(242 days)
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 ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Containers should not be stacked when used within cthylene oxide sterilizers
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 .
- u Container color-coding "labels."
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.
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 ethylene oxide gas sterilizers. The container is intended for use with non-porous materials such as stainless steel surgical instruments. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Standard | Miltex System Reported Performance | Predicate Device Performance
(for comparison but not direct acceptance) |
| :----------------------------------------- | :-------------------------------------------------------------------------- | :------------------------------------------------------------------------------------------- |
| Conformance to appropriate AAMI standards | Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization | 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 |
| Ethylene Oxide Sterile Efficacy Testing | Yes | Yes |
| Aeration Time and EO Residuals | 8-hours/ below maximum acceptable levels | 12-hours/ below maximum acceptable levels |
| Sterility Maintenance (Duration) | 30-day real time w/ weekly handling events | 90-day real time w/ weekly handling events. 30-day real time w/ daily handling events. |
| Load Capacity (Small container) | Up to 16-lbs. | Up to 22-lbs. |
| Load Capacity (Medium container) | Up to 20-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Load Capacity (Large container) | Up to 25-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Inoculated Lumens (Dimensions) | Yes--3-mm I.D. x 200-mm, metal | Yes-- 2.2-mm I.D. x 457-mm, metal |
| Inoculated Stainless Steel Medical Devices Location | Yes (hinge area of medical pliers and knurled instruments) | Yes (blades) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The document refers to "Validation Testing" which usually implies a pre-defined sample size for each test. However, the exact number of containers or tests performed is not detailed.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, as it involves "Validation Testing" and "real-time" sterility maintenance, implying active testing of the Miltex system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies described are performance tests of the device itself (e.g., sterile efficacy, sterility maintenance, load capacity), not studies requiring human expert assessment or ground truth establishment in the way it would be for, say, an AI-powered diagnostic device. The "ground truth" for these tests would typically be established by validated laboratory methods for sterilization effectiveness and sterility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable to the type of studies described. Adjudication methods are typically used in studies involving human interpretation or subjective assessment (e.g., medical image reading) where multiple experts might disagree. The performance tests for a sterilization container are objective and measured against pre-defined physical and biological parameters.
5. 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:
- This is not applicable. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. The Miltex Rigid Sterilization Container System is a physical medical device, not an AI or software-as-a-medical-device (SaMD).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this is a physical medical device, not an algorithm. The "standalone" performance refers to the device's ability to sterilize and maintain sterility based on its design and materials, which is what the validation testing evaluates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance tests would be established through laboratory testing and microbiological methods. For example:
- Ethylene Oxide Sterile Efficacy Testing: Ground truth would be the complete kill (sterilization) of specified resistant microorganisms (e.g., Bacillus atrophaeus spores) inoculated onto test articles within the container, followed by incubation and verification of no growth.
- Aeration Time and EO Residuals: Ground truth would be the measurement of residual EO levels below acceptable safety thresholds using standardized analytical chemistry techniques.
- Sterility Maintenance: Ground truth would be the absence of microbial ingress after specified handling events and storage times, verified by microbiological culture methods.
- Load Capacity: Ground truth would be the ability of the container to hold the specified weight without structural failure or compromise to its function.
8. The sample size for the training set:
- This is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The development of the device would involve engineering design, prototyping, and iterative testing, but not a data-driven training process in the AI sense.
9. How the ground truth for the training set was established:
- This is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the word "Miltex" in a stylized, cursive font. A horizontal line extends from the top right of the "t" in "Miltex" over the "ex". The word appears to be a logo or brand name. The font is bold and black, contrasting with the white background.
DEC 1 2 2006
589 Davies Drive York, PA 17402 phone 717 840-9335 toll-free 800 221-1344 fax 717 840-9347
510(k) Summary [21 CFR §807.92]
Prepared: April 13, 2006
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: Charles Weaver, Regulatory Affairs Specialist
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
- 제 Container baskets,
- Container lids (perforated only), and .
- u 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 ethylene oxide gas sterilizers. 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.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Containers should not be stacked when used within ethylene oxide sterilizers.
Page 8-1, rev 1
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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 |
|---|---|---|
| Intended use to contain instrumentsbeing sterilized in ethylene oxidesterilizers | 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 |
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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 | ||
| Ethylene Oxide Sterile Efficacy Testing | Yes | Yes |
| Aeration Time and EO Residuals | 8-hours/ below maximumacceptable levels | 12-hours/ below maximumacceptable levels |
| Sterility Maintenance | 30-day real time w/ weeklyhandling events. | 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-- 2.2-mm I.D. x 457-mm,metal |
| Inoculated Stainless Steel MedicalDevices | Yes (hinge area of medicalpliers and knurledinstruments) | Yes (blades) |
Conclusion:
The Miltex Rigid Sterilization Containers is substantially equivalent to the SteriTite Container (K023614).
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three overlapping profiles, creating a sense of depth and movement. The seal is simple, yet recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles Weaver Regulatory Affairs Specialist Miltex, Incorporated 589 Davies Drive York, Pennsylvania 17402
DEC 1 2 2006
Re: K061033
Trade/Device Name: Miltex Rigid Sterilization Container System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: November 20, 2006 Received: November 21, 2006
Dear Mr. Weaver:
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. Weaver
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 (QS) 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
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Indications for Use
510(k) Number (if known): K061033
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 ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Containers should not be stacked when used within cthylene oxide sterilizers
The device models that are the subject of this pre-market notification on listed on page 2 of this Indications for Use statement.
Prescription Use Over-The-Counter Use XX 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)
Page 1 of 2
Shula Murphy 15
K 061033
Page 4-1, rev 2
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:
| Part Number | Description | UM |
|---|---|---|
| 3-5100-10 | STERI CONT 1/2 4 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5100-13 | STERI CONT 1/2 5 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5100-15 | STERI CONT 1/2 6 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5110-10 | STERI CONTAINER 1/2 4 PERFORATED BOTTOM, SILVER | EA |
| 3-5110-13 | STERI CONTAINER 1/2 5 PERFORATED BOTTOM, SILVER | EA |
| 3-5110-15 | STERI CONTAINER 1/2 6 PERFORATED BOTTOM, SILVER | EA |
| 3-5172-05 | STERI CONTAINER WIRE BASKET 1/2 2-INCHES | EA |
| 3-5172-07 | STERI CONTAINER WIRE BASKET 1/2 3-INCHES | EA |
| 3-5172-10 | STERI CONTAINER WIRE BASKET 1/2 4-INCHES | EA |
| 3-5174-05 | STERI CONTAINER PERFORATED BASKET 1/2 2-INCHES | EA |
| 3-5174-07 | STERI CONTAINER PERFORATED BASKET 1/2 3-INCHES | EA |
| 3-5174-09 | STERI CONTAINER PERFORATED BASKET 1/2 4-INCHES | EA |
| 3-5300-10 | STERI CONTAINER 3/4 4 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5300-13 | STERI CONTAINER 3/4 5 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5300-15 | STERI CONTAINER 3/4 6 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5310-10 | STERI CONTAINER 3/4 4 PERFORATED BOTTOM, SILVER | EA |
| 3-5310-13 | STERI CONTAINER 3/4 5 PERFORATED BOTTOM, SILVER | EA |
| 3-5310-15 | STERI CONTAINER 3/4 6 PERFORATED BOTTOM, SILVER | EA |
| 3-5372-05 | STERI CONTAINER WIRE BASKET 3/4 2-INCHES | EA |
| 3-5372-07 | STERI CONTAINER WIRE BASKET 3/4 3-INCHES | EA |
| 3-5372-10 | STERI CONTAINER WIRE BASKET 3/4 4-INCHES | EA |
| 3-5374-05 | STERI CONTAINER PERFORATED BASKET 3/4 2-INCHES | EA |
| 3-5374-07 | STERI CONTAINER PERFORATED BASKET 3/4 3-INCHES | EA |
| 3-5374-09 | STERI CONTAINER PERFORATED BASKET 3/4 4-INCHES | EA |
| 3-5500-10 | STERI CONTAINER 1/1 4 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5500-13 | STERI CONTAINER 1/1 5 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5500-15 | STERI CONTAINER 1/1 6 NON-PERFORATED BOTTOM, SILVER | EA |
| 3-5510-10 | STERI CONTAINER 1/1 4 PERFORATED BOTTOM, SILVER | EA |
| 3-5510-13 | STERI CONTAINER 1/1 5 PERFORATED BOTTOM, SILVER | EA |
| 3-5510-15 | STERI CONTAINER 1/1 6 PERFORATED BOTTOM, SILVER | EA |
| 3-5572-05 | STERI CONTAINER WIRE BASKET 1/1 2-INCHES | EA |
| 3-5572-07 | STERI CONTAINER WIRE BASKET 1/1 3-INCHES | EA |
| 3-5572-10 | STERI CONTAINER WIRE BASKET 1/1 4-INCHES | EA |
| 3-5574-05 | STERI CONTAINER PERFORATED BASKET 1/1 2-INCHES | EA |
| 3-5574-07 | STERI CONTAINER PERFORATED BASKET 1/1 3-INCHES | EA |
| 3-5574-09 | STERI CONTAINER PERFORATED BASKET 1/1 4-INCHES | EA |
| 3-5940-01 | STERI CONTAINER LABEL, SILVER | EA |
| 3-5940-02 | STERI CONTAINER LABEL, BLUE | EA |
| 3-5940-03 | STERI CONTAINER LABEL, RED | EA |
| 3-5940-04 | STERI CONTAINER LABEL, GOLD | EA |
| 3-5940-05 | STERI CONTAINER LABEL, GREEN | EA |
| 3-5940-06 | STERI CONTAINER LABEL, BLACK | EA |
| 3-6161-00 | STERI CONTAINER LID 1/2 PERFORATED, SILVER | EA |
| 3-6361-00 | STERI CONTAINER LID 3/4 PERFORATED, SILVER | EA |
:
:
.
:
§ 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).