(91 days)
Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
The provided text describes a medical device called "Advance Medical Designs, Inc Equipment Slush Drape" and its 510(k) submission (K053495). The document focuses on establishing substantial equivalence to a predicate device, rather than reporting on a study validating an AI-powered device. Therefore, many of the requested elements pertaining to AI studies (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or cannot be extracted from this document.
However, I can provide information about the acceptance criteria and the studies mentioned for the slush drape device's material performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Viral Penetration (ASTM Method F 1671) | The material used in this product has been tested to ASTM Method F 1671. |
| Flammability (16 CFR Part 1610) | The material used in this product has been tested to 16 CFR Part 1610. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The tests performed are laboratory material tests, not expert-based clinical evaluations.
4. Adjudication method
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used
For the material performance tests:
- Viral Penetration (ASTM Method F 1671): The "ground truth" would be the standard established by the ASTM F 1671 method for viral penetration, indicating whether the material resists viral passage according to the test protocol's criteria.
- Flammability (16 CFR Part 1610): The "ground truth" would be the standard established by 16 CFR Part 1610, indicating whether the material meets the flammability requirements outlined in the regulation.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI-powered device.
9. How the ground truth for the training set was established
- Not applicable.
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ATTACHMENT 2
16 ...
Substantial Equivalence 510(k) Summary
Advance Medical Designs, Inc Equipment Slush Drape
To Whom It May Concern:
Date: 02/27/2006
Submitter/ Contact Name and Address William Slevin Advance Medical Designs, Inc. 1241 Atlanta Industrial Drive Marietta, GA 30066
Tel: (770) 422-3125
Trade Name: Advance Medical Designs, Inc Equipment Slush Drape
Classification Name: Drape, Surgical
Common/ Usual Name: Equipment Slush Drape
Predicate Legally Marketed Device: MicroTek Equipment Drapes
Intended Use:
Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
Description of the Device:
The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
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:
Performance
The material used in this product has been tested to ASTM Mcthod F 1671 for Viral Penetration and to 16 CFR Part 1610 for Flammability.
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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The symbol in the center consists of three curved lines that appear to be stylized representations of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 16 2008
Mr. William Slevin Ouality Assurance Regulatory Affairs Advance Medical Designs, Incorporated 1241 Atlanta Industrial Drive Marietta, Georgia 30066
Re: K053495
Trade/Device Name: Equipment Slush Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 10, 2006 Received: March 13, 2006
Dear Mr. Slevin:
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 Eederal Register.
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Page 2 -- Mr. Slevin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 Division of 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/industry/support/index.html.
Sincerely yours,
Cluts
Chin Lin, Ph.D.
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 (if known): 长 053495
Device Name: Slush Drape
Indications For Use:
Advance Medical Designs Slush Drapes are equipment covers used to cover a variety of surgical and non surgical equipment in various clinical settings. It is to be used in General and Endoscopic surgery for use with Saline.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K053495 |
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§ 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.