(35 days)
Standard Supreme Sterilization Wrappers are intended to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain steriity of the enclosed device until used.
Standard Supreme Sterilization Wrappers will function as a sterlization wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterily sterilization wraps that are intended to be sterlized and processed by heath care facilities and/or contract sterilization/laundry companies.
Standard Supreme Sterilization Wrappers are made from Standard Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric and then dyed. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.
This document describes the Standard Supreme Sterilization Wrappers, a medical device used to enclose other medical devices for sterilization and maintain sterility. The information provided is from an FDA 510(k) premarket notification summary (K172207).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| Sterile Barrier Function (Whole Package Challenge & Shelf Life) | Standard Supreme Sterilization Wrappers demonstrated their ability in these tests to be an effective sterile barrier after 75 cycles of soiling, washing, drying and sterilization when used as a sequential double wrap for textile packs. |
| Strength (through 75 wash, dry and sterilization cycles) | ASTM #D-5034-2013 >50 psi. (Note: Substantial Equivalence Table states ">20 psi" for both, but the performance section states ">50 psi" for the device, implying it exceeds the predicate's strength.) |
| Linting | 3.5. |
| Wrapping Practices (Oblong and Envelope folds for Fabric Packs) (Intended Use) | Yes, validated for use on textile packs. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for each individual test (e.g., how many wrappers were tested for strength, linting, or sterile barrier). It only describes the tests performed and the outcomes.
The data provenance is retrospective, as this is a 510(k) summary submitted to the FDA, detailing testing that has already been completed. The country of origin of the data is not specified, but the applicant (Standard Textile Co., Inc.) is based in Cincinnati, Ohio, USA, suggesting the testing was likely conducted in the US or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical performance tests (e.g., ASTM standards, cytotoxic tests, sterilization efficacy tests). These types of tests typically rely on established protocols and laboratory measurements rather than human expert consensus for "ground truth" in the same way a diagnostic imaging study would.
4. Adjudication Method for the Test Set
This information is not applicable to the non-clinical performance tests described. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) to establish ground truth or resolve discrepancies. The performance tests here appear to be objective measurements against established criteria.
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 information is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and effects on human reader improvement with AI are irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (a sterilization wrapper), not an algorithm or software. There is no algorithm-only performance to assess.
7. The Type of Ground Truth Used
The ground truth used for these tests appears to be:
- Established industry standards and test methods: e.g., ASTM #D-5034-2013 for strength, AATCC #61-1993(4A) for colorfastness, MEM Elution for cytotoxicity.
- Microbiological challenge studies: For sterilization efficiency/penetration, the "no growth of the indicator organism" serves as the ground truth for effective sterilization.
- Physical and material property measurements: Performance against specified thresholds for linting, strength, and use life.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The development and testing involve manufacturing and material science, not algorithm training.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the same reasons as point 8.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).