healthcare Lullaby™ Phototherapy System
5. 510(K) Summary
ರ GE Healthcare
General Electric Company 8880 Gorman Road, Laurel, MD 20723 AUG -6 2007
Section A
| 1. Submitter: | Ohmeda Medical, a division of GE Healthcare
8880 Gorman Road, Laurel, MD 20723 |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Person: | Thalia Brine
Global Regulatory Leader
Telephone: 410-888-5257 |
| Fax: | 410-888-0544 |
| Date Prepared: | 29 June 2007 |
-
- Device Name:
| Trade Name: | Lullaby™ Phototherapy System |
|---|---|
| Common Name: | Phototherapy device |
| Classification Name: | Neonatal Phototherapy Unit |
| 21 CFR 880.5700 | |
| Product Code: | LBI |
| 3. Marketed Device: | Phoenix Neonatal Phototherapy Unit CFL 101 |
-
Device Description: The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device consists of a freestanding lamp that delivers specific wavelength light to the patient positioned below the lamp.
-
Indications for Use: The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice.
-
Comparison with Predicate Device: The Lullaby™ Phototherapy System has the same intended use as the listed predicate device, the Phoenix Neonatal Phototherapy Unit CFL 101, and the mode of action for neonatal jaundice treatment is the same between the two devices. Details of the similarities and differences between the two devices may be found in Section #11.
Image /page/0/Picture/13 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are white, set against a black background, creating a high-contrast and recognizable emblem.
1
Section B
-
Non-clinical Tests: The device has been evaluated for electrical safety and has been found to conform to applicable medical device safety standards.
-
Clinical Tests: None required.
-
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient treatment. Phototherapy treatment for neonatal jaundice has accumulated a long history of safe and effective use. Additionally the design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems, and the device conforms to applicable medical device safety standards, compliance verified through independent evaluation with ongoing factory surveillance. Therefore, it is the opinion of GE Healthcare that the Lullaby™ Phototherapy System is substantially equivalent with respect to safety and effectiveness to other phototherapy devices currently cleared for market.
Image /page/1/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are decorative flourishes or swirls around the letters within the circle.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 2007
Ms. Thalia Brine Global Regulatory Leader GE Healthcare Clinical Systems 8880 Gorman Road Laurel, Maryland 20723
Re: K071828
Trade/Device Name: LullabyTM Phototherapy System Regulation Number: 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: June 29, 2007 Received: July 3, 2007
Dear Ms. Brine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -Ms. Brine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: Lullaby ™ Phototherapy System
Indications For Use:
The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device is intended for professional use only by trained clinicians.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C
(Cision Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________ K471825
Page 1 of