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 ℃

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.

AI/ML Overview

The Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are designed to protect Gyrus ACMI flexible endoscopes during Ethylene Oxide (EtO) sterilization, using an FDA-cleared sterilization wrap. The key acceptance criterion is to ensure that the trays allow for effective EtO sterilization and maintain sterility through the wrap.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Sterilization Effectiveness: The tray must permit effective EtO sterilization, demonstrating a Sterility Assurance Level (SAL) of $10^{-6}$ (6 log reduction capability).	The system was sterilized successfully in a 30-minute half cycle, demonstrating 6 log reduction capability (SAL of $10^{-6}$).
Residual EtO Levels: Ethylene oxide residuals must be within acceptable limits after aeration, as per ISO 10993-7.	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.
Biocompatibility: The materials used in the trays must be biocompatible (Radel-R).	The trays are constructed of biocompatible RADEL-R. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993.
Compatibility with EtO Sterilization: The tray material must be compatible with EtO sterilization.	Radel-R is compatible with EtO sterilization.
Protection of Endoscopes: The trays must provide protection from physical damage to the flexible endoscope during sterilization and storage. (This is a design feature rather than a quantifiable performance metric for this study, but implied by the intended use).	The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage. (This was assessed through the design and materials, and likely confirmed via visual inspection and functional testing of the endoscopes after processing, though specific data for this aspect isn't detailed in the provided text).

2. Sample Size and Data Provenance:

Sample Size for Test Set: The document mentions "PCDs (process challenge devices) were placed in the trays" and "Test systems were exposed to 60 minute full cycles". This implies multiple trays with PCDs were tested. However, a specific numerical sample size (e.g., number of trays, number of cycles per tray) for the sterilization effectiveness and residual testing is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. FDA for regulatory clearance. The study appears to be prospective in nature, as new testing was conducted specifically for this device (e.g., "The PCDs...were placed in the trays and inoculated...").

3. Number of Experts and Qualifications for Ground Truth (Test Set):

This study is a physical and chemical performance test rather than a diagnostic device that requires expert interpretation of results for ground truth.
The "ground truth" for sterilization effectiveness (6 log reduction) is established by industrial standards and scientific principles related to biological indicators (e.g., spore-forming bacteria) and their inactivation kinetics. This does not involve human experts establishing a "ground truth" in the same way as, for example, radiologists interpreting images.
For EtO residual testing, the "ground truth" is adherence to established chemical safety standards like ISO 10993-7, which are objective measurements.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) is applicable or mentioned, as this is not a study involving human interpretation or subjective assessment of results. The results are based on objective, quantifiable measurements of biological indicator inactivation and chemical residue levels.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are a medical device accessory for sterilization, not a diagnostic tool, and their performance is evaluated through physical and chemical testing.

6. Standalone Performance:

A standalone performance study was done. The described testing, where PCDs and chemical indicators were placed in the trays and processed through sterilization cycles, is a direct assessment of the device's ability to facilitate effective sterilization without human intervention in the sterilization process itself (beyond loading and operating the sterilizer).

7. Type of Ground Truth Used:

The ground truth for sterilization effectiveness was based on the inactivation of biological indicator organisms (demonstrating a 6 log reduction, or a sterility assurance level of $10^{-6}$), which is an objective, scientifically established method for validating sterilization processes.
The ground truth for Ethylene Oxide residuals was based on compliance with ISO 10993-7, a recognized international standard for the biological evaluation of medical devices, specifically regarding acceptable limits for EtO residuals.

8. Sample Size for the Training Set:

Not applicable. This device is a physical accessory evaluated through performance testing, not an algorithm or AI system that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

{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

K040223 K033222

Intended Uses

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

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

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

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.

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

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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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

PAGE. I OF 1

510(k) Number

Regulation Number and Section

§ 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).