MILTEX RIGID STERILIZATION CONTAINER SYSTEM

K050570 · Miltex, Inc. · KCT · Jul 25, 2005 · General Hospital

Device Facts

• Record ID: K050570
• Device Name: MILTEX RIGID STERILIZATION CONTAINER SYSTEM
• Applicant: Miltex, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.

Device Story

Rigid, reusable, sealed container system; used in hospitals/healthcare facilities to house medical instruments during steam sterilization, storage, and transport. Components include perforated/non-perforated bottoms, lids, baskets, and color-coding labels. System utilizes filter technology to permit sterilant entry while preventing microbial migration. Operated by healthcare staff; instruments placed inside container; container processed in high vacuum steam sterilizer. Protects sterile integrity of instruments post-sterilization. Benefits include effective containment and maintenance of sterility for surgical instruments.

Clinical Evidence

Bench testing only. Validation performed using pre-vacuum steam sterilization cycles. Tested with inoculated lumens (3mm I.D. x 400mm and 200mm) and stainless steel medical devices. Conforms to AAMI ST 77 draft standards.

Technological Characteristics

Materials: Aluminum alloy, stainless steel, silicone. Design: Rigid, reusable, sealed container with filter system for sterilant penetration and microbial barrier. Dimensions: Various sizes (Full, 1/2, 1/4). Connectivity: None. Sterilization: High vacuum steam. Standards: AAMI ST 77.

Indications for Use

Indicated for use in hospitals and healthcare facilities to contain medical devices for sterilization via high vacuum steam sterilizers. Validated for instruments with lumens up to 3mm I.D. x 400mm (large) or 200mm (small/medium).

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

• SteriTite® Rigid Sterilization Container System with MediTray Products (K023614)

Submission Summary (Full Text)

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JUL 25 2005

K050570

FDA 510(k) Pre-Market Notification Miltex Rigid Sterilization Container System

> Raving Drive ork. PA 17402

hone 717 840-9335

# 510(k) Summary [21 CFR §807.92]

Prepared: February 25, 2005

Device Trade Name: Miltex Rigid Sterilization Container System.

Device Common Name: Rigid Sterilization Container.

Classification Name: Sterilization wrap containers, trays, cassettes, and other accessories.

Class of Device: Class II device, product code KCT

Predicate Device: SteriTite® Rigid Sterilization Container System with MediTray Products- Case Medical, Incorporated- K023614

Official Contact: Lee Zagar, Vice President Quality Assurance and Regulatory Affairs

### Device Description:

The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:

- Container bottoms (both perforated and non-perforated versions) 트
- . Container baskets,
- Container lids (perforated only), and ■
- Container color-coding "labels." .

The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.

#### Intended Use:

The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.

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Miltex
Redefining Excellence

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Technological Characteristics:

A comparison of the technology characteristics of the Miltex Rigid Sterilization Containers to the predicate device's.

| Properties | Miltex System | SteriTite System |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|
| Indicated for use containing instruments<br>to be sterilized in pre-vacuum (a.k.a. Hi-<br>Vac) steam sterilizers | Yes | Yes |
| Intended to be re-used | Yes | Yes |
| Closed System | Yes | Yes |
| Sealed | Yes | Yes |
| Design | | |
| Incorporates a filter system to permit<br>entry of sterilant agent | Yes | Yes |
| Incorporates a filter system to prevent<br>microbial migration during transport. | Yes | Yes |
| Materials | | |
| Container | Aluminum alloy, Stainless<br>Steel, & Silicone | Aluminum alloy, Stainless<br>Steel, & Silicone |

# Performance Data:

A comparison of the non-clinical performance of the Miltex Rigid Sterilization Containers to the predicate device's.

| Properties | Miltex System | SteriTite System |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Standards | | |
| Conformance to appropriate AAMI<br>standards | Yes, conforms to AAMI ST<br>77 Draft- Containment<br>Devices for Reusable<br>Medical Device<br>Sterilization | Yes, conforms to AAMI ST 33-<br>Guidelines for the Selection and Use<br>of Reusable Rigid Sterilization<br>Container Systems for ETO<br>Sterilization and Steam Sterilization<br>in Health Care Facilities |
| Validation Testing | | |
| Pre-vacuum Steam | Yes | Yes |
| Load | Up to 16-lbs. (small)<br>Up to 20-lbs. (med.)<br>Up to 25-lbs. (large) | Up to 22-lbs. |
| Test Organisms/ Inoculated Product | | |
| Inoculated Lumens | 3-mm I.D. x 400-mm,<br>metal and 3-mm I.D. x<br>200-mm, metal | Yes-- 2.2-mm I.D. x 457-mm,<br>metal |
| Inoculated Stainless Steel Medical<br>Devices | Yes | Yes (blades) |

Conclusion:

The Miltex Rigid Sterilization Containers is substantially equivalent to the SteriTite Container (K023614).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2005

Mr. Lee Zagar Vice President, Quality Assurance & Regulatory Affairs Miltex, Incorporated 589 Davies Drive York, Pennsylvania 17402

Re: K050570

Trade/Device Name: Miltex Rigid Sterilization container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: July 20, 2005 Received: July 21, 2005

Dear Mr. Zagar:

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.

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#### Page 2 - Mr. Zagar

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/industry/support/index.html.

Sincerely yours,

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

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### Indications for Use

510(k) Number (if known): Kosos TO

Device Name: Miltex Rigid Sterilization Container System

Indications for Use:

The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.

Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy, MD 2/2/05

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Division of Anesthesiology, General Hos Infection Control, Dental De

510(k) Number: