(184 days)
HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle.
The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
• One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes
The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
Halyard Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets of HALYARD* Sequential Sterilization Wrap. This allows for convenient wrapping with two sheets simultaneously. The HALYARD SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products, Inc. (ASP) STERRAD 100NX Sterilizer ULTRA™ GI Cycle.
The provided text describes the performance testing for the HALYARD* SMART-FOLD* Sterilization Wrap (H450 and H650).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Sterilant Penetration/Efficacy | ISO 14937 | ||
| AAMI TIR No 12-2010 | Achieving a 10$^{-6}$ sterility assurance level following processing in a worst-case half-cycle | Pass | |
| Performance Testing (Pre-Sterilization and Post-Sterilization) | ANSI/AAMI/ISO 11607-1 Annex B | ||
| ISO 13938-2 | |||
| ASTM D4966-12 | |||
| CPSC 1610 | Complies with the selected physical properties | Pass | |
| Maintenance of Package Integrity | ANSI/AAMI/ISO 11607-1 | ||
| ANSI/AAMI ST79 | |||
| AAMI TIR No 12-2010 | |||
| ANSI/AAMI/ISO 14937 | Maintain sterility for up to 90 days | Pass | |
| Biocompatibility | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| ISO 10993-12 | |||
| ISO 14937 | Non-cytotoxic | ||
| Non-irritating | |||
| Residual level ≤ 9100 µg/cm$^2$ | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for each test. The data provenance is not explicitly mentioned as a country of origin, nor is it stated whether the data is retrospective or prospective. These are non-clinical (laboratory) tests by their nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the tests performed are non-clinical, performance-based, and biocompatibility assessments, which rely on defined technical standards and measurements rather than expert human interpretation of complex data (like image analysis).
4. Adjudication Method
This section is not applicable for the same reasons as point 3.
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 section is not applicable. This submission is for a medical device (sterilization wrap), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI-related effectiveness assessment was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable for the same reasons as point 5.
7. The Type of Ground Truth Used
For the tests conducted, the "ground truth" is defined by the technical standards and specifications outlined in the referenced ISO, AAMI, ASTM, and CPSC documents. For instance:
- Sterilant Penetration/Efficacy: The ground truth is a sterility assurance level (SAL) of 10$^{-6}$. This is an objective measurement based on microbiological testing.
- Performance Testing: The ground truth is compliance with specified physical properties (e.g., tensile strength, tear resistance as defined by the standards).
- Maintenance of Package Integrity: The ground truth is the ability to maintain sterility for up to 90 days, which is determined through microbial barrier testing and accelerated aging studies.
- Biocompatibility: The ground truth is material properties meeting non-cytotoxic, non-irritating, and specific residual level criteria, evaluated through chemical extractions and biological assays.
8. The Sample Size for the Training Set
This section is not applicable as the device is a physical sterilization wrap and does not involve machine learning or AI models with training sets.
9. How the Ground Truth for the Training Set was Established
This section 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).