(189 days)
3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.
3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.
The 3M Steri-Drape Fabric Surgical Drapes are one-piece, dual layer, single use disposable drapes with an AAMI Level 4 Liquid Barrier. The drapes are made of a blue absorbent nonwoven fabric thermally bonded to a blue protective barrier film. The drapes are intended to be placed over the patient prior to surgery and are designed to provide an absorbent sterile barrier during surgical procedures and stop fluid strike-through to protect the surgical site and patient from microbial penetration.
Steri-Drape Fabric Surgical Drapes are either provided sterile to end-users or non-sterile to kit manufacturers for further processing including EtO sterilization according to ISO 11135-1:2007
The drapes are provided in multiple sizes and shapes to meet the requirements of various clinical procedures. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes. All models utilize the same material technology.
The document describes the non-clinical performance testing and acceptance criteria for the 3M™ Steri-Drape™ Fabric Surgical Drapes to establish substantial equivalence to a predicate device (3M™ Steri-Drape™ Fabric Surgical, K031287).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Non-Clinical Performance Test | Acceptance Criteria (Predicate Performance) | Reported Device Performance (3M™ Steri-Drape™ Fabric Surgical Drape) | Substantial Equivalence Comparison |
|---|---|---|---|
| Tensile Strength (MD) | 108 N | 106 N | Substantially Equivalent |
| Tensile Strength (CD) | 70.7 N | 58 N | Substantially Equivalent |
| Burst Strength (Dry) | 225 kPa | 231 kPa | Substantially Equivalent |
| Burst Strength (Wet) | 199 kPa | 193 kPa | Substantially Equivalent |
| Resistance to Liquid Penetration | AAMI Level 4 - Pass with an AQL of 4% and RQL of 20% | AAMI Level 4 - Pass with an AQL of 4% and RQL of 20% | Substantially Equivalent |
| Linting | Pass with a Log10 (lint count) of $\le$ 4.0 | Pass with a Log10 (lint count) of $\le$ 4.0 | Substantially Equivalent |
| Particulate | Pass with an Index Particulate Matter (IPM) of $\le$ 3.5 | Pass with an Index Particulate Matter (IPM) of $\le$ 3.5 | Substantially Equivalent |
| Flammability | Class I Normal | Class I Normal | Substantially Equivalent |
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Substantially Equivalent |
| Irritation | Non-Irritating | Non-Irritating | Substantially Equivalent |
| Sensitization | Non-Sensitizing | Non-Sensitizing | Substantially Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test set. It mentions tests were conducted on the "sterilized, final finished device." The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document details non-clinical performance testing of surgical drapes, which typically relies on laboratory measurements and standardized test methods rather than expert interpretation of data like in medical imaging. Therefore, the concept of "experts establishing ground truth" in the manner of medical professionals is not applicable here. The "ground truth" is defined by the technical specifications and performance characteristics outlined in the relevant ANSI/AAMI, ASTM, ISO, and CFR standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is non-clinical laboratory testing, there is no human adjudication process involved as would be for diagnostic device performance.
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 document pertains to the performance and equivalence of surgical drapes, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" used for these tests is based on established industry standards and regulatory requirements for surgical drapes, such as:
- ANSI/AAMI PB70: 2012 (Liquid barrier performance)
- ASTM F1670-08 (Resistance to synthetic blood penetration)
- ISO 9073-3:1989 (Tensile strength and elongation)
- ISO 13938-1:1999 (Bursting strength)
- ISO 9073-10:2003 (Lint and particle generation)
- 16 CFR Part 1610 (Flammability)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2010 (Irritation and skin sensitization)
The performance of the device is assessed against the numerical and qualitative criteria specified in these standards, with the predicate device's performance serving as the benchmark for "substantially equivalent" claims.
8. The sample size for the training set
Not applicable. This document describes the testing of a 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
Not applicable. There is no training set for this type of device submission.
§ 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.