(73 days)
Incubator Capes are designed to cover and enhance the outer appearance of an incubator.
Incubator Cover (accessory to Incubators)
The provided text is a 510(k) clearance letter from the FDA for an "Incubator Cape." This document does not contain information about acceptance criteria or a study proving device performance as described in your request.
The letter explicitly states: "we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing devices that it does not require a new study to prove its safety or effectiveness. The purpose of a 510(k) notification is to demonstrate substantial equivalence, not to provide new performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
If you have a different document that details performance studies and acceptance criteria for a medical device, please provide it, and I will do my best to extract the information you need.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three curved lines or strokes, possibly representing people or services. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Ms. Jane Getsla Wrapped In Comfort 15760 Via Sonata San Lorenzo, California 94580
Re: K040794 Trade/Device Name: Incubator Cape Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MMP Dated: March 18, 2004 Received: May 26, 2004
Dear Ms. Getsla:
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 received a or 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 approvisions 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 (1 writ), it hay of budyed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 -Ms. Getsla
Please be advised that FDA's issuance of a substantial equivalence determination does not I loase be auvrsou that 12 a determination that your device complies with other requirements mount that I Dri has made statutes and regulations administered by other Federal agencies. of the For of all - Sact's requirements, including, but not limited to: registration r ou intist comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alle fishing (21 et rear in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as sections in the quadistion 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) I ms letter wification. The FDA finding of substantial equivalence of your device to a premarket notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you donts the Office of Compliance at (301) 594-4618. 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 maj obtain Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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K0407941
Indications for Use
510(k) Number: K040794
Device Name: Incubator Cover (accessory to Incubators)
Device Trade Name: Incubator Cape
Indications for Use
Incubator Capes are designed to cover and enhance the outer appearance of an incubator.
Prescription Use _ AND/OR I reseription 000 Subpart D)
Over-The-Counter
(21 CFR 807 Su
Over-The-Counter Use __ X (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)
Am On
(Division Sign-Off) The State Orgil-Oll)
Division of Anesthesiology, General Hospital, tion Control, Dental Devices
510(k) Number: k0449794
Wrapped In Comfort 510(k) Application #K040794 Page 4 of 12
§ 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.