BAHADIR STERILIZATION TRAYS

K131407 · Bahadir USA Corp. · KCT · Aug 12, 2014 · General Hospital

Device Facts

• Record ID: K131407
• Device Name: BAHADIR STERILIZATION TRAYS
• Applicant: Bahadir USA Corp.
• Product Code: KCT · General Hospital
• Decision Date: Aug 12, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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.

Device Story

Bahadir Sterilization Containers are reusable, anodized aluminum alloy containers with silicone seals and paper filters; designed to house medical instruments during steam sterilization. Operated by healthcare staff in hospitals/clinics; containers protect instruments from contamination post-sterilization. Features include colored lids for identification, stacking capability (up to 3 containers, max 18 inches height) for pre-vacuum cycles, and validation for air/power-driven instruments. Output is a sterile-contained instrument set; facilitates efficient OR/clinic workflows by maintaining sterility during storage (up to 6 months) or immediate use. Benefits include standardized, validated sterilization environment for diverse instrument loads.

Clinical Evidence

Bench testing only. Validated via 6-month real-time and accelerated aging studies, microbial barrier integrity tests (post-500 cycles), pre-vacuum sterilization efficacy, Immediate Use sterilization efficacy, and stacking performance protocols. All tests passed.

Technological Characteristics

Anodized aluminum alloy construction; stainless steel handles; silicone gasket seals; single-use paper filters. Dimensions vary by model (Full, 3/4, 1/2, Wide, Flat, Mini, Dental). Sterilization via steam (pre-vacuum or Immediate Use). Conforms to AAMI ST77.

Indications for Use

Indicated for use in hospitals and healthcare facilities to contain medical devices for sterilization via pre-vacuum steam (270°F, 4 min, 20 min dry) or Immediate Use steam sterilization. Suitable for air/power-driven instruments and cannulated devices (lumens ≥1mm diameter; length ≤300mm for Full/Wide, ≤200mm for Half/Mini/Flat/Dental).

Regulatory Classification

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.

Predicate Devices

• Bahadir (K112090)
• Bahadir (K102146)
• Aesculap Sterilcontainer (K053389)
• Sklar Sklarlite (K091720)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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<br>Container | 580X280X100 | 24.75 |
| | 580X280X135 | 24.75 |
| | 580X280X150 | 24.75 |
| | 580X280X200 | 24.75 |
| | 580X280X260 | 24.75 |
| 3/4 Size<br>Container | 465x280x100 | 12.5 |
| | 465x280x135 | 12.5 |
| | 465x280x150 | 12.5 |
| 1/2 Size<br>Container | 285x280x100 | 9.25 |
| | 285x280x135 | 9.25 |
| | 285x280x150 | 9.25 |
| | 285x280x200 | 9.25 |
| | 285x280x260 | 9.25 |
| Wide Body<br>Container | 600x400x120 | 24.75 |
| | 600x400x180 | 24.75 |
| Flat<br>Container | 285x280x55 | 9.25 |
| | 285x280x85 | 9.25 |
| Mini<br>Container | 300x140x40 | 6.0 |
| | 300x140x70 | 6.0 |
| | 300x140x100 | 6.0 |
| Dental<br>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: [phone]

### Submitter / Contact Person

Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757 Contact: Ismail Kilic Tel: [phone] Email: [e-mail]

### 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<br>Container | 285x280x100 | 9.25 |
| | 285x280x135 | 9.25 |
| | 285x280x150 | 9.25 |
| | 285x280x200 | 9.25 |
| | 285x280x260 | 9.25 |
| Wide Body<br>Container | 600x400x120 | 24.75 |
| | 600x400x180 | 24.75 |
| Flat<br>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<br>Subject Device | Bahadir<br>K102146 | Bahadir<br>K112090 | Aesculap Sterilcontainer<br>K053389 | Sklar Sklarlite<br>K091720 |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in<br>hospitals and<br>healthcare facilities to<br>contain medical devices<br>that are to be sterilized.<br>Containers allow<br>sterilization of the<br>enclosed medical<br>devices, including<br>surfaces and lumens,<br>and air power driven<br>instruments using high<br>vacuum steam<br>sterilizers for 270 F for<br>4 minutes with 20<br>minutes dry time,<br>Immediate Use/Pre-<br>Vacuum steam<br>sterilization. | Intended for use in<br>hospitals and<br>healthcare facilities to<br>contain other medical<br>devices that are to be<br>sterilized and to allow<br>sterilization of the<br>enclosed medical<br>devices using steam<br>sterilizers. Sterilized<br>devices may be stored<br>and transferred in<br>container. To be used<br>with a pre-vacuum<br>cycle of 4 minutes at<br>270 degrees F with a<br>dry time of 20<br>minutes. | Intended for use in<br>hospitals and healthcare<br>facilities to contain other<br>medical devices that are<br>to be sterilized.<br>Containers allow<br>sterilization of the<br>enclosed medical<br>devices, including<br>surfaces and lumens,<br>using high vacuum<br>steam sterilizers for 270<br>F for 4 minutes with 20<br>minutes (minimum) dry<br>time. | Intended to be used to<br>enclose other medical<br>devices that are to be<br>sterilized by a healthcare<br>provider. It is intended to<br>allow sterilization of the<br>enclosed device and<br>maintain sterility until used.<br>Validated for pre-vac/flash<br>sterilization. | Intended for use in<br>hospitals and<br>healthcare facilities to<br>contain other medical<br>devices that are to be<br>sterilized. Containers<br>allow sterilization of<br>the enclosed medical<br>devices, including<br>surfaces and lumens,<br>using high vacuum<br>steam sterilizers at 270<br>F for 4 minutes with a<br>30 minute (minimum)<br>drying time. |
| Material | Anodized aluminum<br>alloy, stainless steel<br>handles, silicone seal,<br>paper filter lid colors as<br>follows: green, yellow/<br>golden orange, red,<br>deep black and natural<br>aluminum. | Anodized aluminum<br>alloy, stainless steel<br>handles, silicone seal,<br>paper filter, lid color:<br>natural aluminum | Anodized aluminum<br>alloy, (natural),stainless<br>steel handles, silicone<br>seal, paper filter | Anodized aluminum alloy<br>complete with wired mes<br>baskets and accessory lids.<br>Tamper proof seal, paper<br>filter, lid colors as follows:<br>red, blue, green, gold and<br>natural aluminum | Anodized aluminum<br>alloy with plastic<br>tamper proof seal and<br>to be used with paper<br>filters. Lid colors are as<br>follows: yellow, red,<br>blue, green, black and<br>natural aluminum. |
| Filter | Paper filter-one time<br>use | Paper filter-one time<br>use | Paper filter-one time use | Paper filter-one time use<br>with Immediate Use<br>sterilization and reusable<br>filter available for pre<br>vacuum sterilization. | Paper filter-one time<br>use |
| Sterilization<br>Method | Steam | Steam | Steam | Steam | Steam |
| Configurations<br>/ Dimensions | Flat Size: Y310.05A<br>Flat Size: Y310.08A<br>Flat Size: Y311.08A<br>Mini Size: Y410.04A<br>Mini Size: Y410.07A<br>Mini Size: Y410.10A<br>Mini Size: Y411.04A<br>Mini Size: Y411.07A<br>Mini Size: Y411.10A<br>Dental Size: Y510.04A<br>Dental Size: Y510.06A<br>Dental Size:<br>Y510.08A<br>Dental Size: Y510.10A<br>Dental Size: Y510.13A<br>Dental Size: Y511.04A<br>Dental Size: Y511.06A<br>Dental Size: Y511.08A<br>Dental Size: Y511.10A | Full Size Y110.20W<br>Full Size Y110.15W<br>Full Size Y110.13W<br>Full Size Y110.10W<br>3/4 Size Y210.10W<br>3/4 Size Y210.13W<br>3/4 Size Y210.15W<br>1/2 Size Y310.20W<br>1/2 Size Y310.15W<br>1/2 Size Y310.13W<br>1/2 Size Y310.10W | Full Size Y111.10W<br>Full Size Y111.13W<br>Full Size Y111.15W<br>Full Size Y111.20W<br>Full Size Y111.26W<br>Wide Size Y110.62W<br>Wide Size Y110.68W<br>Wide Size Y111.62W<br>Wide Size Y111.68W<br>3/4 Size Y211.10W<br>3/4 Size Y211.13W<br>3/4 Size Y211.15W<br>1/2 Size Y311.10W<br>1/2 Size Y311.13W<br>1/2 Size Y311.15W<br>1/2 Size Y311.20W<br>1/2 Size Y311.26W | Full Size Lid JK489<br>Bottoms:<br>Full Size JK440<br>Full Size JK441<br>3/4 Size Lid JK789<br>Bottoms:<br>3/4 Size JK740<br>3/4 Size JK741<br>3/4 Size JK742<br>1/2 Size Lid JK389<br>Bottoms:<br>1/2 Size JK339<br>1/2 Size JK340<br>1/2 Size JK341<br>1/2 Size JK342<br>1/2 Size JK344<br>Mini Size Lid JK174<br>Bottoms:<br>Mini JK187<br>Mini JK188 | Full Size<br>580mmX280mm<br>Mid Size<br>465mmx280mm<br>Half Size<br>285mm×280mm |
| K131407 | | | | | |
| | Dental Size: Y511.13A<br>Full size Y110.10W<br>Full size Y111.10W<br>Full size Y110.13W<br>Full size Y111.13W<br>Full size Y110.15W<br>Full size Y111.15W<br>Full size Y110.20W<br>Full size Y111.20W<br>Full size Y111.26W<br>Wide size Y110.62W<br>Wide size Y110.68W<br>Wide size Y111.62W<br>Wide size Y111.68W<br>3/4 size Y210.10W<br>3/4 size Y210.13W<br>3/4 size Y210.15W<br>3/4 size Y211.10W<br>3/4 size Y211.13W<br>1/2 size Y310.10W<br>1/2 size Y310.13W<br>1/2 size Y310.15W<br>1/2 size Y310.20W<br>1/2 size Y310.26W<br>1/2 size Y311.10W<br>1/2 size Y311.13W<br>1/2 size Y311.15W<br>1/2 size Y311.20W<br>1/2 size Y311.26W | | | | |
| Perforation | The units included in<br>this submission include<br>perforated and non<br>perforated lids<br>perforated bottoms. | The units included in<br>this submission include<br>perforated lids and<br>non perforated<br>bottoms. | The units included in<br>this submission include<br>perforated lids and non-<br>perforated bottoms. | Units include both<br>perforated and solid, solid<br>bottoms to be used in Pre<br>Vac/Flash sterilizers. | Units include both<br>perforated and non<br>perforated. |
| Air<br>Permeance | Permits entry of<br>sterilization agent and<br>prevents microbial<br>migration during<br>storage. | Permits entry of<br>sterilization agent and<br>prevents microbial<br>migration during<br>storage. | Permits entry of<br>sterilization agent and<br>prevents microbial<br>migration during<br>storage. | Permits entry of sterilization<br>agent and prevents<br>microbial migration during<br>storage. | Permits entry of<br>sterilization agent and<br>prevents microbial<br>migration during<br>storage. |
| Intended for<br>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<br>Parameters | Pre-Vac 270 F at 4<br>minutes, 20 minutes<br>drying time or<br>Immediate Use<br>Sterilization | 270 F at 4 minutes 20<br>minutes drying time. | 270 F at 4 minutes<br>20 minutes drying time. | Steam, Pre Vacuum cycle of<br>4 minutes at 270 degrees F<br>with a dry time of 15<br>minutes or Immediate Use<br>sterilization. | Pre Vacuum cycle of 4<br>minutes at 270 degrees<br>F with a dry time of 30<br>minutes or Immediate<br>Use sterilization. |
| Conformance<br>to AAMI ST77 | Yes | Yes | Yes | Yes | Yes |
| Use with<br>cannulized,<br>lumen,<br>and air and<br>power driven<br>instruments | Max of one (1) each air<br>driven instruments(air<br>driven hand pieces)<br>weighing no more than<br>3 lb and measuring no<br>more than 4" in length;<br>max of one (1) power<br>driven instrument<br>(endoscopy/arthroscopy<br>shaver & saw) weighing<br>no more than 5 lb and<br>measuring no more<br>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.