GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS

K092682 · Gyrus Acmi, Inc. · KCT · Dec 11, 2009 · General Hospital

Device Facts

• Record ID: K092682
• Device Name: GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
• Applicant: Gyrus Acmi, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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

Device Story

Plastic storage-sterilization trays designed to house and protect Gyrus ACMI flexible endoscopes during ethylene oxide (EtO) sterilization and subsequent storage. Trays feature large holes (approx. 7mm) to facilitate gas ingress/egress. Used in clinical settings by healthcare staff; trays are wrapped in FDA-cleared sterilization wrap prior to processing. Trays do not contact patients. Protects endoscopes from physical damage; sterility maintenance relies on the external wrap. Validated for 100% EtO sterilization cycles.

Clinical Evidence

Bench testing only. PCDs inoculated with biological indicators placed in trays, wrapped, and processed in 30-minute half-cycles. Demonstrated 6-log reduction (SAL 10^-6). EtO residual testing performed after 60-minute full cycles with 12-hour aeration; results within ISO 10993-7 limits.

Technological Characteristics

Constructed of biocompatible RADEL-R (polyphenylsulfone). Dimensions feature large 7mm diameter holes for gas exchange. Compatible with 100% EtO sterilization. Biocompatibility per ISO 10993. Non-patient contacting.

Indications for Use

Indicated for ETO sterilization of specific Gyrus ACMI flexible endoscopes (ICN, DUR-D, ACN, DUR-8, and AUR series) to provide physical protection during sterilization and storage. Not for patient contact.

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

• Symmetry Medical Poly Vac Instrument Delivery System (K040223)
• Olympus Sterilization Trays (K033222)

Submission Summary (Full Text)

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Kogalasa

# DEC 1 1 2009

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### 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. #: [phone] Fax #: [phone]

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

K040223 K033222

### 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 [phone] or [phone] 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