LIGHT DRAPE

K043234 · Wrapped IN Comfort · MMP · May 25, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043234
• Device Name: LIGHT DRAPE
• Applicant: Wrapped IN Comfort
• Product Code: MMP · General, Plastic Surgery
• Decision Date: May 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

Device Story

Light Drape is a decorative accessory designed to cover the exterior of neonatal phototherapy light fixtures. It functions as a non-functional aesthetic enhancement for the device housing. It is intended for use in clinical settings where phototherapy is administered to neonates. The drape is applied by healthcare staff to the light fixture to improve its appearance. It does not interact with the light output or the patient's treatment process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a decorative drape/cover for phototherapy light fixtures. It is classified under 21 CFR 878.4370 (Product Code: MMP). No specific materials, energy sources, or software components are described.

Indications for Use

Indicated for use as a decorative cover for neonatal phototherapy light fixtures.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2005

Ms. Jane M. Getsla Wrapped In Comfort 15760 Via Sonata San Lorenzo, California 94580

Re: K043234

Trade/Device Name: Light Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: MMP Dated: April 5, 2005 Received: April 5, 2005

Dear Ms. Getsla:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becames as a mined the device is substantially equivalent (for the referenced above and have the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to de rood that in to o Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppreation (1 the Act. The general controls provisions of the Act include controls provisions of the remation, 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 If your device is classified (000 additional controls. Existing major regulations affecting (FMA), it may of subject to back adala for 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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Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT 3 issualles or a base your device complies with other requirements meall that IDA has made a deceminaresulations administered by other Federal agencies. of the Act of ally I edelui statutes and regisments, including, but not limited to: registration You must comply with an the Hec Fee b required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laboling (21 cegulation (21 CFR Part 820); and if requirements as set form in the quality brovisions (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 with anow you to begin finding of substantial equivalence of your device to a premarket nothreation. The PDF innuits 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), If you desire specific advice to: Journance 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 other general mirer general meternational and Consumer Assistance at its toll-free Division of 01628-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

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: K043234

Device Name: Light Drape (accessory to Neonatal Phototherapy Light)

Device Trade Name: Light Drape

Indications for Use

Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim D.m

of Anesthesiology, General Ho on Control, Dental De

:(2)(k) Number: K442234

Wrapped In Comfort 510(k) Application

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