(142 days)
Instru-Safe ® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider.
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Instru-Safe Instrument Protection System." This document describes the device, its intended use, and lists various models. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Based on the provided text, I can only provide the following information:
Device Description:
- Trade/Device Name: Instru-Safe Instrument Protection System
- Regulation Number: 21 CFR 880.6850
- Regulation Name: Sterilization Tray
- Regulatory Class: II
- Product Code: KCT
- Manufacturer: Summit Medical Incorporated
Intended Use/Indications for Use:
"Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility."
Sterilization Validation:
The device models were validated with specified rigid containers for:
- Sterrad 100S Standard Cycle
- Sterrad 100NX Standard Cycle
Lumen Claims for Sterrad 100S Standard and Sterrad 100NX Standard Cycles:
- 4 Stainless steel lumens with 3mm inner diameter × 400mm length (All appropriate sized models listed in Table 1 with the exception of IN-2681)
- 2 Stainless steel lumens with 3mm inner diameter × 200mm length
- 1 Stainless steel lumens with 3mm inner diameter × 200mm length (IN-2681)
- 1 Stainless steel lumens with 1mm inner diameter × 65mm length
Missing Information:
The document does not contain any of the following information explicitly related to acceptance criteria or a study proving the device meets them:
- 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 their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. (This device is a physical sterilization tray, not an AI software, so this section is not applicable).
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done. (Not applicable for a physical device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set. (Not applicable for a physical device, as there is no "training set" in the AI/ML sense).
- How the ground truth for the training set was established. (Not applicable).
To obtain the missing information, one would need to review the actual submission documents (e.g., test reports, validation studies) that were provided to the FDA by Summit Medical Incorporated for K140289. The letter provided here is merely the FDA's decision letter based on that submission.
§ 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).