(40 days)
Convertors® Surgical drapes are made from natural and synthetic materials that are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contaminated. The drape is a single use disposable device intended for repackaging and sterilization before use.
This single use product is a disposable non-sterile drape designed to be repackaged and sterilized prior to use. This product maybe sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health Inc.
The exception for Steam sterilization is that the Trilaminate drapes, Trilaminate and Optima drapes with fluid control pouches, cannot undergo steam sterilization. Steam sterilization may cause the polyethylene in the film layer on the Trilaminate drape and the polyethylene in the fluid control pouch on these drapes to melt. Ethylene oxide is the only method of sterilization for these drapes.
The Trilaminate drapes are comprised of an outer and inner layer of polyolefin-based nonwovens with an inner layer of polyolefin-based film.
The Optima drapes are comprised of a wood pulp/polyester spunlace fabric
Several drapes have clear polyethylene side panels on either end of the drapes. Some of the drapes have clear fluid control pouches.
The provided text describes a 510(k) premarket notification for surgical drapes. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the efficacy of a new device through extensive clinical studies. Therefore, the information typically requested in your prompt regarding acceptance criteria, study sizes, expert consensus, and ground truth in the context of diagnostic or AI-based devices is not directly applicable here.
However, I can extract the relevant information from the document that touches upon performance and testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility Tests: | |
| Cytotoxicity | Found to be acceptable for the intended use |
| Sensitization | Found to be acceptable for the intended use |
| Primary Skin Irritation | Found to be acceptable for the intended use |
| Sterilization Compatibility: | |
| Moist Heat Sterilization | Compatible with ANSI/AMMI/ISO 11134 & 11135 methods. Exception: Trilaminate drapes and drapes with fluid control pouches cannot undergo steam sterilization as polyethylene may melt. |
| Ethylene Oxide Sterilization | Compatible with ANSI/AMMI/ISO 11134 & 11135 methods. Only method for Trilaminate drapes and drapes with fluid control pouches. |
| Intended Use: | Functions as a protective patient covering to isolate surgical incision site from contamination. |
| Material Properties: | Materials were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the biocompatibility tests (cytotoxicity, sensitization, primary skin irritation) or for the material properties evaluation.
- Data Provenance: Not applicable in this context. The testing was likely performed on material samples of the drapes themselves, not on external data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to the evaluation of surgical drapes. The "ground truth" here is established by standardized testing protocols and acceptable ranges defined by international standards (e.g., ISO 10993).
4. Adjudication Method for the Test Set
- Not applicable as this is not a study requiring expert adjudication of results but rather objective laboratory testing conforming to established standards.
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 a medical device (surgical drape), not an AI-powered diagnostic or decision-support system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
- The "ground truth" for the performance claims of the drapes is based on adherence to international standards and recognized test methods. Specifically:
- ISO 10993 Part-1 "Biological Evaluation of Medical Devices" for biocompatibility tests (cytotoxicity, sensitization, primary skin irritation).
- ANSI/AMMI/ISO 11134 & 11135 for sterilization validation and routine control (Moist Heat and Ethylene Oxide).
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a physical medical device.
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AUG 0 1 2006
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SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate and Optima Drapes
| Manufacturer: | Cardinal Health Inc.One Butterfield TrailEl Paso, Texas 79906 | |
|---|---|---|
| Regulatory Affairs Contact: | Lavenia Ford | |
| Telephone: | (847) 785-3323 | |
| Date Summary Prepared: | June 19, 2006 | |
| Common Name: | Convertors® Trilaminate and Optima Drapes | |
| Classification: | Class II per 21CFR § 878.4370 | |
| Predicate Device: | Convertors® Trilaminate and Optima Drapes | |
| Description: | The Trilaminate drapes are comprised of an outerand inner layer of polyolefin-based nonwovenswith an inner layer of polyolefin-based film.The Optima drapes are comprised of a woodpulp/polyester spunlace fabricSeveral drapes have clear polyethylene sidepanels on either end of the drapes. Some of thedrapes have clear fluid control pouches. |
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Cardinal health
1500 Waukegan Road
McGaw Park, IL 60085
tel 847.785.3323
fax 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Trilaminate Drapes
Intended Use:
The Convertors® Trilaminate and Optima 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.
The single use product is a disposable non-sterile drape is designed to be repackaged and sterilized prior to use. The product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health, Inc.
Substantial Equivalence: The Convertors® Trilaminate and Optima Drapes are substantially equivalent to the Convertors® Trilaminate and Optima drape materials in that:
- the intended use is the same
- the performance attributes are similar
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Summary of testing:
materials used in the fabrication of the All | Convertors® Trilaminate and Optima 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 primary skin irritation. These materials were also tested in accordance with industry-recognized test methods and were found to be acceptable for the intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 1 2006
Ms. Lavenia Ford Manager, Regulatory Affairs Cardinal Health, Incorporated Medical Products Manufacturing 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re: K061762
Trade/Device Name: Convertors® Trilaminate and Optima Spunlace Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 21, 2006 Received: July 24, 2006
Dear Mr. Ford:
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 cnactment 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. Ford
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
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Indications for Use 510(k) Number (if known): K Olo 1762
Device Name: Convertors®Trilaminate and Optima Spunlace Drapes
Indications for Use:
Convertors® Surgical drapes are made from natural and synthetic materials that are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contaminated. The drape is a single use disposable device intended for repackaging and sterilization before use.
This single use product is a disposable non-sterile drape designed to be repackaged and sterilized prior to use. This product maybe sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health Inc.
The exception for Steam sterilization is that the Trilaminate drapes, Trilaminate and Optima drapes with fluid control pouches, cannot undergo steam sterilization. Steam sterilization may cause the polyethylene in the film layer on the Trilaminate drape and the polyethylene in the fluid control pouch on these drapes to melt. Ethylene oxide is the only method of sterilization for these drapes.
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|
| ------------------------------------------------- | -------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sign-Off | |
|---|---|
| of Anesthesiology, General Hospital, | |
| on Control. Dental Devices | |
| Number | 611262 |
§ 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.