(179 days)
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.
Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135
The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.
The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.
The provided text describes a 510(k) submission for the IMC Surgical Drape and focuses on establishing substantial equivalence to predicate devices. It does not present a study designed to evaluate the device's performance against specific acceptance criteria in the context of clinical or diagnostic accuracy. Instead, it outlines the device's characteristics and compares them to predicate devices, referencing performance tests for material properties.
Therefore, many of the requested details about acceptance criteria and study design are not applicable to the information provided.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance characteristics and test methods for material properties, demonstrating that the IMC Surgical Drape "Meets Intended use" for each. These are implicitly the acceptance criteria for those specific material properties, equating to being "acceptable for the intended use" or meeting the specified standard.
| Performance Characteristics | Test Method | Acceptance Criteria (Implicit) | Reported Device Performance (IMC Surgical Drape K100991) |
|---|---|---|---|
| Flammability of Clothing Textiles | 16 CFR Part 1610 | Class I | Class I |
| Hydrostatic Pressure | AATCC 127-2008 | Meets Intended Use (as per predicate) | Meets Intended use |
| Impact Penetration | AATCC 42-2007 | Meets Intended Use (as per predicate) | Meets Intended use |
| Determine Lint and Other particles | ISO 9073-10 | Meets Intended Use (as per predicate) | Meets Intended use |
| General Tensile Testing of Fabric | ASTM D5034-2009 | Meets Intended Use (as per predicate) | Meets Intended use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the performance tests. The document only states that "These materials were tested." It does not detail how many samples of each material were tested.
- Data Provenance: Not specified. It's likely that the testing was conducted by the manufacturer or a contracted lab, but the location or whether it was retrospective/prospective is not mentioned.
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)
- Not Applicable. This device is a surgical drape, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for material properties is determined by standardized test methods and their defined pass/fail criteria (e.g., Class I for flammability, meeting "intended use" for hydrostatic pressure).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is a material property evaluation, not an interpretation task requiring adjudication by experts.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Material Standard Compliance: For the performance characteristics listed, the "ground truth" is adherence to established industry standards and test methods (e.g., 16 CFR Part 1610 for flammability, AATCC 127-2008 for hydrostatic pressure, ISO 10993-x for biocompatibility). The claim is that the materials "were found to be acceptable for the intended use" based on these tests.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
In summary: The provided 510(k) summary for the IMC Surgical Drape focuses on demonstrating substantial equivalence to predicate devices through comparisons of material composition, design features, and performance characteristics as measured by established material testing standards. It is not an AI-driven or diagnostic device, and therefore, many of the requested details related to "acceptance criteria" in a clinical/diagnostic context and associated study methodologies (like expert review, sample sizes for test/training sets, MRMC studies) are not pertinent to this 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.