(101 days)
No
The device is a physical tray for sterilizing endoscopes and the description focuses on materials, sterilization parameters, and performance studies related to sterilization efficacy, with no mention of AI or ML.
No.
The device is a storage and sterilization tray for endoscopes, designed to protect them during sterilization and storage, not to provide therapy.
No
The device is a tray intended for sterilizing and protecting flexible endoscopes, not for diagnosing medical conditions.
No
The device is a physical tray made of plastic intended for sterilizing and storing endoscopes. It is described as having lids and bottoms with holes and is constructed of biocompatible RADEL-R. There is no mention of software components or functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being used to "enclose and protect Gyrus ACMI flexible endoscopes during sterilization." This is a function related to the processing and maintenance of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the physical characteristics of the trays (plastic lids and bottoms with holes) and their purpose in protecting endoscopes during sterilization. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described relate to the effectiveness of the sterilization process within the trays (demonstrating log reduction of biological indicators and acceptable ethylene oxide residuals). These are tests of the sterilization process and the device's compatibility with it, not diagnostic performance.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Using reagents or assays
In summary, the Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are accessories for sterilizing medical devices (endoscopes), not devices used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray.
The trays are indicated for ETO sterilization of only of the following :
Gyrus ACMI Flexible Endoscopes ICN-0564, ICN-0565 ICN DUR-D DUR-D, DUR-DBA ACN ACN-2T, ACN-2TBA DUR-8 DUR-8, DUR-8-BA, DUR-8E, DUR-8E-BA,DUR-8 Ultra AUR AUR AUR-7. AUR-735
EtO Sterilization parameters:
EtO Sterilize using 100% ethylene oxide
Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃
Product codes
KCT
Device Description
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization trays are comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage. The trays are constructed of biocompatible RADEL-R. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with EtO sterilization.
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
The PCDs (process challenge devices) were placed in the trays and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. The trays were wrapped with two layers of FDA approved sterilization wrap and placed into ethylene oxide sterilizer for processing. The system was sterilized successfully in. a 30 minute half cycle demonstrating 6 log reduction capability ( SAL of 10-6). Test systems were exposed to 60 minute full cycles and ethylene oxide residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations were within acceptable limits.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kogalasa
DEC 1 1 2009
510(k) Summary of Safety and Effectiveness Gyrus ACMI Inc. Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays
General Information
Manufacturer:
Contact Person:
Gyrus ACMI Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Lorraine Calzetta Regulatory Affairs Tel. #: 508-804-2752 Fax #: 508-804-2624
December 3, 2009,
Date Prepared:
Device Description
Classification Name: Sterilization, wrap, containers and trays (21CFR 880.6850), Class II
or Accessories to Endoscope (21CFR876.1500) Class II
Trade Name:
Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays
Generic/Common Name:
Endoscope and accessories
Predicate Devices
Symmetry Medical Poly Vac Instrument Delivery System Olympus Sterilization Trays
Intended Uses
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray.
The trays are indicated for ETO sterilization of only of the following :
Gyrus ACMI Flexible Endoscopes ICN-0564, ICN-0565 ICN DUR-D DUR-D, DUR-DBA
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ACN ACN-2T, ACN-2TBA DUR-8 DUR-8, DUR-8-BA, DUR-8E, DUR-8E-BA,DUR-8 Ultra AUR AUR AUR-7. AUR-735
EtO Sterilization parameters:
EtO Sterilize using 100% ethylene oxide
Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃
Product Description
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization trays are comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage. The trays are constructed of biocompatible RADEL-R. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with EtO sterilization.
Performance Data
The PCDs (process challenge devices) were placed in the trays and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. The trays were wrapped with two layers of FDA approved sterilization wrap and placed into ethylene oxide sterilizer for processing. The system was sterilized successfully in. a 30 minute half cycle demonstrating 6 log reduction capability ( SAL of 10-6). Test systems were exposed to 60 minute full cycles and ethylene oxide residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations were within acceptable limits.
Technological Characteristics and Substantial Equivalence
The Gyrus ACMI® Endoscope Storage-Sterilization Trays are composed of the same naterials and utilize similar features as that of the predicates.
In summary, the Gyrus ACMI Endoscope Storage Sterilization Trays are substantially equivalent to the predicate device and presents no new questions of safety or efficacy.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 1 1 2009
Ms. Lorraine Calzetta Regulatory Affairs Gyrus ACMI, Incorporated 136 Turnpike Road Southborough, Massachusetts 01772
Re: K092682
Trade/Device Name: Gyrus ACM1® Flexible Endoscope Storage-Sterilization Trays Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: October 21, 2009 Received: November 6, 2009
Dear Ms. Calzetta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Calzetta
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
Susan Tanner
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Notitication K092682
Device Name: Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays
510(k) Number: K O 9 2682
Device Name: Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays
Indications for use:
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to encloseand protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray.
The trays are indicated for ETO sterilization of only the following :
| Gyrus ACMI Flexible Endoscopes | ||
|---|---|---|
| ICN | ICN-0564, ICN-0565 | |
| DUR-D | DUR-D, DUR-DBA | |
| ACN | ACN-2T, ACN-2TBA | |
| DUR-8 | DUR-8, DUR-8-BA, DUR-8E, DUR-8E-BA, DUR-8 Ultra | |
| AUR | AUR-7, AUR-735 |
EtO Sterilization parameters:
EtO Sterilize using 100% ethylene oxide,
Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃
Prescription Use: (Per 21 CFR 801.109)
Over-the-Counter Use: OR
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. (Laurie-Wells)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number