(264 days)
CDB Hospital ® Sterilization Wraps intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
· Pre-vacuum Steam 270°F/132°C for 4 minutes
· Advanced Sterilization Products (ASP) STERRAD® 100S
· Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
• STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
- · Validated for dry time of 30 minutes for 44gsm.
- · Validated for dry time of 30 minutes for 70gsm.
- · Validated maximum weight of 6 lbs for 44 gsm.
- · Validated maximum weight of 15 lbs for 70 gsm.
• All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below:
VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES Advanced Sterilization Products (ASP) STERRAD® System and Cycle
Intended Load for 100NX Standard Cycle:
Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: · An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel stainless steel lumens.
Intended Load for 100NX Flex Cycle:
One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle).
Intended Load for 100NX Express Cycle:
Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens.
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems:
• All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below.
· CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.
VALIDATED STERIS AMSCO® V-PRO CYCLES STERIS Amsco® V-PRO Cycle
Intended Load for Lumen Cycle:
Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter.
Intended Load for Non Lumen Cycle:
Non lumened reusable metal and non-metal medical devices.
Intended Load for Flexible Cycle:
Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:
1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter.
2.) An additional tray containing non-lumened medical devices.
The CDB Hospital ® Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The CDB Hospital ® Sterilization Wraps' SMS fabric is made of 100% polypropylene, blue color, and are separated into two distinct product offerings:
CDB Hospital® Sterilization Wraps, 44gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard health care practices.
CDB Hospital® Sterilization Wraps, 70gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
CDB Hospital® Sterilization Wraps are composed of polypropylene with the addition of light blue and dark blue pigment and an antistatic treatment. The CDB Hospital ® Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically. This product is over-the-counter use.
The provided text is a 510(k) summary for a sterilization wrap, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.
Below is a table describing the acceptance criteria and reported device performance from the provided document where information is available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Item) | Test Standard Methods | Reported Device Performance |
|---|---|---|
| Basis Weight | ASTM D3776/D3776M-20 | Meets requirement |
| Tearing Strength | ASTM D5587-15(2019) | Meets requirement |
| Lint Generation | ISO 9073-10:2003 | Meets requirement |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-23 | Meets requirement |
| Hydrostatic Pressure | AATCC Test Method 127-2018 | Meets requirement |
| Air Permeability | ASTM D737-18 | Meets requirement |
| Sterilant penetration - BI incubation | ANSI/AAMI/ISO 11138-7 | Meets requirement |
| Maintenance of Package Sterility - Sterility Test | USP-NF 2022 | Meets requirement |
| Maintenance of Package Sterility - Microbial Aerosol Challenge | ASTM F1608-21 | Meets requirement |
| Biocompatibility - Cytotoxicity and Irritation | ISO 10993-5:2009, ISO 10993-23:2021 | Meets requirement |
| Pre-Vacuum Steam Sterilization (Dry Time 44gsm) | (Implicitly, 30 minutes) | Validated for 30 minutes |
| Pre-Vacuum Steam Sterilization (Dry Time 70gsm) | (Implicitly, 30 minutes) | Validated for 30 minutes |
| Pre-Vacuum Steam Sterilization (Max Weight 44gsm) | (Implicitly, 6 lbs) | Validated for 6 lbs |
| Pre-Vacuum Steam Sterilization (Max Weight 70gsm) | (Implicitly, 15 lbs) | Validated for 15 lbs |
| ASP STERRAD® 100S Sterilization (Max Weight) | (Implicitly, 10.7 lbs) | Validated for 10.7 lbs |
| Maintenance of Sterility | (Implicitly, 180 days) | 180 days |
Study Details:
- 2. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the document mentions "a series of nonclinical tests." The provenance is internal testing by Comercializadora Brever, S.A. de C.V. as stated: "all testing refers to the same product(s) that are manufactured by Comercializadora Brever, S.A. de C.V."
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical device (sterilization wrap), and "ground truth" in the context of expert medical interpretation is not relevant here. The 'ground truth' for these tests would be the established scientific and engineering standards and methods.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing of a sterilization wrap.
- 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): The 'ground truth' for this type of device is established through documented standard test methods (e.g., ASTM, ISO, AATCC, USP-NF) and validated sterilization cycles.
- 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.
Additional Information from the "Summary of Non-Clinical Testing":
The study described the performance data for the CDB Hospital Sterilization Wrap, which included a series of nonclinical tests "associated with specific unique codes." These tests were conducted to demonstrate conformance with microbial barrier properties. The testing encompassed:
- Low Temperature Efficacy
- Steam Efficacy
- Shelf Life (up to 180 days under standard conditions)
- Aerosol Challenge
- Biocompatibility / Cytotoxicity (referencing ISO 10993 parts 5 and 23)
The key finding from these tests was that "All results met the defined acceptance criteria." The purpose of these tests was to validate the wrap's ability to maintain the sterility of package contents after sterilization, across different sterilization methods and for a specified shelf life.
§ 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).