BILISOFT PHOTOTHERAPY SYSTEM

K053568 · Lumitex, Inc. · LBI · Apr 17, 2006 · General Hospital

Device Facts

• Record ID: K053568
• Device Name: BILISOFT PHOTOTHERAPY SYSTEM
• Applicant: Lumitex, Inc.
• Product Code: LBI · General Hospital
• Decision Date: Apr 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BiliSoft Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. The Bili-Soft Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Device Story

Mobile phototherapy device for neonatal hyperbilirubinemia; delivers high-intensity blue light via LEDs to fiber optic pad. System comprises light source box and fiber optic pad (two sizes). LEDs emit narrow-band blue light; no significant UV or IR energy. Features include over-temperature indicator with automatic LED shutoff and hour meter. Used in hospital or home; operated by clinicians or caregivers. Disposable covers prevent cross-contamination. Light therapy reduces bilirubin levels; benefits patient by treating jaundice without excessive warming or UV exposure.

Clinical Evidence

No clinical data. Bench testing only. Treatment of neonatal hyperbilirubinemia with phototherapy is a well-established clinical practice.

Technological Characteristics

LED-based light source; fiber optic pad delivery. Universal voltage 90-264 VAC. Over-temperature protection with automatic shutoff. Hour meter. Disposable hypoallergenic, latex-free pad covers. Non-sterile. No UV or IR emission.

Indications for Use

Indicated for neonates with hyperbilirubinemia (neonatal jaundice) in hospital or home settings.

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

• Ohmeda Medical BiliBlanket Plus High Output Phototherapy System
• Natus neoBLUE LED Phototherapy
• Medela Bili Phototherapy Unit

Submission Summary (Full Text)

{0}------------------------------------------------

K053568

1 of 2

# BiliSoft Phototherapy System

APR 1 7 2006

### 510(k) Summary

#### Submitter Information

Lumitex, Inc. 8443 Dow Circle Strongsville, OH 44136 Phone : [phone] Fax : [phone] Contact Person : Jeff Williams, VP Engineering Email: [e-mail] Date Prepared : September 30th, 2005

#### Device Names

Classification name: Unit, Neonatal Phototherapy Common Name: Phototherapy light, Bili Light Trade Name: BiliSoft™ Phototherapy System

#### Predicate Device Information

The BiliSoft phototherapy System is substantially equivalent to the following, legally marketed products:

- -Ohmeda Medical, a division of Datex-Ohmeda- BiliBlanket Plus High Output Phototherapy System
- -Natus - neoBLUE LED Phototherapy
- Medela Bili Phototherapy Unit -

#### Indications for Use

The Bili-Soft Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. The Bil-Soft Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

#### Product Description

The Bili-Soft Phototherapy System is a mobile phototherapy device that delivers high intensity blue light using blue light emitting diodes (LEDs) that transmit light to a fiber optic pad.

The device consists of a light source box and one of two different size fiber optic pads. The light source operates in a single light intensity mode and includes features such as an over temperature indicator with automatic LED shutoff and an hour meter to indicate life. The light source has an automatic universal voltage selection of 90-264 VAC at 47-63 Hz.

Fiber optic pad covers are made of a clear, medical grade, hypoallergenic and latex-free material. The smaller fiber optic pad emits an average output of 35 µW/cm-/nm through a typical snuggly/pad cover, and the larger fiber optic pad emits an average output of 50 µW/cm /nm through a typical snuggly/pad cover. Disposable fiber optic pad covers are available to help comfortably position the baby on the fiber optic pad and to prevent cross contamination of bodily fluids between infants.

{1}------------------------------------------------

K035568

2 of 2

LED's have very little light degradation over their lifetime with proper use and care. During normal operating conditions the device is expected to last for approximately 10,000 hours. Once the LED's have reached the end of their life a replaceable LED module is available for purchase. LED's emit no appreciable energy in the ultraviolet (UV) region of the spectrum, so there is no concern for UV exposure to the infant. In addition, LED's emit no significant energy in the infrared (IR) region of the spectrum; therefore there is no concern for excessive warming of the infant due to IR energy.

#### Performance Data

Since the treatment of neonatal hyperbilirubinemia with phototherapy is a well establish clinical practice, clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product has been subject to extensive bench testing, and the requirement of 21 CFR 820, Subpart C - Design Controls - were satisfied.

#### Sterilization Information

The BiliSoft Phototherapy system is not intended to be supplied sterile. Cleaning and disinfecting instructions can be found in the Operation and Maintenance Manual.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2006

Mr. Jeff Williams Vice President of Engineering Lumitex, Incorporated 8443 Dow Circle Strongsville, Ohio 44136

Re: K053568

Trade/Device Name: BiliSoft Phototherapy System Regulation Number: 880.5700 Regulation Name: Neonatal phototherapy unit Regulatory Class: II Product Code: LBI Dated: March 16, 2006 Received: March 17, 2006

Dear Mr. Williams:

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 cither 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 - Mr. Jeff Williams

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/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Thiu Lin, Ph. 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: BiliSoft Phototherapy System

## Indications for Use:

The BiliSoft Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. The BiliSoft Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Untung A. m.

n Kiogy General Hospit

5356s

Page 1 of 1