(26 days)
The Convertors®Surgical Drapes are devices 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 drapes are comprised of a base layer of nonwoven material to which the absorbent reinforcement structure is laminated.
The acceptance criteria and the study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. | "The Convertors®Surgical Drapes are devices 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." (Page 0) |
| Biocompatibility: Meet cytotoxicity and primary skin irritation standards. | "The biocompatibility test performed were cytotoxicity and primary skin irritation. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." (Page 1) |
| General Performance Attributes: Similar to currently marketed Allegiance drapes. | "The performance attributes are similar." (Page 1) |
2. Sample Size Used for the Test Set and Data Provenance
The provided documents do not contain information on specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) for Convertors® Surgical Drapes. The testing described is general and refers to adherence to "industry recognized test methods."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "industry recognized test methods" for biocompatibility and general performance, implying standardized protocols rather than expert consensus on specific cases.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (surgical drapes) and the type of testing described (biocompatibility, general performance), a traditional adjudication method for a "test set" as understood in AI/diagnostic device studies is unlikely to be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant to the evaluation of surgical drapes.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical product (surgical drapes), not a software algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be established through adherence to industry recognized test methods for biocompatibility (cytotoxicity and primary skin irritation) and general performance attributes. This likely involves laboratory measurements and assessments against established chemical and physical standards.
8. Sample Size for the Training Set
No information regarding a "training set" or its sample size is provided. This concept is typically relevant for machine learning algorithms, not for physical medical devices like surgical drapes.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
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Image /page/0/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a cluster of small squares arranged in a cross shape. The word is in black and the background is white. The image appears to be a logo or brand name.
a Cardinal Health company
6 2002 NOV
1500 Waukegan Road McGaw Park, IL 60085
tel 847.785.3311 fax 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors®Surgical Drapes
| Sponsor: | Allegiance Healthcare Corporation1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
|---|---|
| Contact Person: | Sharon Nichols |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | October, 2002 |
| Common Name: | Convertors®Surgical Drapes |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors Surgical Drapes |
| Description: | The drapes are comprised of a base layer ofnonwoven material to which the absorbentreinforcement structure is laminated. |
| Intended Use: | The Convertors®Surgical Drapes are devicesmade of natural or synthetic materials intended tobe used as a protective patient covering, such asto isolate a site of surgical incision from microbialand other contamination. |
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K 023425
Image /page/1/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white. The font is bold and slightly italicized.
a Cardinal Health company
1500 Waukegan Road McGaw Park, IL 60085
tel 847.785.3311 fax 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors®Surgical Drapes
| Substantial Equivalence: | The Convertors® Surgical drapes aresubstantially equivalent to the currently marketedAllegiance drapes in that:- the intended use is the same- the performance attributes aresimilar |
|---|---|
| Summary of testing: | The biocompatibility test performed were cytotoxicityand primary skin irritation. These materials also weretested in accordance with industry recognized testmethods and were found to be acceptable for the |
intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 6 2002
Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road Building WM McGaw Park, Illinois 60085
Re: K023425
Trade/Device Name: Convertors® Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: October 10, 2002 Received: October 11, 2002
Dear Ms. Nichols:
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 Federal Register.
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Page 2 – Ms. Nichols
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy J. Ulatowski
Tim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small dots. The font of the word "Allegiance" is slightly slanted to the right, giving it a dynamic appearance.
Cardinal Health company
1500 Waukegan Road
McGaw Park, IL 60085
tel 847.785.3311
fax 847.785.2461
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications for Use
K 0 2 3 4 25
Convertors®Surgical Drapes
The Convertors®Surgical Drapes are devices 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
29
Prescription Use (Per 21 CFR 801.109)
or
Over-The Counter Use
Qum S. Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: K023425
§ 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.