(454 days)
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process.
- 3 containers MAXIMUM can be stacked.
- Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process. Immediate Use sterilized devices cannot be stored.
The devices included in this submission are to be used with a pre-vacuum, three pulse of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.
The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:
| Flat Size Y310.05A | Mini Size Y410.04A | Dental Size Y510.04A |
|---|---|---|
| Flat Size Y310.08A | Mini Size Y410.07A | Dental Size Y510.06A |
| Flat Size Y311.08A | Mini Size Y410.10A | Dental Size Y510.08A |
| Mini Size Y411.04A | Dental Size Y510.10A | |
| Mini Size Y411.07A | Dental Size Y510.13A | |
| Mini Size Y411.10A | Dental Size Y511.04A | |
| Dental Size Y511.06A | ||
| Dental Size Y511.08A | ||
| Dental Size Y511.10A | ||
| Full size Y110.10W | 3/4 size Y210.10W | 1/2 size Y310.10W |
| Full size Y111.10W | 3/4 size Y210.13W | 1/2 size Y310.13W |
| Full size Y110.13W | 3/4 size Y210.15W | 1/2 size Y310.15W |
| Full size Y111.13W | 3/4 size Y211.10W | 1/2 size Y310.20W |
| Full size Y110.15W | 3/4 size Y211.13W | 1/2 size Y310.26W |
| Full size Y111.15W | 3/4 size Y211.15W | 1/2 size Y311.10W |
| Full size Y110.20W | 1/2 size Y311.13W | |
| Full size Y111.20W | 1/2 size Y311.15W | |
| Full size Y111.26W | 1/2 size Y311.20W | |
| Wide size Y110.62W | 1/2 size Y311.26W | |
| Wide size Y110.68W | ||
| Wide Size Y111.62W | ||
| Wide Size Y111.68W |
The devices are composed of anodized aluminum alloy with lid colors as follows: green, yellow/ qolden orange, red, black and natural aluminum.
The provided document describes the acceptance criteria and the studies performed for the Bahadir Sterilization Containers. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in a formal table with corresponding performance metrics in a way that typically applies to AI/software performance (e.g., sensitivity, specificity, AUC). Instead, it describes various validation tests for the physical sterilization containers. The "acceptance criterion" for each test is implicitly that the "Test Passed."
| Acceptance Criteria (Implicit: Test Passed) | Reported Device Performance |
|---|---|
| Device maintains sterility after 6-month real-time aging | Test Passed for Dental Containers |
| Device maintains sterility after 6-month real-time aging | Test Passed for Aluminum Sterilization Containers |
| Device maintains microbial barrier integrity after 6-month accelerated aging | Test Passed for Half, Three Quarter & Full Size Containers; Full and Wide Body Size Containers; Mini, Flat & Dental Size Containers |
| Device effectively sterilizes instruments in pre-vac cycles | Test Passed for Mini, Dental & Flat Containers; Half, Three-Quarter & Full Size Containers; Wide Body Containers |
| Device maintains air impermeability after 500 sterilization cycles | Test Passed |
| Device demonstrates microbial barrier properties | Test Passed |
| Device effectively sterilizes instruments for immediate use | Test Passed for Mini, Dental & Flat Containers; Half, Three Quarter, Full & Wide Body Size Containers |
| Stacking of containers during sterilization is validated | Test Passed for Full, Wide, Three Quarter & Half Size Containers; Dental Sterilization; ¾ Size Containers; Mini Dental Size Containers |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is a 510(k) summary for a physical medical device (sterilization containers), not an AI/software device. Therefore, the concepts of "test set sample size" and "data provenance" (like country of origin of data, retrospective/prospective) as they apply to clinical studies for AI are not directly relevant or reported. The "samples" in this context refer to the physical containers themselves and the items sterilized within them. The specific number of containers tested for each validation is not provided in this summary but is implied to be sufficient for a "Test Passed" conclusion. The provenance of the testing (where the tests were conducted) is not explicitly stated, but it would typically be in a certified testing laboratory.
3. 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)
This information is not applicable to this document. The "ground truth" for a sterilization container is assessed through validated physical and microbiological testing methods, not through expert consensus or interpretation in the way it would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where human interpretation of medical data (e.g., radiology images) is being compared or refined.
5. 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
This information is not applicable. MRMC studies are relevant for AI/software devices that assist human readers (e.g., radiologists, pathologists). This document concerns a physical sterilization container.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. A standalone algorithm performance study applies to AI/software, not physical sterilization containers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the sterilization containers is established through physical and microbiological validation testing. This includes:
- Sterility testing: Ensuring no microbial growth after sterilization and storage.
- Aging studies: Demonstrating maintained integrity over time.
- Microbial barrier integrity studies: Confirming the container prevents microbial ingress.
- Air impermeability testing: Verifying the container's seals and filters function correctly.
- Stacking validation: Confirming structural integrity and sterilization effectiveness when stacked.
8. The sample size for the training set
This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2014
Bahadir USA Corporation Mr. Ismail Kilic President 275 West Hoffman Avenue Lindenhurst, NY 11757
Re: K131407
Trade/Device Name: Bahadir Sterilization Containers Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wraps, Trays, Containers Regulatory Class: II Product Code: KCT Dated: August 1, 2014 Received: August 4, 2014
Dear Mr. Kilic:
This letter corrects our substantially equivalent letter of August 12, 2014.
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 (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. 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.
{1}------------------------------------------------
Page 2 - Mr. Kilic
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use (Page 1 of 3)
510(k) Number: K131407
Device Name: Bahadir Sterilization Containers
Indications For Use:
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised.
Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum confiquration. Containers are marked as to their height to facilitate this process.
- 3 containers MAXIMUM can be stacked.
- 0 Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process.
The devices included in this submission are to be used with a pre-vacuum, three pulse standard cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.
The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:
| Flat Size Y310.05A | Mini Size Y410.04A | Dental Size Y510.04A |
|---|---|---|
| Flat Size Y310.08A | Mini Size Y410.07A | Dental Size Y510.06A |
| Flat Size Y311.08A | Mini Size Y410.10A | Dental Size Y510.08A |
| Mini Size Y411.04A | Dental Size Y510.10A | |
| Mini Size Y411.07A | Dental Size Y510.13A | |
| Mini Size Y411.10A | Dental Size Y511.04A | |
| Dental Size Y511.06A | ||
| Dental Size Y511.08A | ||
| Dental Size Y511.10A | ||
| Dental Size Y511.13A | ||
| Full size Y110.10W | 3/4 size Y210.10W | 1/2 size Y310.10W |
| Full size Y111.10W | 3/4 size Y210.13W | 1/2 size Y310.13W |
| Full size Y110.13W | 3/4 size Y210.15W | 1/2 size Y310.15W |
| Full size Y111.13W | 3/4 size Y211.10W | 1/2 size Y310.20W |
| Full size Y110.15W | 3/4 size Y211.13W | 1/2 size Y310.26W |
| Full size Y111.15W | 3/4 size Y211.15W | 1/2 size Y311.10W |
| Full size Y110.20W | 1/2 size Y311.13W | |
| Full size Y111.20W | 1/2 size Y311.15W | |
| Full size Y111.26W | 1/2 size Y311.20W | |
| Wide size Y110.62W | 1/2 size Y311.26W | |
| Wide size Y110.68W | ||
| Wide size Y111.62W | ||
| Wide size Y111.68W |
{3}------------------------------------------------
Indications for Use (Page 2 of 3)
The Containers have been validated for sterilization of instrument load weights shown below, and may include in this max load weight up to 2 instruments with lumens no smaller than 1 mm in diameter and no longer than 300 mm in length for the Full Size, ¾ Size, and Wide Body Containers, and no smaller than 1 mm in diameter and no longer than 200mm in length for the Half Size, Mini, Flat, & Dental Containers.
The maximum load weights for the Sterilization Containers which are the subject of this premarket notification are as follows:
| Model | Dimensions (mm) | LBS. |
|---|---|---|
| 1/1 SizeContainer | 580X280X100 | 24.75 |
| 580X280X135 | 24.75 | |
| 580X280X150 | 24.75 | |
| 580X280X200 | 24.75 | |
| 580X280X260 | 24.75 | |
| 3/4 SizeContainer | 465x280x100 | 12.5 |
| 465x280x135 | 12.5 | |
| 465x280x150 | 12.5 | |
| 1/2 SizeContainer | 285x280x100 | 9.25 |
| 285x280x135 | 9.25 | |
| 285x280x150 | 9.25 | |
| 285x280x200 | 9.25 | |
| 285x280x260 | 9.25 | |
| Wide BodyContainer | 600x400x120 | 24.75 |
| 600x400x180 | 24.75 | |
| FlatContainer | 285x280x55 | 9.25 |
| 285x280x85 | 9.25 | |
| MiniContainer | 300x140x40 | 6.0 |
| 300x140x70 | 6.0 | |
| 300x140x100 | 6.0 | |
| DentalContainer | 310x190x40 | 9.25 |
| 310x190x65 | 9.25 | |
| 310x190x130 | 9.25 |
Maximum Recommended Load (including basket and contents)
{4}------------------------------------------------
Indications for Use
(Page 3 of 3)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{5}------------------------------------------------
K131407 510(k) Summary (as required by 21 CFR 807.92(c))
Manufacturer Name and Address
Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757 Contact: Ismail Kilic Tel: 631-608-8522
Submitter / Contact Person
Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757 Contact: Ismail Kilic Tel: 631-608-8522 Email: info@bahadirusa.com
Date Prepared
August 12, 2014
Name of Device
BAHADIR STERILIZATION CONTAINERS
Classification Name
Sterilization Wraps, Trays, Containers Class II - KCT
Requlation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray
Predicate Devices
Bahadir — K112090 Bahadir- K102146 Aesculap – K053389 Sklar – K091720
{6}------------------------------------------------
K131407 Intended Use:
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process.
- 3 containers MAXIMUM can be stacked.
- Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process. Immediate Use sterilized devices cannot be stored.
The devices included in this submission are to be used with a pre-vacuum, three pulse of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.
DESCRIPTION OF DEVICE
The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:
| Flat Size Y310.05A | Mini Size Y410.04A | Dental Size Y510.04A |
|---|---|---|
| Flat Size Y310.08A | Mini Size Y410.07A | Dental Size Y510.06A |
| Flat Size Y311.08A | Mini Size Y410.10A | Dental Size Y510.08A |
| Mini Size Y411.04A | Dental Size Y510.10A | |
| Mini Size Y411.07A | Dental Size Y510.13A | |
| Mini Size Y411.10A | Dental Size Y511.04A | |
| Dental Size Y511.06A | ||
| Dental Size Y511.08A | ||
| Dental Size Y511.10A | ||
| Full size Y110.10W | 3/4 size Y210.10W | 1/2 size Y310.10W |
| Full size Y111.10W | 3/4 size Y210.13W | 1/2 size Y310.13W |
| Full size Y110.13W | 3/4 size Y210.15W | 1/2 size Y310.15W |
| Full size Y111.13W | 3/4 size Y211.10W | 1/2 size Y310.20W |
| Full size Y110.15W | 3/4 size Y211.13W | 1/2 size Y310.26W |
| Full size Y111.15W | 3/4 size Y211.15W | 1/2 size Y311.10W |
| Full size Y110.20W | 1/2 size Y311.13W | |
| Full size Y111.20W | 1/2 size Y311.15W | |
| Full size Y111.26W | 1/2 size Y311.20W | |
| Wide size Y110.62W | 1/2 size Y311.26W | |
| Wide size Y110.68W | ||
| Wide Size Y111.62W | ||
| Wide Size Y111.68W |
The devices are composed of anodized aluminum alloy with lid colors as follows: green, yellow/ qolden orange, red, black and natural aluminum.
{7}------------------------------------------------
Indications For Use:
Intended for use in hospitals and healthcare facilties to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process.
The Containers have been validated for sterilization of up to 2 instruments with lumens no smaller than 1 mm in diameter and no longer than 300 mm in length for the Full Size, and Wide Body Containers, and no smaller than 1 mm in diameter and no longer than 200mm in length for the Half Size, Mini, Flat, & Dental Containers. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process
- 3 containers MAXIMUM can be stacked. .
- Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process.
The maximum load weights for the Sterilization Containers which are the subject of this premarket notification are as follows:
| Maximum Recommended Load | (including basket and contents) | |
|---|---|---|
| Model | Dimensions (mm) | LBS. |
| 1/1 Size | 580X280X100 | 24.75 |
| 580X280X135 | 24.75 | |
| 580X280X150 | 24.75 | |
| Container | 580X280X200 | 24.75 |
| 580X280X260 | 24.75 | |
| 3/4 Size | 465x280x100 | 12.5 |
| 465x280x135 | 12.5 | |
| Container | 465x280x150 | 12.5 |
| 1/2 SizeContainer | 285x280x100 | 9.25 |
| 285x280x135 | 9.25 | |
| 285x280x150 | 9.25 | |
| 285x280x200 | 9.25 | |
| 285x280x260 | 9.25 | |
| Wide BodyContainer | 600x400x120 | 24.75 |
| 600x400x180 | 24.75 | |
| FlatContainer | 285x280x55 | 9.25 |
| 285x280x85 | 9.25 | |
| Mini | 300x140x40 | 6.0 |
| 300x140x70 | 6.0 | |
| Container | 300x140x100 | 6.0 |
| Dental | 310x190x40 | 9.25 |
| 310x190x65 | 9.25 | |
| Container | 310x190x130 | 9.25 |
{8}------------------------------------------------
Comparison to Predicate Devices
The containers are the identical design to the predicates. The differences are the dimensions (sizes), addition of colored lids, addition of Pre Vacuum and Immediate Use Sterilization, validation for stacking and use with air and power driven instruments.
| Feature | BahadirSubject Device | BahadirK102146 | BahadirK112090 | Aesculap SterilcontainerK053389 | Sklar SklarliteK091720 |
|---|---|---|---|---|---|
| Intended Use | Intended for use inhospitals andhealthcare facilities tocontain medical devicesthat are to be sterilized.Containers allowsterilization of theenclosed medicaldevices, includingsurfaces and lumens,and air power driveninstruments using highvacuum steamsterilizers for 270 F for4 minutes with 20minutes dry time,Immediate Use/Pre-Vacuum steamsterilization. | Intended for use inhospitals andhealthcare facilities tocontain other medicaldevices that are to besterilized and to allowsterilization of theenclosed medicaldevices using steamsterilizers. Sterilizeddevices may be storedand transferred incontainer. To be usedwith a pre-vacuumcycle of 4 minutes at270 degrees F with adry time of 20minutes. | Intended for use inhospitals and healthcarefacilities to contain othermedical devices that areto be sterilized.Containers allowsterilization of theenclosed medicaldevices, includingsurfaces and lumens,using high vacuumsteam sterilizers for 270F for 4 minutes with 20minutes (minimum) drytime. | Intended to be used toenclose other medicaldevices that are to besterilized by a healthcareprovider. It is intended toallow sterilization of theenclosed device andmaintain sterility until used.Validated for pre-vac/flashsterilization. | Intended for use inhospitals andhealthcare facilities tocontain other medicaldevices that are to besterilized. Containersallow sterilization ofthe enclosed medicaldevices, includingsurfaces and lumens,using high vacuumsteam sterilizers at 270F for 4 minutes with a30 minute (minimum)drying time. |
| Material | Anodized aluminumalloy, stainless steelhandles, silicone seal,paper filter lid colors asfollows: green, yellow/golden orange, red,deep black and naturalaluminum. | Anodized aluminumalloy, stainless steelhandles, silicone seal,paper filter, lid color:natural aluminum | Anodized aluminumalloy, (natural),stainlesssteel handles, siliconeseal, paper filter | Anodized aluminum alloycomplete with wired mesbaskets and accessory lids.Tamper proof seal, paperfilter, lid colors as follows:red, blue, green, gold andnatural aluminum | Anodized aluminumalloy with plastictamper proof seal andto be used with paperfilters. Lid colors are asfollows: yellow, red,blue, green, black andnatural aluminum. |
| Filter | Paper filter-one timeuse | Paper filter-one timeuse | Paper filter-one time use | Paper filter-one time usewith Immediate Usesterilization and reusablefilter available for prevacuum sterilization. | Paper filter-one timeuse |
| SterilizationMethod | Steam | Steam | Steam | Steam | Steam |
| Configurations/ Dimensions | Flat Size: Y310.05AFlat Size: Y310.08AFlat Size: Y311.08AMini Size: Y410.04AMini Size: Y410.07AMini Size: Y410.10AMini Size: Y411.04AMini Size: Y411.07AMini Size: Y411.10ADental Size: Y510.04ADental Size: Y510.06ADental Size:Y510.08ADental Size: Y510.10ADental Size: Y510.13ADental Size: Y511.04ADental Size: Y511.06ADental Size: Y511.08ADental Size: Y511.10A | Full Size Y110.20WFull Size Y110.15WFull Size Y110.13WFull Size Y110.10W3/4 Size Y210.10W3/4 Size Y210.13W3/4 Size Y210.15W1/2 Size Y310.20W1/2 Size Y310.15W1/2 Size Y310.13W1/2 Size Y310.10W | Full Size Y111.10WFull Size Y111.13WFull Size Y111.15WFull Size Y111.20WFull Size Y111.26WWide Size Y110.62WWide Size Y110.68WWide Size Y111.62WWide Size Y111.68W3/4 Size Y211.10W3/4 Size Y211.13W3/4 Size Y211.15W1/2 Size Y311.10W1/2 Size Y311.13W1/2 Size Y311.15W1/2 Size Y311.20W1/2 Size Y311.26W | Full Size Lid JK489Bottoms:Full Size JK440Full Size JK4413/4 Size Lid JK789Bottoms:3/4 Size JK7403/4 Size JK7413/4 Size JK7421/2 Size Lid JK389Bottoms:1/2 Size JK3391/2 Size JK3401/2 Size JK3411/2 Size JK3421/2 Size JK344Mini Size Lid JK174Bottoms:Mini JK187Mini JK188 | Full Size580mmX280mmMid Size465mmx280mmHalf Size285mm×280mm |
| K131407 | |||||
| Dental Size: Y511.13AFull size Y110.10WFull size Y111.10WFull size Y110.13WFull size Y111.13WFull size Y110.15WFull size Y111.15WFull size Y110.20WFull size Y111.20WFull size Y111.26WWide size Y110.62WWide size Y110.68WWide size Y111.62WWide size Y111.68W3/4 size Y210.10W3/4 size Y210.13W3/4 size Y210.15W3/4 size Y211.10W3/4 size Y211.13W1/2 size Y310.10W1/2 size Y310.13W1/2 size Y310.15W1/2 size Y310.20W1/2 size Y310.26W1/2 size Y311.10W1/2 size Y311.13W1/2 size Y311.15W1/2 size Y311.20W1/2 size Y311.26W | |||||
| Perforation | The units included inthis submission includeperforated and nonperforated lidsperforated bottoms. | The units included inthis submission includeperforated lids andnon perforatedbottoms. | The units included inthis submission includeperforated lids and non-perforated bottoms. | Units include bothperforated and solid, solidbottoms to be used in PreVac/Flash sterilizers. | Units include bothperforated and nonperforated. |
| AirPermeance | Permits entry ofsterilization agent andprevents microbialmigration duringstorage. | Permits entry ofsterilization agent andprevents microbialmigration duringstorage. | Permits entry ofsterilization agent andprevents microbialmigration duringstorage. | Permits entry of sterilizationagent and preventsmicrobial migration duringstorage. | Permits entry ofsterilization agent andprevents microbialmigration duringstorage. |
| Intended forreuse | Yes | Yes | Yes | Yes | Yes |
| Sealed | Yes | Yes | Yes | Yes | Yes |
| Gasket | Silicone based | Silicone based | Silicone based | Silicone based | Silicone based |
| Handles | Stainless steel | Stainless steel | Stainless steel | Stainless steel | Stainless steel |
| CycleParameters | Pre-Vac 270 F at 4minutes, 20 minutesdrying time orImmediate UseSterilization | 270 F at 4 minutes 20minutes drying time. | 270 F at 4 minutes20 minutes drying time. | Steam, Pre Vacuum cycle of4 minutes at 270 degrees Fwith a dry time of 15minutes or Immediate Usesterilization. | Pre Vacuum cycle of 4minutes at 270 degreesF with a dry time of 30minutes or ImmediateUse sterilization. |
| Conformanceto AAMI ST77 | Yes | Yes | Yes | Yes | Yes |
| Use withcannulized,lumen,and air andpower driveninstruments | Max of one (1) each airdriven instruments(airdriven hand pieces)weighing no more than3 lb and measuring nomore than 4" in length;max of one (1) powerdriven instrument(endoscopy/arthroscopyshaver & saw) weighingno more than 5 lb andmeasuring no morethan 10" in length | No | No | Yes | No |
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The differences are as follows:
- The dimensions (sizes) ●
- Addition of colored lids green, yellow/ golden orange, red, deep black and ● natural aluminum
- Addition of Immediate Use Sterilization ●
- Addition of stacking option ●
- . Addition of ability to be used with air and power driven instruments
The above differences were addressed with validation testing and do not affect the safety and effectiveness of the subject device when used as labeled.
Non-Clinical Tests Performed
The subject devices were subjected to sterility testing, performance testing and biocompatibility testing.
Aging Studies:
Six Month Real Time Aging Validation For Dental Containers Report- Test Passed
Six Month Real Time Aging Validation For Aluminum Sterilization Containers Report– Test Passed
Six Month Accelerated Aqinq Validation & Container Microbial Barrier Integrity Study for Half, Three Quarter & Full Size Container Report- Test Passed
Six Month Accelerated Aging Validation & Container Microbial Barrier Integrity Study for Full and Wide Body Size Container Report- Test Passed
Six Month Accelerated Aging Validation & Container Microbial Barrier Integrity Study for Mini, Flat & Dental Size Container Report- Test Passed
Pre-Vac Sterilization:
Pre-Vac Sterilization Validation for Mini, Dental & Flat Containers Report- Test Passed
Pre-Vac Sterilization Validation for Half, Three-Quarter & Full Size Containers Report - Test Passed
Pre-Vac Sterilization Validation for Wide Body Containers- Test Passed
Microbial Barrier & Air Impermeability:
Air Impermeability Performance after 500 sterilization cycles Report- Test Passed
Investigation of Microbial Barrier Properties Report- Test Passed
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Six Month Accelerated Aging Validation & Container Microbial Barrier Integrity Study for Half, Three Quarter & Full Size Container Report - Test Passed
Six Month Accelerated Aging Validation & Container Microbial Barrier Integrity Study for Full and Wide Body Size Container Report - Test Passed
Six Month Accelerated Aging Validation & Container Microbial Barrier Integrity Study for Mini, Flat & Dental Size Container Report - Test Passed
Immediate Use:
Immediate Use Sterilization Validation Summary for Mini, Dental & Flat Containers Report -Test Passed
Immediate Use Sterilization Validation Summary for Half, Three Quarter, Full & Wide Body Size Containers Report- Test Passed
Stacking:
Stacking Validation Full, Wide, Three Quarter & Half Size Containers Report - Test Passed
Stacking Validation For Dental Sterilization Report - Test Passed
Stacking Validation Protocol - ¾ Size Containers - Testing completed and passed
Stacking Validation Protocol Mini Dental Size Containers – Testing completed & passed
Summary
The performance and biocompatibility tests demonstrate that the Bahadir Sterilization Containers are substantially equivalent to the predicate devices.
§ 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).