(246 days)
The MTS System (Multiple Tray Sterilization System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks.
The MTS System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the MTS System.
The MTS System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. Single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. An optional STEAMPlus™ tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider.
Adjustable shelves within the cabinet can hold up to three trays (uncovered, perforated or wire mesh) of devices and/or surgical instruments intended for a single patient surgery. No more than 25 pounds can be loaded per tray for a maximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves) can hold up to 300 pounds per load and the MTS225 Cabinet (with three shelves) can hold up to 225 pounds per load.
The loaded cabinet is deployed from the adjustable transfer cart and processed in pre-vacuum steam sterilizers. Processing includes the standard conditioning phase of the autoclave followed by a sterilization cycle time of a minimum of 4 minutes and a dry cycle of a minimum of 10 minutes. Sterility is maintained for up to 30 days.
The provided document is a 510(k) premarket notification letter from the FDA regarding the MTS225 and MTS300 Multiple Tray Sterilization Systems. It outlines the device's indications for use, a comparison with a predicate device, and a summary of nonclinical testing.
However, the document does not describe an AI medical device or a study that assesses a human-AI team's performance. The device in question is a physical sterilization system, and the "study" mentioned refers to nonclinical testing (sterilization efficacy verification studies) of this physical device. Therefore, many of the requested elements for an AI medical device study (such as expert reads, MRMC studies, training/test set ground truth for AI, etc.) are not applicable to this document.
I will provide the information that is available from the document, acknowledging that most of the requested criteria for an AI device are not present.
Acceptance Criteria and Reported Device Performance
The document describes the performance parameters and validation against specific standards for the MTS225 and MTS300 Multiple Tray Sterilization Systems. While not "acceptance criteria" in the sense of a statistical threshold for an AI model, these are the performance goals and validated capabilities of the sterilization system.
| Characteristic | Acceptance Criteria (Implied/Validated) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (SAL) | Achieve a 10⁻⁶ SAL (Sterility Assurance Level) | Achieved a 10⁻⁶ SAL when sterilizing rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm, as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. |
| Minimum Dry Time | Meet or exceed a minimum dry time of 10 minutes (for the subject device, compared to the predicate's 30 minutes). | Demonstrated the ability to meet or exceed the shorter minimum dry time of 10 minutes. |
| Sterility Maintenance Duration | Maintain sterility for up to 30 days. | Maintained sterility for 30 days following rigorous outdoor transportation and storage outside the sterilization facility. |
| Compatible Lumen Dimensions (Smallest/Longest) | Able to sterilize instruments with lumens down to 0.7mm inner diameter and 500mm length, or 1.0mm inner diameter and 850mm length. (Predicate was 3.8mm inner diameter, 370mm length). | The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Devices should not be used with instruments smaller than 0.7mm (ID) and longer than 500mm (length) or smaller than 1.0mm (ID) and longer than 850mm (length). |
| Sterilization Parameters (Prevacuum Steam Sterilizers) | Prevacuum cycle of 270°F and exposure time of 4 minutes. | Validated for use with prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. |
| Load Capacity | No more than 3 trays per shelf or 25 lbs. per tray. Maximum 75 lbs per shelf (3x25lbs). MTS300 Cabinet: up to 300 lbs per load. MTS225 Cabinet: up to 225 lbs per load. | The system specifications state these load capacities. Testing would confirm that sterilization efficacy is maintained at these maximum loads. |
| Volume-to-Vent Ratio (MTS225) | Smaller Volume-to-Vent ratio compared to the MTS300 System, while maintaining efficacy. | MTS225 System has a Volume-to-Vent ratio of 94.725 (MTS300 is 129.131). The document states that the system "demonstrated the ability to... achieve a 10-6 SAL" with this ratio. |
| Regulatory Equivalence | As safe, as effective, and perform as well as or better than the legally marketed predicate device (MTS300 Multiple Tray Sterilization System K152014). | Nonclinical tests demonstrated that the MTS225 and MTS300 Multiple Tray Sterilization Systems are as safe, as effective, and perform as well as or better than the legally marketed predicate device, the MTS300 Multiple Tray Sterilization System (K152014). |
Regarding the study proving the device meets acceptance criteria:
The document refers to "Nonclinical data" and "Sterilization efficacy verification studies".
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample size for the "test set" in terms of number of runs or specific items tested.
- Data Provenance: The studies were performed to ensure the systems meet intended use and were conducted "in accordance with the requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization." The location or specific retrospective/prospective nature of the data collection is not detailed, but it is implied to be laboratory testing for device validation.
-
Number of Experts Used to Establish Ground Truth and Qualifications:
- This is not applicable as the device is a physical sterilizer, not an AI or diagnostic device that requires expert interpretation of data for ground truth establishment. The ground truth for sterilization efficacy is typically established through microbiological methods (e.g., spore tests) and physical/chemical indicators, referencing established standards like SAL (Sterility Assurance Level).
-
Adjudication Method for the Test Set:
- Not applicable. This applies to human reading or AI interpretation studies, not physical device performance validation.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a study design for evaluating the impact of AI on human readers (e.g., radiologists, pathologists). The subject device is a physical sterilization system.
-
Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical device, not a software algorithm.
-
Type of Ground Truth Used:
- The ground truth for sterilization efficacy is established through scientific and regulatory standards, primarily microbiological testing (e.g., achieving a 10⁻⁶ SAL, which implies a one in a million chance of a non-sterile item). This is confirmed by challenging the system with difficult-to-sterilize instruments and ensuring spore elimination. Additionally, physical parameters (temperature, pressure, time) and chemical indicators are used to monitor the sterilization process.
-
Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI model that requires a "training set."
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no AI training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2019
Pmbs, LLC % Annette Hillring President Hillring & Associates, Inc 3012 St. Charles Drive Tampa, Florida 33618
Re: K190541
Trade/Device Name: MTS225 and MTS300 Multiple Tray Sterilization Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 27, 2019 Received: September 30, 2019
Dear Annette Hillring:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190541
Device Name
MTS225 and MTS300 Multiple Tray Sterilization Systems
Indications for Use (Describe)
The MTS System (Multiple Tray Sterilization System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks.
The MTS System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of .7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than .7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm. Use only uncovered, perforated or wire mesh general delivery trays within the MTS System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K190541
| Submitter | PMBS, LLC5419 Delette Ave SSt Petersburg, FL 33707Contact person: Michele E. Mauzerall, CEOPhone: 908-300-7093Email: mem.pmbs@gmail.com |
|---|---|
| Date prepared | November 1, 2019 |
| Device | MTS225 and MTS300 Multiple Tray Sterilization Systems |
| Predicate Device | MTS300 Multiple Tray Sterilization System ("MTS300 System")K152014 |
| Device Description | The MTS System is comprised of the stainless steel sterilization cabinet andadjustable transfer cart. Single use filters and integrity locks with sterilizationindicator dots are used with the system for each sterilization cycle. Anoptional STEAMPlus™ tray record card with STEAMPlus sterilizationintegrator (SPS Medical) may be utilized by the healthcare provider. |
| Adjustable shelves within the cabinet can hold up to three trays (uncovered,perforated or wire mesh) of devices and/or surgical instruments intended for asingle patient surgery. No more than 25 pounds can be loaded per tray for amaximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves)can hold up to 300 pounds per load and the MTS225 Cabinet (with threeshelves) can hold up to 225 pounds per load. | |
| The loaded cabinet is deployed from the adjustable transfer cart and processedin pre-vacuum steam sterilizers. Processing includes the standardconditioning phase of the autoclave followed by a sterilization cycle time of aminimum of 4 minutes and a dry cycle of a minimum of 10 minutes. Sterilityis maintained for up to 30 days. | |
| Indications for Use | The MTS System (Multiple Tray Sterilization System) is indicated forenclosing other medical devices that are to be sterilized by a healthcareprovider. It is intended to allow sterilization of the enclosed materials andmaintain sterility for up to 30 days. The unit must be used with the MTSSystem Transfer Cart, MTS System Filters and MTS System Integrity Locks. |
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The MTS System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the MTS System.
Comparison of Technological Characteristics with the Predicate Device
There are no new technological characteristics associated with the modified (smaller) MTS300 System, the MTS225 System. A comparison of the technological characteristics of the subject device, the MTS System (MTS225 and MTS300 Systems) to the predicate, the currently-marketed MTS300 System, is provided in the table on the following pages.
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Comparison of Technological Characteristics with the Predicate Device
| Characteristic | Subject Device: | Predicate Device: |
|---|---|---|
| MTS System (both the MTS225 and MTS300 | MTS300 System | |
| Systems) K190541 | (K152014) | |
| Indications for Use | The MTS System (Multiple Tray Sterilization System) isindicated for enclosing other medical devices that are to besterilized by a healthcare provider. It is intended to allowsterilization of the enclosed materials and maintain sterility for upto 30 days. The unit must be used with the MTS System TransferCart, MTS System Filters and MTS System Integrity Locks. | The MTS300 System is indicated for enclosing other medicaldevices that are to be sterilized by a healthcare provider. It isintended to allow sterilization of the enclosed materials andmaintain sterility for up to 30 days until used. The unit mustbe used with the MTS300 Transfer Cart, MTS300 filters andintegrity locks. |
| The MTS System is intended to be used in prevacuum steamsterilizers with a prevacuum cycle of 270°F and exposure time of4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray. | The MTS300 System is intended to be used in prevacuumsteam sterilizers with a prevacuum cycle of 270°F andexposure time of 4 minutes. Use no more than 3 trays pershelf or 25 lbs. per tray. | |
| The MTS System was tested and validated with rigid instrumentscontaining lumens with an inner diameter of 0.7mm and anoverall length of 500mm as well as lumens with an innerdiameter of 1.0mm and an overall length of 850mm. Do not usewith instruments containing lumens with an inner diametersmaller than 0.7mm and an overall length longer than 500mm orlumens with an inner diameter smaller than 1.0mm and an overalllength longer than 850mm. | The MTS300 System was tested and validated with rigidinstruments containing lumens with an inner diameter of3.8mm and an overall length of 370mm. Do not use withinstruments containing lumens with an inner diameter smallerthan 3.8mm and an overall length longer than 370mm. | |
| Use only uncovered, perforated or wire mesh general deliverytrays within the MTS System. | Use only uncovered, perforated or wire mesh generaldelivery trays within the MTS300 System. | |
| SterilizationParameters | Prevacuum cycle of 270°F and exposure time of 4minutes | Prevacuum cycle of 270°F and exposure time of 4minutes |
| Drying Time | 10 minutes | 30 minutes |
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Comparison of Technological Characteristics with the Predicate Device
| Characteristic | Subject Device:MTS System (both the MTS225 and MTS300Systems) K190541 | Predicate Device:MTS300 System(K152014) |
|---|---|---|
| SterilityMaintenance | 30 days | 30 days |
| Cabinet Material | 16 gauge stainless steel | 16 gauge stainless steel |
| Weight w/ Shelves | 212 lbs (MTS300) and 185 lbs (MTS225) | 212 lbs |
| Filter Material | Heavy duty sterilization wrap by SPS Medical | Heavy duty sterilization wrap by SPS Medical |
| Volume-to-VentRatio | 129.131 (MTS300) and 94.725 (MTS225) | 129.131 |
| Deployment intoSterilizationChamber | Adjustable transfer cart | Adjustable transfer cart |
| RecommendedSterilization Trays | All manufacturers' trays – uncovered, perforated orwire mesh general delivery trays | All manufacturers' trays - uncovered, perforated or wiremesh general delivery trays |
| RecommendedSterilizers | All makes and models with dimensions compatiblewith the MTS System | All makes and models with dimensions compatible withthe MTS300 System |
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| Comparison ofTechnologicalCharacteristicswith thePredicateDevice | Modifications introduced into the MTS300 Multiple Tray SterilizationSystems do not affect the technological characteristics. The cabinet materialremains stainless steel and a filtration system utilizing disposable filters of thesame material from the same supplier is the method by which sterilization isachieved and maintained. The cabinet continues to be deployed into thesterilization chamber with an adjustable transfer cart. The sterilizationparameters and sterility maintenance specifications are identical to thepredicate device. |
|---|---|
| NonclinicalTesting | Nonclinical data was generated to ensure the MTS Systems meet the intendeduse. Sterilization efficacy verification studies were performed in accordancewith the requirements of ANSI/AAMI ST77:2013 Containment devices forreusable medical device sterilization.The smaller modified MTS300 System (the MTS225 System) isdimensionally smaller in height and lighter weight. Because of its smallersize, the Volume-to-Vent ratio is less than the MTS300 System.The MTS Systems (both the MTS225 and MTS300 Systems) havedemonstrated the ability to: achieve a 10-6 SAL when sterilizing longer and smaller lumen sized instruments (rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm), meet or exceed the shorter minimum dry time of 10 minutes, and maintain sterility for 30 days following rigorous outdoor transportation and storage outside the sterilization facility. |
| Conclusion | The nonclinical tests demonstrate that the MTS225 and MTS300 MultipleTray Sterilization Systems are as safe, as effective, and perform as well as orbetter than the legally marketed device, the MTS300 Multiple TraySterilization System (K152014). |
§ 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).