MILTEX RIGID CONTAINER SYSTEMS

K072563 · Miltex, Inc. · KCT · Feb 12, 2008 · General Hospital

Device Facts

• Record ID: K072563
• Device Name: MILTEX RIGID CONTAINER SYSTEMS
• Applicant: Miltex, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Feb 12, 2008
• 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 gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments. For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 lbs for the three-quarter size container, and 25 lbs for the full size container. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised. Containers should not be stacked when used within gravity steam sterilizers.

Device Story

System of rigid, reusable, sealed containers; includes perforated bottoms, lids, and baskets. Used in hospitals/healthcare facilities to house surgical instruments during gravity steam sterilization. Sterilant penetrates through lid/bottom perforations; filter system prevents microbial migration during transport. Operated by healthcare staff; instruments placed in baskets within containers. Output is a sterile, protected environment for instruments. Benefits include effective sterilization, sterility maintenance for up to 60 days, and safe transport/storage. Not for stacking in sterilizers.

Clinical Evidence

Bench testing only. Validation included gravity steam efficacy testing, thermal profile studies, and sterility maintenance (30-day real-time). Tested with inoculated 3-mm I.D. x 200-mm metal lumens and stainless steel instruments (hinges/knurled surfaces).

Technological Characteristics

Materials: Aluminum alloy, stainless steel, silicone. Design: Rigid, reusable, sealed container with perforated lid/bottom and internal filter system. Energy: Gravity steam sterilization. Connectivity: None. Sterilization: Gravity steam (121°C, 45 min exposure, 20 min dry). Standards: Conforms to AAMI ST 77 (Draft).

Indications for Use

Indicated for use in hospitals and healthcare facilities to contain and sterilize non-porous medical devices (e.g., stainless steel instruments) via gravity steam sterilization. Supports metal lumens up to 3mm diameter and 200mm length. Weight limits: 16 lbs (1/2 size), 20 lbs (3/4 size), 25 lbs (full size).

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 (K022978)

Submission Summary (Full Text)

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# FEB 1 2 2008

### 510(k) Summary [21 CFR §807.92]

Prepared: August 15, 2007

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- K022978

Official Contact: Audie Margrave, Senior Director QA/RA

#### 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 (perforated versions) .
- . Container baskets,
- . Container lids (perforated only)

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 gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments.

For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 lbs for the three-quarter size container, and 25 lbs for the full size container.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised.

Containers should not be stacked when used within gravity steam sterilizers.

The device models that are the subject of this pre-market notification on listed on page 2 of this Indication for Use statement.

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| Part Number | Description | UM |
|-------------|---------------------------------------------------------------------------------------|----|
| 3-5110-10 | STERI CONTAINER ½ (11 ¼ in x 11 in) x 4 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5110-13 | STERI CONTAINER ½ (11 ¼ in x 11 in) x 5 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5110-15 | STERI CONTAINER ½ (11 ¼ in x 11 in) x 6 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5310-10 | STERI CONTAINER ¾ (18 ¼ in x 11 in) x 4 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5310-13 | STERI CONTAINER ¾ (18 ¼ in x 11 in) x 5 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5310-15 | STERI CONTAINER ¾ (18 ¼ in x 11 in) x 6 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5510-10 | STERI CONTAINER 1 (23 in x 11 in)x 4 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5510-13 | STERI CONTAINER 1 (23 in x 11 in)x 5 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-5510-15 | STERI CONTAINER 1 (23 in x 11 in) x 6 inches in height PERFORATED<br>BOTTOM, SILVER | EA |
| 3-6100-00 | STERI CONTAINER LID ½ (11 ¼ in x 11 in) PERFORATED, SILVER | EA |
| 3-6300-00 | STERI CONTAINER LID ¾ (18 ¼ in x 11 in) PERFORATED, SILVER | EA |
| 3-6500-00 | STERI CONTAINER LID 1/1 (23 in x 11 in) PERFORATED, SILVER | EA |

Key - ½ indicates one-half size or 11 ¼ inches x 11 inches % indicates three-quarter size or 18 ¼ inches x 11 inches l indicates full size or 23 inches x 11 inches

## The following container lids can be used for each container base:

| Lid Size | Perforated Base to be used with Lid |
|--------------------------------------------------|---------------------------------------------------------------------------------------------|
| 1/2 size Lid (11 1/4 in x 11 in)<br>PN 3-6100-00 | PN 3-5110-10 (4 in height)<br>PN 3-5110-13 (15 1/3 in height)<br>PN 3-5110-15 (6 in height) |
| 3/4 size Lid (18 1/4 in x 11 in)<br>PN 3-6300-00 | PN 3-5310-10 (4 in height)<br>PN 3-5310-13 (5 1/3 in height)<br>PN 3-5310-15 (6 in height) |
| Full size Lid (23 in x 11 in)<br>PN 3-6500-00 | PN 3-5510-10 (4 in height)<br>PN 3-5510-13 (5 1/3 in height)<br>PN 3-5510-15 (6 in height) |

### Technological Characteristics:

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

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| Properties | Miltex System | SteriTite System |
|--------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|
| Intended use to contain instruments being<br>sterilized in gravity 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 entry of<br>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.

| Properties | Miltex System | SteriTite System |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Standards | | |
| Conformance to appropriate AAMI 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 Healthcare Facilities |
| Validation Testing | | |
| Gravity Steam Efficacy Testing | Yes | Yes |
| Thermal Profile Study | Sterilant penetration can be<br>achieved in a single layer<br>configuration | Sterilant penetration can be achieved<br>in a stacked configuration |
| Sterility Maintenance | 30-day real time w/ weekly<br>handling events (perforated<br>bottom). | 90-day real time w/ weekly handling<br>events. 30-day real time w/ daily<br>handling events. |
| 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 | Yes--3-mm I.D. x 200-<br>mm, metal | Yes |
| Inoculated Stainless Steel Medical Devices | Yes (hinge area of medical<br>pliers and knurled<br>instruments) | Yes |

### Conclusion:

The Miltex Rigid Sterilization Containers is substantially equivalent to the SteriTite Container (K022978).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular seal for the Department of Health and Human Services - USA. The seal features the department's logo, which is a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

# FEB 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Patricia Kihn D.D.S. Manager Quality Systems Compliance & Regulatory Affairs Miltex, Incorporated 589 Davies Drive York, Pennsylvania 17402

Re: K072563

Trade/Device Name: Miltex Rigid Containers Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 25, 2008 Received: January 28, 2008

Dear Dr. Patricia Kihn:

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 -- Dr. Patricia Kihn

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,

Chih-Lin, Ph.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

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# Indications for Use

510(k) Number (if known): K072563

Device Name: Miltex Rigid Containers

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 gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments.

For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 Ibs for the three-quarter size container, and 25 Ibs for the full size container.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised.

| Lid Size | Perforated Base to be used with Lid |
|------------------------------------------------|-------------------------------------------------------------------------------------------|
| 1/2 size Lid (11 ¼ in x 11 in)<br>PN 3-6100-00 | PN 3-5110-10 (4 in height)<br>PN 3-5110-13 (5 in height)<br>PN 3-5110-15-15 (6 in height) |
| 3/4 size Lid (18 ¼ in x 11 in)<br>PN 3-6300-00 | PN 3-5310-10 (4 in height)<br>PN 3-5310-13 (5 in height)<br>PN 3-5310-15 (6 in height) |
| Full size Lid (23 in x 11 in)<br>PN 3-6500-00 | PN 3-5510-10 (4 in height)<br>PN 3-5510-13 (5 in height)<br>PN 3-5510-15 (6 in height) |

Containers should not be stacked when used within gravity steam sterilizers.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K072563

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