(113 days)
Both the Auto Suture* Equipment Covers™ and the Sterile INTENDED USE: Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.
Both the Auto Suture* Equipment Covers™ and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of various sizes and shapes of polyethylene covers which are positioned on surgical equipment. The covers are used to maintain the surgeons sterile field and as an aid in the clean up of equipment after surgery.
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Acceptance Criteria and Study for the Auto Suture® ABBI® System Equipment Cover
Based on the provided document, the "Auto Suture® ABBI® System Equipment Cover" is a relatively simple device – an equipment cover designed to maintain a sterile field and aid in equipment cleanup after surgery. The performance claims focus on its integrity as a barrier.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tear Resistance | "provides an acceptable fluid barrier which is resistant to puncturing, tearing and fluid penetration" |
| Puncture Resistance | "provides an acceptable fluid barrier which is resistant to puncturing, tearing and fluid penetration" |
| Fluid Penetration Resistance | "provides an acceptable fluid barrier which is resistant to puncturing, tearing and fluid penetration" |
| Material Thickness | Not explicitly stated as "acceptable" but "Testing consisted of an evaluation of... material thickness." Presumably, it met an internal standard. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the performance testing. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. The "ground truth" here is objective physical properties (tear strength, puncture resistance, fluid impermeability), not expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set:
This information is not applicable. As stated above, the performance is measured by objective physical tests, not subjective expert judgment that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices, not for simple equipment covers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, in a conceptual sense. The performance testing described (tear resistance, puncture resistance, fluid penetration resistance, material thickness) represents the standalone performance of the physical device itself without human intervention affecting the measurement of those properties. There's no "algorithm" in this context.
7. The Type of Ground Truth Used:
The ground truth used was based on objective, physical measurements of the material properties of the equipment cover. This is derived from standardized testing methods for properties like tear strength, puncture resistance, and fluid barrier performance.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical product, not a software algorithm that requires a "training set" in the machine learning sense. The materials are likely engineered and tested based on established quality control processes, not a data-driven training paradigm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8. The "ground truth" for the material selection and manufacturing process would be based on established engineering standards, material science, and manufacturing specifications to ensure the product meets its intended physical properties.
§ 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.