(262 days)
This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. Towel is further used as a fluid-absorbing towel during surgery or as a device to dry hands of the O.R. personnel.
This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. towel is also to be used for the absorption of fluids, including blood and body fluids or as a general use towel for drying hands.
The Indus Textiles O.R. Towels are made of 100% cotton that have been pre-washed and delinted. The towels are offered sterile and non-sterile and are available in blue.
Here's an analysis of the provided text regarding the Indus Textiles O.R. Towels, focusing on acceptance criteria and the supporting study, while addressing your specific questions.
Based on the provided documents (510(k) summary), the "device" in question is a surgical towel. The acceptance criteria and "study" are related to demonstrating substantial equivalence to predicate devices, primarily through physical and performance testing, rather than clinical trials involving human subjects, multi-reader studies, or complex AI algorithms.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For a surgical towel, "acceptance criteria" are typically defined by performance standards for physical properties. The document doesn't explicitly state quantitative acceptance criteria (e.g., "absorptive capacity must be > X ml"), but it lists the tests performed and the standards used, implying that meeting the requirements of these standards constitutes acceptable performance. The "reported device performance" is implicitly that the device passed these tests, thus demonstrating substantial equivalence to its predicates.
| Acceptance Criteria (Implied by Test and Standard) | Reported Device Performance |
|---|---|
| Absorptive Capacity (per IST 10.1 and ASTM D1117) | Met requirements of standards |
| Imbibition Test (per AATCC 8-1996 – Saline Crocking) | Met requirements of standard |
| Flammability (per 16 CFR 1610.4) | Met requirements of standard |
| Tearing Resistance (per ASTM D1424-96) | Met requirements of standard |
| Grab Tensile (per ASTM D1682) | Met requirements of standard |
| Biocompatibility (post-gamma and EtO sterilization) | Investigated and documented (implicitly acceptable as no adverse findings are noted) |
Notes:
- The document states: "The material and blue dye are identical to the predicate devices listed above. The toxicology and biocompaibility have been thoroughly investigated and documented with these predicate devices." This implies that for toxicology and general biocompatibility, the predicate's established safety profile is leveraged, with additional testing initiated for the specific sterilization methods used for the new device.
- The "reported device performance" is a high-level summary. The detailed results (e.g., specific absorption values, tear strength in newtons) are not provided in this 510(k) summary but would have been in the full submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each physical test. These tests typically involve multiple samples to ensure statistical validity according to the respective ASTM, IST, and AATCC standards.
- Data Provenance: The tests were performed by or for Indus Textiles, Inc. (the manufacturer). The provenance is therefore the manufacturer's internal testing. The country of origin of the data is not explicitly stated but would typically be where the manufacturer's testing facilities are located or where contract labs were commissioned (likely within the U.S. or a country with comparable regulatory standards given the FDA submission). This is retrospective testing performed on the finished product to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to this type of device and study. The "ground truth" for a surgical towel's performance is established by objective physical and chemical testing against recognized standards, not by expert consensus or clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or image-based diagnostic AI evaluations where expert interpretation is involved. For physical product testing, results are typically objective measurements against fixed criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices (especially in radiology) where human readers interpret medical data, and the effect of AI assistance on their performance is evaluated. A surgical towel does not involve human interpretation of data for diagnosis.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This concept applies to AI algorithms. The "device" here is a physical product (a towel), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" (or benchmark for performance) used for the Indus Textiles O.R. Towels is based on objective physical and chemical testing standards, such as ASTM, IST, AATCC, and CFR regulations. These standards define the accepted methods and performance parameters for textile products. The performance of the predicate devices also serves as a baseline for substantial equivalence.
8. Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of a physical surgical towel and its associated performance testing. Training sets are used to develop and train AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
§ 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.