← Product Code [MMP](/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP) · K040794 # INCUBATOR CAPE (K040794) _Wrapped IN Comfort · MMP · Jun 10, 2004 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MMP/K040794 ## Device Facts - **Applicant:** Wrapped IN Comfort - **Product Code:** [MMP](/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP.md) - **Decision Date:** Jun 10, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4370 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Pediatric ## Intended Use Incubator Capes are designed to cover and enhance the outer appearance of an incubator. ## Device Story Incubator Cape is a fabric cover designed to fit over an infant incubator. It functions as a decorative accessory to enhance the aesthetic appearance of the incubator unit. It is intended for use in clinical settings where incubators are utilized. The device is applied manually by hospital staff or caregivers. It does not interface with the incubator's electronic or life-support functions. The primary benefit is the improvement of the visual environment for patients and families within the clinical setting. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Fabric-based cover designed for external placement on infant incubators. Non-powered, passive accessory. No electronic components, software, or specialized materials specified. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MMP/K040794](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MMP/K040794) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com