Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical sterilization container and its compatibility with sterilization cycles. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device is designed for holding instruments during sterilization and maintaining sterility, not for directly treating or diagnosing patients.

Diagnostic

No

Explanation: The device is a sterilization container used for holding and maintaining the sterility of other medical instruments. Its function is to facilitate sterilization and storage, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "reusable, metal, sterilization container," indicating it is a physical hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for holding operating room instruments and textiles during sterilization and maintaining sterility during storage and transport. This is a function related to the sterilization and handling of medical devices, not for performing tests on biological samples to diagnose or monitor a medical condition.
Device Description: The description reinforces that it's a reusable container system for sterilization and storage of other medical devices.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterlity during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below:

*STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles
*STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles
*STERRAD 100NX - Duo, Express, Standard and Flex Cycles
*STERRAD NX - Standard and Advanced Cycles

Product codes

KCT

Device Description

The Bahadir Sterilization Containers are a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:

STERIS VPRO maX/maX2: Lumen, Non Lumen, Flexible
STERIS VPRO s2/60: Lumen, Non Lumen, Flexible ●
STERRAD NX: Standard, Advanced ●
. STERRAD 100NX: Standard, Express, Flex, Duo

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

Not Found

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 device underwent performance testing to demonstrate compatibility with indicated sterilizers, microbial barrier properties, sterilization validation, material compatibility, and shelf life.

Microbial Aerosol Challenge Testing

Purpose: To determine the microbial barrier properties of the Bahadir Container Systems in maintaining sterility package integrity when subjected to a microbial aerosol challenge test following processing in STERIS V-PRO Lumen Cycle and STERRAD 100NX Standard Sterilization Cycles for 100 cycles. Tested containers included Full Size (Mid Case), 3/4 Size (Worst Case), and 1/2 Size (Best Case).
Acceptance Criteria: The container systems must maintain sterility of its contents following whole package microbial aerosol challenge after 100 cleaning cycles and sterilization cycles. The worst case, mid case and best case containers must be tested.
Results: PASS - The results conclude that the Bahadir Container System maintained sterility of its contents following a whole package microbial aerosol challenge after 100 mechanical cleaning and STERIS V-PRO Lumen Cycle sterilization cycles, and 100 mechanical cleaning and STERRAD 100NX Standard Sterilization Cycles. This was confirmed for Full Size (Mid Case), 3/4 Size (Worst Case), and 1/2 Size (Best Case) containers.

Sterilization Validation

Purpose: To validate the sterilization efficacy of the Bahadir Container Systems when processed in STERIS V-PRO 60/s2, STERIS V-PRO maX/maX2 lumen cycle, STERRAD 100NX DUO, STERRAD NX Advanced, STERRAD 100NX Standard, and STERRAD 100NX Flex Cycles. Also, to demonstrate effective sterilization with lumened devices and max loads. Specific tests included:
- STERRAD 100NX DUO Sterilization Cycle
- STERRAD 100NX Flex Cycle
- STERRAD NX Advanced Sterilization Cycle
- STERRAD 100NX Express Cycle
- STERRAD 100NX Standard Cycle
- STERRAD NX Standard Cycle
- STERIS V-PRO 60/s2 Flexible Cycle (¾ size Worst Case load)
- STERIS V-PRO maX / maX 2 Flexible Cycle (¾ size Worst Case load)
- STERIS V-PRO maX/maX2 and 60/s2 Non Lumen Cycle
- STERIS V-PRO maX/maX2 and 60/s2 Lumen Cycle
Acceptance Criteria: The container system must achieve an SAL of 10-6 when processed using the different sterilization modalities. Testing also must demonstrated sterilization efficacy with lumened devices and max loads.
Results: PASS - Results from testing have demonstrated that the Bahadir Container Systems was able to achieve a 10-6 SAL when processed in all tested cycles (STERRAD 100NX DUO, FLEX, EXPRESS, STANDARD, STERRAD NX Advanced, STANDARD and STERIS V-PRO Flexible, Non-Lumen, and Lumen Cycles) for various container sizes (3/4 Size Worst Case, 1/2 Size Best Case, Full Size Mid Case). Effective sterilization was demonstrated for cannulized instruments and maximum loads as specified in the indications for use.

Material Compatibility

Purpose: To verify the material compatibility of the Bahadir Container Systems following automated cleaning and STERRAD 100NX Sterilization and STERIS V-PRO Sterilization.
Acceptance Criteria: The containers must show no signs of degradation after automated cleaning and using different sterilization modalities.
Results: PASS: No degradation was observed.

30 Day Event Related Shelf Life Study

Purpose: To demonstrate that the Bahadir Container Systems (1/2 Size Best Case, 3/4 Size Worst Case, Full Size Mid Case) can effectively maintain the sterility of its internal contents following exposure to STERRAD 100NX Standard Sterilization cycle and STERIS V-PRO lumen cycle for a minimum 30-day event related storage period.
Acceptance Criteria: The containers must maintain sterility of internal components for a minimum of 30 days following exposure to STERRAD 100NX Standard cycle and STERIS V-PRO lumen cycle.
Results: PASS: Based on the results of the testing the Bahadir Container Systems for 1/2 Size (Best Case), 3/4 Size (Worst Case), and Full Size (Mid Case) maintained the sterility of their contents following exposure to both STERRAD 100NX Standard Sterilization Cycle and STERIS V-PRO lumen cycle for a minimum of a thirty (30) day shelf life storage period.

180 Day Event Related Shelf Life Study

Purpose: To demonstrate that the Bahadir Container Systems (1/2 Size Best Case, 3/4 Size Worst Case, Full Size Mid Case) can effectively maintain the sterility of its internal contents following exposure to STERIS V-PRO lumen cycle and STERRAD 100NX Standard cycle for a minimum 180-day event related storage period.
Acceptance Criteria: The containers must maintain sterility of their contents for a minimum of 180 days following STERIS V-PRO lumen cycle and STERRAD 100NX Standard cycle.
Results: PASS: Based on the results of the testing the Bahadir Container Systems for 1/2 Size (Best Case), 3/4 Size (Worst Case), and Full Size (Mid Case) maintained the sterility of their contents following exposure to STERIS V-PRO lumen cycle and STERRAD 100NX Standard Sterilization Cycle and a minimum 180 day shelf life storage period.

Cytotoxicity Testing

Purpose: To verify that the materials used for the Bahadir Sterilization Containers are non-cytotoxic. Testing included: 1/2 size (Best Case) ISO Elution Method following STERIS V-PRO Sterilization, and 1/2 size (Best Case) MEM Elution Method following STERRAD 100NX Standard Cycle Sterilization.
Acceptance Criteria: The container materials must be classified as non-toxic per ISO 10994-5 standard.
Results: PASS – The device was determined not to be cytotoxic. No cytotoxicity or cell lysis was noted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K131407, K214041

Reference Device(s)

K214041

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

March 22, 2024

Bahadir USA LLC % Joseph Azary Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K233578

Trade/Device Name: Bahadir Sterilization Containers Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 21, 2024 Received: February 21, 2024

Dear Joseph Azary:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/7 description: The image contains the name "Stephen A. Anisko -S" in a large, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The background is a light color, and the text is dark, providing good contrast and readability. The letter S is slightly cut off.

Digitally signed by Stephen A. Anisko -S Date: 2024.03.22 11:03:05 -04'00'

for Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

2

OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233578

Device Name Bahadir Sterilization Containers

Indications for Use (Describe)

Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterlity during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below:

*STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles *STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles *STERRAD 100NX - Duo, Express, Standard and Flex Cycles *STERRAD NX - Standard and Advanced Cycles

Bahadir Sterilization Containers Lumen Configurations

Sterilization Cycle	Container Size	Compatible Lumens
STERIS VPRO maX/maX2
Lumen Cycle	Full Size	≥0.77mm x ≤527mm (single, dual
or triple channel)
≥0.8mm x ≤542mm (single, dual or
triple channel)
≥0.48mm x ≤100mm (single, dual
or triple channel) ≥1.3mm x
≤73mm (dead end lumen)
≥3mm x ≤298mm (rigid non-
metallic lumen)

4mm x ≤424mm (rigid non-
metallic lumen) |
| | Three-Quarter Size | ≥0.77mm x ≤527mm (single, dual
or triple channel)
≥0.8mm x ≤542mm (single, dual or
triple channel)
≥0.48mm x ≤100mm (single, dual
or triple channel)
≥1.3mm x ≤73mm (dead end
lumen)
≥3mm x ≤298mm (rigid non-
metallic lumen)
4mm x ≤424mm (rigid non-
metallic lumen) |
| | Half Size | ≥0.77mm x ≤527mm (single, dual
or triple channel)
≥0.8mm x ≤542mm (single, dual or
triple channel)
≥0.48mm x ≤100mm (single, dual
or triple channel)
≥1.3mm x ≤73mm (dead end
lumen)
≥3mm x ≤298mm (rigid non-
metallic lumen) |
| | | ≥4mm x ≤424mm (rigid non-metallic lumen) |
| STERIS VPRO maX/maX2
Flexible Cycle | Full Size | (2) flexible endoscopes with light
cord (if not integral to endoscope)
and mat with no additional load.
The flexible endoscopes may
contain Single or Dual channel
lumens ≥1mm x ≤1050mm
Or
(1) flexible endoscope with light
cord (if not integral to endoscope),
endoscope accessories, mat and
additional instruments. The flexible
endoscope may contain Single or
dual channel lumens that are ≥1mm
x ≤1050mm. Additional single, dual
or triple channel stainless steel
lumen device that is ≥0.48mm x
Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/11/Picture/0 description: The image shows the contact information for BAHADIR USA LLC. The address is 431 S. Pennsville-Auburn Road Carneys Point, New Jersey 08069 USA. The phone number is (856) 517-3080, the fax number is (856) 517-3081, the website is www.BahadirUSA.com, and the email address is info@bahadirusa.com.

510(k) Summary K233578

March 16, 2024 DATE PREPARED:

COMPANY NAME: BAHADIR USA LLC 431 SOUTH PENNSVILLE AUBURN RD CARNEYS POINT, NJ 08069
CONTACT: ISMAIL KILIC EMAIL: INFO@BAHADIRUSA.COM OFFICE: 856-517-3080 FAX: 856-517-3081

PRIMARY CORRESPONDANT/CONSULTANT

CONTACT:	JOSEPH AZARY
	AZTECH REGULATORY AND QUALITY LLC
EMAIL:	JAZARY@RCN.COM
OFFICE:	(203)242-6670

BAHADIR STERILIZATION CONTAINERS TRADE NAME: COMMON NAME/ CLASSIFICATION STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES, AND OTHER ACCESSORIES NAME: CLASS OF DEVICE: CLASS II PRODUCT CODE: КСТ REGULATION: 21 CFR880.6850 REVIEW PANEL: GENERAL HOSPITAL ESTABLISHMENT REGESTRATION NUMBER: 3005741909 PREDICATE DEVICE: K131407, Bahadir Sterilization Containers (Primary Predicate) K214041, AESCULAP Aicon Container (Secondary Predicate)

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DESCRIPTION OF DEVICE:

The Bahadir Sterilization Containers are a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:

STERIS VPRO maX/maX2: Lumen, Non Lumen, Flexible
STERIS VPRO s2/60: Lumen, Non Lumen, Flexible ●
STERRAD NX: Standard, Advanced ●
. STERRAD 100NX: Standard, Express, Flex, Duo

INDICATIONS FOR USE:

Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterility during storage and transport under proper hospital container system is compatible for use with the following low temperature sterilizers and the cycles identified below:

*STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles *STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles *STERRAD 100NX - Duo, Express, Standard and Flex Cycles *STERRAD NX - Standard and Advanced Cycles

Bahadir Sterilization Containers Lumen Configurations

Sterilization Cycle	Container Size	Compatible Lumens
STERIS VPRO maX/maX2
Lumen Cycle	Full Size	≥0.77mm x ≤527mm (single, dual
or triple channel)
		≥0.8mm x ≤542mm (single, dual
or triple channel)
		≥0.48mm x ≤100mm (single, dual
or triple channel)
		≥1.3mm x ≤73mm (dead end
lumen)
		≥3mm x ≤298mm (rigid non-
metallic lumen)
		≥4mm x ≤424mm (rigid non-
metallic lumen)
	Three-Quarter Size	≥0.77mm x ≤527mm (single, dual
or triple channel)
		≥0.8mm x ≤542mm (single, dual
or triple channel)
		≥0.48mm x ≤100mm (single, dual
or triple channel)
		≥1.3mm x ≤73mm (dead end
lumen)
		≥3mm x ≤298mm (rigid non-
metallic lumen)
		≥4mm x ≤424mm (rigid non-
metallic lumen)
	Half Size	≥0.77mm x ≤527mm (single, dual
or triple channel)
		≥0.8mm x ≤542mm (single, dual
or triple channel)
		≥0.48mm x ≤100mm (single, dual
or triple channel)
		≥1.3mm x ≤73mm (dead end
lumen)
≥3mm x ≤298mm (rigid non-
metallic lumen)
≥4mm x ≤424mm (rigid non-
metallic lumen)
STERIS VPRO maX/maX2
Flexible Cycle	Full Size	(2) flexible endoscopes with light
cord (if not integral to
endoscope) and mat with no
additional load. The flexible
endoscopes may contain Single
or Dual channel lumens ≥1mm x
≤1050mm
Or
(1) flexible endoscope with light
cord (if not integral to
endoscope), endoscope
accessories, mat and additional
instruments. The flexible
endoscope may contain Single or
dual channel lumens that are
≥1mm x ≤1050mm. Additional
single, dual or triple channel
stainless steel lumen device that
is ≥0.48mm x ≤100mm OR non-
	Three-Quarter Size	lumen device
(2) flexible endoscopes with light
cord (if not integral to
endoscope) and mat with no
additional load. The flexible
endoscopes may contain Single
or Dual channel lumens ≥1mm x
≤1050mm
Or
(1) flexible endoscope with light
cord (if not integral to
endoscope), endoscope
accessories, mat and additional
instruments. The flexible
endoscope may contain Single or
dual channel lumens that are
≥1mm x ≤1050mm. Additional
single, dual or triple channel
stainless steel lumen device that
is ≥0.48mm x ≤100mm OR non-
lumen device
	Half Size	(2) flexible endoscopes with light
cord (if not integral to
endoscope) and mat with no
additional load. The flexible
endoscopes may contain Single
or Dual channel lumens ≥1mm x
≤1050mm
Or
(1) flexible endoscope with light
		cord (if not integral to
endoscope), endoscope
accessories, mat and additional
instruments. The flexible
endoscope may contain Single or
dual channel lumens that are
$\ge$ 1mm x $\le$ 1050mm. Additional
single, dual or triple channel
stainless steel lumen device that
is $\ge$ 0.48mm x $\le$ 100mm OR non-
lumen device

STERIS VPRO maX/maX2
Non-Lumen Cycle	Full Size	-Non lumened instruments
STERIS VPRO maX/maX2
Non-Lumen Cycle	Three-Quarter Size	-Non lumened instruments
STERIS VPRO maX/maX2
Non-Lumen Cycle	Half Size	-Non lumened instruments
STERIS VPRO s2/60
Lumen cycle	Full Size	$\ge$ 0.77mm x $\le$ 410mm (single or
dual channel)
$\ge$ 1.8mm x $\le$ 542mm (single or
dual channel)
$\ge$ 1.2mm x $\le$ 275mm (triple
channel)
$\ge$ 1.8mm x $\le$ 310mm (triple
channel)
$\ge$ 2.8mm x $\le$ 317mm (triple
channel)
STERIS VPRO s2/60
Lumen cycle	Three-Quarter Size	$\ge$ 0.77mm x $\le$ 410mm (single or
dual channel)
$\ge$ 1.8mm x $\le$ 542mm (single or
dual channel)
$\ge$ 1.2mm x $\le$ 275mm (triple
channel)
$\ge$ 1.8mm x $\le$ 310mm (triple
channel)
$\ge$ 2.8mm x $\le$ 317mm (triple
channel)
STERIS VPRO s2/60
Lumen cycle	Half Size	$\ge$ 0.77mm x $\le$ 410mm (single or
dual channel)
$\ge$ 1.8mm x $\le$ 542mm (single or
dual channel)
$\ge$ 1.2mm x $\le$ 275mm (triple
channel)
$\ge$ 1.8mm x $\le$ 310mm (triple
channel)
$\ge$ 2.8mm x $\le$ 317mm (triple
channel)
STERIS VPRO s2/60	Full Size	-Non-lumened instruments and
instruments with diffusion
restricted spaces (such as the
hinged portion of forceps and
scissors)
-(1) surgical flexible endoscope
or bronchoscope with light cord
(if not integral to the endoscope).
The flexible endoscope may be
		single or dual lumen device with
lumens that are $\ge$ 1mm x $\le$ 990mm
Flexible Cycle	Three-Quarter Size	-Non-lumened instruments and
instruments with diffusion
restricted spaces (such as the
hinged portion of forceps and
scissors)
-(1) surgical flexible endoscope
or bronchoscope with light cord
(if not integral to the endoscope).
The flexible endoscope may be
single or dual lumen device with
lumens that are $\ge$ 1mm x $\le$ 990mm
	Half Size	-Non-lumened instruments and
instruments with diffusion
restricted spaces (such as the
hinged portion of forceps and
scissors)
-(1) surgical flexible endoscope
or bronchoscope with light cord
(if not integral to the endoscope).
The flexible endoscope may be
single or dual lumen device with
lumens that are $\ge$ 1mm x $\le$ 990mm
STERIS VPRO s2/60
Non-Lumen Cycle	Full Size	-Non lumened instruments
	Three-Quarter Size	-Non lumened instruments
	Half Size	-Non lumened instruments
STERRAD NX	Full Size	(5) SS lumens 1mm I.D. x 150mm L
(5) SS lumens 2mm I.D. x 400mm L
Standard Cycle	Three-Quarter Size	(10) SS lumens 1mm I.D. x
150mm L
	Half Size	(10) SS lumens 1mm I.D. x
150mm L
STERRAD NX
Advanced Cycle	Full Size	(10) SS lumens 2mm I.D. x
500mm L
	Three-Quarter Size	(6) SS lumens 1mm I.D. x 350mm
L
	Half Size	(10) SS lumens 1mm I.D. x
200mm L
STERRAD 100NX
Standard Cycle	Full Size	(5) SS lumens 1mm I.D. x 500mm
L
	Three-Quarter Size	(5) SS lumens 1mm I.D. x 350mm
L
	Half Size	(5) SS lumens 0.7mm I.D. x
200mm L
STERRAD 100NX
Express Cycle	Full Size	Non lumened SS instruments
	Three-Quarter Size	Non lumened SS instruments
STERRAD 100NX	Full Size	(1)PTFE tubing 1.5 mm I.D. x
850mm L
Duo Cycle	Three-Quarter Size	(1)PTFE tubing 1.5 mm I.D. x
850mm L
	Half Size	(1)PTFE tubing 1.5 mm I.D. x
850mm L

STERRAD 100 NX	Full Size	(1) Scope lumen 1mm I.D. x
850mm L
Flexible Cycle	Three-Quarter Size	(1) Scope lumen 1mm I.D. x
850mm L
	Half Size	(1)PTFE tubing 1mm I.D. x 850mm
L

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Bahadir Sterilization Containers Configurations

| Sterilization
Cycle | Container Size | Container Name | Total Loaded Container
(lbs) | |
|-----------------------------------------------|-------------------------|----------------|---------------------------------|----|
| STERIS VPRO
maX/maX2
Lumen Cycle | Full Size 4⅛" | Y111.10 | 19.65 | |
| | Full Size 5¼" | Y111.13 | 19.65 | |
| | Full Size 5⅝" | Y111.15 | 19.65 | |
| | Full Size 7¾" | Y111.20 | 19.65 | |
| | Full Size 10¼ " | Y111.26 | 19.65 | |
| | Full Size 7¾" | Y111.70 | 19.65 | |
| | Three-Quarter Size 4⅛" | Y211.10 | 19.65 | |
| | Three-Quarter Size 5¼" | Y211.13 | 19.65 | |
| | Three-Quarter Size 5⅝" | Y211.15 | 19.65 | |
| | Three-Quarter Size 7¾" | Y211.20 | 19.65 | |
| | Half Size 4⅛" | Y311.10 | 15 | |
| | Half Size 5¼" | Y311.13 | 15 | |
| | Half Size 5⅝" | Y311.15 | 15 | |
| | Half Size 7¾" | Y311.20 | 15 | |
| | Half Size 10¼" | Y311.26 | 15 | |
| STERIS VPRO
max/maX2
Flexible Cycle | Full Size 4⅛" | Y111.10 | 21 | |
| | Full Size 5¼" | Y111.13 | 21 | |
| | Full Size 5⅝" | Y111.15 | 21 | |
| | Full Size 7¾" | Y111.20 | 21 | |
| | Full Size 10¼ " | Y111.26 | 21 | |
| | Full Size 7¾" | Y111.70 | 21 | |
| | Three-Quarter Size 4⅛" | Y211.10 | 21 | |
| | Three-Quarter Size 5¼" | Y211.13 | 21 | |
| | Three-Quarter Size 5⅝" | Y211.15 | 21 | |
| | Three-Quarter Size 7¾" | Y211.20 | 21 | |
| | Half Size 4⅛" | Y311.10 | 21 | |
| | Half Size 5¼" | Y311.13 | 21 | |
| | Half Size 5⅝" | Y311.15 | 21 | |
| | Half Size 7¾" | Y311.20 | 21 | |
| | Half Size 10¼" | Y311.26 | 21 | |
| | Full Size 4⅛" | Y111.10 | 26 | |
| | Full Size 5¼" | Y111.13 | 26 | |
| | Full Size 5⅝" | Y111.15 | 26 | |
| | Full Size 7¾" | Y111.20 | 26 | |
| | | | | |
| STERIS VPRO
max/max2
Non-Lumen
Cycle | Full Size | 10 ¼ " | Y111.26 | 26 |
| | Full Size | 7 3/4" | Y111.70 | 26 |
| | Three-Quarter Size | 4 1/8" | Y211.10 | 26 |
| | Three-Quarter Size | 5 1/4" | Y211.13 | 26 |
| | Three-Quarter Size | 5 7/8" | Y211.15 | 26 |
| | Three-Quarter Size | 7 3/4" | Y211.20 | 26 |
| | Half Size | 4 1/8" | Y311.10 | 19 |
| | Half Size | 5 1/4" | Y311.13 | 19 |
| | Half Size | 5 7/8" | Y311.15 | 19 |
| | Half Size | 7 3/4" | Y311.20 | 19 |
| | Half Size | 10 1/4" | Y311.26 | 19 |
| STERIS VPRO
S2/60
Lumen Cycle | Full Size | 4 1/8" | Y111.10 | 11 |
| | Full Size | 5 1/4" | Y111.13 | 11 |
| | Full Size | 5 7/8" | Y111.15 | 11 |
| | Full Size | 7 3/4" | Y111.20 | 11 |
| | Full Size | 10 1/4 " | Y111.26 | 11 |
| | Full Size | 7 3/4" | Y111.70 | 11 |
| | Three-Quarter Size | 4 1/8" | Y211.10 | 11 |
| | Three-Quarter Size | 5 1/4" | Y211.13 | 11 |
| | Three-Quarter Size | 5 7/8" | Y211.15 | 11 |
| | Three-Quarter Size | 7 3/4" | Y211.20 | 11 |
| | Half Size | 4 1/8" | Y311.10 | 11 |
| | Half Size | 5 1/4" | Y311.13 | 11 |
| | Half Size | 5 7/8" | Y311.15 | 11 |
| | Half Size | 7 3/4" | Y311.20 | 11 |
| | Half Size | 10 1/4" | Y311.26 | 11 |
| STERIS VPRO
S2/60
Flexible Cycle | Full Size | 4 1/8" | Y111.10 | 11 |
| | Full Size | 5 1/4" | Y111.13 | 11 |
| | Full Size | 5 7/8" | Y111.15 | 11 |
| | Full Size | 7 3/4" | Y111.20 | 11 |
| | Full Size | 10 1/4 " | Y111.26 | 11 |
| | Full Size | 7 3/4" | Y111.70 | 11 |
| | Three-Quarter Size | 4 1/8" | Y211.10 | 11 |
| | Three-Quarter Size | 5 1/4" | Y211.13 | 11 |
| | Three-Quarter Size | 5 7/8" | Y211.15 | 11 |
| | Three-Quarter Size | 7 3/4" | Y211.20 | 11 |
| | Half Size | 4 1/8" | Y311.10 | 11 |
| | Half Size | 5 1/4" | Y311.13 | 11 |
| | Half Size | 5 7/8" | Y311.15 | 11 |
| | Half Size | 7 3/4" | Y311.20 | 11 |
| | Half Size | 10 1/4" | Y311.26 | 11 |
| STERIS VPRO
S2/60 | Full Size | 4 1/8" | Y111.10 | 19 |
| | Full Size | 5 1/4" | Y111.13 | 19 |
| | Full Size | 5 7/8" | Y111.15 | 19 |
| | Full Size | 7 3/4" | Y111.20 | 19 |
| | Full Size | 10 1/4 " | Y111.26 | 19 |
| | Full Size | 7 3/4" | Y111.70 | 19 |
| | Three-Quarter Size | 4 1/8" | Y211.10 | 19 |
| | Three-Quarter Size | 5 1/4" | Y211.13 | 19 |
| Cycle | | | | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 19 | |
| | Half Size 4⅛" | Y311.10 | 12.5 | |
| | Half Size 5¼" | Y311.13 | 12.5 | |
| | Half Size 5⅞" | Y311.15 | 12.5 | |
| | Half Size 7 ¾" | Y311.20 | 12.5 | |
| | Half Size 10 ¼" | Y311.26 | 12.5 | |
| | Full Size 4⅛" | Y111.10 | 10.7 | |
| | Full Size 5¼" | Y111.13 | 10.7 | |
| | Full Size 5⅞" | Y111.15 | 10.7 | |
| | Full Size 7 ¾" | Y111.20 | 10.7 | |
| | Full Size 10 ¼ " | Y111.26 | 10.7 | |
| | Full Size 7 ¾" | Y111.70 | 10.7 | |
| STERRAD NX
Standard Cycle | Three-Quarter Size 4⅛" | Y211.10 | 10.7 | |
| | Three-Quarter Size 5¼" | Y211.13 | 10.7 | |
| | Three-Quarter Size 5⅞" | Y211.15 | 10.7 | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 10.7 | |
| | Half Size 4⅛" | Y311.10 | 10.7 | |
| | Half Size 5¼" | Y311.13 | 10.7 | |
| | Half Size 5⅞" | Y311.15 | 10.7 | |
| | Half Size 7 ¾" | Y311.20 | 10.7 | |
| | Half Size 10 ¼" | Y311.26 | 10.7 | |
| | Full Size 4⅛" | Y111.10 | 10.7 | |
| | Full Size 5¼" | Y111.13 | 10.7 | |
| | Full Size 5⅞" | Y111.15 | 10.7 | |
| | Full Size 7 ¾" | Y111.20 | 10.7 | |
| | Full Size 10 ¼ " | Y111.26 | 10.7 | |
| | Full Size 7 ¾" | Y111.70 | 10.7 | |
| STERRAD NX
Advanced Cycle | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | |
| | Three-Quarter Size 5¼" | Y211.13 | 13.85 | |
| | Three-Quarter Size 5⅞" | Y211.15 | 13.85 | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | |
| | Half Size 4⅛" | Y311.10 | 10.7 | |
| | Half Size 5¼" | Y311.13 | 10.7 | |
| | Half Size 5⅞" | Y311.15 | 10.7 | |
| | Half Size 7 ¾" | Y311.20 | 10.7 | |
| | Half Size 10 ¼" | Y311.26 | 10.7 | |
| | Full Size 4⅛" | Y111.10 | 21.4 | |
| | Full Size 5¼" | Y111.13 | 21.4 | |
| | Full Size 5⅞" | Y111.15 | 21.4 | |
| | Full Size 7 ¾" | Y111.20 | 21.4 | |
| | Full Size 10 ¼ " | Y111.26 | 21.4 | |
| | Full Size 7 ¾" | Y111.70 | 21.4 | |
| STERRAD 100NX
Standard Cycle | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | |
| | Three-Quarter Size 5¼" | Y211.13 | 13.85 | |
| | Three-Quarter Size 5⅞" | Y211.15 | 13.85 | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | |
| | Half Size 4⅛" | Y311.10 | 13.85 | |
| | Half Size 5¼" | Y311.13 | 13.85 | |
| | Half Size 5⅞" | Y311.15 | 13.85 | |
| | Half Size 7 ¾" | Y311.20 | 13.85 | |
| | Half Size
10 ¼" | Y311.26 | 13.85 | |
| | Full Size 4⅛" | Y111.10 | 21.4 | |
| | Full Size 5 ¼" | Y111.13 | 21.4 | |
| | Full Size 5 ⅞" | Y111.15 | 21.4 | |
| | Full Size 7 ¾" | Y111.20 | 21.4 | |
| | Full Size 10 ¼ " | Y111.26 | 21.4 | |
| | Full Size 7 ¾" | Y111.70 | 21.4 | |
| STERRAD 100NX | Three-Quarter Size 4 ⅛" | Y211.10 | 13.85 | |
| | Three-Quarter Size 5 ¼" | Y211.13 | 13.85 | |
| Express Cycle | Three-Quarter Size 5 ⅞" | Y211.15 | 13.85 | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | |
| | Half Size 4⅛" | Y311.10 | 13.85 | |
| | Half Size 5 ¼" | Y311.13 | 13.85 | |
| | Half Size 5 ⅞" | Y311.15 | 13.85 | |
| | Half Size 7 ¾" | Y311.20 | 13.85 | |
| | Half Size 10 ¼" | Y311.26 | 13.85 | |
| | Full Size 4⅛" | Y111.10 | 13.2 | |
| | Full Size 5 ¼" | Y111.13 | 13.2 | |
| | Full Size 5 ⅞" | Y111.15 | 13.2 | |
| | Full Size 7 ¾" | Y111.20 | 13.2 | |
| | Full Size 10 ¼ " | Y111.26 | 13.2 | |
| | Full Size 7 ¾" | Y111.70 | 13.2 | |
| STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.2 | |
| | Three-Quarter Size 5 ¼" | Y211.13 | 13.2 | |
| DUO Cycle | Three-Quarter Size 5 ⅞" | Y211.15 | 13.2 | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 13.2 | |
| | Half Size 4⅛" | Y311.10 | 7.2 | |
| | Half Size 5 ¼" | Y311.13 | 7.2 | |
| | Half Size 5 ⅞" | Y311.15 | 7.2 | |
| | Half Size 7 ¾" | Y311.20 | 7.2 | |
| | Half Size 10 ¼" | Y311.26 | 7.2 | |
| | Full Size 4⅛" | Y111.10 | 12.59 | |
| | Full Size 5 ¼" | Y111.13 | 12.59 | |
| | Full Size 5 ⅞" | Y111.15 | 12.59 | |
| | Full Size 7 ¾" | Y111.20 | 12.59 | |
| | Full Size 10 ¼ " | Y111.26 | 12.59 | |
| | Full Size 7 ¾" | Y111.70 | 12.59 | |
| STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | |
| | Three-Quarter Size 5 ¼" | Y211.13 | 13.85 | |
| Flexible Cycle | Three-Quarter Size 5 ⅞" | Y211.15 | 13.85 | |
| | Three-Quarter Size 7 ¾" | Y211.20 | 13.85 | |
| | Half Size 4⅛" | Y311.10 | 13.85 | |
| | Half Size 5 ¼" | Y311.13 | 13.85 | |
| | Half Size 5 ⅞" | Y311.15 | 13.85 | |
| | Half Size 7 ¾" | Y311.20 | 13.85 | |
| | Half Size 10 ¼" | Y311.26 | 13.85 | |

17

18

19

20

Bahadir Sterilization Containers may be used with Bahadir accessories according to the table below:

| Cycle | Baskets including holding pins,
holding clamps, silicone
holders, partition sheets,
tamper evident locks | Silicone Mats |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------|
| Steris VPRO 60/s2
Lumen, Non-Lumen, Flex | YES | YES |
| Steris VPRO maX/maX2
Lumen, Non-Lumen, Flex | YES | YES |
| STERRAD NX - Standard | YES | NO |
| STERRAD NX - Advanced | YES | NO |
| STERRAD 100NX - Standard | YES | NO |
| STERRAD 100NX - Duo | YES | NO |
| STERRAD 100NX – Flex | YES | NO |
| STERRAD 100NX - Express | YES | YES |

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The table below provides a summary of the device technological characteristics comparing the subject device and the predicate device(s). The subject device is offered in similar sizes and is comprised of similar materials of construction with the same principals of operation as the predicate devices.

| Characteristic | Subject Device: | Primary Predicate
Device: | Reference Predicate
Device: | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bahadir
Sterilization
Containers Product
Code:KCT | Bahadir
Sterilization
Containers
(K131407)
Product Code:KCT | AESCULAP
Aicon Container
(K214041)
Product Code: KCT | |
| Intended Use | Container to store
devices during
sterilization | Container to store
devices during
sterilization | Container to store
devices during
sterilization | SAME |
| Indications for
Use | A device intended to
be used to enclosed
another medical
device that is to be
sterilized by a
healthcare provider. It
is intended to allow
sterilization of the
enclosed medical
device and also to
maintain sterility of
the enclosed device
until used | A device intended to
be used to enclosed
another medical
device that is to be
sterilized by a
healthcare provider. It
is intended to allow
sterilization of the
enclosed medical
device and also to
maintain sterility of
the enclosed device
until used | A device intended to
be used to enclosed
another medical
device that is to be
sterilized by a
healthcare provider. It
is intended to allow
sterilization of the
enclosed medical
device and also to
maintain sterility of
the enclosed device
until used | SAME |
| Sterilization
Modalities | -STERIS VPRO
maX/maX2: Lumen,
Non-Lumen, Flexible
-STERIS VPRO
60/s2: Lumen, Non-
Lumen, Flexible
-STERRAD NX:
standard, advanced
-STERRAD 100NX: | -Prevac Steam | -Prevac Steam
-STERIS VPRO
maX/maX2: Lumen,
Non-Lumen,
Flexible
-STERIS VPRO 60
Lumen, Non-Lumen,
Flexible
-STERRAD NX: | SIMILAR
The primary
predicate is
cleared for
Prevac Steam
versus the
subject device
and reference |
| | Standard, DUO,
Express, Flexible | | standard, advanced
-STERRAD 100NX:
Standard, DUO,
Express, Flexible
-Ethylene Oxide | predicate are
cleared for Steris
and Sterrad
modalities. |
| | | | -STERRAD 100S
-STERIZONE VP4 | |
| Material | Container:Anodized
Aluminum
Gasket:Silicone | Container:Anodized
Aluminum
Gasket:Silicone | Container:Anodized
Aluminum
Gasket:Silicone | SAME |
| Filter type and
material | Single use
(polypropylene) | Single use (paper) | Single use
(polypropylene) | SIMILAR
The primary
predicate uses
paper filters
whereas the
subject device
and reference
predicate use
polypropylene
filters which are
more appropriate
for the low
temperature
hydrogen
peroxide
sterilization. |
| Container design | Perforated bottom
with Perforated lid | Perforated or Non-
Perforated bottom
with Perforated Lid | Solid (non -
perforated) bottom or
Solid bottom with
enhanced drying
system with with
Perforated Lid | SIMILAR
Testing indicates
that subject
device performs
equivalent to
secondary
predicate |
| 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 | SAME |
| Intended for
Reuse | Yes | Yes | Yes | SAME |
| Conformance to
AAMI ST77 | Yes | Yes | Yes | SAME |
| Use with
Cannulized
Instruments | Yes | Yes | Yes | SAME |

K233578, Page 10 of 17

21

The Bahadir Sterilization Containers has the same intended use and principles of operation as the previously cleared predicate devices. The Bahadir Sterilization Container system previously cleared in K131407 and demonstrated the same technical and performance characteristics. All functional and design characteristics of the subject device are the same as the primary predicate K131407, and similar to the reference predicate K214041.

The primary difference is that the subject device and reference predicate device both use low temperature hydrogen peroxide sterilization and use polypropylene filters, whereas the primary predicate device uses steam sterilization and paper filters.

Sterilization efficacy testing has been conducted to support the performance of the device when using the low temperature hydrogen peroxide sterilization cycles included in the new indications.

22

PERFORMANCE TESTING

Based on the testing performed on the Bahadir Sterilization Containers, compatibility has been demonstrated with the sterilizers indicated above. Results are summarized in the table below.

Test Method	Purpose	Acceptance Criteria	Results
Microbial Aerosol
Challenge Testing

Testing per standards
AAMI ST77:2013/ (R)2018

AAMI ISO 11607-1:2019

AAMI ISO 14937:2009/
(R)2013

Test to be conducted
post Mechanical
Cleaning and STERIS V-
PRO Lumen Cycle using
worst case, mid case and
best case containers.

Test to be conducted
post Mechanical
Cleaning and STERRAD
100NX Standard
Sterilization Cycle using
worst case, mid case and
best case containers. | To determine the microbial
barrier properties of the
Bahadir Container Systems
in maintaining sterility
package integrity when
subjected to a microbial
aerosol challenge test
following processing:
In one hundred mechanical
cleaning and STERIS V-PRO
Lumen Cycle sterilization
cycles.
In one hundred (100)
mechanical cleaning and
STERRAD 100NX Standard
Sterilization Cycles.
Full Size (Mid Case) in a
STERIS V-PRO Lumen Cycle
sterilization cycle.
3/4 Size (Worst Case) in a
STERIS V-PRO Lumen Cycle
sterilization cycle.
3/4 size (Worst Case) in a
STERRAD 100NX Standard
Sterilization Cycle.
1/2 size (Best Case) in a
STERRAD 100NX Standard
Sterilization Cycle.
full size (Mid Case) in a
STERRAD 100NX Standard
Sterilization Cycle. | The container systems must
maintain sterility of its contents
following whole package
microbial aerosol challenge
after 100 cleaning cycles and
sterilization cycles (STERIS V-
PRO Lumen Cycle and
STERRAD 100NX Standard).

The worst case, mid case and
best case containers must be
tested. | PASS - The results conclude
that the Bahadir Container
System maintained sterility of
its contents following a whole
package microbial aerosol
challenge following processing:
In one hundred mechanical
cleaning and STERIS V-PRO
Lumen Cycle sterilization
cycles.
In one hundred (100)
mechanical cleaning and
STERRAD 100NX Standard
Sterilization Cycles.
Full Size (Mid Case) in a STERIS
V-PRO Lumen Cycle
sterilization cycle.
3/4 Size (Worst Case) in a
STERIS V-PRO Lumen Cycle
sterilization cycle.
¾ size (Worst Case) in a
STERRAD 100NX Standard
Sterilization Cycle.
½ size (Best Case) in a
STERRAD 100NX Standard
Sterilization Cycle.
full size (Mid Case) in a
STERRAD 100NX Standard
Sterilization Cycle. |
| Sterilization Validation | To validate the sterilization
efficacy of the Bahadir
Container Systems | The container system must
achieve an SAL of 10-6 when
processed using the different
sterilization modalities (STERIS
V-PRO 60/s2, STERIS V-PRO
maX/maX2 lumen cycle and
STERRAD 100NX DUO,
STERRAD NX Advanced, 100NX
Standard, and 100NX Flex
Cycles. | PASS - Results from testing
have demonstrated that the
Bahadir Container Systems was
able to achieve a 10-6 SAL when
processed in: |
| Testing per standards | 3/4 Size (Worst Case)
Full Size (Mid Case)
1/2 Size (Best Case)
when processed using: | Testing also must
demonstrated sterilization
efficacy with lumened devices
and max loads. | |
| AAMI ST77:2013/ (R)2018 | - STERRAD 100NX
DUO Sterilization
Cycle | | 3/4 Size (Worst Case), 1/2 Size
(Best Case) and Full (Mid Case)
when processed in a STERRAD
100NX DUO Sterilization Cycle. |
| AAMI ST81:2004/ (R)2016 | - STERRAD 100NX
Flex Cycle | | |
| AAMI ISO 14937:2009/
(R)2013Cycle. | - STERRAD NX
Advanced
Sterilization Cycle | | 3/4 (Worst Case), Full (Mid Case)
after processing STERRAD NX
Advanced Cycle. |
| Test containers in the
STERIS V-PRO 60/s2
Flexible Cycle. | - STERRAD 100 NX
Express Cycle | | 3/4 Size (Worst Case), 1/2 Size
(Best Case) and Full Size (Mid
Case) after processing
STERRAD 100NX FLEX
Sterilization Cycle. |
| Test containers in the
STERIS V-PRO maX / maX
2 lumen cycle and
STERIS V-PRO 60/s2
lumen cycle. | - STERRAD 100NX
Standard Cycle | | 3/4 Size (Worst Case), 1/2 Size
(Best Case) and Full Size (Mid
Case) after processing
STERRAD 100NX Express
Sterilization Cycle. |
| Test containers for
STERRAD 100NX DUO,
STERRAD NX Advanced,
100NX Standard, and
100NX Flex Cycle. | - STERRAD NX
Standard Cycle | | 3/4 Size (Worst Case), 1/2 Size
(Best Case) and Full Size (Mid
Case) after processing
STERRAD 100NX Standard
Sterilization Cycle. |
| | | | 3/4 Size (Worst Case), 1/2 Size
(Best Case) and Full Size (Mid
Case) after processing
STERRAD NX Standard
Sterilization Cycle. |
| Sterilization Validation | | Continued | |
| (continued) | The testing was to
demonstrate effective
sterilization using Bahadir
Sterilization Containers in:

The STERIS V-PRO 60/s2
Flexible Cycle. The test load
was prepared using a ¾ size
(Worst Case).
The STERIS V-PRO maX /
maX 2 Flexible Cycle. The
test load was prepared using
a ¾ size (Worst Case).
The STERIS V-PRO
maX/maX2 and 60/s2 Non
Lumen Cycle
The STERIS V-PRO
maX/maX2 and 60/s2
Lumen Cycle | | PASS - Effective sterilization
using Bahadir Sterilization
Containers was demonstrated
after processing in the STERIS
V-PRO 60/s2 Flexible Cycle with
max load allowed ss lumens.
Testing was performed with the
worst-case container size and
verified the claims for
sterilizing:

One flexible surgical endoscope
may be single or dual lumen
device with lumen that are ≥
1mm ID and ≤ 990mm in length.

Additional load up to 11 lb can
include stainless steel lumens
with following dimensions ≥
1.8mm ID and ≤ 543mm in
length, ≥ 0.76mm ID and ≤ 233
mm in length and ≥ 1.0mm ID
and ≤ 254mm in length.

And in the STERIS V-PRO
maX/maX2 and 60/s2 non
lumen cycle in a load using
worst case sterilant penetration
conditions in the V-PRO maX
non lumen cycle. The testing
verified that V-PRO maX/maX 2
non lumen cycle can sterilize
non-lumened instruments and
non-lumened rigid, semi-rigid
and flexible endoscopes.

And in the STERIS V-PRO
maX/maX2 and 60/s2 Lumen
Cycle in a load using worst case
sterilant penetration conditions
in the V-PRO maX/maX 2 lumen
cycle can sterilize lumened
device of different dimensions
as outlined in the report. |
| Sterilization validation
(continued) | (continued) | (continued) | And in the STERIS V-PRO maX /
maX 2 Flexible Cycle in a load
containing the maximum
allowed ss lumens. Testing was
performed with the worst case
container and verified the
claims for sterilizing:

Two flexible endoscopes with
no additional load. The flexible
endoscopes may be single or
dual lumen device with lumen
that are $\ge$ 1mm ID and $\le$
1050mm in length.

One flexible endoscope with
accessories and additional
instruments. The flexible
endoscope may contain single
or dual channel lumens that are
$\ge$ 1mm ID and $\le$ 1050mm in
length.

Additional instruments may
include non-lumened or
lumened medical devices with
lumen that is $\ge$ 0.48mm ID and
$\le$ 100mm in length. |
| Material Compatibility of
the Bahadir Containers
to be assessed after
Automated Cleaning and
sterilization modalities (
STERRAD 100NX
Sterilization and STERIS
V-PRO Sterilization) | To verify the material
compatibility of the Bahadir
Container Systems following
automated cleaning and
STERRAD 100NX
Sterilization and STERIS V-
PRO Sterilization | The containers must show no
signs of degradation after
automated cleaning and using
different sterilization modalities
(STERRAD 100NX and STERIS V-
PRO) | PASS: No degradation was
observed. |
| 30 Day Event Related
Shelf Life Study | To demonstrate that the
Bahadir Container Systems | The containers must maintain
sterility of internal components
for a minimum of 30 days
following exposure to STERRAD
100NX Standard cycle and
STERIS V-PRO lumen cycle. | PASS: Based on the results of
the testing the Bahadir
Container Systems |
| Test performed per
standards:

AAMI ST77:2013/ (R)2018

ISO 11607-
1:2006/A1:2014/
(R)2019.

ISO 14937:2009/ (R)2013

The testing is to include
Worst case, mid case
and best case for Bahadir
containers following
STERRAD 100NX
Standard and STERIS V-
PRO Lumen Cycles. | - 1/2 Size (Best Case)

3/4 Size (Worst Case)
Full Size (Mid Case)
can effectively maintain the
sterility of its internal
contents following exposure
to a
STERRAD 100NX
Standard
Sterilization cycle
STERIS V-PRO
lumen cycle
and a minimum 30-day
event related storage period. | | - 1/2 Size (Best Case)
3/4 Size (Worst Case)
Full Size (Mid Case)
maintained the sterility of their
contents following exposure to
a
STERRAD 100NX
Standard Sterilization
Cycle
STERIS V-PRO lumen
cycle
For a minimum of a thirty (30)
day shelf life storage period. |
| 180 Day Event Related
Shelf Life Study | To demonstrate that the
Bahadir Container Systems | The containers must maintain
sterility of their contents for a
minimum of 180 days following
STERIS V-PRO lumen cycle and
STERRAD 100NX Standard
cycle). | PASS: Based on the results of
the testing the Bahadir
Container Systems |
| Testing performed per
standards:

AAMI ST77:2013/ (R)2018

ISO 11607-
1:2006/A1:2014/
(R)2019.

ISO 14937:2009/ (R)2013

Testing to include best
case, worst case and mid
case of the Bahadir
Containers for different
sterilization modalities
(STERIS V-PRO Lumen
cycle, STERRAD 100NX | - 1/2 Size (Best Case)

3/4 Size (Worst Case)
Full Size (Mid Case)
can effectively maintain the
sterility of its internal
contents following exposure
to a
STERIS V-PRO
lumen cycle
STERRAD 100NX
Standard cycle
and a minimum 180-day
event related storage period. | | - 1/2 Size (Best Case)
3/4 Size (Worst Case)
Full Size (Mid Case)
maintained the sterility of their
contents following exposure to
a
STERIS V-PRO lumen
cycle
STERRAD 100NX
Standard Sterilization
Cycle
and a minimum 180 day shelf
life storage period. |
| Cytotoxicity Testing | | The container materials must | PASS – The device was |
| | To verify that the materials
used for the Bahadir
Sterilization Containers are
non-cytotoxic. | be classified as non-toxic per
ISO 10994-5 standard. | determined not to be cytotoxic. |
| Testing conducted per
standard
ISO 10993-5 | | | No cytotoxicity or cell lysis was
noted. |
| | The testing included:
½ size (Best Case)
ISO Elution Method
following STERIS V-
PRO Sterilization
½ size (Best Case)
MEM Elution
Method following
STERRAD 100NX
Standard Cycle
Sterilization | | |

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SAFETY AND EFFICACY

The subject device has been tested to and complies with applicable consensus standards and FDA Guidance. All of the testing passed and there were no identified issues that would impact the safety, performance or efficacy of the subject device.

CONCLUSION

The conclusion drawn from the non-clinical testing demonstrates that the subject device, BAHADIR Sterilization Containers, submitted under K233578, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K131407.