STERILIZATION CASES AND TRAYS

K023658 · Carr Metal Products, Inc. · FRG · Mar 25, 2003 · General Hospital

Device Facts

• Record ID: K023658
• Device Name: STERILIZATION CASES AND TRAYS
• Applicant: Carr Metal Products, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Mar 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 °C for a 4-minute minimum plus a minimum of 15 minutes drying time.

Device Story

Sterilization cases, trays, and cassettes designed to secure medical and dental instrumentation during cleaning and sterilization. Containers feature lids and internal holding mechanisms for instruments. Constructed from metal and plastic. Used in hospitals, ORs, and dental offices. Compatible with Pulsing High Vacuum (pre-vac) steam sterilization (132°C, 4-minute cycle, 15-minute drying). Facilitates organized instrument handling throughout the sterilization workflow.

Clinical Evidence

Bench testing only. Performance validated according to AAMI TIR No. 12-1994 for Pulsing High Vacuum (pre-vacuum) steam sterilization. Validation included half-cycle testing to challenge the sterilization method.

Technological Characteristics

Materials: Aluminum, stainless steel, plastic. Design: Container with lid, internal instrument holding features, optional latch system. Dimensions: 10.375" x 21.75" x 2.5" to 10.375" x 21.75" x 5". Sterilization: Pulsing High Vacuum steam (132°C, 4-min exposure, 15-min dry).

Indications for Use

Indicated for holding medical device instrumentation in place during use, cleaning, and sterilization cycles in hospital, OR, physician, and dental office settings.

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

• C/T Med-Systems Cassette system (K980065)
• Symmetry - PolyVac surgical instrument delivery system (K012105)

Submission Summary (Full Text)

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

K023658

## 510(k) Summary of Safety and Effectiveness

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 January 10, 2003

| Carr Medical Products, Inc.<br>3735 N. Arlington Ave.<br>Indianapolis, IN 46218 | Tel - [phone]<br>Fax - [phone] |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Alan L. Booker - Operations Manager |
| Proprietary or Trade Name: | Sterilization Cases, Trays, and Cassettes |
| Common/Usual Name: | Sterilization cases, trays, and cassettes |
| Classification Name: | Sterilization Wrapper Pack, Bag, and Accessories |
| Predicate Devices: | C/T Med-Systems Cassette system (Carr Medical<br>Products) - K980065<br>Symmetry - PolyVac surgical instrument delivery<br>system - K012105 |

## Device Description:

Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.

## Indicated Use:

Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle.

These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 ℃ for a 4-minute minimum with a 15-minute drying time.

## Environment of Use:

Hospital, Operating Room (OR), physician and dental office or places where instruments are sterilized.

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

## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 January 10, 2003

#### Summary of Performance testing:

The Carr Metal Products Sterilization Cases, Trays, and Cassettes were independently tested according to AAMI TIR No. 12-1994 for their performance with the Pulsing High Vacuum (prevacuum) Steam sterilization method.

#### General Technical Characteristics

| Attribute | Proposed devices |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Indicated for holding medical device instrumentation in<br>place throughout entire instrument use, cleaning, and<br>sterilization cycle |
| Sterilization Method | Pulsing High Vacuum (pre-vacuum) steam sterilization<br>at 132°C 4 minute minimum cycle with a 15-minute<br>minimum drying time. |
| Intended to be reused | Yes |
| Intended Environment of Use | Hospital, Operating Room (OR), physician and dental<br>office or places where instruments are sterilized |
| Design | |
| Various sizes of cases and lids and associated trays<br>and cassettes offered | 10.375 " x 21.75" x 2.5" to 10.375" x 21.75" x 5" with<br>trays and cassettes of similar size, which are stacked<br>inside the case |
| Utilizes various methods of holding instruments in<br>place | Yes |
| May incorporate latch system to hold lid in place | Yes |
| Materials | |
| Aluminum, stainless steel, plastic | Yes |
| Performance Standards | |
| None under Section 514 | Yes |
| Tested in accordance to AAMI TIR No. 12-1994 | Yes |
| Validation study performed with half cycles to<br>challenge sterilization method used | Yes |

## Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the predicates, C/T Med-Systems – K980065 other than larger sizes and Symmetry – PolyVac surgical instrument delivery system - K012105.

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

MAR 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carr Metal Products, Incorporated C/O Mr. Paul Dryden ProMedic, Incorporated 6329 West Waterview Court McCordsville, Indiana 46055-9501

Re: K023658

Trade/Device Name: Carr Sterilization Cases, Trays and Cassettes Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 10, 2003 Received: January 13, 2003

Dear Mr. Dryden:

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 such 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}------------------------------------------------

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you 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 marketed 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 contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Kuono

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

# Page 1 of 1

| 510(k) Number: | K023658 (To be assigned) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Carr sterilization cases, trays, and cassettes |
| Intended Use: | Medical device instrumentation cases, trays, and cassettes<br>intended to hold instruments and accessories in place<br>throughout the entire instrument use, cleaning, and<br>sterilization cycle. |
| | These cases, trays, and cassettes are suitable for Pulsing<br>High Vacuum (pre-vac) steam sterilization at 132 °C for a<br>4-minute minimum plus a minimum of 15 minutes drying<br>time. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109)

or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

Clim S. Lim

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Der e 40/6) Niimb

Page 6