LULLABY

K071828 · Ge Healthcare Clinical Systems · LBI · Aug 6, 2007 · General Hospital

Device Facts

• Record ID: K071828
• Device Name: LULLABY
• Applicant: Ge Healthcare Clinical Systems
• Product Code: LBI · General Hospital
• Decision Date: Aug 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Lullaby™ Phototherapy System treats neonatal hyperbilirubinemia; consists of freestanding lamp delivering specific wavelength light to neonate positioned below. Used in clinical settings by trained clinicians. Device provides phototherapy to reduce bilirubin levels; benefits patient by treating jaundice. No complex algorithms or software; operates as standard phototherapy unit.

Clinical Evidence

No clinical data. Bench testing only; device evaluated for electrical safety and conformance to applicable medical device safety standards.

Technological Characteristics

Freestanding lamp phototherapy unit; delivers specific wavelength light. Conforms to electrical safety standards. Design/development conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485.

Indications for Use

Indicated for treatment of neonatal hyperbilirubinemia (neonatal jaundice) in neonates. For professional use by trained clinicians only.

Regulatory Classification

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.

Predicate Devices

• Phoenix Neonatal Phototherapy Unit CFL 101 (K040853)

Submission Summary (Full Text)

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Traditional 510(K) Premarket Notification GE Healthcare Lullaby™ Phototherapy System

# 5. 510(K) Summary

K071828

## 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<br>8880 Gorman Road, Laurel, MD 20723 |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Person: | Thalia Brine<br>Global Regulatory Leader<br>Telephone: [phone] |
| Fax: | 410-888-0544 |
| Date Prepared: | 29 June 2007 |

- 2. 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 |

#K040853

4. 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.

5. Indications for Use: The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice.

6. 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

1. Non-clinical Tests: The device has been evaluated for electrical safety and has been found to conform to applicable medical device safety standards.

2. Clinical Tests: None required.

3. 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 [phone]. 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 [phone] or [phone] 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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