(75 days)
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Not Found
No
The summary describes a physical sterilization container system and its intended use, without any mention of software, algorithms, or data processing that would suggest AI/ML.
No
This device is a sterilization container system used to organize, protect, and facilitate the sterilization of surgical instruments. It does not directly treat or diagnose a disease or condition in a patient.
No
The device is a sterilization container system used to organize, protect, and facilitate the sterilization of surgical instruments, and maintain their sterility. It does not diagnose any conditions or provide diagnostic information.
No
The device description and intended use clearly describe a physical sterilization container system, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Aygün Sterilization Container System is used to organize, protect, and facilitate the sterilization of surgical instruments. It does not analyze or test any biological specimens from a patient.
- Intended Use: The intended use clearly describes the device's function in the reprocessing and storage of surgical instruments, not in diagnostic testing.
Therefore, this device falls under the category of medical devices used for sterilization and instrument management, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and health care facilities
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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