GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY

K120474 · Gyrus Acmi, Inc. · KCT · Jul 10, 2012 · General Hospital

Device Facts

• Record ID: K120474
• Device Name: GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
• Applicant: Gyrus Acmi, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jul 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Gyrus ACMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACMI telescopes during Steam Sterilization using the following parameters: STEAM Sterilization Parameters: PreVacuum, Temp: 275°F/132°C, Pressure 26psigs, Exposure 3 minutes, Dry Time 20 minutes. The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time. Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the sterilization wrap and follow manufacturers recommended storage conditions and timeframes for shelf life.

Device Story

Two-piece plastic container (lid with 14 holes, tray with 18 holes) designed to house and protect Gyrus ACMI telescopes during steam sterilization; facilitates steam ingress. Used in clinical environments by healthcare staff to prepare instruments for sterilization. Device is double-wrapped with FDA-cleared sterilization wrap prior to processing. Validated for pre-vacuum steam sterilization (275°F/132°C, 26 psigs, 3-minute exposure, 20-minute dry time). Does not maintain sterility independently; relies on external sterilization wrap. Protects telescopes from physical damage during handling and storage.

Clinical Evidence

Bench testing only. Validation performed to ensure sterility of Gyrus ACMI telescopes when processed in the tray using specified steam sterilization parameters (275°F/132°C, 26 psigs, 3-minute exposure, 20-minute dry time).

Technological Characteristics

Two-piece plastic container; lid (14 holes) and tray (18 holes) for steam ingress. Materials compatible with ISO10993-1. Complies with AAMI/ANSI ST77 and ST79. Non-patient contacting. Passive device; no energy source or software.

Indications for Use

Indicated for the protection and enclosure of Gyrus ACMI telescopes (non-lumened, 2.7mm-4mm diameter, up to 31cm length) during steam sterilization. Used in clinical settings for instrument reprocessing.

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

• K092682

Submission Summary (Full Text)

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

K120474

Image /page/0/Picture/1 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are large and black, and they are spaced closely together. There is a registered trademark symbol to the right of the letter "S". The word is likely a logo or branding for the company Olympus.

Your Vision Our Fut

#### 6) 510(k) Summary

JUL 1 0 2012

510(k) Summary for Gyrus ACMI Telescope Storage-Sterilization Tray

### General Information

Manufacturer:

# Gyrus ACMI Inc. 136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

Contact Person:

Device Description

Classification Name: Product Code Trade Name:

Generic/Common Name:

Predicate Device

3003790304

Graham Baillie Manager, Regulatory Affairs

Sterilization Wrap КСТ Gyrus ACMI Telescope Storage-Sterilization Tray

Sterilization wrap containers, trays, cassettes & other accessories

#### K092682

#### Intended Use

The Gyrus ACMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACMI telescopes during Steam Sterilization using the following parameters:

STEAM Sterilization Parameters:

| | PreVacuum |
|----------|----------------|
| Temp: | 275°F<br>132°C |
| Pressure | 26psigs |
| Exposure | 3 minutes |
| Dry Time | 20 minutes |

The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time.

Gyrus ACMI, Inc 136 Turnpike Road Southborough, MA 01772

office 508.804.2600

508.804.2624 lax www.gyrusacmi.com

Image /page/0/Picture/28 description: The image shows the logo for "GYRUS ACMI". Above the text is a graphic of a triangle made of several lines. Below the text is the phrase "Power through integration".

- Olympus

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

Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the approved sterilization wrap and follow recommended storage conditions and timeframes for shelf life of the sterilization wrap.

## Product Description

The Gyrus ACMI Telescope Storage-Sterilization Trav is a two-piece container made of a plastic lid containing 14 holes, and a plastic trav containing 18 holes that permit ready ingress of Steam. The tray provides protection to the telescopes during sterilization and storage.

#### Design

Compliance to Voluntary Standards

The design of the DEVICE complies with the following standards: ISO10993-1, AAMI/ANSI ST77, AAMI/ANSI ST79

#### Material

The DEVICE does not come into contact with patients. The materials used are the same as the materials in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI. Materials are compatible with testing identified in ISO10993-1.

Summary of Sterilization and Shelf Life Discussion

The DEVICE was validated to sterilize Gyrus ACMI telescopes using Steam with the following parameters:

| Temp: | Pre Vacuum |
|----------|------------|
| | 275°F |
| | 132°C |
| Pressure | 26 psigs |
| Exposure | 3 minutes |
| Dry Time | 20 minutes |

Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the sterilization wrap and follow manufacturers recommended storage conditions and timeframes for shelf life of the sterilization wrap.

Technological Characteristics and Substantial Equivalence

The Gyrus ACMI Telescope Storage-Sterilization Tray is composed of the same materials as the predicates and utilizes the same features as the predicates. Validation testing was performed to ensure sterility of devices recommended for use with the proposed device.

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

# Conclusion:

In summary, based on intended use, technological characteristics and performance data, the Gyrus ACMI Telescope Storage-Sterilization Tray is substantially equivalent to previously cleared Gyrus ACMI storage-sterilization trays.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Graham Baillie Manager, Regulatory Affairs Gyrus ACMI, Incorporated 136 Turnpike Road Southborough, Massachusetts 01772

JUL 10 2012

Re: K120474

Trade/Device Name: Gyrus ACMI Telescope Storage-Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 14, 2012 Received: June 15, 2012

Dear Mr. Baillie:

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. 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.

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

# Page 2 - Mr. Baillie

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

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

{5}------------------------------------------------

K120474

## 5) Indications for Use Statement

#### Statement of Intended Use

510(k) Number (if Known):

Gyrus ACMI Telescope Storage-Sterilization Tray Device Name:

Indications For Use:

The Gyrus ACMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACMI telescopes during Steam Sterilization using the following parameters:

STEAM Sterilization Parameters:

| | PreVacuum |
|----------|----------------|
| Temp: | 275°F<br>132°C |
| Pressure | 26psigs |
| Exposure | 3 minutes |
| Dry Time | 20 minutes |

The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time.

Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the sterilization wrap and follow manufacturers recommended storage conditions and timeframes for shelf life .

Prescription Use And/Or Over the Counter Use X

(21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation, ODE

Eglit D-Claudio Will

Page of

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120474