(160 days)
Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days.
A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together.
Here's a breakdown of the acceptance criteria and study information for the Carr Sterilization Container System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Carr Container Performance |
|---|---|
| Suitability for Pre-vacuum steam (270°F - 275°F) for a minimum of 4 minutes | Yes |
| Suitability for Ethylene Oxide (EO) sterilization (following manufacturer's recommendations; minimum 12 hours aeration) | Yes |
| Maintained shelf life sterility of at least 30 days | Yes |
| AAMI ST 33-R-11/95 Standard testing and requirements | Yes |
| 3.2 Permits transfer of contaminated materials | Yes |
| 3.3.1 Removable filter assembly disassembles | Yes |
| 3.3.4 Labeling - reusable labels | Yes |
| 3.4 - 3.5 Instructions provided for different cleaning methods | Yes |
| 3.6 - 4.2 Instructions for inspections | Yes |
| 6.2.2 Sterilization - manufacturer documentation available | Yes |
| 6.2.3 Drying time in labeling | Yes |
| 6.2.4 EO residual removal - in labeling | Yes |
| 6.2.5 Sterility maintenance - discussed in labeling, claimed in independent testing | Yes |
| 6.3 User (basic) responsibilities listed in labeling | Yes |
| 7.3.1 Routine inspection in labeling | Yes |
| Testing of container under a challenge per ANSI / AAMI ST 41-1992 and ST24-1992 for prevacuum steam and EO sterilization | Passed |
| Validation study performed to determine that contents would be sterile utilizing prevacuum steam and ethylene oxide | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of containers tested). It mentions that "The Carr Container system was independently tested."
- Data Provenance: Retrospective, as the testing was completed prior to the 510(k) submission. The country of origin of the data is not specified, but the applicant (Carr Metal Products, Inc.) is based in Indianapolis, IN, USA, and the FDA review is for the USA market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states, "The Carr Container system was independently tested according to AAMI ST 33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its performance." This implies that the validation of the device's sterility and performance was conducted by a testing facility or experts in sterilization standards. However, the exact number and qualifications of these experts are not specified in the provided text.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. Performance was assessed against established industry standards (AAMI, ANSI) and the criteria within those standards. It's likely that a "pass/fail" determination was made based on meeting these pre-defined criteria, rather than a subjective adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a sterilization container, not an AI-assisted diagnostic tool for which such a study would be relevant.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was performed. The testing described focuses solely on the performance of the Carr Container system itself, independent of human interaction beyond normal use for loading/unloading and sterilization processes. The results ("Passed all criteria") reflect the device's intrinsic capabilities.
7. The type of ground truth used
The ground truth was established by compliance with recognized industry performance standards/specifications for sterilization containers, specifically:
- AAMI ST 33-R-11/95
- ANSI / AAMI ST 41-1992
- ST 24-1992 (likely ST24-1992, as listed elsewhere in the document)
- Validation studies demonstrating sterility of contents after sterilization.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device (sterilization container), not an AI algorithm requiring data for machine learning.
9. How the Ground Truth for the Training Set was Established
As explained in point 8, a training set is not relevant for this type of 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).