PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101

K040853 · International Hospital Supply Co. · LBI · Jun 21, 2004 · General Hospital

Device Facts

• Record ID: K040853
• Device Name: PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
• Applicant: International Hospital Supply Co.
• Product Code: LBI · General Hospital
• Decision Date: Jun 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly known as jaundice, during the newborn period in the hospital.

Device Story

The PHOENIX Neonatal Phototherapy Unit CFL 101 is a medical device designed to treat neonatal hyperbilirubinemia. It utilizes light therapy to reduce bilirubin levels in newborns. The device is intended for use in hospital environments by healthcare professionals. By exposing the infant to specific wavelengths of light, the unit facilitates the breakdown of bilirubin, aiding in the management of jaundice. The device is operated by clinical staff to provide therapeutic intervention for newborns.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Neonatal phototherapy unit; utilizes light therapy for hyperbilirubinemia treatment; classified as Class II (21 CFR 880.5700); product code LBI.

Indications for Use

Indicated for the treatment of hyperbilirubinemia (jaundice) in newborns within a hospital setting.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2004

International Hospital Supply Company C/O Ms. Angelika Scherp Submission Correspondent Business Support International Amstel 320-1 Amsterdam, NETHERLANDS, 1017AP

Re: K040853

Trade/Device Name: PHOENIX Neonatal Phototherapy Unit CFL 101 Regulation Number: 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: March 30, 2004 Received: April 12, 2004

Dear Ms. Scherp:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your betermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichuments, or to do rosses Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Mrs), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oo found to found announcements concerning your device in the Federal Register.

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Page 2 - Ms. Scherp

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DT 3 issualles of that your device complies with other requirements mean that 1127 has mace a actes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and reguirements, including, but not limited to: registration You must comply with and are reseling (21 CFR Part 801); good manufacturing practice a and listing (21 CFR Part 607), laceling (21 CFR Parts (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality is a 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) This letter will anow yourse overnment of substantial equivalence of your device to a premaired notification. THC I Drillaning on 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), IT you desire specific au roo for your we 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 may obtain 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/dsma/dsmamain.html

Sincerely yours,

Shiu-Ling Lin, Ph.D.

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): K040853

Device Name: PHOENIX Neonatal Phototherapy Unit CFL 101

Indications for Use:

The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice, during the newborn period in the hospital.

Prescription Use _ X (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)

Antin V my

Division Sian-Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _