Who is the manufacturer of BAHADIR STERILIZATION CONTAINERS?

Bahadir USA, LLC filed the 510(k) submission for BAHADIR STERILIZATION CONTAINERS (K233578).

What is the FDA product code for BAHADIR STERILIZATION CONTAINERS?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BAHADIR STERILIZATION CONTAINERS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BAHADIR STERILIZATION CONTAINERS?

Bahadir Sterilization Containers (K131407); AESCULAP Aicon Container (K214041).

Who can help prepare an FDA 510(k) submission like BAHADIR STERILIZATION CONTAINERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BAHADIR STERILIZATION CONTAINERS

K233578 · Bahadir USA, LLC · KCT · Mar 22, 2024 · General Hospital

Device Facts

Record ID	K233578
Device Name	BAHADIR STERILIZATION CONTAINERS
Applicant	Bahadir USA, LLC
Product Code	KCT · General Hospital
Decision Date	Mar 22, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended 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.

Device Story

Reusable metal sterilization container system; holds surgical instruments/textiles during low-temperature hydrogen peroxide sterilization; maintains sterility during storage/transport. Used in hospital settings by sterile processing staff. Input: medical instruments/textiles. Operation: perforated container design allows sterilant penetration while polypropylene filters prevent microbial migration. Output: sterilized, protected instrument load. Benefits: ensures instrument sterility for surgery; supports various lumen/non-lumen configurations.

Clinical Evidence

Bench testing only. Validated sterilization efficacy (SAL 10^-6) across specified STERIS and STERRAD cycles. Microbial aerosol challenge testing confirmed barrier integrity after 100 cleaning/sterilization cycles. Shelf-life studies (30 and 180 days) confirmed sterility maintenance. Cytotoxicity testing (ISO 10993-5) confirmed non-cytotoxic materials.

Technological Characteristics

Materials: Anodized aluminum container, silicone gasket, single-use polypropylene filters. Design: Perforated bottom and lid. Principle: Air-permeable filter system for sterilant entry and microbial barrier. Sterilization: Low-temperature hydrogen peroxide. Conformance: AAMI ST77, ISO 11607-1, ISO 14937, ISO 10993-5.

Indications for Use

Indicated 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 conditions. Compatible with STERIS V-PRO maX/maX2, STERIS V-PRO s2/60, STERRAD 100NX, and STERRAD NX sterilization cycles.

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 Sterilization Containers (K131407)
AESCULAP Aicon Container (K214041)

Related Devices

K242762 — Aesculap Aicon® Series Container System · Aesculap, Inc. · May 13, 2025
K142109 — STERILUCENT STERILIZATION CONTAINER SYSTEM · Sterilucent, Inc. · Jan 20, 2015
K142529 — Genesis Reusable Rigid Container System · Carefusion 2200, Inc. · Jan 8, 2015
K050570 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM · Miltex, Inc. · Jul 25, 2005
K240898 — SteriTite rigid reusable sterilization container with MediTray Products · Case Medical · Jul 31, 2024

Submission Summary (Full Text)

{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 {3}------------------------------------------------ ## 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 <100mm OR non-lumen device | | | Three-Quarter 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-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 ≥1mm x ≤1050mm. Additional single, dual or triple channel stainless steel lumen device that is ≥0.48mm x <100mm OR non-lumen device | | STERIS VPRO maX/maX2 Non-Lumen Cycle | Full Size | -Non lumened instruments | | | Three-Quarter Size | -Non lumened instruments | | | Half Size | -Non lumened instruments | | | Full Size | ≥0.77mm x ≤410mm (single or dual channel) | {4}------------------------------------------------ {5}------------------------------------------------ | | | | ≥1.8mm x ≤542mm (single or dual channel) | |--------------------------------------|--------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | STERIS VPRO s2/60 | | | ≥1.2mm x ≤275mm (triple channel) ≥1.8mm x ≤310mm (triple channel) ≥2.8mm x ≤317mm (triple channel) | | Lumen cycle | Three-Quarter Size | | ≥0.77mm x ≤410mm (single or dual channel) ≥1.8mm x ≤542mm (single or dual channel) | | | Half Size | | ≥1.2mm x ≤275mm (triple channel) ≥1.8mm x ≤310mm (triple channel) ≥2.8mm x ≤317mm (triple channel) | | | | | ≥0.77mm x ≤410mm (single or dual channel) ≥1.8mm x ≤542mm (single or dual channel) | | | 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 ≥1mm x ≤990mm | | STERIS VPRO s2/60 | | | | | 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 ≥1mm x ≤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 ≥1mm x ≤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 | | | | Half Size | Non lumened SS instruments | | | STERRAD 100NX Duo Cycle | Full Size | (1)PTFE tubing 1.5 mm I.D. x 850mm L | | | | 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 Flexible Cycle | Full Size | (1) Scope lumen 1mm I.D. x 850mm L | | | | Three-Quarter Size | (1) Scope lumen 1mm I.D. x 850mm L | | | | Half Size | (1)PTFE tubing 1mm I.D. x 850mm L | | {6}------------------------------------------------ ## Bahadir Sterilization Containers Configurations | Sterilization Cycle | Container Size | Container Name | Total Loaded Container (lbs) | |--------------------------------------------|-------------------------|----------------|------------------------------| | STERIS VPRO maX/maX2 Lumen Cycle | Full Size 4 ⅛” | Y111.10 | 19.65 | | | Full Size 5 ¼” | Y111.13 | 19.65 | | | Full Size 5 ⅞” | Y111.15 | 19.65 | | | Full Size 7 ¾” | Y111.20 | 19.65 | | | Full Size 10 ¼ “ | Y111.26 | 19.65 | | | Full Size 7 ¾” | Y111.70 | 19.65 | | | Three-Quarter Size 4 ⅛” | Y211.10 | 19.65 | | | Three-Quarter Size 5 ¼” | Y211.13 | 19.65 | | | Three-Quarter Size 5 ⅞” | Y211.15 | 19.65 | | | Three-Quarter Size 7 ¾” | Y211.20 | 19.65 | | | Half Size 4 ⅛” | Y311.10 | 15 | | | Half Size 5 ¼” | Y311.13 | 15 | | | Half Size 5 ⅞” | Y311.15 | 15 | | | Half Size 7 ¾” | Y311.20 | 15 | | | Half Size 10 ¼” | Y311.26 | 15 | | | Full Size 4 ⅛” | Y111.10 | 21 | | | Full Size 5 ¼” | Y111.13 | 21 | | | Full Size 5 ⅞” | Y111.15 | 21 | | | Full Size 7 ¾” | Y111.20 | 21 | | | Full Size 10 ¼ “ | Y111.26 | 21 | | | Full Size 7 ¾” | Y111.70 | 21 | | STERIS VPRO | Size | | | | maX/maX2 Flexible Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 21 | | | Three-Quarter Size 5 ¼" | Y211.13 | 21 | | | Three-Quarter Size 5 ⅞" | Y211.15 | 21 | | | Three-Quarter Size 7 ¾" | Y211.20 | 21 | | | Half Size 4 ⅛" | Y311.10 | 21 | | | Half Size 5 ¼" | Y311.13 | 21 | | | Half Size 5 ⅞" | Y311.15 | 21 | | | Half Size 7 ¾" | Y311.20 | 21 | | | Half Size 10 ¼" | Y311.26 | 21 | | | Full Size 4 ⅛" | Y111.10 | 26 | | | Full Size 5 ¼" | Y111.13 | 26 | | | Full Size 5 ⅞" | Y111.15 | 26 | | | Full Size 7 ¾" | Y111.20 | 26 | | | Full Size 10 ¼" | Y111.26 | 26 | | | Full Size 7 ¾" | Y111.70 | 26 | | STERIS VPRO maX/maX2 Non-Lumen Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 26 | | | Three-Quarter Size 5 ¼" | Y211.13 | 26 | | | Three-Quarter Size 5 ⅞" | Y211.15 | 26 | | | Three-Quarter Size 7 ¾" | Y211.20 | 26 | | | Half Size 4 ⅛" | Y311.10 | 19 | | | Half Size 5 ¼" | Y311.13 | 19 | | | Half Size 5 ⅞" | Y311.15 | 19 | | | Half Size 7 ¾" | Y311.20 | 19 | | | Half Size 10 ¼" | Y311.26 | 19 | | | Full Size 4 ⅛" | Y111.10 | 11 | | | Full Size 5 ¼" | Y111.13 | 11 | | | Full Size 5 ⅞" | Y111.15 | 11 | | | Full Size 7 ¾" | Y111.20 | 11 | | | Full Size 10 ¼" | Y111.26 | 11 | | | Full Size 7 ¾" | Y111.70 | 11 | | STERIS VPRO S2/60 Lumen Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 11 | | | Three-Quarter Size 5 ¼" | Y211.13 | 11 | | | Three-Quarter Size 5 ⅞" | Y211.15 | 11 | | | Three-Quarter Size 7 ¾" | Y211.20 | 11 | | | Half Size 4 ⅛" | Y311.10 | 11 | | | Half Size 5 ¼" | Y311.13 | 11 | | | Half Size 5 ⅞" | Y311.15 | 11 | | | Half Size 7 ¾" | Y311.20 | 11 | | | Half Size 10 ¼" | Y311.26 | 11 | | | Full Size 4 ⅛" | Y111.10 | 11 | | | Full Size 5 ¼" | Y111.13 | 11 | | | Full Size 5 ⅞" | Y111.15 | 11 | | | Full Size 7 ¾" | Y111.20 | 11 | | | Full Size 10 ¼" | Y111.26 | 11 | | | Full Size 7 ¾" | Y111.70 | 11 | | STERIS VPRO S2/60 Flexible Cycle | Three-Quarter Size 4 ⅛" | Y211.10 | 11 | | | Three-Quarter Size 5 ¼" | Y211.13 | 11 | | | Three-Quarter Size 5 ⅞" | Y211.15 | 11 | | | Three-Quarter Size 7 ¾" | Y211.20 | 11 | | | Half Size 4 ⅛" | Y311.10 | 11 | | | Half Size 5 ¼" | Y311.13 | 11 | | | Half Size 5 ⅞" | Y311.15 | 11 | | | Half Size 7 ¾" | Y311.20 | 11 | | | Half Size 10 ¼" | Y311.26 | 11 | | | Full Size 4 ⅛" | Y111.10 | 19 | | | Full Size 5 ¼" | Y111.13 | 19 | | | Full Size 5 ⅛” | Y111.15 | 19 | | | Full Size 7 ¾” | Y111.20 | 19 | | | Full Size 10 ¼ “ | Y111.26 | 19 | | | Full Size 7 ¾” | Y111.70 | 19 | | STERIS VPRO S2/60 Non-Lumen Cycle | Three-Quarter Size 4 ⅛” | Y211.10 | 19 | | | Three-Quarter Size 5 ¼” | Y211.13 | 19 | | | Three-Quarter Size 5 ⅞” | Y211.15 | 19 | | | Three-Quarter Size 7 ¾” | Y211.20 | 19 | | | Half Size 4 ⅛” | Y311.10 | 12.5 | | | Half Size 5 ¼” | Y311.13 | 12.5 | | | Half Size 5 ⅞” | Y311.15 | 12.5 | | | Half Size 7 ¾” | Y311.20 | 12.5 | | | Half Size 10 ¼” | Y311.26 | 12.5 | | | Full Size 4 ⅛” | Y111.10 | 10.7 | | | Full Size 5 ¼” | Y111.13 | 10.7 | | | Full Size 5 ⅞” | 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 4 ⅛” | Y211.10 | 10.7 | | | Three-Quarter Size 5 ¼” | Y211.13 | 10.7 | | | Three-Quarter Size 5 ⅞” | Y211.15 | 10.7 | | | Three-Quarter Size 7 ¾” | Y211.20 | 10.7 | | | Half Size 4 ⅛” | Y311.10 | 10.7 | | | Half Size 5 ¼” | Y311.13 | 10.7 | | | Half Size 5 ⅞” | Y311.15 | 10.7 | | | Half Size 7 ¾” | Y311.20 | 10.7 | | | Half Size 10 ¼” | Y311.26 | 10.7 | | | Full Size 4 ⅛” | Y111.10 | 10.7 | | | Full Size 5 ¼” | Y111.13 | 10.7 | | | Full Size 5 ⅞” | 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 4 ⅛” | Y211.10 | 13.85 | | | Three-Quarter Size 5 ¼” | Y211.13 | 13.85 | | | Three-Quarter Size 5 ⅞” | Y211.15 | 13.85 | | | Three-Quarter Size 7 ¾” | Y211.20 | 13.85 | | | Half Size 4 ⅛” | Y311.10 | 10.7 | | | Half Size 5 ¼” | Y311.13 | 10.7 | | | Half Size 5 ⅞” | Y311.15 | 10.7 | | | Half Size 7 ¾” | Y311.20 | 10.7 | | | Half Size 10 ¼” | Y311.26 | 10.7 | | | Full Size 4 ⅛” | 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 Standard Cycle | Three-Quarter Size 4 ⅛” | Y211.10 | 13.85 | | | Three-Quarter Size 5 ¼” | Y211.13 | 13.85 | | | Three-Quarter Size 5 ⅞” | Y211.15 | 13.85 | | | Three-Quarter Size 7 ¾” | Y211.20 | 13.85 | | | Half Size 4 ⅛” | Y311.10 | 13.85 | | | Half Size 7¾" | Y311.20 | 13.85 | | | Half Size 10¼" | Y311.26 | 13.85 | | | Full Size 4⅛" | Y111.10 | 21.4 | | | Full Size 5¼" | Y111.13 | 21.4 | | | Full Size 5⅞" | Y111.15 | 21.4 | | | Full Size 7¾" | Y111.20 | 21.4 | | | Full Size 10¼" | Y111.26 | 21.4 | | | Full Size 7¾" | Y111.70 | 21.4 | | STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | | Express Cycle | Three-Quarter Size 5¼" | Y211.13 | 13.85 | | | Three-Quarter Size 5⅞" | Y211.15 | 13.85 | | | Three-Quarter Size 7¾" | 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 7¾" | Y311.20 | 13.85 | | | Half Size 10¼" | Y311.26 | 13.85 | | | Full Size 4⅛" | Y111.10 | 13.2 | | | Full Size 5¼" | Y111.13 | 13.2 | | | Full Size 5⅞" | Y111.15 | 13.2 | | | Full Size 7¾" | Y111.20 | 13.2 | | | Full Size 10¼" | Y111.26 | 13.2 | | | Full Size 7¾" | Y111.70 | 13.2 | | STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.2 | | DUO Cycle | Three-Quarter Size 5¼" | Y211.13 | 13.2 | | | Three-Quarter Size 5⅞" | Y211.15 | 13.2 | | | Three-Quarter Size 7¾" | Y211.20 | 13.2 | | | Half Size 4⅛" | Y311.10 | 7.2 | | | Half Size 5¼" | Y311.13 | 7.2 | | | Half Size 5⅞" | Y311.15 | 7.2 | | | Half Size 7¾" | Y311.20 | 7.2 | | | Half Size 10¼" | Y311.26 | 7.2 | | | Full Size 4⅛" | Y111.10 | 12.59 | | | Full Size 5¼" | Y111.13 | 12.59 | | | Full Size 5⅞" | Y111.15 | 12.59 | | | Full Size 7¾" | Y111.20 | 12.59 | | | Full Size 10¼" | Y111.26 | 12.59 | | | Full Size 7¾" | Y111.70 | 12.59 | | STERRAD 100NX | Three-Quarter Size 4⅛" | Y211.10 | 13.85 | | Flexible Cycle | Three-Quarter Size 5¼" | Y211.13 | 13.85 | | | Three-Quarter Size 5⅞" | Y211.15 | 13.85 | | | Three-Quarter Size 7¾" | 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 7¾" | Y311.20 | 13.85 | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Bahadir Sterilization Containers may be used with Bahadir USA 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 | Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {11}------------------------------------------------ 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) {12}------------------------------------------------ #### 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…

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BAHADIR STERILIZATION CONTAINERS

Device Facts

Intended Use

Device Story

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Predicate Devices

Related Devices

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