(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.
§ 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.