INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS

K051157 · Micromedics, Inc. · KCT · Sep 1, 2005 · General Hospital

Device Facts

• Record ID: K051157
• Device Name: INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
• Applicant: Micromedics, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid The Instru-Safe System cassettes are not intended on the own to maintain sterility.

Device Story

Instru-Safe Instrument Protection System consists of cassettes designed to organize and protect medical instruments during sterilization. Cassettes are placed inside legally marketed sterilization wraps or Genesis rigid containers. Device facilitates steam (132°C) or ethylene oxide (EO) sterilization by allowing sterilant penetration. Used in clinical settings by sterile processing staff. Benefits include organized instrument handling and protection of devices during sterilization cycles. Does not maintain sterility on its own; relies on external packaging systems.

Clinical Evidence

Bench testing only. Validation performed for steam sterilization (132°C, 8-minute preconditioning) and ethylene oxide sterilization (131°F, 70% humidity, 2-hour exposure, 12-hour aeration) using various wrap types and Genesis containers. Dry times specified for each configuration.

Technological Characteristics

Cassette-based instrument protection system. Materials and construction designed for compatibility with pre-vacuum steam and ethylene oxide sterilization. Dimensions and form factor vary by instrument configuration. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by healthcare providers to organize and protect medical devices during pre-vacuum steam or ethylene oxide sterilization cycles. Must be used with legally marketed sterilization wrap or a Genesis rigid container. Not intended to maintain sterility independently.

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.

Reference Devices

• Genesis Container

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with three stripes on its wing, symbolizing health, service, and human dignity. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEP - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom A. Lopac Micromedics, Incorporated 1270 Eagan Industrial Road Suite 120 Eagan, Minneapolis 55121

Re: K051157

Trade/Device Name: INSTRU-SAFE Instrument Protection Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: II Product Code: KCT Dated: August 22, 2005 Received: August 23, 2005

Dear Mr. Lopac:

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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to oonimer to provision of has need 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 I ou may, aron's brovisions 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 rr your device is classinod (600 as 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_

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

Page 2 - Mr. Lopac

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be actived that I Drimination that your device complies with other requirements of the Act that I Dr Hos intatutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 80 7), accems (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. product radiation of to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottorers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sunlite Y. Michael Dm.D

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K051157

Device Name: Instru-Safe Instrument Protection Systems

Indications for Use:

Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid The Instru-Safe System cassettes are not intended on the own to maintain container. sterility.

Sterilization methods and configurations

| | 140 count woven wrap | Non-woven wrap (Kimberly Clark) | Genesis Container (reference Table 1 for filter paper to use |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------------------------------------------------------|
| Steam<br>8 minute preconditioning at 132°C | 10 minute dry time | 50 minute dry time | 30 minute dry time |
| Ethylene Oxide (EO) | 1 hour preconditioning at 131 °F (55 °C) with relative Humidity of 70±15% 2 hours exposure at 131 °F (55 °C) 12 hours aeration | | |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sile N. Murphy A/24/05
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control Dental Devices

510(k) Number: K051157