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.

Device 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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bahadir USA STERILIZATION TRAYS, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical tests performed rather than specific quantitative acceptance criteria or their corresponding performance results in a structured format. However, based on the types of tests performed and the ultimate goal of substantial equivalence for sterilization trays, we can infer the implied acceptance criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Effectiveness: - Pass steam sterilization (pre-vacuum cycle: 4 min at 270°F, 20 min dry time). - Effective sterilization of various loads (empty, full textile, full surgical instruments). - Prevention of microbial migration during storage.	The devices were subjected to "sterility testing" and "half cycle" tests. Validation included three types of loads: empty, full load of textiles, and full load of surgical instruments. The trays "Permits entry of sterilization agent and prevents microbial migration during storage."
Cleaning Effectiveness: - Device can be effectively cleaned.	The devices were subjected to "cleaning validation."
Material Durability/Aging: - Device maintains integrity and function over time/usage.	The devices were subjected to "aging studies."
Product Performance/Integrity: - Device physically holds contents. - Maintains seal integrity. - Withstands sterilization cycle conditions.	The devices were subjected to "performance testing." Features like "Sealed: Yes" and "Gasket: Silicone Based" indicate an expectation of seal integrity.
Biocompatibility/Safety (Implied): - Materials are safe for medical device contact.	The main material is anodized aluminum (with stainless steel handles, silicone seal, paper filter). Substantial equivalence to predicate devices (also aluminum alloy with similar components) implies material safety.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "The devices were subjected to cleaning validation, aging studies, half cycle, sterility testing and performance testing." It refers to "the devices included in this submission" as a set of specific models (11 different sizes). It does not specify how many units of each model, or total units, were tested for each type of study.
Data Provenance: Not explicitly stated. It's unclear if the testing was done by the manufacturer, an independent lab, or in a specific country. Given the manufacturer's address in New York, USA, it is likely the testing was conducted in the USA or supervised from there. The study appears to be prospective in nature, as it describes tests performed on the physical devices to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a physical sterilization tray, and the "ground truth" for its performance is established through objective physical, biological, and chemical tests (e.g., sterility indicators, microbial challenge tests, physical integrity checks, material degradation analysis). There were no human experts establishing a "ground truth" through interpretation or consensus, unlike in studies involving diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for this type of device is based on objective scientific testing, not expert consensus or adjudication. Test results would be interpreted against predefined pass/fail criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. Sterilization trays do not involve human interpretation in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the studies performed (cleaning validation, aging studies, half cycle, sterility testing, performance testing) represent a "standalone" evaluation of the device's physical and functional properties, without human interaction as an integral part of its direct performance (beyond setup and monitoring). The device itself, independent of human interpretive input during use, was tested for its intended function.

7. The Type of Ground Truth Used

The ground truth used for these studies would be based on:

Biological Indicators/Chemical Indicators: For sterility testing, the absence of viable microorganisms after sterilization, often confirmed by biological indicator sterility (e.g., spore strips showing no growth) and chemical indicator changes.
Physical Measurements/Observation: For cleaning validation (absence of residual soil), aging studies (material integrity, absence of cracks/corrosion), and performance testing (device remaining intact, seals functional, filters allowing air passage while trapping microbes).
Adherence to Standards: Compliance with relevant industry standards (e.g., AAMI ST77, as mentioned).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or training set, this question is not relevant.

Summary

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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

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

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:

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:

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 inhospitals andhealthcare facilitiesto contain othermedical devices thatare to be sterilized.Containers allowsterilization of theenclosed medicaldevices, includingsurfaces andlumens, using highvacuum steamsterilizers for 270 Ffor 4 minutes with20 minutes(minimum) dry time.	Intended for use inhospitals andhealthcare facilitiesto contain othermedical devices thatare to be sterilizedand to allowsterilization of theenclosed medicaldevices, includingsurfaces andlumens, usinggravity steamsterilizers.	Intended for use inhospitals andhealthcare facilitiesto contain othermedical devices thatare to be sterilized.Containers allowsterilization of theenclosed medicaldevices, includingsurfaces andlumens, using highvacuum steamsterilizers for 270 Ffor 4 minutes with30 minutes(minimum) dry time.
Material	Aluminum Alloy,stainless steelhandles, siliconeseal, paper filter	Aluminum Alloy,stainless steelhandles, siliconeseal, paper filter	Aluminum Alloy,stainless steelhandles, siliconeseal, paper filter
Filter	Paper Filter	Paper FilterPTFE Teflon Filter(for Ethylene Oxide)*Miltex had EOcleared in another510k.	Paper Filter
Sterilization Method	Steam	Ethylene OxideSteam*Miltex has EOcleared in another510k	Steam
Configurations /Dimensions	Includes 1/2 size, 3/4size, and full size	Includes 1/2 size, 3/4size, and full size**Miltex has theirdimension in inches.The below is a	Full size580mm x 280mm x200mm580mm x 280mm x150mm

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			K102146CONFIDENTIAL DOCUMENT
	Full size	units.	135mm
	580mm x 280mm x200mm	Full size	580mm x 280mm x100mm
	580mm x 280mm x150mm	580mm x 280mm x150mm	580mm x 280mm x260mm
	580mm x 280mm x135mm	580mm x 280mm x135mm	3/4 Size
	580mm x 280mm x100mm	580mm x 280mm x100mm	465mm x 280mm x150mm
	3/4 Size	3/4 Size	465mm x 280mm x135mm
	465mm x 280mm x150mm	465mm x 280mm x150mm	465mm x 280mm x100mm
	465mm x 280mm x135mm	465mm x 280mm x135mm	1/2 size
	465mm x 280mm x100mm	465mm x 280mm x100mm	285mm x 280mm x200mm
	1/2 size	1/2 size	285mm x 280mm x150mm
	285mm x 280mm x200mm	285mm x 280mm x150mm	285mm x 280mm x135mm
	285mm x 280mm x150mm	285mm x 280mm x135mm	285mm x 280mm x100mm
	285mm x 280mm x135mm	285mm x 280mm x100mm	285mm x 280mm x260mm
	285mm x 280mm x100mm
Perforation	The units included inthis submissioninclude perforatedlids and non-perforated bottoms.	The units included intheir 510k includedperforated lids andperforated bottoms.	The units included intheir 510k includedperforated and non-perforated lids andperforated and non-perforated bottoms.
Air Permeance	Permits entry ofsterilization agentand preventsmicrobial migrationduring storage.	Permits entry ofsterilization agentand preventsmicrobial migrationduring storage.	Permits entry ofsterilization agentand preventsmicrobial migrationduring storage.
Intended to be re-used	Yes	Yes	Yes
Sealed	Yes	Yes	Yes
Conformance toAAMI ST 77	Yes	Yes	Yes
Gasket	Silicone Based (graycolor)	Silicone Based (redcolor)	Silicone Based (graycolor)
Handles	Wider handles withsilicone holder	Smaller handles (noholder)	Smaller handles (noholder)
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

Page 1 of 1

510(k) Number: K102146

Regulation Number and Section

§ 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).