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Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterlity during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below:

*STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles *STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles *STERRAD 100NX - Duo, Express, Standard and Flex Cycles *STERRAD NX - Standard and Advanced Cycles

Device Description

The Bahadir Sterilization Containers are a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:

STERIS VPRO maX/maX2: Lumen, Non Lumen, Flexible
STERIS VPRO s2/60: Lumen, Non Lumen, Flexible ●
STERRAD NX: Standard, Advanced ●
. STERRAD 100NX: Standard, Express, Flex, Duo

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the Bahadir Sterilization Containers (K233578). This is a medical device for sterilizing and storing instruments. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
Microbial Aerosol Challenge Testing	To determine the microbial barrier properties of the Bahadir Container Systems in maintaining sterility package integrity when subjected to a microbial aerosol challenge test following processing: In one hundred mechanical cleaning and STERIS V-PRO Lumen Cycle sterilization cycles. In one hundred (100) mechanical cleaning and STERRAD 100NX Standard Sterilization Cycles. Full Size (Mid Case) in a STERIS V-PRO Lumen Cycle sterilization cycle. 3/4 Size (Worst Case) in a STERIS V-PRO Lumen Cycle sterilization cycle. 3/4 size (Worst Case) in a STERRAD 100NX Standard Sterilization Cycle. 1/2 size (Best Case) in a STERRAD 100NX Standard Sterilization Cycle. full size (Mid Case) in a STERRAD 100NX Standard Sterilization Cycle.	The container systems must maintain sterility of its contents following whole package microbial aerosol challenge after 100 cleaning cycles and sterilization cycles (STERIS V-PRO Lumen Cycle and STERRAD 100NX Standard). The worst case, mid case and best case containers must be tested.	PASS - The results conclude that the Bahadir Container System maintained sterility of its contents following a whole package microbial aerosol challenge following processing: In one hundred mechanical cleaning and STERIS V-PRO Lumen Cycle sterilization cycles. In one hundred (100) mechanical cleaning and STERRAD 100NX Standard Sterilization Cycles. Full Size (Mid Case) in a STERIS V-PRO Lumen Cycle sterilization cycle. 3/4 Size (Worst Case) in a STERIS V-PRO Lumen Cycle sterilization cycle. ¾ size (Worst Case) in a STERRAD 100NX Standard Sterilization Cycle. ½ size (Best Case) in a STERRAD 100NX Standard Sterilization Cycle. full size (Mid Case) in a STERRAD 100NX Standard Sterilization Cycle.
Sterilization Validation	To validate the sterilization efficacy of the Bahadir Container Systems. 3/4 Size (Worst Case) Full Size (Mid Case) 1/2 Size (Best Case) when processed using: - STERRAD 100NX DUO Sterilization Cycle - STERRAD 100NX Flex Cycle - STERRAD NX Advanced Sterilization Cycle - STERRAD 100 NX Express Cycle - STERRAD 100NX Standard Cycle - STERRAD NX Standard Cycle The testing was to demonstrate effective sterilization using Bahadir Sterilization Containers in: - The STERIS V-PRO 60/s2 Flexible Cycle. The test load was prepared using a ¾ size (Worst Case). - The STERIS V-PRO maX / maX 2 Flexible Cycle. The test load was prepared using a ¾ size (Worst Case). - The STERIS V-PRO maX/maX2 and 60/s2 Non Lumen Cycle - The STERIS V-PRO maX/maX2 and 60/s2 Lumen Cycle	The container system must achieve an SAL of 10-6 when processed using the different sterilization modalities (STERIS V-PRO 60/s2, STERIS V-PRO maX/maX2 lumen cycle and STERRAD 100NX DUO, STERRAD NX Advanced, 100NX Standard, and 100NX Flex Cycles. Testing also must demonstrated sterilization efficacy with lumened devices and max loads.	PASS - Results from testing have demonstrated that the Bahadir Container Systems was able to achieve a 10-6 SAL when processed in: 3/4 Size (Worst Case), 1/2 Size (Best Case) and Full (Mid Case) when processed in a STERRAD 100NX DUO Sterilization Cycle, STERRAD NX Advanced Cycle, STERRAD 100NX FLEX Sterilization Cycle, STERRAD 100NX Express Sterilization Cycle, STERRAD 100NX Standard Sterilization Cycle, STERRAD NX Standard Sterilization Cycle. PASS - Effective sterilization using Bahadir Sterilization Containers was demonstrated after processing in the STERIS V-PRO 60/s2 Flexible Cycle with max load allowed ss lumens, STERIS V-PRO maX / maX 2 Flexible Cycle, STERIS V-PRO maX/maX2 and 60/s2 non lumen cycle, and STERIS V-PRO maX/maX2 and 60/s2 Lumen Cycle, verifying claims for various loads and instrument types.
Material Compatibility	To verify the material compatibility of the Bahadir Container Systems following automated cleaning and STERRAD 100NX Sterilization and STERIS V-PRO Sterilization.	The containers must show no signs of degradation after automated cleaning and using different sterilization modalities (STERRAD 100NX and STERIS V-PRO).	PASS: No degradation was observed.
30 Day Event Related Shelf Life Study	To demonstrate that the Bahadir Container Systems - 1/2 Size (Best Case) - 3/4 Size (Worst Case) - Full Size (Mid Case) can effectively maintain the sterility of its internal contents following exposure to a - STERRAD 100NX Standard Sterilization cycle - STERIS V-PRO lumen cycle and a minimum 30-day event related storage period.	The containers must maintain sterility of internal components for a minimum of 30 days following exposure to STERRAD 100NX Standard cycle and STERIS V-PRO lumen cycle. The testing is to include Worst case, mid case and best case for Bahadir containers.	PASS: Based on the results of the testing the Bahadir Container Systems - 1/2 Size (Best Case) - 3/4 Size (Worst Case) - Full Size (Mid Case) maintained the sterility of their contents following exposure to a - STERRAD 100NX Standard Sterilization Cycle - STERIS V-PRO lumen cycle For a minimum of a thirty (30) day shelf life storage period.
180 Day Event Related Shelf Life Study	To demonstrate that the Bahadir Container Systems - 1/2 Size (Best Case) - 3/4 Size (Worst Case) - Full Size (Mid Case) can effectively maintain the sterility of its internal contents following exposure to a - STERIS V-PRO lumen cycle - STERRAD 100NX Standard cycle and a minimum 180-day event related storage period.	The containers must maintain sterility of their contents for a minimum of 180 days following STERIS V-PRO lumen cycle and STERRAD 100NX Standard cycle. Testing to include best case, worst case and mid case of the Bahadir Containers for different sterilization modalities.	PASS: Based on the results of the testing the Bahadir Container Systems - 1/2 Size (Best Case) - 3/4 Size (Worst Case) - Full Size (Mid Case) maintained the sterility of their contents following exposure to a - STERIS V-PRO lumen cycle - STERRAD 100NX Standard Sterilization Cycle and a minimum 180 day shelf life storage period.
Cytotoxicity Testing	To verify that the materials used for the Bahadir Sterilization Containers are non-cytotoxic. The testing included: - ½ size (Best Case) ISO Elution Method following STERIS V-PRO Sterilization - ½ size (Best Case) MEM Elution Method following STERRAD 100NX Standard Cycle Sterilization	The container materials must be classified as non-toxic per ISO 10994-5 standard.	PASS – The device was determined not to be cytotoxic. No cytotoxicity or cell lysis was noted.

Important Note: The provided text is a 510(k) summary, which typically summarizes the results of studies rather than detailing the methodology and raw data. Therefore, some of the requested specific details, such as sample sizes for test sets, data provenance, number and qualifications of experts, and adjudication methods, are not explicitly stated in this document.

Additional Requested Information:

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: The document mentions "worst case, mid case and best case containers" for most tests, and "one hundred mechanical cleaning and STERIS V-PRO Lumen Cycle sterilization cycles" and "one hundred (100) mechanical cleaning and STERRAD 100NX Standard Sterilization Cycles" for microbial barrier testing. However, the exact number of individual containers or test replicates for each specific configuration within these "case" categories is not provided.
Data Provenance: Not explicitly stated. The nature of the tests (sterilization validation, microbial barrier) suggests that these are controlled laboratory studies, likely prospective experiments designed specifically for this submission. There is no indication of country of origin of the data within the provided text.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable as this is not an AI/diagnostic imaging device that typically requires expert review for ground truth establishment. The ground truth for sterilization efficacy is typically determined by established microbiological methods (e.g., spore kill, sterility testing).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for the types of performance tests described (microbial challenge, sterilization validation, material compatibility, cytotoxicity, shelf-life). These are objective laboratory tests with defined pass/fail criteria.

4. 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 device is a sterilization container, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the Microbial Aerosol Challenge Testing and Sterilization Validation, the ground truth is microbiological sterility, typically assessed by the absence of microbial growth after exposure to a certified biological indicator or direct inoculation and subsequent incubation. An SAL (Sterility Assurance Level) of 10^-6 is a key ground truth criterion.
For Material Compatibility, the ground truth is the absence of visual or functional degradation, likely assessed against pre-defined criteria.
For Shelf Life Studies, the ground truth is sustained sterility and material integrity over time, assessed through the same microbiological and material compatibility tests after storage periods.
For Cytotoxicity Testing, the ground truth is cellular viability and the absence of cytotoxic effects, often measured by standardized assays such as those described in ISO 10993-5.

7. The sample size for the training set:

Not applicable. This device is a physical product and does not involve AI or machine learning models that require training sets.

8. How the ground truth for the training set was established:

Not applicable, as no training set is relevant for this device.

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