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.

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

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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (Miltex System)
Intended Use: Contain instruments for sterilization in gravity steam sterilizers	Yes
Intended Use: Re-usable	Yes
Intended Use: Closed System	Yes
Intended Use: Sealed	Yes
Design: Incorporates a filter system to permit entry of sterilant agent	Yes
Design: Incorporates a filter system to prevent microbial migration during transport	Yes
Materials (Container): Aluminum alloy, Stainless Steel, & Silicone	Aluminum alloy, Stainless Steel, & Silicone
Conformance to appropriate AAMI standards	Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization
Gravity Steam Efficacy Testing	Yes
Thermal Profile Study (Sterilant penetration)	Sterilant penetration can be achieved in a single layer configuration
Sterility Maintenance (maximum duration)	60 days (validated for 30-day real time w/ weekly handling events)
Maximum Load (small container)	16 lbs
Maximum Load (medium container)	20 lbs
Maximum Load (large container)	25 lbs
Inoculated Lumens Testing	Yes (3-mm I.D. x 200-mm, metal)
Inoculated Stainless Steel Medical Devices Testing	Yes (hinge area of medical pliers and knurled instruments)

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not specify the exact sample size for each performance test (e.g., number of sterilization cycles, number of containers tested for sterility maintenance). It only states that tests were performed for various parameters.
Data Provenance: The document implies that the data was generated by the manufacturer, Miltex, Incorporated, as part of their 510(k) submission. The country of origin for the data is not explicitly stated but is implicitly the United States given the submission to the FDA. The study is prospective as it involves the testing and validation of the Miltex device.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for the performance testing of the device (e.g., for interpreting sterilization efficacy, sterility maintenance, or thermal profiles). Performance criteria are likely based on established industry standards (AAMI) and direct laboratory measurements rather than expert consensus on individual "cases."

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method as it does not involve subjective interpretations of "cases" by multiple reviewers. The performance testing appears to involve objective measurements and adherence to predefined protocols and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data (e.g., medical images), not for sterilization containers whose performance is assessed through objective physical and microbiological testing.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The "Performance Data" section directly reports the performance of the Miltex System for various properties and validation tests (Gravity Steam Efficacy Testing, Thermal Profile Study, Sterility Maintenance, Load, Test Organisms/Inoculated Product). This evaluation is based on the algorithm/device's own performance against established criteria and the predicate device.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluation is based on objective experimental results and adherence to recognized industry standards. This includes:
- Microbiological testing: Efficacy of sterilization based on inactivation of test organisms (e.g., in inoculated lumens and stainless steel medical devices).
- Physical measurements: Thermal profiles to confirm sterilant penetration, weight load capacity tests.
- Time-based validation: Sterility maintenance over a specified duration (30 days in real-time with handling events).
- Conformance to standards: Meeting the requirements of AAMI ST 77 Draft.

8. Sample Size for the Training Set:

The concept of a "training set" is relevant to machine learning or AI algorithms. As this device is a physical rigid sterilization container system, there is no training set in the context of AI or machine learning. Performance is verified through physical and microbiological validation testing.

9. How the Ground Truth for the Training Set was Established:

Since there is no "training set" as defined in machine learning contexts, this question is not applicable. The "ground truth" for the device's performance was established through rigorous, standardized laboratory and engineering tests designed to directly measure its efficacy and adherence to performance specifications.

Summary

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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:

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:

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.

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 PERFORATEDBOTTOM, SILVER	EA
3-5110-13	STERI CONTAINER ½ (11 ¼ in x 11 in) x 5 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5110-15	STERI CONTAINER ½ (11 ¼ in x 11 in) x 6 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5310-10	STERI CONTAINER ¾ (18 ¼ in x 11 in) x 4 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5310-13	STERI CONTAINER ¾ (18 ¼ in x 11 in) x 5 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5310-15	STERI CONTAINER ¾ (18 ¼ in x 11 in) x 6 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5510-10	STERI CONTAINER 1 (23 in x 11 in)x 4 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5510-13	STERI CONTAINER 1 (23 in x 11 in)x 5 inches in height PERFORATEDBOTTOM, SILVER	EA
3-5510-15	STERI CONTAINER 1 (23 in x 11 in) x 6 inches in height PERFORATEDBOTTOM, 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)PN 3-6100-00	PN 3-5110-10 (4 in height)PN 3-5110-13 (15 1/3 in height)PN 3-5110-15 (6 in height)
3/4 size Lid (18 1/4 in x 11 in)PN 3-6300-00	PN 3-5310-10 (4 in height)PN 3-5310-13 (5 1/3 in height)PN 3-5310-15 (6 in height)
Full size Lid (23 in x 11 in)PN 3-6500-00	PN 3-5510-10 (4 in height)PN 3-5510-13 (5 1/3 in height)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 beingsterilized 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 ofsterilant agent	Yes	Yes
Incorporates a filter system to preventmicrobial migration during transport.	Yes	Yes
Materials
Container	Aluminum alloy, StainlessSteel, & Silicone	Aluminum alloy, StainlessSteel, & 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 ST77 Draft- ContainmentDevices for ReusableMedical DeviceSterilization	Yes, conforms to AAMI ST-33 -Guidelines for the Selection and Useof Reusable Rigid SterilizationContainer Systems for ETOSterilization and Steam Sterilizationin Healthcare Facilities
Validation Testing
Gravity Steam Efficacy Testing	Yes	Yes
Thermal Profile Study	Sterilant penetration can beachieved in a single layerconfiguration	Sterilant penetration can be achievedin a stacked configuration
Sterility Maintenance	30-day real time w/ weeklyhandling events (perforatedbottom).	90-day real time w/ weekly handlingevents. 30-day real time w/ dailyhandling events.
Load	Up to 16-lbs. (small)Up to 20-lbs. (med.)Up to 25-lbs. (large)	Up to 22-lbs.
Test Organisms/ Inoculated Product
Inoculated Lumens	Yes--3-mm I.D. x 200-mm, metal	Yes
Inoculated Stainless Steel Medical Devices	Yes (hinge area of medicalpliers and knurledinstruments)	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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).