(101 days)
SafePASS Sterilization Pouches are intended for use as sterility barrier packaging in the steam sterilization of various medical devices, kits, instruments, etc.
A SafePASS Sterilization Pouch is 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.
SafePASS Sterilization Pouches are pouches made of previously 510(k) cleared sterilization wrap material. SafePASS Sterilization Pouches are provided to the end user in a partially folded condition, representing the first step of a patented folding system. After inserting the item or items to be sterilized, the pouch is closed by making the final two folds as described in the instructions for use. Once closed in this method and sterilized, the pouch allows convenient aseptic presentation of the enclosed device by following that section of the instructions for use.
SafePASS Sterilization Pouches are provided in both single and double thickness versions.
Safe PASS Sterilization Pouches are manufactured using the same material that is used to produce the SupraShield Sterilization Wrap product.
The difference is how the finished device is presented to the end user. For a SafePASS Sterilization Pouch, a sheet of material is folded over and sealed along two edges forming a pouch. This pouch then has a portion of the open end folded concentrically back over itself, thereby forming a cuff. From this point, the user inserts the item or items to be sterilized and closes the pouch by making the final two folds as instructed in the directions for use. The SupraShield Sterilization Wrap is provided to the end user as a flat sheet with the user folding it around the item to be sterilized as desired.
In some situations it is desired that two layers of sterilization wrap be used. For those situations SafePASS Sterilization Pouches will be available in both a single thickness and a double thickness version.
The provided documentation states that "This section is not required for this submission because substantial equivalence is based on intended use and device characteristics and specifications, and not on an assessment of performance data." This indicates that a study demonstrating that the device meets acceptance criteria was not part of this 510(k) submission.
Therefore, I cannot provide the requested information for the following points as they are dependent on a performance study that was not submitted:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The submission's basis for substantial equivalence is primarily on the device's intended use and its characteristics/specifications, which are stated to be similar or identical to a legally marketed predicate device (SupraShield hospital sterilization wrap, 510(k) number K921243). The key difference highlighted is the presentation of the device to the end-user (pre-folded pouch vs. flat sheet).
§ 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).