(184 days)
Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.
Light Drape (accessory to Neonatal Phototherapy Light)
The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Light Drape." This document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.
The letter explicitly states: "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... You may, therefore, market the device." This indicates that the FDA has found the device to be substantially equivalent to a predicate device, which means it likely does not require extensive new clinical studies or detailed performance metrics to be established for market approval.
The "Indications for Use" section (Image/page/2) merely states: "Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures." This is a functional description, not a performance claim that would necessitate specific acceptance criteria or a study with the details requested.
Therefore, I cannot populate the requested information from the provided document.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the agency's mission to protect the health of all Americans.
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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Page 2 - Ms. Getsla
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 (240) 276-0115. 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 (301) 443-6597 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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
Page 4 of 13 #K043234
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.