(136 days)
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
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
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
March 22, 2024
Bahadir USA LLC % Joseph Azary Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K233578
Trade/Device Name: Bahadir Sterilization Containers Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 21, 2024 Received: February 21, 2024
Dear Joseph Azary:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/7 description: The image contains the name "Stephen A. Anisko -S" in a large, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The background is a light color, and the text is dark, providing good contrast and readability. The letter S is slightly cut off.
Digitally signed by Stephen A. Anisko -S Date: 2024.03.22 11:03:05 -04'00'
for Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233578
Device Name Bahadir Sterilization Containers
Indications for Use (Describe)
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
Bahadir Sterilization Containers Lumen Configurations
| Sterilization Cycle | Container Size | Compatible Lumens |
|---|---|---|
| STERIS VPRO maX/maX2Lumen Cycle | Full Size | ≥0.77mm x ≤527mm (single, dualor triple channel)≥0.8mm x ≤542mm (single, dual ortriple channel)≥0.48mm x ≤100mm (single, dualor triple channel) ≥1.3mm x≤73mm (dead end lumen)≥3mm x ≤298mm (rigid non-metallic lumen)>4mm x ≤424mm (rigid non-metallic lumen) |
| Three-Quarter Size | ≥0.77mm x ≤527mm (single, dualor triple channel)≥0.8mm x ≤542mm (single, dual ortriple channel)≥0.48mm x ≤100mm (single, dualor triple channel)≥1.3mm x ≤73mm (dead endlumen)≥3mm x ≤298mm (rigid non-metallic lumen)>4mm x ≤424mm (rigid non-metallic lumen) | |
| Half Size | ≥0.77mm x ≤527mm (single, dualor triple channel)≥0.8mm x ≤542mm (single, dual ortriple channel)≥0.48mm x ≤100mm (single, dualor triple channel)≥1.3mm x ≤73mm (dead endlumen)≥3mm x ≤298mm (rigid non-metallic lumen) | |
| ≥4mm x ≤424mm (rigid non-metallic lumen) | ||
| STERIS VPRO maX/maX2Flexible Cycle | Full Size | (2) flexible endoscopes with lightcord (if not integral to endoscope)and mat with no additional load.The flexible endoscopes maycontain Single or Dual channellumens ≥1mm x ≤1050mmOr(1) flexible endoscope with lightcord (if not integral to endoscope),endoscope accessories, mat andadditional instruments. The flexibleendoscope may contain Single ordual channel lumens that are ≥1mmx ≤1050mm. Additional single, dualor triple channel stainless steellumen device that is ≥0.48mm x<100mm OR non-lumen device |
| Three-Quarter Size | (2) flexible endoscopes with lightcord (if not integral to endoscope)and mat with no additional load.The flexible endoscopes maycontain Single or Dual channellumens ≥1mm x ≤1050mmOr(1) flexible endoscope with lightcord (if not integral to endoscope),endoscope accessories, mat andadditional instruments. The flexibleendoscope may contain Single ordual channel lumens that are ≥1mmx ≤1050mm. Additional single, dualor triple channel stainless steellumen device that is ≥0.48mm x<100mm OR non-lumen device | |
| Half Size | (2) flexible endoscopes with lightcord (if not integral to endoscope)and mat with no additional load.The flexible endoscopes maycontain Single or Dual channellumens ≥1mm x ≤1050mmOr(1) flexible endoscope with lightcord (if not integral to endoscope),endoscope accessories, mat andadditional instruments. The flexibleendoscope may contain Single ordual channel lumens that are ≥1mmx ≤1050mm. Additional single, dualor triple channel stainless steellumen device that is ≥0.48mm x<100mm OR non-lumen device | |
| STERIS VPRO maX/maX2Non-Lumen Cycle | Full Size | -Non lumened instruments |
| Three-Quarter Size | -Non lumened instruments | |
| Half Size | -Non lumened instruments | |
| Full Size | ≥0.77mm x ≤410mm (single or dualchannel) |
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| ≥1.8mm x ≤542mm (single or dualchannel) | |||
|---|---|---|---|
| STERIS VPRO s2/60 | ≥1.2mm x ≤275mm (triple channel)≥1.8mm x ≤310mm (triple channel)≥2.8mm x ≤317mm (triple channel) | ||
| Lumen cycle | Three-Quarter Size | ≥0.77mm x ≤410mm (single or dualchannel)≥1.8mm x ≤542mm (single or dualchannel) | |
| Half Size | ≥1.2mm x ≤275mm (triple channel)≥1.8mm x ≤310mm (triple channel)≥2.8mm x ≤317mm (triple channel) | ||
| ≥0.77mm x ≤410mm (single or dualchannel)≥1.8mm x ≤542mm (single or dualchannel) | |||
| Full Size | -Non-lumened instruments andinstruments with diffusionrestricted spaces (such as thehinged portion of forceps andscissors)-(1) surgical flexible endoscope orbronchoscope with light cord (if notintegral to the endoscope). Theflexible endoscope may be single ordual lumen device with lumens thatare ≥1mm x ≤990mm | ||
| STERIS VPRO s2/60 | |||
| Flexible Cycle | Three-Quarter Size | -Non-lumened instruments andinstruments with diffusionrestricted spaces (such as thehinged portion of forceps andscissors)-(1) surgical flexible endoscope orbronchoscope with light cord (if notintegral to the endoscope). Theflexible endoscope may be single ordual lumen device with lumens thatare ≥1mm x ≤990mm | |
| Half Size | -Non-lumened instruments andinstruments with diffusionrestricted spaces (such as thehinged portion of forceps andscissors)-(1) surgical flexible endoscope orbronchoscope with light cord (if notintegral to the endoscope). Theflexible endoscope may be single ordual lumen device with lumens thatare ≥1mm x ≤990mm | ||
| STERIS VPRO s2/60Non-Lumen Cycle | Full Size | -Non lumened instruments | |
| Three-Quarter Size | -Non lumened instruments | ||
| Half Size | -Non lumened instruments | ||
| STERRAD NX | Full Size | (5) SS lumens 1mm I.D. x 150mmL(5) SS lumens 2mm I.D. x 400mmL | |
| Standard Cycle | Three-Quarter Size | (10) SS lumens 1mm I.D. x 150mm L | |
| Half Size | (10) SS lumens 1mm I.D. x 150mm L | ||
| STERRAD NXAdvanced Cycle | Full Size | (10) SS lumens 2mm I.D. x 500mm L | |
| Three-Quarter Size | (6) SS lumens 1mm I.D. x 350mm L | ||
| Half Size | (10) SS lumens 1mm I.D. x 200mm L | ||
| STERRAD 100NXStandard Cycle | Full Size | (5) SS lumens 1mm I.D. x 500mm L | |
| Three-Quarter Size | (5) SS lumens 1mm I.D. x 350mm L | ||
| Half Size | (5) SS lumens 0.7mm I.D. x 200mm L | ||
| STERRAD 100NXExpress Cycle | Full Size | Non lumened SS instruments | |
| Three-Quarter Size | Non lumened SS instruments | ||
| Half Size | Non lumened SS instruments | ||
| STERRAD 100NXDuo Cycle | Full Size | (1)PTFE tubing 1.5 mm I.D. x 850mm L | |
| Three-Quarter Size | (1)PTFE tubing 1.5 mm I.D. x 850mm L | ||
| Half Size | (1)PTFE tubing 1.5 mm I.D. x 850mm L | ||
| STERRAD 100 NXFlexible Cycle | Full Size | (1) Scope lumen 1mm I.D. x 850mm L | |
| Three-Quarter Size | (1) Scope lumen 1mm I.D. x 850mm L | ||
| Half Size | (1)PTFE tubing 1mm I.D. x 850mm L |
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Bahadir Sterilization Containers Configurations
| Sterilization Cycle | Container Size | Container Name | Total Loaded Container (lbs) |
|---|---|---|---|
| STERIS VPROmaX/maX2Lumen Cycle | Full Size 4 ⅛” | Y111.10 | 19.65 |
| Full Size 5 ¼” | Y111.13 | 19.65 | |
| Full Size 5 ⅞” | Y111.15 | 19.65 | |
| Full Size 7 ¾” | Y111.20 | 19.65 | |
| Full Size 10 ¼ “ | Y111.26 | 19.65 | |
| Full Size 7 ¾” | Y111.70 | 19.65 | |
| Three-Quarter Size 4 ⅛” | Y211.10 | 19.65 | |
| Three-Quarter Size 5 ¼” | Y211.13 | 19.65 | |
| Three-Quarter Size 5 ⅞” | Y211.15 | 19.65 | |
| Three-Quarter Size 7 ¾” | Y211.20 | 19.65 | |
| Half Size 4 ⅛” | Y311.10 | 15 | |
| Half Size 5 ¼” | Y311.13 | 15 | |
| Half Size 5 ⅞” | Y311.15 | 15 | |
| Half Size 7 ¾” | Y311.20 | 15 | |
| Half Size 10 ¼” | Y311.26 | 15 | |
| Full Size 4 ⅛” | Y111.10 | 21 | |
| Full Size 5 ¼” | Y111.13 | 21 | |
| Full Size 5 ⅞” | Y111.15 | 21 | |
| Full Size 7 ¾” | Y111.20 | 21 | |
| Full Size 10 ¼ “ | Y111.26 | 21 | |
| Full Size 7 ¾” | Y111.70 | 21 | |
| STERIS VPRO | Size | ||
| maX/maX2Flexible Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 21 |
| Three-Quarter Size 5 ¼" | Y211.13 | 21 | |
| Three-Quarter Size 5 ⅞" | Y211.15 | 21 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 21 | |
| Half Size 4 ⅛" | Y311.10 | 21 | |
| Half Size 5 ¼" | Y311.13 | 21 | |
| Half Size 5 ⅞" | Y311.15 | 21 | |
| Half Size 7 ¾" | Y311.20 | 21 | |
| Half Size 10 ¼" | Y311.26 | 21 | |
| Full Size 4 ⅛" | Y111.10 | 26 | |
| Full Size 5 ¼" | Y111.13 | 26 | |
| Full Size 5 ⅞" | Y111.15 | 26 | |
| Full Size 7 ¾" | Y111.20 | 26 | |
| Full Size 10 ¼" | Y111.26 | 26 | |
| Full Size 7 ¾" | Y111.70 | 26 | |
| STERIS VPROmaX/maX2Non-Lumen Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 26 |
| Three-Quarter Size 5 ¼" | Y211.13 | 26 | |
| Three-Quarter Size 5 ⅞" | Y211.15 | 26 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 26 | |
| Half Size 4 ⅛" | Y311.10 | 19 | |
| Half Size 5 ¼" | Y311.13 | 19 | |
| Half Size 5 ⅞" | Y311.15 | 19 | |
| Half Size 7 ¾" | Y311.20 | 19 | |
| Half Size 10 ¼" | Y311.26 | 19 | |
| Full Size 4 ⅛" | Y111.10 | 11 | |
| Full Size 5 ¼" | Y111.13 | 11 | |
| Full Size 5 ⅞" | Y111.15 | 11 | |
| Full Size 7 ¾" | Y111.20 | 11 | |
| Full Size 10 ¼" | Y111.26 | 11 | |
| Full Size 7 ¾" | Y111.70 | 11 | |
| STERIS VPROS2/60Lumen Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 11 |
| Three-Quarter Size 5 ¼" | Y211.13 | 11 | |
| Three-Quarter Size 5 ⅞" | Y211.15 | 11 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 11 | |
| Half Size 4 ⅛" | Y311.10 | 11 | |
| Half Size 5 ¼" | Y311.13 | 11 | |
| Half Size 5 ⅞" | Y311.15 | 11 | |
| Half Size 7 ¾" | Y311.20 | 11 | |
| Half Size 10 ¼" | Y311.26 | 11 | |
| Full Size 4 ⅛" | Y111.10 | 11 | |
| Full Size 5 ¼" | Y111.13 | 11 | |
| Full Size 5 ⅞" | Y111.15 | 11 | |
| Full Size 7 ¾" | Y111.20 | 11 | |
| Full Size 10 ¼" | Y111.26 | 11 | |
| Full Size 7 ¾" | Y111.70 | 11 | |
| STERIS VPROS2/60Flexible Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 11 |
| Three-Quarter Size 5 ¼" | Y211.13 | 11 | |
| Three-Quarter Size 5 ⅞" | Y211.15 | 11 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 11 | |
| Half Size 4 ⅛" | Y311.10 | 11 | |
| Half Size 5 ¼" | Y311.13 | 11 | |
| Half Size 5 ⅞" | Y311.15 | 11 | |
| Half Size 7 ¾" | Y311.20 | 11 | |
| Half Size 10 ¼" | Y311.26 | 11 | |
| Full Size 4 ⅛" | Y111.10 | 19 | |
| Full Size 5 ¼" | Y111.13 | 19 | |
| Full Size 5 ⅛” | Y111.15 | 19 | |
| Full Size 7 ¾” | Y111.20 | 19 | |
| Full Size 10 ¼ “ | Y111.26 | 19 | |
| Full Size 7 ¾” | Y111.70 | 19 | |
| STERIS VPROS2/60Non-Lumen Cycle | Three-Quarter Size 4 ⅛” | Y211.10 | 19 |
| Three-Quarter Size 5 ¼” | Y211.13 | 19 | |
| Three-Quarter Size 5 ⅞” | Y211.15 | 19 | |
| Three-Quarter Size 7 ¾” | Y211.20 | 19 | |
| Half Size 4 ⅛” | Y311.10 | 12.5 | |
| Half Size 5 ¼” | Y311.13 | 12.5 | |
| Half Size 5 ⅞” | Y311.15 | 12.5 | |
| Half Size 7 ¾” | Y311.20 | 12.5 | |
| Half Size 10 ¼” | Y311.26 | 12.5 | |
| Full Size 4 ⅛” | Y111.10 | 10.7 | |
| Full Size 5 ¼” | Y111.13 | 10.7 | |
| Full Size 5 ⅞” | Y111.15 | 10.7 | |
| Full Size 7 ¾” | Y111.20 | 10.7 | |
| Full Size 10 ¼ “ | Y111.26 | 10.7 | |
| Full Size 7 ¾” | Y111.70 | 10.7 | |
| STERRAD NXStandard Cycle | Three-Quarter Size 4 ⅛” | Y211.10 | 10.7 |
| Three-Quarter Size 5 ¼” | Y211.13 | 10.7 | |
| Three-Quarter Size 5 ⅞” | Y211.15 | 10.7 | |
| Three-Quarter Size 7 ¾” | Y211.20 | 10.7 | |
| Half Size 4 ⅛” | Y311.10 | 10.7 | |
| Half Size 5 ¼” | Y311.13 | 10.7 | |
| Half Size 5 ⅞” | Y311.15 | 10.7 | |
| Half Size 7 ¾” | Y311.20 | 10.7 | |
| Half Size 10 ¼” | Y311.26 | 10.7 | |
| Full Size 4 ⅛” | Y111.10 | 10.7 | |
| Full Size 5 ¼” | Y111.13 | 10.7 | |
| Full Size 5 ⅞” | Y111.15 | 10.7 | |
| Full Size 7 ¾” | Y111.20 | 10.7 | |
| Full Size 10 ¼ “ | Y111.26 | 10.7 | |
| Full Size 7 ¾” | Y111.70 | 10.7 | |
| STERRAD NXAdvanced Cycle | Three-Quarter Size 4 ⅛” | Y211.10 | 13.85 |
| Three-Quarter Size 5 ¼” | Y211.13 | 13.85 | |
| Three-Quarter Size 5 ⅞” | Y211.15 | 13.85 | |
| Three-Quarter Size 7 ¾” | Y211.20 | 13.85 | |
| Half Size 4 ⅛” | Y311.10 | 10.7 | |
| Half Size 5 ¼” | Y311.13 | 10.7 | |
| Half Size 5 ⅞” | Y311.15 | 10.7 | |
| Half Size 7 ¾” | Y311.20 | 10.7 | |
| Half Size 10 ¼” | Y311.26 | 10.7 | |
| Full Size 4 ⅛” | Y111.10 | 21.4 | |
| Full Size 5 ¼” | Y111.13 | 21.4 | |
| Full Size 5 ⅞” | Y111.15 | 21.4 | |
| Full Size 7 ¾” | Y111.20 | 21.4 | |
| Full Size 10 ¼ “ | Y111.26 | 21.4 | |
| Full Size 7 ¾” | Y111.70 | 21.4 | |
| STERRAD100NXStandard Cycle | Three-Quarter Size 4 ⅛” | Y211.10 | 13.85 |
| Three-Quarter Size 5 ¼” | Y211.13 | 13.85 | |
| Three-Quarter Size 5 ⅞” | Y211.15 | 13.85 | |
| Three-Quarter Size 7 ¾” | Y211.20 | 13.85 | |
| Half Size 4 ⅛” | Y311.10 | 13.85 | |
| Half Size 7¾" | Y311.20 | 13.85 | |
| Half Size 10¼" | Y311.26 | 13.85 | |
| Full Size 4⅛" | Y111.10 | 21.4 | |
| Full Size 5¼" | Y111.13 | 21.4 | |
| Full Size 5⅞" | Y111.15 | 21.4 | |
| Full Size 7¾" | Y111.20 | 21.4 | |
| Full Size 10¼" | Y111.26 | 21.4 | |
| Full Size 7¾" | Y111.70 | 21.4 | |
| STERRAD100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.85 |
| Express Cycle | Three-Quarter Size 5¼" | Y211.13 | 13.85 |
| Three-Quarter Size 5⅞" | Y211.15 | 13.85 | |
| Three-Quarter Size 7¾" | Y211.20 | 13.85 | |
| Half Size 4⅛" | Y311.10 | 13.85 | |
| Half Size 5¼" | Y311.13 | 13.85 | |
| Half Size 5⅞" | Y311.15 | 13.85 | |
| Half Size 7¾" | Y311.20 | 13.85 | |
| Half Size 10¼" | Y311.26 | 13.85 | |
| Full Size 4⅛" | Y111.10 | 13.2 | |
| Full Size 5¼" | Y111.13 | 13.2 | |
| Full Size 5⅞" | Y111.15 | 13.2 | |
| Full Size 7¾" | Y111.20 | 13.2 | |
| Full Size 10¼" | Y111.26 | 13.2 | |
| Full Size 7¾" | Y111.70 | 13.2 | |
| STERRAD100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.2 |
| DUO Cycle | Three-Quarter Size 5¼" | Y211.13 | 13.2 |
| Three-Quarter Size 5⅞" | Y211.15 | 13.2 | |
| Three-Quarter Size 7¾" | Y211.20 | 13.2 | |
| Half Size 4⅛" | Y311.10 | 7.2 | |
| Half Size 5¼" | Y311.13 | 7.2 | |
| Half Size 5⅞" | Y311.15 | 7.2 | |
| Half Size 7¾" | Y311.20 | 7.2 | |
| Half Size 10¼" | Y311.26 | 7.2 | |
| Full Size 4⅛" | Y111.10 | 12.59 | |
| Full Size 5¼" | Y111.13 | 12.59 | |
| Full Size 5⅞" | Y111.15 | 12.59 | |
| Full Size 7¾" | Y111.20 | 12.59 | |
| Full Size 10¼" | Y111.26 | 12.59 | |
| Full Size 7¾" | Y111.70 | 12.59 | |
| STERRAD100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.85 |
| Flexible Cycle | Three-Quarter Size 5¼" | Y211.13 | 13.85 |
| Three-Quarter Size 5⅞" | Y211.15 | 13.85 | |
| Three-Quarter Size 7¾" | Y211.20 | 13.85 | |
| Half Size 4⅛" | Y311.10 | 13.85 | |
| Half Size 5¼" | Y311.13 | 13.85 | |
| Half Size 5⅞" | Y311.15 | 13.85 | |
| Half Size 7¾" | Y311.20 | 13.85 |
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Bahadir Sterilization Containers may be used with Bahadir USA accessories according to the table below:
| Cycle | Baskets including holding pins,holding clamps, silicone holders,partition sheets, tamper evidentlocks | Silicone Mats |
|---|---|---|
| Steris VPRO 60/s2Lumen, Non-Lumen, Flex | YES | YES |
| Steris VPRO maX/maX2Lumen, Non-Lumen, Flex | YES | YES |
| STERRAD NX - Standard | YES | NO |
| STERRAD NX - Advanced | YES | NO |
| STERRAD 100NX - Standard | YES | NO |
| STERRAD 100NX - Duo | YES | NO |
| STERRAD 100NX - Flex | YES | NO |
| STERRAD 100NX - Express | YES | YES |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/11/Picture/0 description: The image shows the contact information for BAHADIR USA LLC. The address is 431 S. Pennsville-Auburn Road Carneys Point, New Jersey 08069 USA. The phone number is (856) 517-3080, the fax number is (856) 517-3081, the website is www.BahadirUSA.com, and the email address is info@bahadirusa.com.
510(k) Summary K233578
March 16, 2024 DATE PREPARED:
- COMPANY NAME: BAHADIR USA LLC 431 SOUTH PENNSVILLE AUBURN RD CARNEYS POINT, NJ 08069
CONTACT: ISMAIL KILIC EMAIL: INFO@BAHADIRUSA.COM OFFICE: 856-517-3080 FAX: 856-517-3081
PRIMARY CORRESPONDANT/CONSULTANT
| CONTACT: | JOSEPH AZARY |
|---|---|
| AZTECH REGULATORY AND QUALITY LLC | |
| EMAIL: | JAZARY@RCN.COM |
| OFFICE: | (203)242-6670 |
- BAHADIR STERILIZATION CONTAINERS TRADE NAME: COMMON NAME/ CLASSIFICATION STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES, AND OTHER ACCESSORIES NAME: CLASS OF DEVICE: CLASS II PRODUCT CODE: КСТ REGULATION: 21 CFR880.6850 REVIEW PANEL: GENERAL HOSPITAL ESTABLISHMENT REGESTRATION NUMBER: 3005741909 PREDICATE DEVICE: K131407, Bahadir Sterilization Containers (Primary Predicate) K214041, AESCULAP Aicon Container (Secondary Predicate)
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DESCRIPTION OF DEVICE:
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
INDICATIONS FOR USE:
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 sterility during storage and transport under proper hospital 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
Bahadir Sterilization Containers Lumen Configurations
| Sterilization Cycle | Container Size | Compatible Lumens |
|---|---|---|
| STERIS VPRO maX/maX2Lumen Cycle | Full Size | ≥0.77mm x ≤527mm (single, dualor triple channel) |
| ≥0.8mm x ≤542mm (single, dualor triple channel) | ||
| ≥0.48mm x ≤100mm (single, dualor triple channel) | ||
| ≥1.3mm x ≤73mm (dead endlumen) | ||
| ≥3mm x ≤298mm (rigid non-metallic lumen) | ||
| ≥4mm x ≤424mm (rigid non-metallic lumen) | ||
| Three-Quarter Size | ≥0.77mm x ≤527mm (single, dualor triple channel) | |
| ≥0.8mm x ≤542mm (single, dualor triple channel) | ||
| ≥0.48mm x ≤100mm (single, dualor triple channel) | ||
| ≥1.3mm x ≤73mm (dead endlumen) | ||
| ≥3mm x ≤298mm (rigid non-metallic lumen) | ||
| ≥4mm x ≤424mm (rigid non-metallic lumen) | ||
| Half Size | ≥0.77mm x ≤527mm (single, dualor triple channel) | |
| ≥0.8mm x ≤542mm (single, dualor triple channel) | ||
| ≥0.48mm x ≤100mm (single, dualor triple channel) | ||
| ≥1.3mm x ≤73mm (dead endlumen)≥3mm x ≤298mm (rigid non-metallic lumen)≥4mm x ≤424mm (rigid non-metallic lumen) | ||
| STERIS VPRO maX/maX2Flexible Cycle | Full Size | (2) flexible endoscopes with lightcord (if not integral toendoscope) and mat with noadditional load. The flexibleendoscopes may contain Singleor Dual channel lumens ≥1mm x≤1050mmOr(1) flexible endoscope with lightcord (if not integral toendoscope), endoscopeaccessories, mat and additionalinstruments. The flexibleendoscope may contain Single ordual channel lumens that are≥1mm x ≤1050mm. Additionalsingle, dual or triple channelstainless steel lumen device thatis ≥0.48mm x ≤100mm OR non- |
| Three-Quarter Size | lumen device(2) flexible endoscopes with lightcord (if not integral toendoscope) and mat with noadditional load. The flexibleendoscopes may contain Singleor Dual channel lumens ≥1mm x≤1050mmOr(1) flexible endoscope with lightcord (if not integral toendoscope), endoscopeaccessories, mat and additionalinstruments. The flexibleendoscope may contain Single ordual channel lumens that are≥1mm x ≤1050mm. Additionalsingle, dual or triple channelstainless steel lumen device thatis ≥0.48mm x ≤100mm OR non-lumen device | |
| Half Size | (2) flexible endoscopes with lightcord (if not integral toendoscope) and mat with noadditional load. The flexibleendoscopes may contain Singleor Dual channel lumens ≥1mm x≤1050mmOr(1) flexible endoscope with light | |
| cord (if not integral toendoscope), endoscopeaccessories, mat and additionalinstruments. The flexibleendoscope may contain Single ordual channel lumens that are$\ge$ 1mm x $\le$ 1050mm. Additionalsingle, dual or triple channelstainless steel lumen device thatis $\ge$ 0.48mm x $\le$ 100mm OR non-lumen device | ||
| STERIS VPRO maX/maX2Non-Lumen Cycle | Full Size | -Non lumened instruments |
| STERIS VPRO maX/maX2Non-Lumen Cycle | Three-Quarter Size | -Non lumened instruments |
| STERIS VPRO maX/maX2Non-Lumen Cycle | Half Size | -Non lumened instruments |
| STERIS VPRO s2/60Lumen cycle | Full Size | $\ge$ 0.77mm x $\le$ 410mm (single ordual channel)$\ge$ 1.8mm x $\le$ 542mm (single ordual channel)$\ge$ 1.2mm x $\le$ 275mm (triplechannel)$\ge$ 1.8mm x $\le$ 310mm (triplechannel)$\ge$ 2.8mm x $\le$ 317mm (triplechannel) |
| STERIS VPRO s2/60Lumen cycle | Three-Quarter Size | $\ge$ 0.77mm x $\le$ 410mm (single ordual channel)$\ge$ 1.8mm x $\le$ 542mm (single ordual channel)$\ge$ 1.2mm x $\le$ 275mm (triplechannel)$\ge$ 1.8mm x $\le$ 310mm (triplechannel)$\ge$ 2.8mm x $\le$ 317mm (triplechannel) |
| STERIS VPRO s2/60Lumen cycle | Half Size | $\ge$ 0.77mm x $\le$ 410mm (single ordual channel)$\ge$ 1.8mm x $\le$ 542mm (single ordual channel)$\ge$ 1.2mm x $\le$ 275mm (triplechannel)$\ge$ 1.8mm x $\le$ 310mm (triplechannel)$\ge$ 2.8mm x $\le$ 317mm (triplechannel) |
| STERIS VPRO s2/60 | Full Size | -Non-lumened instruments andinstruments with diffusionrestricted spaces (such as thehinged portion of forceps andscissors)-(1) surgical flexible endoscopeor bronchoscope with light cord(if not integral to the endoscope).The flexible endoscope may be |
| single or dual lumen device withlumens that are $\ge$ 1mm x $\le$ 990mm | ||
| Flexible Cycle | Three-Quarter Size | -Non-lumened instruments andinstruments with diffusionrestricted spaces (such as thehinged portion of forceps andscissors)-(1) surgical flexible endoscopeor bronchoscope with light cord(if not integral to the endoscope).The flexible endoscope may besingle or dual lumen device withlumens that are $\ge$ 1mm x $\le$ 990mm |
| Half Size | -Non-lumened instruments andinstruments with diffusionrestricted spaces (such as thehinged portion of forceps andscissors)-(1) surgical flexible endoscopeor bronchoscope with light cord(if not integral to the endoscope).The flexible endoscope may besingle or dual lumen device withlumens that are $\ge$ 1mm x $\le$ 990mm | |
| STERIS VPRO s2/60Non-Lumen Cycle | Full Size | -Non lumened instruments |
| Three-Quarter Size | -Non lumened instruments | |
| Half Size | -Non lumened instruments | |
| STERRAD NX | Full Size | (5) SS lumens 1mm I.D. x 150mm L(5) SS lumens 2mm I.D. x 400mm L |
| Standard Cycle | Three-Quarter Size | (10) SS lumens 1mm I.D. x150mm L |
| Half Size | (10) SS lumens 1mm I.D. x150mm L | |
| STERRAD NXAdvanced Cycle | Full Size | (10) SS lumens 2mm I.D. x500mm L |
| Three-Quarter Size | (6) SS lumens 1mm I.D. x 350mmL | |
| Half Size | (10) SS lumens 1mm I.D. x200mm L | |
| STERRAD 100NXStandard Cycle | Full Size | (5) SS lumens 1mm I.D. x 500mmL |
| Three-Quarter Size | (5) SS lumens 1mm I.D. x 350mmL | |
| Half Size | (5) SS lumens 0.7mm I.D. x200mm L | |
| STERRAD 100NXExpress Cycle | Full Size | Non lumened SS instruments |
| Three-Quarter Size | Non lumened SS instruments | |
| STERRAD 100NX | Full Size | (1)PTFE tubing 1.5 mm I.D. x850mm L |
| Duo Cycle | Three-Quarter Size | (1)PTFE tubing 1.5 mm I.D. x850mm L |
| Half Size | (1)PTFE tubing 1.5 mm I.D. x850mm L | |
| STERRAD 100 NX | Full Size | (1) Scope lumen 1mm I.D. x850mm L |
| Flexible Cycle | Three-Quarter Size | (1) Scope lumen 1mm I.D. x850mm L |
| Half Size | (1)PTFE tubing 1mm I.D. x 850mmL |
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Bahadir Sterilization Containers Configurations
| SterilizationCycle | Container Size | Container Name | Total Loaded Container(lbs) | |
|---|---|---|---|---|
| STERIS VPROmaX/maX2Lumen Cycle | Full Size 4⅛" | Y111.10 | 19.65 | |
| Full Size 5¼" | Y111.13 | 19.65 | ||
| Full Size 5⅝" | Y111.15 | 19.65 | ||
| Full Size 7¾" | Y111.20 | 19.65 | ||
| Full Size 10¼ " | Y111.26 | 19.65 | ||
| Full Size 7¾" | Y111.70 | 19.65 | ||
| Three-Quarter Size 4⅛" | Y211.10 | 19.65 | ||
| Three-Quarter Size 5¼" | Y211.13 | 19.65 | ||
| Three-Quarter Size 5⅝" | Y211.15 | 19.65 | ||
| Three-Quarter Size 7¾" | Y211.20 | 19.65 | ||
| Half Size 4⅛" | Y311.10 | 15 | ||
| Half Size 5¼" | Y311.13 | 15 | ||
| Half Size 5⅝" | Y311.15 | 15 | ||
| Half Size 7¾" | Y311.20 | 15 | ||
| Half Size 10¼" | Y311.26 | 15 | ||
| STERIS VPROmax/maX2Flexible Cycle | Full Size 4⅛" | Y111.10 | 21 | |
| Full Size 5¼" | Y111.13 | 21 | ||
| Full Size 5⅝" | Y111.15 | 21 | ||
| Full Size 7¾" | Y111.20 | 21 | ||
| Full Size 10¼ " | Y111.26 | 21 | ||
| Full Size 7¾" | Y111.70 | 21 | ||
| Three-Quarter Size 4⅛" | Y211.10 | 21 | ||
| Three-Quarter Size 5¼" | Y211.13 | 21 | ||
| Three-Quarter Size 5⅝" | Y211.15 | 21 | ||
| Three-Quarter Size 7¾" | Y211.20 | 21 | ||
| Half Size 4⅛" | Y311.10 | 21 | ||
| Half Size 5¼" | Y311.13 | 21 | ||
| Half Size 5⅝" | Y311.15 | 21 | ||
| Half Size 7¾" | Y311.20 | 21 | ||
| Half Size 10¼" | Y311.26 | 21 | ||
| Full Size 4⅛" | Y111.10 | 26 | ||
| Full Size 5¼" | Y111.13 | 26 | ||
| Full Size 5⅝" | Y111.15 | 26 | ||
| Full Size 7¾" | Y111.20 | 26 | ||
| STERIS VPROmax/max2Non-LumenCycle | Full Size | 10 ¼ " | Y111.26 | 26 |
| Full Size | 7 3/4" | Y111.70 | 26 | |
| Three-Quarter Size | 4 1/8" | Y211.10 | 26 | |
| Three-Quarter Size | 5 1/4" | Y211.13 | 26 | |
| Three-Quarter Size | 5 7/8" | Y211.15 | 26 | |
| Three-Quarter Size | 7 3/4" | Y211.20 | 26 | |
| Half Size | 4 1/8" | Y311.10 | 19 | |
| Half Size | 5 1/4" | Y311.13 | 19 | |
| Half Size | 5 7/8" | Y311.15 | 19 | |
| Half Size | 7 3/4" | Y311.20 | 19 | |
| Half Size | 10 1/4" | Y311.26 | 19 | |
| STERIS VPROS2/60Lumen Cycle | Full Size | 4 1/8" | Y111.10 | 11 |
| Full Size | 5 1/4" | Y111.13 | 11 | |
| Full Size | 5 7/8" | Y111.15 | 11 | |
| Full Size | 7 3/4" | Y111.20 | 11 | |
| Full Size | 10 1/4 " | Y111.26 | 11 | |
| Full Size | 7 3/4" | Y111.70 | 11 | |
| Three-Quarter Size | 4 1/8" | Y211.10 | 11 | |
| Three-Quarter Size | 5 1/4" | Y211.13 | 11 | |
| Three-Quarter Size | 5 7/8" | Y211.15 | 11 | |
| Three-Quarter Size | 7 3/4" | Y211.20 | 11 | |
| Half Size | 4 1/8" | Y311.10 | 11 | |
| Half Size | 5 1/4" | Y311.13 | 11 | |
| Half Size | 5 7/8" | Y311.15 | 11 | |
| Half Size | 7 3/4" | Y311.20 | 11 | |
| Half Size | 10 1/4" | Y311.26 | 11 | |
| STERIS VPROS2/60Flexible Cycle | Full Size | 4 1/8" | Y111.10 | 11 |
| Full Size | 5 1/4" | Y111.13 | 11 | |
| Full Size | 5 7/8" | Y111.15 | 11 | |
| Full Size | 7 3/4" | Y111.20 | 11 | |
| Full Size | 10 1/4 " | Y111.26 | 11 | |
| Full Size | 7 3/4" | Y111.70 | 11 | |
| Three-Quarter Size | 4 1/8" | Y211.10 | 11 | |
| Three-Quarter Size | 5 1/4" | Y211.13 | 11 | |
| Three-Quarter Size | 5 7/8" | Y211.15 | 11 | |
| Three-Quarter Size | 7 3/4" | Y211.20 | 11 | |
| Half Size | 4 1/8" | Y311.10 | 11 | |
| Half Size | 5 1/4" | Y311.13 | 11 | |
| Half Size | 5 7/8" | Y311.15 | 11 | |
| Half Size | 7 3/4" | Y311.20 | 11 | |
| Half Size | 10 1/4" | Y311.26 | 11 | |
| STERIS VPROS2/60 | Full Size | 4 1/8" | Y111.10 | 19 |
| Full Size | 5 1/4" | Y111.13 | 19 | |
| Full Size | 5 7/8" | Y111.15 | 19 | |
| Full Size | 7 3/4" | Y111.20 | 19 | |
| Full Size | 10 1/4 " | Y111.26 | 19 | |
| Full Size | 7 3/4" | Y111.70 | 19 | |
| Three-Quarter Size | 4 1/8" | Y211.10 | 19 | |
| Three-Quarter Size | 5 1/4" | Y211.13 | 19 | |
| Cycle | ||||
| Three-Quarter Size 7 ¾" | Y211.20 | 19 | ||
| Half Size 4⅛" | Y311.10 | 12.5 | ||
| Half Size 5¼" | Y311.13 | 12.5 | ||
| Half Size 5⅞" | Y311.15 | 12.5 | ||
| Half Size 7 ¾" | Y311.20 | 12.5 | ||
| Half Size 10 ¼" | Y311.26 | 12.5 | ||
| Full Size 4⅛" | Y111.10 | 10.7 | ||
| Full Size 5¼" | Y111.13 | 10.7 | ||
| Full Size 5⅞" | Y111.15 | 10.7 | ||
| Full Size 7 ¾" | Y111.20 | 10.7 | ||
| Full Size 10 ¼ " | Y111.26 | 10.7 | ||
| Full Size 7 ¾" | Y111.70 | 10.7 | ||
| STERRAD NXStandard Cycle | Three-Quarter Size 4⅛" | Y211.10 | 10.7 | |
| Three-Quarter Size 5¼" | Y211.13 | 10.7 | ||
| Three-Quarter Size 5⅞" | Y211.15 | 10.7 | ||
| Three-Quarter Size 7 ¾" | Y211.20 | 10.7 | ||
| Half Size 4⅛" | Y311.10 | 10.7 | ||
| Half Size 5¼" | Y311.13 | 10.7 | ||
| Half Size 5⅞" | Y311.15 | 10.7 | ||
| Half Size 7 ¾" | Y311.20 | 10.7 | ||
| Half Size 10 ¼" | Y311.26 | 10.7 | ||
| Full Size 4⅛" | Y111.10 | 10.7 | ||
| Full Size 5¼" | Y111.13 | 10.7 | ||
| Full Size 5⅞" | Y111.15 | 10.7 | ||
| Full Size 7 ¾" | Y111.20 | 10.7 | ||
| Full Size 10 ¼ " | Y111.26 | 10.7 | ||
| Full Size 7 ¾" | Y111.70 | 10.7 | ||
| STERRAD NXAdvanced Cycle | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | |
| Three-Quarter Size 5¼" | Y211.13 | 13.85 | ||
| Three-Quarter Size 5⅞" | Y211.15 | 13.85 | ||
| Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | ||
| Half Size 4⅛" | Y311.10 | 10.7 | ||
| Half Size 5¼" | Y311.13 | 10.7 | ||
| Half Size 5⅞" | Y311.15 | 10.7 | ||
| Half Size 7 ¾" | Y311.20 | 10.7 | ||
| Half Size 10 ¼" | Y311.26 | 10.7 | ||
| Full Size 4⅛" | Y111.10 | 21.4 | ||
| Full Size 5¼" | Y111.13 | 21.4 | ||
| Full Size 5⅞" | Y111.15 | 21.4 | ||
| Full Size 7 ¾" | Y111.20 | 21.4 | ||
| Full Size 10 ¼ " | Y111.26 | 21.4 | ||
| Full Size 7 ¾" | Y111.70 | 21.4 | ||
| STERRAD 100NXStandard Cycle | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | |
| Three-Quarter Size 5¼" | Y211.13 | 13.85 | ||
| Three-Quarter Size 5⅞" | Y211.15 | 13.85 | ||
| Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | ||
| Half Size 4⅛" | Y311.10 | 13.85 | ||
| Half Size 5¼" | Y311.13 | 13.85 | ||
| Half Size 5⅞" | Y311.15 | 13.85 | ||
| Half Size 7 ¾" | Y311.20 | 13.85 | ||
| Half Size10 ¼" | Y311.26 | 13.85 | ||
| Full Size 4⅛" | Y111.10 | 21.4 | ||
| Full Size 5 ¼" | Y111.13 | 21.4 | ||
| Full Size 5 ⅞" | Y111.15 | 21.4 | ||
| Full Size 7 ¾" | Y111.20 | 21.4 | ||
| Full Size 10 ¼ " | Y111.26 | 21.4 | ||
| Full Size 7 ¾" | Y111.70 | 21.4 | ||
| STERRAD 100NX | Three-Quarter Size 4 ⅛" | Y211.10 | 13.85 | |
| Three-Quarter Size 5 ¼" | Y211.13 | 13.85 | ||
| Express Cycle | Three-Quarter Size 5 ⅞" | Y211.15 | 13.85 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | ||
| Half Size 4⅛" | Y311.10 | 13.85 | ||
| Half Size 5 ¼" | Y311.13 | 13.85 | ||
| Half Size 5 ⅞" | Y311.15 | 13.85 | ||
| Half Size 7 ¾" | Y311.20 | 13.85 | ||
| Half Size 10 ¼" | Y311.26 | 13.85 | ||
| Full Size 4⅛" | Y111.10 | 13.2 | ||
| Full Size 5 ¼" | Y111.13 | 13.2 | ||
| Full Size 5 ⅞" | Y111.15 | 13.2 | ||
| Full Size 7 ¾" | Y111.20 | 13.2 | ||
| Full Size 10 ¼ " | Y111.26 | 13.2 | ||
| Full Size 7 ¾" | Y111.70 | 13.2 | ||
| STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.2 | |
| Three-Quarter Size 5 ¼" | Y211.13 | 13.2 | ||
| DUO Cycle | Three-Quarter Size 5 ⅞" | Y211.15 | 13.2 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 13.2 | ||
| Half Size 4⅛" | Y311.10 | 7.2 | ||
| Half Size 5 ¼" | Y311.13 | 7.2 | ||
| Half Size 5 ⅞" | Y311.15 | 7.2 | ||
| Half Size 7 ¾" | Y311.20 | 7.2 | ||
| Half Size 10 ¼" | Y311.26 | 7.2 | ||
| Full Size 4⅛" | Y111.10 | 12.59 | ||
| Full Size 5 ¼" | Y111.13 | 12.59 | ||
| Full Size 5 ⅞" | Y111.15 | 12.59 | ||
| Full Size 7 ¾" | Y111.20 | 12.59 | ||
| Full Size 10 ¼ " | Y111.26 | 12.59 | ||
| Full Size 7 ¾" | Y111.70 | 12.59 | ||
| STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | |
| Three-Quarter Size 5 ¼" | Y211.13 | 13.85 | ||
| Flexible Cycle | Three-Quarter Size 5 ⅞" | Y211.15 | 13.85 | |
| Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | ||
| Half Size 4⅛" | Y311.10 | 13.85 | ||
| Half Size 5 ¼" | Y311.13 | 13.85 | ||
| Half Size 5 ⅞" | Y311.15 | 13.85 | ||
| Half Size 7 ¾" | Y311.20 | 13.85 | ||
| Half Size 10 ¼" | Y311.26 | 13.85 |
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Bahadir Sterilization Containers may be used with Bahadir accessories according to the table below:
| Cycle | Baskets including holding pins,holding clamps, siliconeholders, partition sheets,tamper evident locks | Silicone Mats |
|---|---|---|
| Steris VPRO 60/s2Lumen, Non-Lumen, Flex | YES | YES |
| Steris VPRO maX/maX2Lumen, Non-Lumen, Flex | YES | YES |
| STERRAD NX - Standard | YES | NO |
| STERRAD NX - Advanced | YES | NO |
| STERRAD 100NX - Standard | YES | NO |
| STERRAD 100NX - Duo | YES | NO |
| STERRAD 100NX – Flex | YES | NO |
| STERRAD 100NX - Express | YES | YES |
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The table below provides a summary of the device technological characteristics comparing the subject device and the predicate device(s). The subject device is offered in similar sizes and is comprised of similar materials of construction with the same principals of operation as the predicate devices.
| Characteristic | Subject Device: | Primary PredicateDevice: | Reference PredicateDevice: | Comparison |
|---|---|---|---|---|
| BahadirSterilizationContainers ProductCode:KCT | BahadirSterilizationContainers(K131407)Product Code:KCT | AESCULAPAicon Container(K214041)Product Code: KCT | ||
| Intended Use | Container to storedevices duringsterilization | Container to storedevices duringsterilization | Container to storedevices duringsterilization | SAME |
| Indications forUse | A device intended tobe used to enclosedanother medicaldevice that is to besterilized by ahealthcare provider. Itis intended to allowsterilization of theenclosed medicaldevice and also tomaintain sterility ofthe enclosed deviceuntil used | A device intended tobe used to enclosedanother medicaldevice that is to besterilized by ahealthcare provider. Itis intended to allowsterilization of theenclosed medicaldevice and also tomaintain sterility ofthe enclosed deviceuntil used | A device intended tobe used to enclosedanother medicaldevice that is to besterilized by ahealthcare provider. Itis intended to allowsterilization of theenclosed medicaldevice and also tomaintain sterility ofthe enclosed deviceuntil used | SAME |
| SterilizationModalities | -STERIS VPROmaX/maX2: Lumen,Non-Lumen, Flexible-STERIS VPRO60/s2: Lumen, Non-Lumen, Flexible-STERRAD NX:standard, advanced-STERRAD 100NX: | -Prevac Steam | -Prevac Steam-STERIS VPROmaX/maX2: Lumen,Non-Lumen,Flexible-STERIS VPRO 60Lumen, Non-Lumen,Flexible-STERRAD NX: | SIMILARThe primarypredicate iscleared forPrevac Steamversus thesubject deviceand reference |
| Standard, DUO,Express, Flexible | standard, advanced-STERRAD 100NX:Standard, DUO,Express, Flexible-Ethylene Oxide | predicate arecleared for Sterisand Sterradmodalities. | ||
| -STERRAD 100S-STERIZONE VP4 | ||||
| Material | Container:AnodizedAluminumGasket:Silicone | Container:AnodizedAluminumGasket:Silicone | Container:AnodizedAluminumGasket:Silicone | SAME |
| Filter type andmaterial | Single use(polypropylene) | Single use (paper) | Single use(polypropylene) | SIMILARThe primarypredicate usespaper filterswhereas thesubject deviceand referencepredicate usepolypropylenefilters which aremore appropriatefor the lowtemperaturehydrogenperoxidesterilization. |
| Container design | Perforated bottomwith Perforated lid | Perforated or Non-Perforated bottomwith Perforated Lid | Solid (non -perforated) bottom orSolid bottom withenhanced dryingsystem with withPerforated Lid | SIMILARTesting indicatesthat subjectdevice performsequivalent tosecondarypredicate |
| Air Permeance | Permits entry ofsterilization agent andprevents microbialmigration duringstorage | Permits entry ofsterilization agent andprevents microbialmigration duringstorage | Permits entry ofsterilization agent andprevents microbialmigration duringstorage | SAME |
| Intended forReuse | Yes | Yes | Yes | SAME |
| Conformance toAAMI ST77 | Yes | Yes | Yes | SAME |
| Use withCannulizedInstruments | Yes | Yes | Yes | SAME |
K233578, Page 10 of 17
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The Bahadir Sterilization Containers has the same intended use and principles of operation as the previously cleared predicate devices. The Bahadir Sterilization Container system previously cleared in K131407 and demonstrated the same technical and performance characteristics. All functional and design characteristics of the subject device are the same as the primary predicate K131407, and similar to the reference predicate K214041.
The primary difference is that the subject device and reference predicate device both use low temperature hydrogen peroxide sterilization and use polypropylene filters, whereas the primary predicate device uses steam sterilization and paper filters.
Sterilization efficacy testing has been conducted to support the performance of the device when using the low temperature hydrogen peroxide sterilization cycles included in the new indications.
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PERFORMANCE TESTING
Based on the testing performed on the Bahadir Sterilization Containers, compatibility has been demonstrated with the sterilizers indicated above. Results are summarized in the table below.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Microbial AerosolChallenge TestingTesting per standardsAAMI ST77:2013/ (R)2018AAMI ISO 11607-1:2019AAMI ISO 14937:2009/(R)2013Test to be conductedpost MechanicalCleaning and STERIS V-PRO Lumen Cycle usingworst case, mid case andbest case containers.Test to be conductedpost MechanicalCleaning and STERRAD100NX StandardSterilization Cycle usingworst case, mid case andbest case containers. | To determine the microbialbarrier properties of theBahadir Container Systemsin maintaining sterilitypackage integrity whensubjected to a microbialaerosol challenge testfollowing processing:In one hundred mechanicalcleaning and STERIS V-PROLumen Cycle sterilizationcycles.In one hundred (100)mechanical cleaning andSTERRAD 100NX StandardSterilization Cycles.Full Size (Mid Case) in aSTERIS V-PRO Lumen Cyclesterilization cycle.3/4 Size (Worst Case) in aSTERIS V-PRO Lumen Cyclesterilization cycle.3/4 size (Worst Case) in aSTERRAD 100NX StandardSterilization Cycle.1/2 size (Best Case) in aSTERRAD 100NX StandardSterilization Cycle.full size (Mid Case) in aSTERRAD 100NX StandardSterilization Cycle. | The container systems mustmaintain sterility of its contentsfollowing whole packagemicrobial aerosol challengeafter 100 cleaning cycles andsterilization cycles (STERIS V-PRO Lumen Cycle andSTERRAD 100NX Standard).The worst case, mid case andbest case containers must betested. | PASS - The results concludethat the Bahadir ContainerSystem maintained sterility ofits contents following a wholepackage microbial aerosolchallenge following processing:In one hundred mechanicalcleaning and STERIS V-PROLumen Cycle sterilizationcycles.In one hundred (100)mechanical cleaning andSTERRAD 100NX StandardSterilization Cycles.Full Size (Mid Case) in a STERISV-PRO Lumen Cyclesterilization cycle.3/4 Size (Worst Case) in aSTERIS V-PRO Lumen Cyclesterilization cycle.¾ size (Worst Case) in aSTERRAD 100NX StandardSterilization Cycle.½ size (Best Case) in aSTERRAD 100NX StandardSterilization Cycle.full size (Mid Case) in aSTERRAD 100NX StandardSterilization Cycle. |
| Sterilization Validation | To validate the sterilizationefficacy of the BahadirContainer Systems | The container system mustachieve an SAL of 10-6 whenprocessed using the differentsterilization modalities (STERISV-PRO 60/s2, STERIS V-PROmaX/maX2 lumen cycle andSTERRAD 100NX DUO,STERRAD NX Advanced, 100NXStandard, and 100NX FlexCycles. | PASS - Results from testinghave demonstrated that theBahadir Container Systems wasable to achieve a 10-6 SAL whenprocessed in: |
| Testing per standards | 3/4 Size (Worst Case)Full Size (Mid Case)1/2 Size (Best Case)when processed using: | Testing also mustdemonstrated sterilizationefficacy with lumened devicesand max loads. | |
| AAMI ST77:2013/ (R)2018 | - STERRAD 100NXDUO SterilizationCycle | 3/4 Size (Worst Case), 1/2 Size(Best Case) and Full (Mid Case)when processed in a STERRAD100NX DUO Sterilization Cycle. | |
| AAMI ST81:2004/ (R)2016 | - STERRAD 100NXFlex Cycle | ||
| AAMI ISO 14937:2009/(R)2013Cycle. | - STERRAD NXAdvancedSterilization Cycle | 3/4 (Worst Case), Full (Mid Case)after processing STERRAD NXAdvanced Cycle. | |
| Test containers in theSTERIS V-PRO 60/s2Flexible Cycle. | - STERRAD 100 NXExpress Cycle | 3/4 Size (Worst Case), 1/2 Size(Best Case) and Full Size (MidCase) after processingSTERRAD 100NX FLEXSterilization Cycle. | |
| Test containers in theSTERIS V-PRO maX / maX2 lumen cycle andSTERIS V-PRO 60/s2lumen cycle. | - STERRAD 100NXStandard Cycle | 3/4 Size (Worst Case), 1/2 Size(Best Case) and Full Size (MidCase) after processingSTERRAD 100NX ExpressSterilization Cycle. | |
| Test containers forSTERRAD 100NX DUO,STERRAD NX Advanced,100NX Standard, and100NX Flex Cycle. | - STERRAD NXStandard Cycle | 3/4 Size (Worst Case), 1/2 Size(Best Case) and Full Size (MidCase) after processingSTERRAD 100NX StandardSterilization Cycle. | |
| 3/4 Size (Worst Case), 1/2 Size(Best Case) and Full Size (MidCase) after processingSTERRAD NX StandardSterilization Cycle. | |||
| Sterilization Validation | Continued | ||
| (continued) | The testing was todemonstrate effectivesterilization using BahadirSterilization Containers in:- The STERIS V-PRO 60/s2Flexible Cycle. The test loadwas prepared using a ¾ size(Worst Case).- The STERIS V-PRO maX /maX 2 Flexible Cycle. Thetest load was prepared usinga ¾ size (Worst Case).- The STERIS V-PROmaX/maX2 and 60/s2 NonLumen Cycle- The STERIS V-PROmaX/maX2 and 60/s2Lumen Cycle | PASS - Effective sterilizationusing Bahadir SterilizationContainers was demonstratedafter processing in the STERISV-PRO 60/s2 Flexible Cycle withmax load allowed ss lumens.Testing was performed with theworst-case container size andverified the claims forsterilizing:One flexible surgical endoscopemay be single or dual lumendevice with lumen that are ≥1mm ID and ≤ 990mm in length.Additional load up to 11 lb caninclude stainless steel lumenswith following dimensions ≥1.8mm ID and ≤ 543mm inlength, ≥ 0.76mm ID and ≤ 233mm in length and ≥ 1.0mm IDand ≤ 254mm in length.And in the STERIS V-PROmaX/maX2 and 60/s2 nonlumen cycle in a load usingworst case sterilant penetrationconditions in the V-PRO maXnon lumen cycle. The testingverified that V-PRO maX/maX 2non lumen cycle can sterilizenon-lumened instruments andnon-lumened rigid, semi-rigidand flexible endoscopes.And in the STERIS V-PROmaX/maX2 and 60/s2 LumenCycle in a load using worst casesterilant penetration conditionsin the V-PRO maX/maX 2 lumencycle can sterilize lumeneddevice of different dimensionsas outlined in the report. | |
| Sterilization validation(continued) | (continued) | (continued) | And in the STERIS V-PRO maX /maX 2 Flexible Cycle in a loadcontaining the maximumallowed ss lumens. Testing wasperformed with the worst casecontainer and verified theclaims for sterilizing:Two flexible endoscopes withno additional load. The flexibleendoscopes may be single ordual lumen device with lumenthat are $\ge$ 1mm ID and $\le$1050mm in length.One flexible endoscope withaccessories and additionalinstruments. The flexibleendoscope may contain singleor dual channel lumens that are$\ge$ 1mm ID and $\le$ 1050mm inlength.Additional instruments mayinclude non-lumened orlumened medical devices withlumen that is $\ge$ 0.48mm ID and$\le$ 100mm in length. |
| Material Compatibility ofthe Bahadir Containersto be assessed afterAutomated Cleaning andsterilization modalities (STERRAD 100NXSterilization and STERISV-PRO Sterilization) | To verify the materialcompatibility of the BahadirContainer Systems followingautomated cleaning andSTERRAD 100NXSterilization and STERIS V-PRO Sterilization | The containers must show nosigns of degradation afterautomated cleaning and usingdifferent sterilization modalities(STERRAD 100NX and STERIS V-PRO) | PASS: No degradation wasobserved. |
| 30 Day Event RelatedShelf Life Study | To demonstrate that theBahadir Container Systems | The containers must maintainsterility of internal componentsfor a minimum of 30 daysfollowing exposure to STERRAD100NX Standard cycle andSTERIS V-PRO lumen cycle. | PASS: Based on the results ofthe testing the BahadirContainer Systems |
| Test performed perstandards:AAMI ST77:2013/ (R)2018ISO 11607-1:2006/A1:2014/(R)2019.ISO 14937:2009/ (R)2013The testing is to includeWorst case, mid caseand best case for Bahadircontainers followingSTERRAD 100NXStandard and STERIS V-PRO Lumen Cycles. | - 1/2 Size (Best Case)- 3/4 Size (Worst Case)- Full Size (Mid Case)can effectively maintain thesterility of its internalcontents following exposureto a- STERRAD 100NXStandardSterilization cycle- STERIS V-PROlumen cycleand a minimum 30-dayevent related storage period. | - 1/2 Size (Best Case)- 3/4 Size (Worst Case)- Full Size (Mid Case)maintained the sterility of theircontents following exposure toa- STERRAD 100NXStandard SterilizationCycle- STERIS V-PRO lumencycleFor a minimum of a thirty (30)day shelf life storage period. | |
| 180 Day Event RelatedShelf Life Study | To demonstrate that theBahadir Container Systems | The containers must maintainsterility of their contents for aminimum of 180 days followingSTERIS V-PRO lumen cycle andSTERRAD 100NX Standardcycle). | PASS: Based on the results ofthe testing the BahadirContainer Systems |
| Testing performed perstandards:AAMI ST77:2013/ (R)2018ISO 11607-1:2006/A1:2014/(R)2019.ISO 14937:2009/ (R)2013Testing to include bestcase, worst case and midcase of the BahadirContainers for differentsterilization modalities(STERIS V-PRO Lumencycle, STERRAD 100NX | - 1/2 Size (Best Case)- 3/4 Size (Worst Case)- Full Size (Mid Case)can effectively maintain thesterility of its internalcontents following exposureto a- STERIS V-PROlumen cycle- STERRAD 100NXStandard cycleand a minimum 180-dayevent related storage period. | - 1/2 Size (Best Case)- 3/4 Size (Worst Case)- Full Size (Mid Case)maintained the sterility of theircontents following exposure toa- STERIS V-PRO lumencycle- STERRAD 100NXStandard SterilizationCycleand a minimum 180 day shelflife storage period. | |
| Cytotoxicity Testing | The container materials must | PASS – The device was | |
| To verify that the materialsused for the BahadirSterilization Containers arenon-cytotoxic. | be classified as non-toxic perISO 10994-5 standard. | determined not to be cytotoxic. | |
| Testing conducted perstandardISO 10993-5 | No cytotoxicity or cell lysis wasnoted. | ||
| The testing included:- ½ size (Best Case)ISO Elution Methodfollowing STERIS V-PRO Sterilization- ½ size (Best Case)MEM ElutionMethod followingSTERRAD 100NXStandard CycleSterilization |
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SAFETY AND EFFICACY
The subject device has been tested to and complies with applicable consensus standards and FDA Guidance. All of the testing passed and there were no identified issues that would impact the safety, performance or efficacy of the subject device.
CONCLUSION
The conclusion drawn from the non-clinical testing demonstrates that the subject device, BAHADIR Sterilization Containers, submitted under K233578, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K131407.
§ 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).