(49 days)
The Convertors® Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
These drapes will be composed of nonwoven fabrics adhesively laminated to a synthetic polymer film. The film is a finely embossed blended polyethylene construction. The drapes also have clear polyethylene side panels on either end of the drapes.
The provided text describes a 510(k) summary for "Convertors® Trilaminate Drapes," a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel diagnostic AI product might.
Therefore, many of the requested categories for AI-based device evaluation are not applicable or cannot be extracted from this document, as it concerns a physical medical drape.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (based on text) | Reported Device Performance (based on text) |
|---|---|---|
| Biocompatibility | ISO 10993 Part-1 "Biological Evaluation of Medical Devices" evaluation for cytotoxicity, sensitization, and intracutaneous reactivity. | All materials used "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Hydrostatic Head | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Impact Penetration | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Synthetic Blood Penetration | ASTM 1670-1995 standards for resistance to penetration by synthetic blood. | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Viral Penetration | ASTM 1671-1995 standards (specifically mentioning Phi X174, a bacteriophage, often used as a substitute for viruses in penetration testing). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Grab Tensile | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Basis Weight | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Flammability | Class 1 flammability standard. | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for each test mentioned (e.g., how many drapes were tested for synthetic blood penetration). The data provenance is not described as it would be for clinical data (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based material testing rather than clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for material properties is established by the results of standardized laboratory tests, not by expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance claims cited in the document is the adherence to and successful completion of standardized industry test methods and biological qualification safety tests, as outlined by ISO 10993 Part-1 and various ASTM standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI model.
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JUL 10 1998
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate Drapes
| Manufacturer: | Allegiance Healthcare CorporationConvertors® OperationsOne Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Sharon RobbinsAllegiance Healthcare Corporation1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | May 1998 |
| Common Name: | Convertors® Trilaminate Drapes |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors® Drape Materials |
| Description: | These drapes will be composed of nonwovenfabrics adhesively laminated to a syntheticpolymer film. The film is a finely embossedblended polyethylene construction. The drapesalso have clear polyethylene side panels oneither end of the drapes. |
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Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road AcGaw Park. Illinois 60085-6787 847.473.1500 AX: 847.785.2461
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate Drapes
The Convertors® Trilaminate Drapes are devices Intended Use: intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The Convertors® Trilaminate Drapes are Substantial Equivalence:
substantially equivalent to the Convertors® drape materials in that:
-
the intended use is the same
-
the performance attributes are similar
Summary of testing:
All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as in in ISO 10993 Part-1 "Biological outlined Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity. sensitization, and intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods for hydrostatic head. impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 (ASTM 1671-1995), Grab Tensile, Basis Weight, and flammability, Class 1. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.
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XIII. SAMPLE
A prototype drawing of a drape has been provided (enclosed) to visually assist with the review. (See Appendix K).
KIT CERTIFICATION XIV.
This submission is for drapes only. This submission is not for a kit or tray. As with the predicate device, these drapes will be placed in kits and trays that are already cleared through the premarket notification process or are exempt per the Convenience Kit Guidance dated 5/97 which allow drapes to be placed in kits and trays.
21 CFR 807.95 -CONFIDENTIALITY XIV.
Allegiance Healthcare Corporation regards its intent to market the Convertors® drape material as confidential commercial information. We have not divulged this intent to market information to anyone other than Allegiance employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 1998
Ms. Sharon Robbins ·Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, Illinois 60085-6787
K981818 Re : Convertors® Trilaminate Drapes Trade Name: Requlatory Class: II Product Code: KKX Dated: May 21, 1998 Received: May 22, 1998
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Robbins
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing 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 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a cluster of dots arranged in a diamond shape. The word is slightly slanted to the right, giving it a dynamic appearance. The overall impression is one of strength and stability.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 17.473.1500 FAX: 847.785.2461
Page 1 of 1
510(k) Number (if known):
Unknown
Convertors® Trilaminate Drapes
Indications For Use:
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Device Name:
The Convertors® Trilaminate Drapes are devices 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)
1
Prescription Use (Per 21 CFR 801.109) or
Over-The-Counter Use X
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number
§ 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.