POLYVAC INSTRUMENT DELIVERY SYSTEM

K040223 · Symmetry Medical USA, Inc. · KCT · Oct 22, 2004 · General Hospital

Device Facts

• Record ID: K040223
• Device Name: POLYVAC INSTRUMENT DELIVERY SYSTEM
• Applicant: Symmetry Medical USA, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap.

Device Story

PolyVac Surgical Instrument Delivery System consists of perforated plastic or metal trays and lids; designed to house and protect medical instruments during sterilization, transport, and storage. System utilizes evenly distributed hole patterns to allow sterilant penetration and air removal. Used in clinical settings; operated by healthcare personnel. Requires use of approved sterilization wrap. Compatible with Prevacuum Steam, Gravity Steam, and Ethylene Oxide sterilization cycles. Protects instruments from damage; ensures sterility maintenance post-processing.

Clinical Evidence

Bench testing only. Ethylene Oxide qualification testing performed using spore strips and biological indicators in a 60-minute half-cycle, achieving a six-log reduction. Residual evaluation of Radel-R materials confirmed EO, ECH, and EGly concentrations within acceptable limits after 11 hours 35 minutes of aeration.

Technological Characteristics

Materials include plastic (Radel-R) and metal. Features perforated base and lid design for steam/gas penetration. Reusable. Sterilization methods: Prevacuum Steam, Gravity Steam, Ethylene Oxide. No new technological characteristics compared to predicate devices.

Indications for Use

Indicated for use as a container system to protect medical instrumentation and facilitate sterilization via steam or Ethylene Oxide for healthcare facilities.

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

• Aptimax Sterilization cases
• Metapak (K993535)

Submission Summary (Full Text)

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Ko4022}

### 510(k) Summary Pursuant to 21 CFR 807.92

- Symmetry Medical Inc. 1. Submitted By: 220 West Market Street Warsaw. Indiana 46582
D. Darin Martin 2. Contact: Symmetry Medical Inc. 220 West Market Street Warsaw, Indiana 46582

> Poly Vac Surgical Instrument Delivery System 880.6850 Sterilization Wrap Class II Pack, Sterilization Wrapper, Bag and Accessories 80 KCT

- 4. Common Names: Minitainer Instrument Cassettes Standard Modultainer Modultainer II Modultainer II Hybrid LapCare / Arthrocare
Modultainer IV Opitainer Universal Modultainer III . Vault

#### Description:

3. Product:

PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use.

The Delivery Systems are designed using plastic and metal materials that can be reused with steam or Ethylene Oxide sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.

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## urgical Instrument Delivery System

#### Intended Use:

PolyVac's delivery systems are intended to protect medical device instrumentation and to facilitate the sterilization process by allowing steam penetration and air removal, When used in conjunction with an approved sterilization wrap,

PolyVac's delivery systems are to be sterilized in one of the following cycles:

Prevacuum Steam : 132°C - 4 minutes minimum Dry for 20 - 40 minutes as needed

132°C - 30 minutes minimum Gravity Steam: Gravity Steam: Dry for 20 - 50 minutes as needed

Ethylene Oxide

#### Technological Characteristics:

The PolyVac Delivery System does not incorporate any new technological characteristics or material as compared to legally marketed devices.

#### Performance Data:

A summary of the following testing is provided to support the premarket notification for the new Ethylene Oxide indication:

Ethylene Oxide Qualification: The test articles were inoculated with spore strips and biological indicator organisms, and chemical indicators were placed. They were then wrapped in a double layer of approved sterilization wrap and placed into the ethylene oxide sterilizer for processing. The system was successfully sterilized in a 60 minute ETO half cycle. The sterilization tests demonstrate a six log reduction capability of all spores strips and inoculated devices.

Ethylene Oxide Residual Evaluation: Radel-R materials were exposed to full Ethylene Oxide Cycles and aerated for 11 hr. and 35 min. Residual concentrations of EO, ECH, and EGly, were all within acceptable limits.

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#### Substantial Equivalence:

The Delivery Systems offered by Poly Vac are of the same design as The Delivery Bystems Circs manufactured by PolyVac under a previously stermzanon cases and any mix devices are substantially equivalent to other sterilization cases cleared for use with Ethylene Oxide: Aptimax -Sterifization cases etc. Sterilization Products, and Metapak - K993535, Riley Medical, Inc.

#### Conclusions:

The studies conducted on PolyVac's Delivery Systems demonstrate that the The stubles occantially equivalent to other sterilization cases and trays currently in commercial distribution. Additionally, it provides a reliable means of packaging, transporting, and storing instruments for sterilization.

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Image /page/3/Picture/1 description: The image is a black and white 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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, with three lines representing the arms and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Symmetry Medical, Incorporated C/O Mr. David C. Furr Official Correspondent FDC Services 7822 Ladue Glen Fort Wayne, Indiana 46804

Re: K040223

Ro40223 Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: August 5, 2004 Received: August 6, 2004

Dear Mr. Furr:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 interstate conmiseree prior to that have been reclassified in accordance with the provisions of Amendinens, of to devroes and nove of the (Act) that do not require approval of a premarket the Federal 1 000; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 If your device is classified (oos as a vitional controls. Existing major regulations affecting (1 Mr.), it may of each of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Furr

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that I Dri 3 issuaired on that your device complies with other requirements Incall that I DX nas made a decembers and regulations administered by other Federal agencies. of the Act of ally I oderal bake and squirements, including, but not limited to: registration You must comply with an the Piore ong (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality 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) I his letter will anow you to began mail as a substantial equivalence of your device to a premarket notification. - The PD Fridation 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), If you desire specific act 100 for Joinner 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 may obtain outer generational 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 yours,

Chiu Lin, Ph.D.

Chiu Lin. Ph 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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# Indications for Use Statement

| 510(k) Number: | K040223 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PolyVac Surgical Instrument Delivery System |
| Intended Use: | PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap. |
| Sterilization Method: | Ethylene Oxide |
| Prescription Use (Per CFR 801.109) | or |
| Over-the-counter use | X |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Janette Y. Michael C.M.S.
FOR DR. CHIU LIN

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoontal Devices

510(k) Number: K040223