K Number
K050570
Device Name
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
Manufacturer
Date Cleared
2005-07-25

(143 days)

Product Code
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The device description and intended use focus on a physical container system for sterilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
This device is a sterilization container system used to hold medical devices for sterilization, storage, and transport. It does not provide any therapeutic effect to a patient.

No
The device is a sterilization container system used to hold medical devices during sterilization, storage, and transport. It does not perform any diagnostic function.

No

The device description clearly outlines physical components such as container bottoms, lids, baskets, and labels, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for containing and sterilizing other medical devices. It is not used to perform tests on biological samples (like blood, urine, or tissue) to diagnose diseases or conditions.
  • Device Description: The description details a system of containers, baskets, and lids designed for sterilization. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
  • Lack of IVD-Specific Information: The provided information does not include details about:
    • Biological samples: What kind of samples would be tested?
    • Analytes: What substances would be measured or detected?
    • Assay principles: How would the test work?
    • Performance metrics relevant to diagnostics: Sensitivity, specificity, etc., are not mentioned in the context of diagnostic testing.

This device is a sterilization container system, which is a type of medical device used in the process of preparing other medical devices for use. It falls under the category of devices used in healthcare facilities for infection control and sterilization.

N/A

Intended Use / 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.

Product codes

KCT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospitals and health care facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Properties: Performance Standards
Miltex System: Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization
SteriTite System: Yes, conforms to AAMI ST 33- Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for ETO Sterilization and Steam Sterilization in Health Care Facilities

Properties: Validation Testing
Miltex System: Pre-vacuum Steam - Yes
SteriTite System: Pre-vacuum Steam - Yes

Properties: Load
Miltex System: Up to 16-lbs. (small) Up to 20-lbs. (med.) Up to 25-lbs. (large)
SteriTite System: Up to 22-lbs.

Properties: Test Organisms/ Inoculated Product
Miltex System: Inoculated Lumens - 3-mm I.D. x 400-mm, metal and 3-mm I.D. x 200-mm, metal
SteriTite System: Inoculated Lumens - Yes-- 2.2-mm I.D. x 457-mm, metal

Properties: Inoculated Stainless Steel Medical
Devices
Miltex System: Yes
SteriTite System: Yes (blades)

Key Metrics

Not Found

Predicate Device(s)

K023614

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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:

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.

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.

PropertiesMiltex SystemSteriTite System
Indicated for use containing instruments
to be sterilized in pre-vacuum (a.k.a. Hi-
Vac) steam sterilizersYesYes
Intended to be re-usedYesYes
Closed SystemYesYes
SealedYesYes
Design
Incorporates a filter system to permit
entry of sterilant agentYesYes
Incorporates a filter system to prevent
microbial migration during transport.YesYes
Materials
ContainerAluminum alloy, Stainless
Steel, & SiliconeAluminum alloy, Stainless
Steel, & Silicone

Performance Data:

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

PropertiesMiltex SystemSteriTite System
Performance Standards
Conformance to appropriate AAMI
standardsYes, conforms to AAMI ST
77 Draft- Containment
Devices for Reusable
Medical Device
SterilizationYes, conforms to AAMI ST 33-
Guidelines for the Selection and Use
of Reusable Rigid Sterilization
Container Systems for ETO
Sterilization and Steam Sterilization
in Health Care Facilities
Validation Testing
Pre-vacuum SteamYesYes
LoadUp to 16-lbs. (small)
Up to 20-lbs. (med.)
Up to 25-lbs. (large)Up to 22-lbs.
Test Organisms/ Inoculated Product
Inoculated Lumens3-mm I.D. x 400-mm,
metal and 3-mm I.D. x
200-mm, metalYes-- 2.2-mm I.D. x 457-mm,
metal
Inoculated Stainless Steel Medical
DevicesYesYes (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:

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

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: