(85 days)
For use in hospitals, clinics, laboratories or other facilities where absorbent toweling may be used.
For use as absorbent toweling for cleanup, preparation or squaring off a surgical incision site. For use during surgical procedures to provide extra absorption of blood and body fluids.
For use a) to dry off surgeons, doctor or nurses hands after scrubbing, (b) to square off a surgical incision site, and (c) to absorb blood or body fluids during a surgical procedure.
Not intended for use as surgical packing.
Operating Room Towels are a 100% cotton woven towel. The are generally available in white (undyed), green or blue colors. O.R. Towels have been used throughout the Healthcare industry for a variety of purposes. These absorbent towels are utilized for hand drying, cleanup, and also for squaring off the surgical incision site, and to provide increased absorbency of blood and bodily fluids.
The provided document describes the 510(k) premarket notification for "Sterile O.R. Towels" by International Medsurg Connection. This submission is for a medical device that is a commodity product (surgical drapes/towels) and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices already on the market, primarily through physical performance characteristics and biocompatibility testing, rather than a clinical study involving human readers or sophisticated algorithms.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity | Met USP test requirements for cytotoxicity (all three colors tested). |
| - Primary Skin Irritation | Acceptable. |
| - Dermal Sensitization | Acceptable. |
| Physical Performance: | |
| - Tear Strength | Tested per ASTM D5034. Results showed substantial equivalence to legally marketed devices. |
| - Tensile Strength | Tested per ASTM D1424 (Note: Standard withdrawn Jan 1995). Results showed substantial equivalence to legally marketed devices. |
| - Absorbency | Tested per USP. Results showed substantial equivalence to legally marketed devices. |
| General Characteristics: | |
| - Weight | Similar to predicate devices (minor differences may occur). |
| - Dimension | Similar to predicate devices (minor differences may occur). |
| - Size | Similar to predicate devices (minor differences may occur). |
| - Color | Generally available in white (undyed), green, or blue. Must be colorfast. |
| - Thread Count | Similar to predicate devices (minor differences may occur). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for the biocompatibility or physical performance tests (e.g., how many towels were tested for tear strength, absorbency). It only states that "testing" was done.
- Data Provenance: Not specified, but given the context of a 510(k) submission in the US, it's implied the testing was conducted either internally by International Medsurg Connection or by a contracted lab, with the results provided to the FDA. The tests are standard industry tests (USP, ASTM).
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 question is not applicable to this device. For a sterile O.R. towel, "ground truth" is established through standardized laboratory testing (e.g., chemical assays for cytotoxicity, physical measurements for strength and absorbency) rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The testing for O.R. towels involves direct measurement against established standards.
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
- This question is not applicable to this device. This is a commodity medical device (surgical towel), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to this device. This is not an algorithmic or software-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of these surgical towels is based on established industry standards and tests:
- Biocompatibility: USP (United States Pharmacopeia) test requirements for cytotoxicity, and standard methods for Primary Skin Irritation and Dermal Sensitization.
- Physical Performance: ASTM (American Society for Testing and Materials) standards for a Tear Strength (ASTM D5034) and Tensile Strength (ASTM D1424), and USP standards for Absorbency.
8. The sample size for the training set
- This question is not applicable to this device. As a traditional medical product and not an AI/ML system, there is no "training set."
9. How the ground truth for the training set was established
- This question is not applicable to this device. There is no training set for this type of medical 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.