BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

K040068 · Ohmeda Medical · FMZ · Apr 16, 2004 · General Hospital

Device Facts

• Record ID: K040068
• Device Name: BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
• Applicant: Ohmeda Medical
• Product Code: FMZ · General Hospital
• Decision Date: Apr 16, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 know as neonatal jaundice, 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 phototherapy for neonatal hyperbilirubinemia and transillumination for clinical procedures. In phototherapy mode, illuminator transmits blue light (425-475 nm) through fiberoptic cable to blanket applied to neonate; maximizes skin contact. In transillumination mode, white light is transmitted through fiberoptic cable tip to assist in vascular access or diagnostic visualization (pneumothoraces/hydrocephalus). Used in NICUs, nurseries, or home settings; operated by clinicians or caregivers. Output intensity is adjustable. Benefits include effective jaundice treatment and improved visualization for clinical procedures. Device is non-sterile; disposable covers available for light-emitting pad.

Clinical Evidence

No clinical or animal testing was performed. The manufacturer states that phototherapy for neonatal hyperbilirubinemia is a well-established clinical practice. Evidence consists of extensive bench testing to verify performance specifications and safety.

Technological Characteristics

System comprises an illuminator box, fiberoptic cable, and light-emitting blanket. Phototherapy mode utilizes blue light (425-475 nm); transillumination mode utilizes white light. Light output: 21-50 +35% -25% µW/cm²/nm. Device is AC powered. Not sterile; cleaning/disinfection per manual; disposable covers available. No software-based algorithms or connectivity features described.

Indications for Use

Indicated for neonates with hyperbilirubinemia (neonatal jaundice) requiring phototherapy in hospital or home settings. Also indicated for transillumination procedures (e.g., locating venipuncture sites, detecting pneumothoraces or hydrocephalus) in neonates.

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 High Output (original) (K993712)

Submission Summary (Full Text)

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Ko40068

## APR 1 6 2004

## Ohmeda Medical BiliBlanket Plus High Output (67,5 yW/cm2/nm max) Phototherapy System (modified)

### 510(k) Summary

#### Submitter Information

Alberto F. Profumo, RAC (also contact person) 8880 Gorman Road Laurel, MD 20723 Tcl. 410-888-5204

Summary prepared on December 29, 2003

#### Device Name(s)

Classification Names:

- Neonatal Phototherapy Unit .
- AC powered Transilluminator .

Common Names:

- Phototherapy Lamp .
- t Transilluminator

Proprietary Name:

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

The BiliBlacker Plus High Outpur Phototherapy System is substantially equivalent to the following, legally marketed product:

Ohrneda - BiliBlanket Plus High Ourput (original) 510(k) No. K993712

#### Indications for Use

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

> BiliBlanket Plus High Output 510(k) Summary Page 1

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#### Product Description

The BiliBlankel 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 b) detecting 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 (42.5 - 475 nm), is transmitted from the illuminator to the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket.

The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the tip 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.

#### Description of Modification

Light output level increased from 18-45 ± 25% µW/cm²/nm to 21-50 +35% -25% µW/cm²/nm

#### Performance Data

Since treatment of neonatal hyperbilirulinemia 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 BillBlanket 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 should not be sterilized. Cleaning and disinfecting instructions can be found in the Operation and Maintenance Manual. Disposable covers for the light cmitting pad are available and instructions for their use are provided in the manual.

> BiliBlanket Plus High Output 510(k) Summary Page 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 6 2004

Dr. Alberto F. Profumo, R.A.C. Director, Quality and Regulatory Systems Ohmeda, Medical 8880 Gorman Road Laurel, Maryland 20723

Re: K040068

Trade/Device Name: Biliblanket Plus High Output Phototherapy System Regulation Number: 880.5400, 886.1945 Regulation Name: Neonatal Incubator, Transilluminator Regulatory Class: II Product Code: FMZ, HJM Dated: January 12, 2004 Received: January 20, 2004

Dear Dr. Profumo:

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 - Dr. Profumo

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be actived that 12 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rice of any I with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n from at 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 gencral information on your responsibilities under the Act from the micr Sound 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,

Qur

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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K040068

Page 1 of I

510(k) Number (if known):

K 04/0068

Device Name: BiliBlankst Plus High Output Phototherapy System

Indications For Use:

The BiliBlanket Plus High Output (67.5 µW/cm²/nm maximum )Phototherapy System provides I he BillBlaiket I lust Ingh Output (01:5 | in binemia, commonly know as neonatal jaundice, in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

William M. Burden Rha. Chris. Lerr

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

510(k) Number: K040068

Prescription Use (Per 21 CFR 801.109)

OR

Over- The Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)