(64 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 sing e layer of degradable spunlaced nonwoven fabric with various reinforcements. The fiber is water soluble in temperatures above approximate v 190 degrees F.
The provided document is a 510(k) summary for a medical device (Convertors® Surgical Drapes) and does not contain information about the acceptance criteria and study proving device performance as typically understood for AI/ML-based medical devices or diagnostic tools.
Instead, this document describes a traditional medical device (surgical drapes) and focuses on demonstrating substantial equivalence to a predicate device based on:
- Same Intended Use: The drapes are for isolating surgical sites from contamination.
- Similar Performance Attributes: This is assessed through biological qualification safety tests and industry-recognized test methods.
- Materials: The drapes are made of a single layer of degradable spunlaced nonwoven fabric.
The "Summary of testing" section details the following:
- Biocompatibility tests:
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous reactivity
- These tests were performed "as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'."
- Materials were also tested "in accordance with industry recognized test methods" and found acceptable.
Therefore, an attempt to fill out the requested table and answer the questions based on the provided text will show many fields as "Not Applicable" or "Not Provided" because the context is for a physical medical device, not a software algorithm or diagnostic tool.
Table of Acceptance Criteria and Reported Device Performance (based on provided text):
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | The intended use is the same as the predicate device (Isolyser Enviroguard Drapes): "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." |
| Performance Attributes | Similar to the predicate device. |
| Biocompatibility | Materials evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1. |
| - Cytotoxicity | Found acceptable. |
| - Sensitization | Found acceptable. |
| - Irritation/Intracutaneous Reactivity | Found acceptable. |
| Material Testing | Materials tested in accordance with industry recognized test methods. |
| - General Acceptability | Found acceptable for the intended use. |
Detailed Answers to Questions (based on provided text):
-
A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are implied by the tests performed to demonstrate substantial equivalence and safety. The "reported device performance" is that it met the requirements of these tests.
-
Sample size used for the test set and the data provenance:
- Not Provided. The document mentions "All materials used... were evaluated" but does not specify the sample size of materials or subjects for the biological tests.
- Data Provenance: Not specified, but generally, ISO 10993 tests are conducted in a controlled laboratory setting.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for biocompatibility tests is typically determined by laboratory measurements and established biological safety parameters, not expert consensus on diagnostic images or results.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As explained above, this isn't a diagnostic device with human adjudicators.
-
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 a physical surgical drape, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance, in terms of safety and biocompatibility, is established through standardized ISO 10993-1 biological evaluation methods and industry-recognized test methods. This involves laboratory assays and physical/chemical characterization against established safety thresholds.
-
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of a physical medical device demonstrating substantial equivalence through material testing.
-
How the ground truth for the training set was established:
- Not Applicable. See point 8.
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JAN 1 2 2000
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is slightly slanted to the right, giving it a dynamic appearance.
cGaw Park. Illinois 60085-6787 X- 847 785 2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Drapes
Manufacturer:
Allegiance Healthcare Corporation One Butterfield Trail El Paso, Texas 79906
- Regulatory Affairs Contact:
Sharon Robbins 1500 Waukegan Road MPWM McGaw Park, IL 60085 (847) 785-3311
Telephone:
September, 1999 Date Summary Prepared:
Common Name: Convertors® Surgical Drapes
Class II per 21CFR § 878.4370 Classification:
Predicate Device: Isolyser Enviroguard Drapes.
Description: The drapes are comprised of a sing e layer of degradable spunlaced nonwoven fabric with various reinforcements. The fiber is water soluble in temperatures above approximate v 190 degrees F.
Intended Use:
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.
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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a cluster of dots arranged in a cross-like shape. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 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 IsolyserEnviroguard drapes in that: |
|---|---|
| -------------------------- | ---------------------------------------------------------------------------------------------------------------- |
- the intended use is the same
- the performance attributes are similar
- All materials used in the fabrication of this Summary of testing: Convertors® Surgical drapes were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Ms. Sharon Robbins Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re : K993795
Convertors® Surgical Drapes Trade Name: Requlatory Class: II Product Code: KKX Dated: November 8, 1999 November 9, 1999 Received:
Dear Ms. Robbins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Paqe 2 - Ms. Robbins
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, Timotiny A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 347.473.1500 FAX: 847.785.2461
510(k) Number (if known):
Device Name:
Convertors® Surgical Drapes
Unknown
Indications For Use:
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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) or
Over-The Counter Use
unter Use X
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(Division Sign-Off) Division of Dental, Infection Con and General Hospi 510(k) Numbe
116
§ 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.