BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1

K072097 · Medical Select, Inc. · LBI · Oct 30, 2007 · General Hospital

Device Facts

• Record ID: K072097
• Device Name: BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
• Applicant: Medical Select, Inc.
• Product Code: LBI · General Hospital
• Decision Date: Oct 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a vellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-shelf AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home.

Device Story

BiliBee LED Phototherapy System treats neonatal hyperbilirubinemia via blue light emission. Device consists of flexible LED array (470nm) housed in disposable synthetic fabric sheath. Patient placed directly on panel; no eye protection required. Powered by rechargeable 6V battery or AC/DC supply. Used in hospital or home settings by caregivers. Provides continuous phototherapy (24 hours/day) for 3 days to 3 weeks to degrade bilirubin. Audible alarm signals low battery. Benefits include portability and non-invasive treatment of jaundice.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and operating principles shared with predicate devices.

Technological Characteristics

Flexible LED array emitting blue light at 470nm; max output 60µW/nm/cm2. Dimensions: 4" x 8" x 0.4". Power: rechargeable 6V battery or AC/DC supply. Control: solid-state electronics. Disposable synthetic woven fabric sheath barrier. Audible low battery alarm.

Indications for Use

Indicated for infants diagnosed with hyperbilirubinemia (neonatal jaundice).

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

• Natus Medical, Inc. neoBLUE™ LED Phototherapy System (K022196)
• Respironics Wallaby®3 Phototherapy System (K991627)
• Medela, Inc. Bilibed® Phototherapy Unit (K984589)

Submission Summary (Full Text)

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OCT % 9 2007

## Attachment B. 510(k) Summary

| Contents: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------<br>< 1 /1 / 1 . )<br>ั<br>summarv<br> |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 16 Th<br>Number of<br>Pages: | |

# 510K Summary

| Date of Submission: | July 24, 2007 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Amy Jones<br>National Marketing Manager<br>TriE Medical, Inc.<br>120 Southcenter Ct, Suite 400<br>Morrisville, NC 27560<br>[phone] (office)<br>[e-mail] |
| Proprietary Name: | Bilibee LED Phototherapy System |
| Common Usual / Name: | Neonatal Phototherapy Device |
| Device Classification Name: | Unit, Neonatal Phototherapy |
| Classification Reference: | 21 CFR 880.5700 |
| Classification: | Class II |
| Appropriate Classification Panel: | General Hospital |
| Product Code: | LBI |
| Predicated Devices: | Natus Medical, Inc. neoBLUE™ LED Phototherapy System (K022196)<br>Respironics Wallaby®3 Phototherapy System (K991627)<br>Medela, Inc. Bilibed® Phototherapy Unit (K984589). |
| Reason for Submission: | New Device |

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#### Substantial Equivalence:

Medical Select believes that the BiliBee LED Phototherapy System is substantially equivalent to several legally marketed devices for the treatment of neonatal hyperbilirubinemia (jaundice) that use the same operating principle of delivery of light to degrade bilirubin and therefore does not raise any new safety concerns.

1 (P. 20A2)

#### Intended Use:

The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a vellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-shelf AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home.

#### Device Description:

The BiliBee LED Phototherapy System is both a battery-operated device or AC/DC regulated power that provides therapeutic light through an LED illuminator panel for the treatment of neonatal jaundice (hyperbilirubinemia). Treatment is applied by placing the patient (neonate) on the BiliBee LED Phototherapy System panel with a disposable sheath separating the child from the panel's surface. The patient's eyes do not need to be covered during treatment. Treatment is intended to be applied 24 hours a day until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Treatment time is expected to range from 3 days to 3 weeks. Phototherapy treatment of neonatal jaundice using the BiliBee LED Phototherapy System can be applied at home or in a hospital.

| overall dimensions | width ~ 4", length ~ 8", thickness ~ 0.4" |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| treatment area | width = 4", length = 6" |
| weight | light panel < 0.5 lb.<br>battery pack < 1 lb. |
| power source | removable rechargeable 6V battery. (Note that two batteries are<br>provided so that one can be recharged while the other is in use). |
| control mechanism | solid state electronics |
| light source | Flexible LED (Light Emitting Diode) array emitting blue light @<br>470nm. Distance between LEDs is .25" to 0.5", depending on<br>flexing. |
| light output | 60µW/nm/cm2 (maximum) |
| alarms | audible low battery warning |

#### BiliBee LED Phototherapy System Physical Characteristics:

#### Disposable Barrier (Sheath)

The disposable sheath consists of two pieces of synthetic woven fabric sewn together on 3 of 4 sides. It is designed to slide over the BiliBee LED Phototherapy System like a sock to serve as a barrier between the patient and the flexible LED array during treatment.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CCT & 9 2007

Medical Select, Incorporated C/O Ms. Amy Jones National Marketing Manager/ Regulatory Affairs TriE Medical, Incorporated 120 Southcenter Court, Suite 400 Morrisville, North Carolina 27560

Re: K072097

Trade/Device Name: Bilibee LED Phototherapy System Regulation Number: 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: July 24, 2007 Received: July 31. 2007

Dear Ms. Jones:

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. Jones

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 (OS) 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 yours,

Neil R.P. Ogle

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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## Attachment A. Indications for Use Statement

| Contents | Indications for Use Statement |
|-----------------|-------------------------------|
| Number of Pages | 1 |

### INDICATIONS FOR USE STATEMENT

The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-self AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home

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510(k) Number: K072497