BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

K993712 · Ohmeda Medical · FMZ · Nov 9, 1999 · General Hospital

Device Facts

• Record ID: K993712
• Device Name: BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
• Applicant: Ohmeda Medical
• Product Code: FMZ · General Hospital
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly knowas neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

Device Story

Device consists of an illuminator box, fiberoptic cable, and blanket; provides two modes: phototherapy and transillumination. Phototherapy mode transmits blue light (400-550 nm) via fiberoptic cable to blanket for patient contact to treat neonatal hyperbilirubinemia. Transillumination mode transmits white light via fiberoptic cable to assist clinicians in NICUs/nurseries with venipuncture, pneumothorax detection, or hydrocephalus assessment. Operated by healthcare professionals in hospital or home settings. Device output (light) facilitates clinical treatment of jaundice or visualization for diagnostic/procedural support. Benefits include non-invasive jaundice management and improved visibility for neonatal procedures.

Clinical Evidence

Bench testing only. No clinical or animal testing performed as phototherapy for neonatal hyperbilirubinemia is a well-established clinical practice.

Technological Characteristics

Illuminator box with fiberoptic cable and blanket. Phototherapy mode: blue light (400-550 nm). Transillumination mode: white light. Non-sterile device. No software or electronic processing described.

Indications for Use

Indicated for neonates with hyperbilirubinemia (neonatal jaundice) requiring phototherapy in hospital or home settings; optional transillumination for neonates to assist in vascular access or detection of pneumothoraces/hydrocephalus.

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• Ohmeda - BiliBlanket Plus (original)
• PEP - Ultra BiliLight
• Medela - BiliBed

Submission Summary (Full Text)

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X993712

# Ohmeda Medical BiliBlanket Plus High Output

## 510(k) Summary

#### Submitter Information

Alberto F. Profumo, RAC (also contact person) 9065 Guilford Road Columbia, MD 21046-1801 Tel. [phone] Summary prepared on November 2, 1999

#### Device Name(s)

Classification Names:

- . Neonatal Phototherapy Unit
- AC- powered Transilluminator ●

Common Names:

- Phototherapy Lamp .
- . Transilluminator

Proprietary Name:

- BiliBlanket Plus High Output Phototherapy System .
#### Predicate Device Information

The BiliBlanket Plus High Output Phototherapy System is substantially equivalent to the following, legally marketed products:

- . Ohmeda - BiliBlanket Plus (original)
- . PEP - Ultra BiliLight
- . Medela - BiliBed

#### Indications for Use

The BiliBlanket Plus High Output 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. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

#### Product Description

The BiliBlanket Plus High Output Phototherapy System has two modes of operation:

- phototherapy, used for the treatment of hyperbilirubinemia; and a)
- transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting b) pneumothoraces or hydrocephalus.

In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (400 - 550 nm), is transmitted from the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket.

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The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces. Transilluminators have been used, and are being used, in NICUs and nurseries all over the world. Their intended use and user familiarity are well established.

#### Performance Data

Since treatment of neonatal hyperbilirubinemia with phototherapy is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied.

#### Assessment of Technological Characteristics

The technological characteristics of the BiliBlanket Plus High Output Phototherapy System are similar to those of the predicate devices and do not raise new safety or effectiveness issues.

#### Sterilization Information

The BiliBlanket Plus High output Phototherapy System is not intended to be sterilized. Cleaning and disinfecting instructions can be found in the Operation and Maintenance Manual.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov - 9 1999

Alberto F. Profumo, R.A.C. Director, Product Assurance Ohmeda Medical 9065 Guilford Road 21046-1801 Columbia, MD

Re : K993712 Ohmeda Medical-BiliBlanket Plus High Output Trade Name: Phototherapy System Regulatory Class: II Product Code: FMZ November 2, 1999 Dated: November 3, 1999 Received:

Dear Mr. Profumo:

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 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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Profumo

obligation you might have under sections 531 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 asbeing 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 diaqnostic 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" (21 CFR 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/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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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510(k) Number (if known):

K9937/2

Device Name: BiliBlanket Plus High Output Phototherapy System

Indications For Use:

The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly knowas neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span></span> ✓ |
|------------------------------------------|-----------------|
|------------------------------------------|-----------------|

OR

| Over- The Counter Use | _________________ |
|--------------------------|-------------------|
| (Optional Format 1-2-96) | |

________________________________
(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | K993712 |
|---------------|---------|
|---------------|---------|