(27 days)
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- · Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
- · Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
- Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
- Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
- The recommended hydrogen peroxide vapor sterilization cycle is :
- · Standard Cycle of STERRAD® 100S
- Standard cycle and Advanced cycle of STERRAD® NX
- · Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
- · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX
The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:
- Standard Cycle of STERRAD® 100S
- inside diameter ≥ 1 mm and length ≤ 125 mm
- inside diameter ≥ 2 mm and length ≤ 250 mm
- Standard cycle of STERRAD® NX
- · Single channel stainless steel lumens with:
- Inside diameter ≥ 1 mm and length ≤ 150 mm
- Inside diameter ≥ 2 mm and length ≤ 400 mm
- · Single channel PE/PTFE tubing with:
- Inside diameter ≥ 1 mm and length ≤ 350 mm
- Advanced cycle of STERRAD® NX
- · Single channel stainless steel lumens with:
- Inside diameter ≥ 1 mm and length ≤ 500 mm
- · Single PTFE lumen tubing with:
- Inside diameter ≥ 1 mm and length ≤ 1000 mm
- · Single channel PE/PTFE flexible endoscopes with:
- Inside diameter ≥ 1 mm and length ≤ 850 mm
- Standard cycle of STERRAD® 100NX
- · Single channel stainless steel lumens with:
- Inside diameter ≥ 0.7 mm and length ≤ 500 mm
- Single channel PE/PTFE instruments with:
- Inside diameter ≥ 1 mm and length ≤ 1000 mm
- Flex cycle of STERRAD® 100NX
- Single channel PE/PTFE flexible endoscope with:
- Inside diameter ≥ 1 mm and length ≤ 850 mm
- Lumen Cycle of V-PRO® maX
△ Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
△ Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: - Single channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and
The device is made from porous material printed chemical indicator thermally sealed to a plastic film, additionally Self-Seal has medical double side tape.
They are divided according to porous material to paper pouch and Tyvek pouch. Paper Pouch are constructed from uncoated medical paper and plastic film; it can be used with steam and EO sterilization. Tyvek Pouch are constructed from an uncoated Tyvek and plastic film, , it can be used with hydrogen peroxide sterilization.
The device is preformed sterile barrier systems, sealed 2 sides (roll for left and right) or 3 sides(pouch for left, right and top). The remaining edges can be Heat-Sealed or Self-Sealed to form a sealing system. The Self-Seal pouch permits sealing of the pouch without Heat-Sealing equipment, whereas the Heat-Sealable pouches must be Heat-Sealed prior to the cycle.
The pouches and rolls are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions. The medical devices are inserted into Pouches or rolls and sealed.
The devices contain chemical process indicator intended to demonstrate that the device has been exposed to the steam, EO and vapor hydrogen peroxide Sterilization.
The provided text describes the regulatory clearance for "Safe Secure Sterilization Pouches and Rolls" and details non-clinical testing performed to establish its substantial equivalence to a predicate device. It is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not present in this document.
The document focuses on the physical and chemical performance of sterilization pouches, not on an algorithm's diagnostic or predictive capabilities.
However, I can extract the general acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard or Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seal Width | Ruler | More than 8mm | Pass |
| Seal Strength | ASTM F88/F88M | Pre Sterilization: ≥ 2N/15mm | |
| Post Sterilization: | |||
| Steam: ≥ 1.5N/15mm | |||
| EO: ≥ 1.2N/15mm | |||
| H2O2: ≥ 2.0N/15mm | Pass | ||
| Dye Penetration | ASTM F1929 | No Channels with Dye penetration. | Pass |
| Peeling Open | Peeling open and visual | No broken paper or film | Pass |
| Chemical Indicator Color Change | ISO 11140-1 | Meets the requirements of Guidance for Industry and FDA Staff | Pass |
| Sterilant Penetration | ISO 11138-1, ISO 11737-2, ISO 22441 (Half cycles were used to validate the cycle.) | The positive control group had bacterial growth, the negative control group had no growth, and the experimental group had no growth. | Pass |
| Maintenance of Package Integrity | Expiry date Validation Test; Conducted the expiry date testing as real-time aging method. | The device performance shall meet the requirements of maintenance of package integrity. | |
| Paper Pouch: | |||
| after Steam sterilization: 12 months. | |||
| after EO sterilization: 24 months. | |||
| Tyvek Pouch: | |||
| after hydrogen peroxide sterilization: 24 months. | Pass | ||
| Shelf Life | Shelf Life Validation Test; Conducted the shelf life testing as real-time aging method. | The device performance shall meet the requirements of shelf life. | |
| Paper Pouch: 5 years before Sterilization | |||
| Tyvek Pouch: 2 years before Sterilization | Pass | ||
| Biocompatibility | ISO 10993-5 | Non-cytotoxic. | Pass |
Points 2-9 are not applicable/available based on the provided text, as this document pertains to a physical medical device (sterilization pouches) and its physical and chemical properties, not a software-based AI/ML medical device.
- 2. Sample sized used for the test set and the data provenance: Not applicable. Testing involves physical units of pouches and rolls. The data provenance is laboratory testing rather than patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements and established standards (e.g., integrity, strength, color change), not expert consensus on interpretations of complex data like medical images.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established engineering and materials science standards for sterile barrier systems (e.g., seal strength, dye penetration for integrity, microbial ingress for sterility maintenance, chemical color change for indicator function).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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).