(100 days)
This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
Surgical Drapes including various sizes and configurations of table covers, flat drape sheets, Lap drapes, cardiovascular drapes, head & neck drapes, general use drapes, cysto drapes, c-section drapes, orthopedic drapes and specialty drapes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the International Medsurg Connection Surgical Drape:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993 - Part 5 | Meets standard requirements | Pass (implied) |
| Skin Irritation | ISO 10993 - Part 10 | Meets standard requirements | Pass (implied) |
| Skin Sensitivity | ISO 10993 - Part 11 | Meets standard requirements | Pass (implied) |
| Systemic Toxicity | ISO 10993 - Part 11 | Meets standard requirements | Pass (implied) |
| Flammability | 16 CFR Part 1610 | Meets standard requirements | Pass (implied) |
| Hydrostatic Pressure | AATCC 127 | Meets standard requirements | Pass (implied) |
| Impact Penetration | AATCC 42 | Meets standard requirements | Pass (implied) |
| Lint | IST 160.1 | Meets standard requirements | Pass (implied) |
| Tensile Strength | ASTM D5034 | Meets standard requirements | Pass (implied) |
Note: The document explicitly lists the tests and the standards they adhere to, implying that meeting these standards constitutes the acceptance criteria. The phrase "All material used in the fabrication of the IMC Surgical Drapes were evaluated for" followed by the list of tests strongly suggests that the device met the requirements of these standards. However, specific quantitative performance data for each test (e.g., actual hydrostatic pressure achieved) is not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on:
- Sample size used for the test set.
- Data provenance (e.g., country of origin, retrospective or prospective).
The tests listed are material property tests rather than clinical studies on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of testing described. The tests are laboratory-based material property assessments against established industry standards (ISO, AATCC, ASTM, CFR). Ground truth in this context is defined by the specifications and methodologies within these standards, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable. As discussed above, the tests are objective laboratory evaluations against material standards, not analyses requiring expert 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 and is not relevant for this type of device (surgical drapes). This device is a physical barrier, not an AI or diagnostic tool that would involve human readers interpreting data.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical product, not a software algorithm. The tests performed are for material properties.
7. The Type of Ground Truth Used
The ground truth used for these tests is scientific and engineering standards and specifications. For instance:
- ISO 10993 (Biocompatibility): Standards define acceptable levels of cytotoxicity, irritation, and sensitization based on established biological safety principles.
- 16 CFR Part 1610 (Flammability): Federal regulations specify flammability performance requirements for textiles.
- AATCC (Textile Chemistry): Standards provide methodologies and criteria for properties like hydrostatic pressure and impact penetration.
- ASTM (Materials Testing): Standards outline methods for evaluating tensile strength.
The "ground truth" is adherence to these widely accepted and documented industrial standards.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device (surgical drapes), not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as 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.