(454 days)
Not Found
No
The document describes passive sterilization containers and their physical properties and performance under sterilization conditions. There is no mention of any computational or analytical functions that would involve AI or ML.
No
The device is a sterilization container used to hold other medical devices. It does not directly treat or diagnose a medical condition in a patient.
No.
Explanation: The device is a "sterilization container" used to hold other medical devices for sterilization. It does not perform any diagnostic function.
No
The device description clearly states the devices are physical containers made of anodized aluminum alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being for containing other medical devices for sterilization. This is a function related to the preparation and handling of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The device is described as a container made of anodized aluminum alloy. This physical description aligns with a sterilization container, not a device used for in vitro diagnostic testing.
- Performance Studies: The performance studies listed (sterility testing, performance testing, biocompatibility testing, aging studies, sterilization validation, microbial barrier & air impermeability, stacking) are all relevant to the function and safety of a sterilization container. They do not involve the analysis of biological samples for diagnostic purposes.
In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not perform any such function.
N/A
Intended Use / 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.
- 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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/ golden orange, red, black and natural aluminum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject devices were subjected to sterility testing, performance testing and biocompatibility testing. The tests performed are:
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
- 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
Key results: The performance and biocompatibility tests demonstrate that the Bahadir Sterilization Containers are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112090, K102146, K053389, K091720
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 Size | ||
| Container | 580X280X100 | 24.75 |
| 580X280X135 | 24.75 | |
| 580X280X150 | 24.75 | |
| 580X280X200 | 24.75 | |
| 580X280X260 | 24.75 | |
| 3/4 Size | ||
| Container | 465x280x100 | 12.5 |
| 465x280x135 | 12.5 | |
| 465x280x150 | 12.5 | |
| 1/2 Size | ||
| Container | 285x280x100 | 9.25 |
| 285x280x135 | 9.25 | |
| 285x280x150 | 9.25 | |
| 285x280x200 | 9.25 | |
| 285x280x260 | 9.25 | |
| Wide Body | ||
| Container | 600x400x120 | 24.75 |
| 600x400x180 | 24.75 | |
| Flat | ||
| Container | 285x280x55 | 9.25 |
| 285x280x85 | 9.25 | |
| Mini | ||
| Container | 300x140x40 | 6.0 |
| 300x140x70 | 6.0 | |
| 300x140x100 | 6.0 | |
| Dental | ||
| Container | 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 Size | ||
| Container | 285x280x100 | 9.25 |
| 285x280x135 | 9.25 | |
| 285x280x150 | 9.25 | |
| 285x280x200 | 9.25 | |
| 285x280x260 | 9.25 | |
| Wide Body | ||
| Container | 600x400x120 | 24.75 |
| 600x400x180 | 24.75 | |
| Flat | ||
| Container | 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 | Bahadir
Subject Device | Bahadir
K102146 | Bahadir
K112090 | Aesculap Sterilcontainer
K053389 | Sklar Sklarlite
K091720 |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in
hospitals and
healthcare facilities to
contain medical devices
that are to be sterilized.
Containers allow
sterilization of the
enclosed medical
devices, including
surfaces and lumens,
and air power driven
instruments using high
vacuum steam
sterilizers for 270 F for
4 minutes with 20
minutes dry time,
Immediate Use/Pre-
Vacuum steam
sterilization. | Intended for use in
hospitals and
healthcare facilities to
contain other medical
devices that are to be
sterilized and to allow
sterilization of the
enclosed medical
devices using steam
sterilizers. Sterilized
devices may be stored
and transferred in
container. To be used
with a pre-vacuum
cycle of 4 minutes at
270 degrees F with a
dry time of 20
minutes. | Intended for use in
hospitals and healthcare
facilities to contain other
medical devices that are
to be sterilized.
Containers allow
sterilization of the
enclosed medical
devices, including
surfaces and lumens,
using high vacuum
steam sterilizers for 270
F for 4 minutes with 20
minutes (minimum) dry
time. | Intended to be used to
enclose other medical
devices that are to be
sterilized by a healthcare
provider. It is intended to
allow sterilization of the
enclosed device and
maintain sterility until used.
Validated for pre-vac/flash
sterilization. | Intended for use in
hospitals and
healthcare facilities to
contain other medical
devices that are to be
sterilized. Containers
allow sterilization of
the enclosed medical
devices, including
surfaces and lumens,
using high vacuum
steam sterilizers at 270
F for 4 minutes with a
30 minute (minimum)
drying time. |
| Material | Anodized aluminum
alloy, stainless steel
handles, silicone seal,
paper filter lid colors as
follows: green, yellow/
golden orange, red,
deep black and natural
aluminum. | Anodized aluminum
alloy, stainless steel
handles, silicone seal,
paper filter, lid color:
natural aluminum | Anodized aluminum
alloy, (natural),stainless
steel handles, silicone
seal, paper filter | Anodized aluminum alloy
complete with wired mes
baskets and accessory lids.
Tamper proof seal, paper
filter, lid colors as follows:
red, blue, green, gold and
natural aluminum | Anodized aluminum
alloy with plastic
tamper proof seal and
to be used with paper
filters. Lid colors are as
follows: yellow, red,
blue, green, black and
natural aluminum. |
| Filter | Paper filter-one time
use | Paper filter-one time
use | Paper filter-one time use | Paper filter-one time use
with Immediate Use
sterilization and reusable
filter available for pre
vacuum sterilization. | Paper filter-one time
use |
| Sterilization
Method | Steam | Steam | Steam | Steam | Steam |
| Configurations
/ Dimensions | Flat Size: Y310.05A
Flat Size: Y310.08A
Flat Size: Y311.08A
Mini Size: Y410.04A
Mini Size: Y410.07A
Mini Size: Y410.10A
Mini Size: Y411.04A
Mini Size: Y411.07A
Mini Size: Y411.10A
Dental Size: Y510.04A
Dental Size: Y510.06A
Dental Size:
Y510.08A
Dental Size: Y510.10A
Dental Size: Y510.13A
Dental Size: Y511.04A
Dental Size: Y511.06A
Dental Size: Y511.08A
Dental Size: Y511.10A | Full Size Y110.20W
Full Size Y110.15W
Full Size Y110.13W
Full Size Y110.10W
3/4 Size Y210.10W
3/4 Size Y210.13W
3/4 Size Y210.15W
1/2 Size Y310.20W
1/2 Size Y310.15W
1/2 Size Y310.13W
1/2 Size Y310.10W | Full Size Y111.10W
Full Size Y111.13W
Full Size Y111.15W
Full Size Y111.20W
Full Size Y111.26W
Wide Size Y110.62W
Wide Size Y110.68W
Wide Size Y111.62W
Wide Size Y111.68W
3/4 Size Y211.10W
3/4 Size Y211.13W
3/4 Size Y211.15W
1/2 Size Y311.10W
1/2 Size Y311.13W
1/2 Size Y311.15W
1/2 Size Y311.20W
1/2 Size Y311.26W | Full Size Lid JK489
Bottoms:
Full Size JK440
Full Size JK441
3/4 Size Lid JK789
Bottoms:
3/4 Size JK740
3/4 Size JK741
3/4 Size JK742
1/2 Size Lid JK389
Bottoms:
1/2 Size JK339
1/2 Size JK340
1/2 Size JK341
1/2 Size JK342
1/2 Size JK344
Mini Size Lid JK174
Bottoms:
Mini JK187
Mini JK188 | Full Size
580mmX280mm
Mid Size
465mmx280mm
Half Size
285mm×280mm |
| K131407 | | | | | |
| | Dental Size: Y511.13A
Full size Y110.10W
Full size Y111.10W
Full size Y110.13W
Full size Y111.13W
Full size Y110.15W
Full size Y111.15W
Full size Y110.20W
Full size Y111.20W
Full size Y111.26W
Wide size Y110.62W
Wide size Y110.68W
Wide size Y111.62W
Wide size Y111.68W
3/4 size Y210.10W
3/4 size Y210.13W
3/4 size Y210.15W
3/4 size Y211.10W
3/4 size Y211.13W
1/2 size Y310.10W
1/2 size Y310.13W
1/2 size Y310.15W
1/2 size Y310.20W
1/2 size Y310.26W
1/2 size Y311.10W
1/2 size Y311.13W
1/2 size Y311.15W
1/2 size Y311.20W
1/2 size Y311.26W | | | | |
| Perforation | The units included in
this submission include
perforated and non
perforated lids
perforated bottoms. | The units included in
this submission include
perforated lids and
non perforated
bottoms. | The units included in
this submission include
perforated lids and non-
perforated bottoms. | Units include both
perforated and solid, solid
bottoms to be used in Pre
Vac/Flash sterilizers. | Units include both
perforated and non
perforated. |
| Air
Permeance | Permits entry of
sterilization agent and
prevents microbial
migration during
storage. | Permits entry of
sterilization agent and
prevents microbial
migration during
storage. | Permits entry of
sterilization agent and
prevents microbial
migration during
storage. | Permits entry of sterilization
agent and prevents
microbial migration during
storage. | Permits entry of
sterilization agent and
prevents microbial
migration during
storage. |
| Intended for
reuse | 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 |
| Cycle
Parameters | Pre-Vac 270 F at 4
minutes, 20 minutes
drying time or
Immediate Use
Sterilization | 270 F at 4 minutes 20
minutes drying time. | 270 F at 4 minutes
20 minutes drying time. | Steam, Pre Vacuum cycle of
4 minutes at 270 degrees F
with a dry time of 15
minutes or Immediate Use
sterilization. | Pre Vacuum cycle of 4
minutes at 270 degrees
F with a dry time of 30
minutes or Immediate
Use sterilization. |
| Conformance
to AAMI ST77 | Yes | Yes | Yes | Yes | Yes |
| Use with
cannulized,
lumen,
and air and
power driven
instruments | Max of one (1) each air
driven instruments(air
driven hand pieces)
weighing no more than
3 lb and measuring no
more than 4" in length;
max of one (1) power
driven instrument
(endoscopy/arthroscopy
shaver & saw) weighing
no more than 5 lb and
measuring no more
than 10" in length | No | No | Yes | No |
9
10
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
11
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.