PHOTOTHERAPY LAMP

K984589 · Medela, Inc. · LBI · Apr 20, 1999 · General Hospital

Device Facts

• Record ID: K984589
• Device Name: PHOTOTHERAPY LAMP
• Applicant: Medela, Inc.
• Product Code: LBI · General Hospital
• Decision Date: Apr 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Medela's phototherapy lamp is intended for the treatment of excessive serumbilirubin concentrations in newborn babies.

Device Story

Phototherapy lamp emits light to treat excessive serum bilirubin concentrations in newborns. Used in clinical settings to reduce bilirubin levels via photo-oxidation. Operated by healthcare professionals. Device provides therapeutic light exposure to the infant; clinical decision-making based on monitoring serum bilirubin levels. Benefits include prevention of complications associated with severe neonatal hyperbilirubinemia.

Clinical Evidence

No clinical data provided; substantial equivalence based on established use of phototherapy for neonatal hyperbilirubinemia.

Technological Characteristics

Phototherapy lamp; light-based therapeutic device; Class II; Product Code LBI. Specific materials and electrical specifications not detailed in provided text.

Indications for Use

Indicated for the treatment of hyperbilirubinemia in newborn infants.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 1995

Mr. Stephen D. Smith Director of RA/QA Medela®, Incorporated P.O. Box 660 4610 Prime Parkway McHenery, Illinois 60051-7005

Re: K984589 Phototherapy Lamp Trade Name: Regulatory Class: II Product Code: LBI Dated: January 28, 1999 Received: January 29, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Smith

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamaip.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Medela's phototherapy lamp is intended for the treatment of excessive serumbilirubin concentrations in newborn babies.

Patrice Ciacente

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

510(k) Number K984587

**Prescription Use**
(Per 21 CFR 801.109)