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 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)
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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Miltex Rigid Sterilization Container System. It does not describe an AI or algorithm-based device, but rather a medical device designed for sterilizing other medical instruments. Therefore, many of the requested details, such as those related to AI performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes, are not applicable to this document.

However, I can extract information related to the device's performance against relevant standards and the nature of the study conducted, which is a validation study demonstrating the device's sterilization capabilities.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Miltex Rigid Sterilization Container System are based on conformance to AAMI standards and successful validation testing for steam sterilization.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance for Miltex System
Performance Standards	Conformance to appropriate AAMI standards for containment devices for reusable medical device sterilization.	Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization.
Validation Testing - Sterilization	Demonstrated effectiveness in pre-vacuum steam sterilization.	Yes, validated through pre-vacuum steam sterilization testing.
Validation Testing - Load Capacity	Ability to accommodate specified weights of instruments for different container sizes.	Up to 16-lbs. (small) Up to 20-lbs. (medium) Up to 25-lbs. (large)
Validation Testing - Lumens	Effective sterilization of instruments with lumens of specific internal diameter and length. This is a critical performance aspect for sterilization containers, demonstrating sterilant penetration.	Up to 3-mm I.D. x 400-mm length (Full/large size container) for metal instruments. Up to 3-mm I.D. x 200-mm length (½ /small and ¼ /medium size containers) for metal instruments. (Tested with inoculated lumens—the document implies successful sterilization, as it's presented as a performance characteristic meeting the intended use).
Validation Testing - Medical Devices	Effective sterilization of inoculated medical devices.	Yes, testing was conducted with inoculated stainless steel medical devices (implied successful sterilization based on context).
Functional Characteristics	Intended for use with instruments to be sterilized in pre-vacuum (Hi-Vac) steam sterilizers, reusable, closed system, sealed, incorporates a filter system to permit entry of sterilant agent, incorporates a filter system to prevent microbial migration during transport. These are design and functional requirements for a rigid sterilization container to ensure safe and effective use.	Yes (Indicated for use in Hi-Vac steam sterilizers) Yes (Reusable) Yes (Closed System) Yes (Sealed) Yes (Incorporates a filter system to permit entry of sterilant agent) Yes (Incorporates a filter system to prevent microbial migration during transport) (These are fundamental design and functional requirements inherent to the product category, and the "Yes" confirms they are met for the Miltex system).

Study Information (as applicable for a non-AI medical device):

Sample size used for the test set and the data provenance:
- The document does not explicitly state a sample size in terms of number of containers or tests in a statistical sense for the validation. Rather, it describes the conditions and types of loads tested.
- The "test set" in this context refers to the conditions and materials used during the validation testing: "inoculated lumens" (3-mm I.D. x 400-mm, metal, and 3-mm I.D. x 200-mm, metal) and "inoculated stainless steel medical devices."
- Data provenance: Not specified, but likely laboratory-based (in-vitro) testing conducted by the manufacturer or a contracted lab to demonstrate efficacy for regulatory submission. It is prospective in the sense that the testing was performed specifically to validate the device's performance prior to market approval.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of device validation. Ground truth for sterilization efficacy is established through scientific methods like spore-kill assays and sterility testing, not expert consensus interpretation. The "ground truth" here is the absence of viable microorganisms after the sterilization cycle.
Adjudication method for the test set:
- Not applicable. Sterilization efficacy is typically determined by objective biological and physical indicators (e.g., biological indicators showing no growth, chemical indicators showing proper sterilant exposure, physical parameters like temperature and pressure).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This study is for a physical medical device (sterilization container), not an AI algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used:
- The ground truth for adequate sterilization is based on microbiological sterility (absence of viable microorganisms) for the inoculated test pieces (lumens and stainless steel devices), confirmed by appropriate biological indicators and sterility testing methods. This aligns with scientific and regulatory standards (like AAMI) for sterilization efficacy.
The sample size for the training set:
- Not applicable. This is not an AI or algorithm-based device that requires a training set. The "training" here would refer to the developmental process of the container design and manufacturing.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document details the conformance and validation testing of a physical medical device (sterilization container) against established performance standards and functional requirements. It does not pertain to software, AI, or diagnostic algorithms, and therefore, many of the requested categories related to such technologies are not relevant.

Summary

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

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:

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:

Page 8-1, rev 1

Miltex
Redefining Excellence

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

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 instrumentsto be sterilized in pre-vacuum (a.k.a. Hi-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 permitentry of sterilant 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's.

Properties	Miltex System	SteriTite System
Performance Standards
Conformance to appropriate AAMIstandards	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 Health Care Facilities
Validation Testing
Pre-vacuum Steam	Yes	Yes
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	3-mm I.D. x 400-mm,metal and 3-mm I.D. x200-mm, metal	Yes-- 2.2-mm I.D. x 457-mm,metal
Inoculated Stainless Steel MedicalDevices	Yes	Yes (blades)

Conclusion:

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

Page 8-2, rev 1

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

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.

{3}------------------------------------------------

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 (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,

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

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

Indications for Use

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

Device Name: Miltex Rigid Sterilization Container System

Indications for Use:

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

Page I of I

Page 4-1, rev. 1

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hos Infection Control, Dental De

510(k) Number:

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).