(164 days)
The intended use of the ENDODRAPE™ Upper Endoscopy Drape is to protect patients, staff and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.
The Vortek Surgical ENDODRAPE™ Upper Endoscopy Drape is a single use, disposable covering intended for use in non-sterile surgical and diagnostic procedures. The ENDODRAPE™ Upper Endoscopy Drape consists of a non-woven surgical drape measuring 38" x 54" (97cm X 137cm), similar to other surgical drapes currently being marketed. As with the predicate colonoscopy drape, the ENDODRAPE™ Upper Endoscopy Drape is intended to protect patients, staff, and equipment from bodily secretions present during non sterile endoscopic procedures, with the only variation in size and configuration to provide optimal protection for upper gastrointestinal endoscopic procedures. The ENDODRAPE™ Upper Endoscopy Drape consist of materials commonly used for medical drape manufacturing including commercially available non-woven surgical drape fabric, Krayton, Velcro, LDPE, medical grade tapes, SMS, medical grade adhesives, hot melt, cold glue. The drape is intended for non-sterile use by the end-user and is supplied in individual heat sealed polybags.
The provided text describes the ENDODRAPE™ Upper Endoscopy Drape and its substantial equivalence to a predicate device, focusing on physical, biocompatibility, and liquid barrier properties. It does not describe an AI/ML powered device, therefore no information is available for certain sections of your request.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Test Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Weight | ASTM D3776 | Identical to predicate | Identical |
| Grab Tensile Strength | ASTM D5034 | Identical to predicate | Identical |
| Water Impact | INDA IST 80.3 | Identical to predicate | Identical |
| Water Hydrostatic | INDA IST 80.4 | Identical to predicate | Identical |
| Surface Wetting Spray | INDA IST 80.1 (range 0-100) | Identical to predicate | Identical |
| Alcohol Repellency | INDA IST 80.6 (range 0-10) | Identical to predicate | Identical |
| Flame Retardency (rated Class I) | 16 CFR Part 1610.4 | Identical to predicate | Identical |
| Cytotoxicity (MEM Elution) | ISO 10993-1:2003 | Identical to predicate | Identical |
| Skin Irritation | ISO 10993-1:2003 | Identical to predicate | Identical |
| Skin Sensitivity | ISO 10993-1:2003 | Identical to predicate | Identical |
| AAMI Liquid Barrier Classification | AAMI PB 70:2003, Level 2 | Identical to predicate (Level 2) | Identical (Level 2) |
Study Proving Device Meets Acceptance Criteria:
A "Non-Clinical Performance (Bench Testing)" study was conducted. This testing covered "Physical, Mechanical, Liquid Barrier Penetration and Biocompatibility" in accordance with applicable industry recognized test methods. The study found the ENDODRAPE™ Upper Endoscopy Drape to be "acceptable for its intended use and identical to the predicate device." The primary method for proving acceptance was comparison to a legally marketed predicate device (ENDODRAPE™ Surgical and Diagnostic Procedure Drape used in colonoscopy). Since the new device demonstrated identical performance across all tested properties to the predicate, it was deemed substantially equivalent for its intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the bench testing.
The data provenance is from bench testing carried out by Vortek Surgical, LLC. No country of origin for the data is explicitly mentioned beyond the company's US location (Indianapolis, IN). The data is retrospective in the sense that it's a comparison to an already marketed predicate device and likely represents testing performed on a sample batch of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is physical and biocompatibility bench testing, not a diagnostic study involving human interpretation or ground truth established by experts in that context. The "ground truth" here is objective measurements against established standards and comparison to a predicate device's known performance.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is physical and biocompatibility bench testing, which involves objective measurements against standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study relates to diagnostic performance with human readers, which is not relevant for a surgical drape.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical surgical drape, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Established industry standards and test methods: ASTM, INDA IST, 16 CFR, ISO 10993-1, AAMI PB 70.
- Performance of a legally marketed predicate device: The ENDODRAPE™ Surgical and Diagnostic Procedure Drape (K070406). The performance of the new device was evaluated against the established performance of this predicate device across various physical and biological properties.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of physical product testing for a surgical drape, as it's not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this 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.