(34 days)
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.
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.
This document describes the GE Healthcare Lullaby™ Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia (neonatal jaundice).
Acceptance Criteria and Device Performance:
The document does not explicitly state numerical acceptance criteria for the Lullaby™ Phototherapy System's performance in treating neonatal hyperbilirubinemia. Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit from submission) | Reported Device Performance |
|---|---|---|
| Intended Use | Treatment of neonatal hyperbilirubinemia (neonatal jaundice). | The Lullaby™ Phototherapy System is intended for this specified use. |
| Mode of Action | Delivery of specific wavelength light for neonatal jaundice treatment. | Employs the same mode of action as the predicate device (light therapy). |
| Electrical Safety | Conformance to applicable medical device safety standards. | Evaluated and found to conform to applicable medical device safety standards. |
| Quality Systems | Design and development process conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. | Manufacturer's process conforms to these standards, with compliance verified through independent evaluation and ongoing factory surveillance. |
| Substantial Equivalence | Demonstrated substantial equivalence to a legally marketed predicate device (Phoenix Neonatal Phototherapy Unit CFL 101, K040853) with respect to safety and effectiveness. | Concluded to be substantially equivalent to the predicate device. |
Study Details:
The document states: "Clinical Tests: None required." This indicates that no specific clinical study was conducted as part of this 510(k) submission to demonstrate the device's performance against specific acceptance criteria. The approval is based on the established safety and effectiveness of the phototherapy treatment modality itself and the device's substantial equivalence to a predicate device.
Therefore, many of the typical study-related questions are not applicable to this submission.
- Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study was used for performance evaluation since no clinical tests were required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set was established as no clinical tests were performed.
- Adjudication method for the test set: Not applicable.
- 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. This is a phototherapy device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. Its performance is inherent in its physical and functional design.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a specific study within this submission. The ground truth for the effectiveness of phototherapy for neonatal hyperbilirubinemia is implicitly based on the long history of safe and effective use established in traditional clinical practice for this type of treatment.
- The sample size for the training set: Not applicable. No training set for an algorithm was used.
- How the ground truth for the training set was established: Not applicable.
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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 Healthcare8880 Gorman Road, Laurel, MD 20723 |
|---|---|
| Contact Person: | Thalia BrineGlobal Regulatory LeaderTelephone: 410-888-5257 |
| Fax: | 410-888-0544 |
| Date Prepared: | 29 June 2007 |
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- 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 |
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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.
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Indications for Use: The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice.
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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.
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Section B
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Non-clinical Tests: The device has been evaluated for electrical safety and has been found to conform to applicable medical device safety standards.
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Clinical Tests: None required.
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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.
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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.
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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
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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
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§ 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).