(94 days)
Barrier Supreme Sterilization Wrappers are intended to be used 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 sterility of the enclosed device until used.
Barrier Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Barrier Supreme Sterilization Wrappers are made from Barrier Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric, dyed and treated with a fluoropolymer finish. 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Barrier Supreme Sterilization Wrappers:
Please Note: The provided document is a 510(k) premarket notification summary for a medical device (sterilization wrappers), not a typical AI/software medical device submission. Therefore, many of the requested fields (like sample size for test set/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable or explicitly mentioned in this type of document, as it concerns a physical product and its non-clinical performance testing.
Acceptance Criteria and Reported Device Performance for Barrier Supreme Sterilization Wrappers
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from predicate or general standards) | Reported Device Performance (Barrier Supreme Wrappers) |
|---|---|---|
| Material Strength | >20 psi (from predicate device WrapPel "T") | >50 psi (demonstrated in testing, per ASTM #D-5034-2013) * |
| Sterile Barrier | Effective sterile barrier for 30 days | Demonstrated ability to be an effective sterile barrier after 75 cycles of soiling, washing, drying, and sterilization (as sequential double wrap) |
| Use Life (Cycles) | 75 wash, dry, & sterilization cycles | Achieved 75 processing (wash, dry and sterilization) cycles |
| Linting | 3.5 (AATCC #61-1993(4A)) |
Note: The table lists ">20 psi" for the predicate in the comparative table on page 6, but the specific test description on page 5 lists ">50 psi" for the Barrier Supreme product. This indicates the Barrier Supreme product met and exceeded the general strength requirement, likely derived from the predicate or industry standards.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of wrappers tested) for each specific test (e.g., how many wrappers were subjected to 75 cycles, how many were used in the whole package challenge). However, the language implies that testing was conducted on "Barrier Supreme Sterilization Wrappers" as a product line.
- Data Provenance: The tests are non-clinical performance tests, likely conducted in a laboratory setting by the manufacturer (Standard Textile Co., Inc.) or a contracted testing facility. The document does not specify a country of origin for the data beyond the manufacturer's location in Cincinnati, Ohio, USA. The studies are by nature prospective as they are simulating real-world use conditions to determine performance before market introduction.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable to this type of device submission. The "ground truth" for a physical product like sterilization wrappers is established through objective, measurable non-clinical performance tests (e.g., tensile strength, biological indicator results, linting measurements), not through expert consensus on interpretations of data or images.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging. For physical product performance, results are typically objective measurements against a predefined standard.
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. This is a submission for a physical medical device (sterilization wrap) and does not involve AI, human readers, or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. No algorithm or AI is involved in this device.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of the Barrier Supreme Sterilization Wrappers is established through objective non-clinical performance test results. These include:
- Laboratory measurements of physical properties (e.g., strength, linting).
- Biological challenge tests (e.g., sterilization efficiency, cytotoxicity) with clear pass/fail criteria (e.g., "no growth of indicator organism," "non-toxic").
- Simulated use cycles (e.g., 75 wash, dry, and sterilization cycles) to assess durability and continued sterile barrier effectiveness.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of a physical medical device that undergoes non-clinical performance testing. Training sets are relevant for AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As there is no training set for this type of device, no ground truth was established for it.
§ 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).