BAHADIR STERILIZATION TRAYS
Device Facts
| Record ID | K102146 |
|---|---|
| Device Name | BAHADIR STERILIZATION TRAYS |
| Applicant | Bahadir USA Corp. |
| Product Code | KCT · General Hospital |
| Decision Date | Nov 18, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
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 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 rigid containers designed to house surgical instruments during steam sterilization; storage; and transport. Constructed of anodized aluminum with stainless steel handles and silicone gaskets; trays feature perforated lids and non-perforated bottoms. Operation involves placing instruments inside; sealing the container; and subjecting it to a pre-vacuum steam sterilization cycle (270°F for 4 minutes; 20-minute dry time). Used in hospitals and healthcare facilities by clinical staff. Output is a sterilized container protecting instruments from contamination during storage. Benefits include maintaining sterility of surgical tools until point of use. Handles include silicone holders to prevent thermal injury to users.
Clinical Evidence
Bench testing only. Validation included cleaning validation, aging studies, half-cycle testing, sterility testing, and performance testing using empty, textile-loaded, and surgical instrument-loaded configurations.
Technological Characteristics
Anodized aluminum containers; stainless steel handles; silicone gaskets; paper filters. Dimensions range from 1/2 size to full size. Steam sterilization compatibility (pre-vacuum 270°F). Conforms to AAMI ST 77. Non-powered, passive mechanical device.
Indications for Use
Indicated for use in hospitals and healthcare facilities to contain medical devices for steam sterilization and subsequent storage/transfer. Not validated for use with lumened devices, air-driven instruments, power systems, or cannulized instruments.
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
- Miltex Rigid Sterilization Trays (K050570)
- Sklar – SklarLite Rigid Sterilization Container (K091720)
Submission Summary (Full Text)
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# 510(k) Summary (as required by 21 CFR 807.92(c))
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## Manufacturer Name and Address
Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757 Contact: Ismail Kilic Tel: 631-608-8522
NOV 1 8 2010
FIDENTIAL DOCUMENT
__. ___ ____ _________________________________________________________________________________________________________________________________________________________________
### Submitter / Contact Person / Regulatory Correspondent
Ismail Kilic Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757
Tel: 631-608-8522 Email: info@bahadirusa.com
510(k) Written By: Joseph Azary / Orchid Design
Date Prepared Revised September 23, 2010
### Name of Device
BAHADIR STERILIZATION TRAYS
### Classification Name
Sterilization Wraps, Trays, Containers Class 2 - KCT
### Predicate Device
Miltex Rigid Sterilization Trays - K050570 Sklar – SklarLite Rigid Sterilization Container – K091720
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K102146
CONFIDENTIAL DOCUMENT
p2 of 6
## Description of the Device Intended 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 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 1/1 Y110.20 Full Size 1/1 Y110.15 Full Size 1/1 Y110.13 Full Size 1/1 Y110.10 3/4 Size Y210.10 34 Size Y210.15 3/4 Size Y210.13 1/2 Size Y310.20 1/2 Size Y310.15 1/2 Size Y310.13 1/2 Size Y310.10
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for 34 size, and 9.25 Ibs for 1/2 size. The sterilization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments.
The subject trays are not validated for use with lumened devices, air driven instruments, power systems, or cannulized instruments.
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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. Stacking during sterilization is not recommended.
The devices subject to this submission are as follows:
Full Size 1/1 Y110.20 (580 x 280 x 200mm) Full Size 1/1 Y110.15 (580 x 280 x 150mm) Full Size 1/1 Y110.13 (580 x 280 x 135mm) Full Size 1/1 Y110.10 (580 x 280 x 100mm) 3/4 Size Y210.15 (465 x 280 x 150mm) 3/4 Size Y210.13 (465 x 280 x 135mm) 3/4 Size Y210.10 (465 x 280 x 100mm) 1/2 Size Y310.20 (285 x 280 x 200mm) 1/2 Size Y310.15 (285 x 280 x 150mm) 1/2 Size Y310.13 (285 x 280 x 135mm) 1/2 Size Y310.10 (285 x 280 x 100mm)
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for ¾ size, and 9.25 lbs for 1/2 size.
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 same design, same materials, same shapes, and sizes.
| Feature | Bahadir | Miltex K072563 | SklarLite K091720 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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>and to allow<br>sterilization of the<br>enclosed medical<br>devices, including<br>surfaces and<br>lumens, using<br>gravity steam<br>sterilizers. | 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>30 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 | Aluminum Alloy,<br>stainless steel<br>handles, silicone<br>seal, paper filter |
| Filter | Paper Filter | Paper Filter<br>PTFE Teflon Filter<br>(for Ethylene Oxide)<br>*Miltex had EO<br>cleared in another<br>510k. | Paper Filter |
| Sterilization Method | Steam | Ethylene Oxide<br>Steam<br>*Miltex has EO<br>cleared in another<br>510k | Steam |
| Configurations /<br>Dimensions | Includes 1/2 size, 3/4<br>size, and full size | Includes 1/2 size, 3/4<br>size, and full size*<br>*Miltex has their<br>dimension in inches.<br>The below is a | Full size<br>580mm x 280mm x<br>200mm<br>580mm x 280mm x<br>150mm |
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| | | | K102146<br>CONFIDENTIAL DOCUMENT | | p5cf6 |
|------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|-------|
| | Full size | units. | 135mm | | |
| | 580mm x 280mm x<br>200mm | Full size | 580mm x 280mm x<br>100mm | | |
| | 580mm x 280mm x<br>150mm | 580mm x 280mm x<br>150mm | 580mm x 280mm x<br>260mm | | |
| | 580mm x 280mm x<br>135mm | 580mm x 280mm x<br>135mm | 3/4 Size | | |
| | 580mm x 280mm x<br>100mm | 580mm x 280mm x<br>100mm | 465mm x 280mm x<br>150mm | | |
| | 3/4 Size | 3/4 Size | 465mm x 280mm x<br>135mm | | |
| | 465mm x 280mm x<br>150mm | 465mm x 280mm x<br>150mm | 465mm x 280mm x<br>100mm | | |
| | 465mm x 280mm x<br>135mm | 465mm x 280mm x<br>135mm | 1/2 size | | |
| | 465mm x 280mm x<br>100mm | 465mm x 280mm x<br>100mm | 285mm x 280mm x<br>200mm | | |
| | 1/2 size | 1/2 size | 285mm x 280mm x<br>150mm | | |
| | 285mm x 280mm x<br>200mm | 285mm x 280mm x<br>150mm | 285mm x 280mm x<br>135mm | | |
| | 285mm x 280mm x<br>150mm | 285mm x 280mm x<br>135mm | 285mm x 280mm x<br>100mm | | |
| | 285mm x 280mm x<br>135mm | 285mm x 280mm x<br>100mm | 285mm x 280mm x<br>260mm | | |
| | 285mm x 280mm x<br>100mm | | | | |
| Perforation | The units included in<br>this submission<br>include perforated<br>lids and non-<br>perforated bottoms. | The units included in<br>their 510k included<br>perforated lids and<br>perforated bottoms. | The units included in<br>their 510k included<br>perforated and non-<br>perforated lids and<br>perforated 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. | Permits entry of<br>sterilization agent<br>and prevents<br>microbial migration<br>during storage. | | |
| Intended to be re-<br>used | Yes | Yes | Yes | | |
| Sealed | Yes | Yes | Yes | | |
| Conformance to<br>AAMI ST 77 | Yes | Yes | Yes | | |
| Gasket | Silicone Based (gray<br>color) | Silicone Based (red<br>color) | Silicone Based (gray<br>color) | | |
| Handles | Wider handles with<br>silicone holder | Smaller handles (no<br>holder) | Smaller handles (no<br>holder) | | |
| Cycle Parameters | 270 F at 4 minutes | 270 F at 4 minutes | 270 F at 4 minutes | | |
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K102146 Confidential Document
The differences - are - as - follows :-
- Sterilization Method (Miltex has received FDA to also use Ethylene ● Oxide. Bahadir USA is not pursuing EO at this time).
- Filter (the devices are offered with paper filters, but Miltex also offers . a PTFE Teflon filter for EO)
- The devices use a silicone based gasket around the lid. There is a . difference in color. Bahadir USA and Sklar use gray and Miltex uses red. We believe this difference is more cosmetic than performance related.
- Both devices have stainless steel handles. The handles on the ● Bahadir USA containers are wider and include a silicone holder to prevent the user from getting burned when the handles are hot.
- The Bahadir USA containers in this submissions are with perforated . lids and non-perforated bottoms. The Miltex and Sklar includes perforated lids and bottoms.
- The Sklar and Miltex 510(k)'s included larger range of sizes. .
- Sklar is offered in anodized colored lids, whereas Bahadir and Miltex . in silver (aluminum color).
### Non-Clinical Tests Performed
The devices were subjected to cleaning validation, aging studies, half cycle, 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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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.
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
NOV 1:8 . 2010 .
Re: K102146
Trade/Device Name: Bahadir USA Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT . Dated: November 1, 2010 Received: November 8, 2010
Dear Mr. Ismail:
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
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 (reporting of medical device-related 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 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.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 Small Manufacturers, International and Consumer Assistance 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,
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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510(k) Number (if known):
Device Name: Bahadir USA Sterilization Trays
NOV 1 8 2010
Indications For Use:
Intended for use in hospitals and healthies to contain other medical devices that are to be sterlized and to allow sterliization 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 1/1 Y 10.20 Full Size 1/1 Y 110.15 Full Size 1/1 Y 110.13 Full Size 1/1 Y 110.10 % Size Y210.10 ¾ Size Y210.15 ¾ Size Y2I0.13 ½ Size Y310.20 % Size Y310.15 1/2 Size Y310.13 ½ Size Y310.10
The maximum load weight is 24.75 lbs for % size, and 9.25 lbs for ½ size. The sterlization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments.
The subject trays are not validated for use with luments, power systems, or cannulized instruments.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Surr Puorer
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
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510(k) Number: K102146
