Aygün Sterilization Container Systems

K233222 · Aygun Surgical Instruments Co., Inc. · KCT · Dec 12, 2023 · General Hospital

Device Facts

• Record ID: K233222
• Device Name: Aygün Sterilization Container Systems
• Applicant: Aygun Surgical Instruments Co., Inc.
• Product Code: KCT · General Hospital
• Decision Date: Dec 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Aygün Sterilization Container Systems is indicated for use by hospitals and health care facilities to: · Organize and protect stainless steel, aluminum, plastic, and silicone surgical instruments during the reprocessing process. · Facilitate the sterilization of the enclosed instruments via pre-vacuum steam sterilization cycles, • Maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container remains uncompromised, · The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is designed for use with stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. For effective sterilization and drying of any size Aygün Sterilization Container System, the recommended maximum combined weight of the single container, lid, baskettray, and basket/tray contents is defined below. The qualified lumen size, representing the minimum diameter and maximum length, which has been qualified for use, is also shown below. Type: Pre-vacuum Steam Sterilization. Cycle: Temperature: 132°C, Exposure Time: 4 minutes, Drying Time: 30 minutes. Stackable: No. Instrument Type: stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. Lumen Size: ≥ Full Size:1mm x 500mm, ≤ Three Quarter Size: 1mm x 200mm Maximum Weight: > Three Quarter Size: 25 lbs., ≤ Half Size 15 lbs.

Device Story

Aygün Sterilization Container Systems are rigid containers used in hospitals and healthcare facilities to house surgical instruments during pre-vacuum steam sterilization. The system consists of a container, lid, and internal basket/tray. Instruments (stainless steel, aluminum, titanium, plastic, silicone) are placed inside the container, which is then subjected to a pre-vacuum steam sterilization cycle (132°C for 4 minutes, 30-minute drying time). The container protects instruments during reprocessing and maintains sterility for up to 180 days during storage and transport within the facility. The device is operated by healthcare staff. It does not provide diagnostic output or clinical decision support; it serves as a protective barrier for sterile processing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Rigid sterilization container system composed of container, lid, and basket/tray. Materials include stainless steel, aluminum, titanium, plastic, and silicone. Designed for pre-vacuum steam sterilization (132°C). Qualified for specific lumen sizes (1mm x 500mm for full size; 1mm x 200mm for three-quarter size) and weight limits (25 lbs for > three-quarter size; 15 lbs for ≤ half size).

Indications for Use

Indicated for use in hospitals and healthcare facilities to organize, protect, and facilitate pre-vacuum steam sterilization of stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. Maintains sterility for up to 180 days during internal facility storage/transport. Not tested for transport outside the facility.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 12, 2023

Aygun Surgical Instruments Co., Inc. % Raymond Kelly Consultant Licensale Inc 3422 Leonardo Lane New Smyrna Beach, Florida 32168

Re: K233222

Trade/Device Name: Aygün Sterilization Container Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 30, 2023 Received: November 30, 2023

Dear Raymond Kelly:

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.

{1}------------------------------------------------

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" (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 QS 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control

{2}------------------------------------------------

and Plastic and Reconstructive Surgery Devices 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) K233222

Device Name

Aygün Sterilization Container Systems

#### Indications for Use (Describe)

The Aygün Sterilization Container Systems is indicated for use by hospitals and health care facilities to:

· Organize and protect stainless steel, aluminum, plastic, and silicone surgical instruments during the reprocessing process.

· Facilitate the sterilization of the enclosed instruments via pre-vacuum steam sterilization cycles,

• Maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container remains uncompromised,

· The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is designed for use with stainless steel, aluminum, titanium, plastic, and silicone surgical instruments.

For effective sterilization and drying of any size Aygün Sterilization Container System, the recommended maximum combined weight of the single container, lid, baskettray, and basket/tray contents is defined below. The qualified lumen size, representing the minimum diameter and maximum length, which has been qualified for use, is also shown below.

Type: Pre-vacuum Steam Sterilization.

Cycle: Temperature: 132°C, Exposure Time: 4 minutes, Drying Time: 30 minutes. Stackable: No. Instrument Type: stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. Lumen Size: ≥ Full Size:1mm x 500mm, ≤ Three Quarter Size: 1mm x 200mm Maximum Weight: > Three Quarter Size: 25 lbs., ≤ Half Size 15 lbs.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

X 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."