(35 days)
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are 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
- Gravity Steam 250°F/121°C for 30 minutes
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 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.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, 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.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.
The provided text describes a medical device, Reliance® Solo and Reliance® Tandem Sterilization Wraps, and its performance data to demonstrate substantial equivalence to a predicate device. However, it does not contain information about an AI/ML powered device, nor does it detail acceptance criteria and a study in the context of AI/ML performance metrics.
The document is a 510(k) premarket notification for a sterilization wrap, which is a physical product, not a software or AI/ML device. Therefore, the requested information regarding sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth types, and training set details are not applicable to this submission.
The document does include some "performance data" in a general sense, but this refers to the physical properties and functionality of the sterilization wrap (e.g., maintaining sterility, dry times, material compatibility, microbial barrier properties, toxicological properties) and its compatibility with various sterilization methods.
Therefore, I cannot populate the table or provide the requested details because the input document does not pertain to 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).