GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT

K102970 · Gyrus Acmi, Inc. · KCT · May 20, 2011 · General Hospital

Device Facts

• Record ID: K102970
• Device Name: GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
• Applicant: Gyrus Acmi, Inc.
• Product Code: KCT · General Hospital
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Gyrus ACMI® CyberWand™ Transducer and Accessories Storage-Sterilization Trays are intended to be used to enclose and protect only CyberWand transducers and accessories during steam or EO sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand transducers and accessories for which they are designed. The trays are indicated for steam or ETO sterilization of only the following maximum load per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets. I Wrench, I Cleaning stylet

Device Story

Plastic sterilization tray designed to house and protect CyberWand transducers and accessories during EtO sterilization and storage. Tray features perforated lid and bottom (approx. 7mm holes) to facilitate gas ingress/egress; secured with stainless steel clips. Used in clinical settings by staff to prepare equipment for reuse. Device does not contact patient; serves as protective container during sterilization cycle. Benefits include physical protection of delicate transducers during processing.

Clinical Evidence

Bench testing only. Validation included EtO sterilization cycle testing using biological indicators (6-log reduction, SAL 10^-6) and chemical indicators. EtO residual testing performed per ISO 10993-7 with 12-hour aeration; results within acceptable limits.

Technological Characteristics

Material: Radel-R (polyphenylsulfone) per ISO 10993. Design: Plastic lid/bottom with ~7mm perforations; stainless steel locking clips. Sterilization: EtO (100% concentration, 55°C, 60-min exposure). Form factor: Accessory storage tray.

Indications for Use

Indicated for ETO sterilization of specific CyberWand accessories (2 transducers, 2 probe sets, 1 wrench, 1 cleaning stylet) within a protective tray and FDA-cleared wrap. No patient population specified as device does not contact patient.

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

• Gyros ACMI Flexible Endoscope Storage Sterilization Trays (K092682)
• Symmetry Medical PolyVac Instrument Delivery System (K040223)

Submission Summary (Full Text)

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Gyrus ACMI CyberWand Transducer and Accessories Storage-Sterilization Trays Traditional 510(k) Notification Gyrus ACMI Incorporated 136 Turnpike Road Southborough, MA 01772

MAY 2 0 2011

# 510(k) Summary of Safety and Effectiveness Gyrus ACMI Inc. Gyrus ACMI CyberWand™ Storage-Sterilization Trays

.

5108 # : K102970

#### General Information

Manufacturer:

Contact Person:

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

Lorraine Calzetta Regulatory Affairs Tel. #: [phone] Fax #: [phone]

Date Prepared:

Device Description

August 26, 2010

Classification Name: Sterilization, wrap, containers and trays (21CFR 880.6850), Class II

Gyrus ACMI Cyber Wand Transducer and

Accessories Sterilization Trays

Trade Name:

Generic/Common Name:

Sterilization trays

#### Predicate Devices

| Gyros ACMI Flexible Endoscope Storage Sterilization Trays | K092682 |
|-----------------------------------------------------------|---------|
| Symmetry Medical PolyVac Instrument Delivery System | K040223 |

#### Intended Uses

The Gyrus ACMI® CyberWand™ Transducer and Accessories Storage-Sterilization Trays are intended to be used to enclose and protect only CyberWand transducers and accessories during steam or EO sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand transducers and accessories for which they are designed. The trays are indicated for steam or ETO sterilization of only the following maximum load per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets. I Wrench, I Cleaning stylet

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Gyrus ACMI CyberWand Transducer and Accessories Storage-Sterilization Trays Traditional S10(k) Notification Gyrus ACMI Incorporated 136 Turnpike Road Southborough, MA 01772

EtO Sterilization parameters:

EtO Sterilize using 100% ethylene oxide

Temp: 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃

# Product Description

The Gyrus ACMI® Cyber wand 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 transducer and accessories during EtO 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 E1O sterilization.

# Performance Data

The maximum load was placed in the tray 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 by EtO demonstrating 6 log reduction capabilities (SAL of 10°).

Test systems were exposed to full cycles for EtO. EtO 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® CyberWand Transducer and Accessories Storage-Sterilization Tray s are composed of the same materials and utilize similar features as that of the predicates.

The Gyrus ACMI® CyberWand Sterilization trays are comprised of Radel-R 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 constructed of biocompatible RADEL-R. The trays are locked shut with stainless steel clips on each end. The predicate trays have similar design features ( numerous large hole that permit ingress and egress of gases.

Like the predicates , the intended use of the trays to provide protection from physical damage to accessories during EtO sterilization and storage. 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.

The predicates are also composed of Radel R and have the same design philosophy and construction and are compatible with the same sterilization modalities

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized blue eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

NOV 29 2011

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

Re: K102970

Trade/Device Name: ACMI CyberWand™ Transducer and Accessories Storage -Sterilization Trays Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: October 24, 2011 Received: October 25, 2011

Dear Mr. Baillie:

This letter corrects our substantially equivalent letter of May 20, 2011.

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 (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 - 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Antara

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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Oct 21, 2011

## Indications for Use

## 510(k) Number:

Device Name: Gyrus ACMI CyberWand™Transducer and Accessories Storage - Sterilization Trays

Indications for Use:

The Gyrus ACMI Cyber Wand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed.

The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet.

EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide: Temp 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration 12 hours @55°C.

Prescription Use: (Per 21 CFR 801.109) OR Over-the-Counter Use: X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy, MD, F.C. Lavine-Williams

(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102970