BAHADIR STERILIZATION TRAYS

K112090 · Bahadir USA Corp. · KCT · Jun 7, 2012 · General Hospital

Device Facts

• Record ID: K112090
• Device Name: BAHADIR STERILIZATION TRAYS
• Applicant: Bahadir USA Corp.
• Product Code: KCT · General Hospital
• Decision Date: Jun 7, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Intended for use in hosoitals 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 the container. The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

Device Story

Bahadir Sterilization Trays are reusable, anodized aluminum containers designed to house medical instruments during steam sterilization; used in hospitals and healthcare facilities. Trays feature perforated lids and either perforated or non-perforated bottoms; include silicone gaskets and paper filters to maintain sterility during storage. Operation involves placing instruments into the tray, sealing with the lid, and subjecting to a validated pre-vacuum steam cycle (270°F for 4 minutes, 20-minute dry time). Trays protect instruments from contamination during transport and storage. The device benefits patients by ensuring the sterility of surgical instruments prior to use. Healthcare providers use these containers to organize and maintain the sterile integrity of instrument sets.

Clinical Evidence

Bench testing only. Sterility and performance testing conducted to validate the sterilization cycle and container integrity.

Technological Characteristics

Materials: Anodized aluminum, stainless steel handles, silicone gasket, paper filter. Form factor: Various full, 3/4, and 1/2 size containers. Sterilization: Steam (pre-vacuum). Conformance: AAMI ST 77. Connectivity: None.

Indications for Use

Indicated for use in hospitals and healthcare facilities to contain medical devices for steam sterilization, storage, and transfer. Compatible with pre-vacuum steam cycles (270°F, 4 min, 20 min dry time). Supports cannulated instruments (min 1mm diameter).

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 (K102146)

Submission Summary (Full Text)

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#### KII2090 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

Revised July 8, 2011 Revised February 27, 2012 Revised April 2, 2012 Revised May 22, 2012

#### Name of Device

BAHADIR STERILIZATION TRAYS (INCLUDING WIDE BODY)

### Classification Name

Sterilization Wraps, Trays, Containers Class 2 - KCT

## Predicate Device

Bahadir — K102146

JUN - 7 2012

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## Description of the Device Intended Use

Intended for use in hosoitals 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 the container.

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices (natural aluminum color containers and lids) subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length

% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W

1% Max Load Wt. 12.5 Ibs including basket & instruments) Lumen Size min 1mm diameter X 200mm length

(1/2 Size Max Load Wt. 9.25 Ibs including basket & instruments} Lumen size min 1mm diameter X 200mm length

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## DESCRIPTION

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W

The devices are composed of anodized aluminum (this does not include colored anodized lids).

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## Comparison to Predicate Devices

The containers are the identical design, materials, sterilization cycle, and indications for use. The only difference is the dimensions (sizes).

| Feature | Bahadir | Bahadir K102146 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in<br>hospitals and<br>healthcare facilities<br>to contain other<br>medical devices that<br>are to be sterilized.<br>Containers allow<br>sterilization of the<br>enclosed medical<br>devices, including<br>surfaces and<br>lumens, using high<br>vacuum steam<br>sterilizers for 270 F<br>for 4 minutes with<br>20 minutes<br>(minimum) dry time. | Intended for use in<br>hospitals and<br>healthcare facilities<br>to contain other<br>medical devices that<br>are to be sterilized.<br>Containers allow<br>sterilization of the<br>enclosed medical<br>devices, including<br>surfaces and<br>lumens, using high<br>vacuum steam<br>sterilizers for 270 F<br>for 4 minutes with<br>20 minutes<br>(minimum) dry time. |
| Material | Aluminum Alloy,<br>stainless steel<br>handles, silicone<br>seal, paper filter | Aluminum Alloy,<br>stainless steel<br>handles, silicone<br>seal, paper filter |
| Filter | Paper Filter | Paper Filter |
| Sterilization Method | Steam | Steam |
| Configurations /<br>Dimensions | Includes:<br><br>Full Size Y111.10W<br>(580x280x100mm)<br>Full Size Y111.13W<br>(580x280x135mm)<br>Full Size Y111.15W<br>(580x280x150mm)<br>Full Size Y111.20W<br>(580x280x200mm)<br>Full Size Y111.26W<br>(580x280x260mm) | Includes 1/2 size, 3/4<br>size, and full size<br><br>Full size<br>580mm x 280mm x<br>200mm<br>580mm x 280mm x<br>150mm<br>580mm x 280mm x<br>135mm<br>580mm x 280mm x<br>100mm |

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| | Full Size Y110.62W<br>(600x400x120mm)<br>Full Size Y110.68W<br>(600x400x180mm)<br>Full Size Y111.62W<br>(600x400x120mm)<br>Full Size Y111.68W<br>(600x400x180mm)<br>3/4 Size Y211.10W<br>(465x280x100mm)<br>3/4 Size Y211.13W<br>(465x280x135mm)<br>3/4 Size Y211.15W<br>(465x280x150mm)<br>1/2 Size Y311.10W<br>(285x280x100mm)<br>1/2 Size Y311.13W<br>(285x280x135mm)<br>1/2 Size Y311.15W<br>(285x280x150mm)<br>1/2 Size Y311.20W<br>(285x280x200mm)<br>1/2 Size Y311.26W<br>(285x280x260mm) | 3/4 Size<br>465mm x 280mm x<br>150mm<br>465mm x 280mm x<br>135mm<br>465mm x 280mm x<br>100mm<br>1/2 size<br>285mm x 280mm x<br>200mm<br>285mm x 280mm x<br>150mm<br>285mm x 280mm x<br>135mm<br>285mm x 280mm x<br>100mm | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Perforation | The units included in<br>this submission<br>include perforated<br>lids and both non-<br>perforated and<br>perforated bottoms. | The units included in<br>this submission<br>include perforated<br>lids and non-<br>perforated bottoms. | | |
| Air Permeance | Permits entry of<br>sterilization agent<br>and prevents<br>microbial migration<br>during storage. | Permits entry of<br>sterilization agent<br>and prevents<br>microbial migration<br>during storage. | | |
| Intended to be re-<br>used | Yes | Yes | | |
| Sealed | Yes | Yes | | |
| Conformance to<br>AAMI ST 77 | Yes | Yes | | |
| Gasket | Silicone Based (gray<br>color) | Silicone Based (gray<br>color) | | |
| Handles | Wider handles with<br>silicone holder | Wider handles with<br>silicone holder | | |
| Cycle Parameters | 270 F at 4 minutes | 270 F at 4 minutes | | |

.

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The differences are as follows:

- The only difference is the dimensions (wide body size). .
- Includes non-perforated and perforated bottom o
- Can be used with cannulized instruments o

## Non-Clinical Tests Performed

The subject devices were subjected to sterility testing and performance testing.

### Summary

In conclusion we believe the devices are substantially equivalent to the predicate devices and do not introduce new issues of safety or effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ismail Kilic President Bahadir USA Corporation 275 West Hoffman Avenue Lindenhurst, New York 11757

JUN - 7 2012

Re: K112090

Trade/Device Name: Bahadir USA Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 29, 2012 Received: May 31, 2012

Dear Mr. Kilic:

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.

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#### Page 2 - Mr. Kilic

Enclosure

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 requirenients 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.goy/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): 11 2090

Device Name: Bahadir USA Sterilization Trays

· Indications For Use:

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 sterilized devices may be stored and transferred in the container.

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices (natural aluminum color containers and lids) subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length

% Size Y211.10W % Size Y211.13W % Size Y211.15W

(% Max Load Wt. 12.5 Ibs

including basket & instruments)

Lumen Size min 1mm diameter

½ Size Y311.26W

(½ Size Max Load Wt. 9.25 Ibs including basket & instruments) Lumen size min 1mm diameter X 200mm length

½ Size Y311.10W

½ Size Y311.13W

½ Size Y311.15W

1/2 Size Y311.20W

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

X 200mm length

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) |
|--------------------------------------------------------|
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| (Division Sign-Off) |
|----------------------------------------------|
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |

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| 510(k) Number: | K112090 |
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