(246 days)
Not Found
No
The device description and performance studies focus on the physical design and sterilization efficacy of a containment system, with no mention of AI or ML technologies.
No
The device is described as a sterilization system intended for enclosing other medical devices to be sterilized, not for treating patients directly. Its purpose is to maintain sterility, making it an auxiliary device for medical procedures rather than a therapeutic one.
No
The device is a sterilization and containment system for other medical devices, not a diagnostic device. Its purpose is to sterilize and maintain the sterility of medical instruments.
No
The device description clearly states it is comprised of a stainless steel sterilization cabinet and adjustable transfer cart, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MTS System is for "enclosing other medical devices that are to be sterilized by a healthcare provider." It facilitates the sterilization process and maintains sterility of the enclosed items.
- Device Description: The description details a physical system (stainless steel cabinet, transfer cart, filters, locks) used for holding and processing medical devices in a steam sterilizer.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, urine, tissue) outside of the body to diagnose, monitor, or treat a disease or condition.
The MTS System is a sterilization containment device, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
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
healthcare provider
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical data was generated to ensure the MTS Systems meet the intended use. Sterilization efficacy verification studies were performed in accordance with the requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization.
The smaller modified MTS300 System (the MTS225 System) is dimensionally smaller in height and lighter weight. Because of its smaller size, the Volume-to-Vent ratio is less than the MTS300 System.
The MTS Systems (both the MTS225 and MTS300 Systems) have demonstrated 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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.
1
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
2
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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3
510(k) Summary: K190541
| Submitter | PMBS, LLC
5419 Delette Ave S
St Petersburg, FL 33707
Contact person: Michele E. Mauzerall, CEO
Phone: 908-300-7093
Email: 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 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. |
| Indications for Use | 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. |
4
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.
5
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) 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 MTS300 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 until used. The unit must | ||
| be used with the MTS300 Transfer Cart, MTS300 filters and | ||
| 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 MTS300 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. | The MTS300 System was tested and validated with rigid | |
| instruments containing lumens with an inner diameter of | ||
| 3.8mm and an overall length of 370mm. Do not use with | ||
| instruments containing lumens with an inner diameter smaller | ||
| than 3.8mm and an overall length longer than 370mm. | ||
| Use only uncovered, perforated or wire mesh general delivery | ||
| trays within the MTS System. | Use only uncovered, perforated or wire mesh general | |
| delivery trays within the MTS300 System. | ||
| Sterilization | ||
| Parameters | Prevacuum cycle of 270°F and exposure time of 4 | |
| minutes | Prevacuum cycle of 270°F and exposure time of 4 | |
| minutes | ||
| Drying Time | 10 minutes | 30 minutes |
6
Comparison of Technological Characteristics with the Predicate Device
| Characteristic | Subject Device:
MTS System (both the MTS225 and MTS300
Systems) K190541 | Predicate Device:
MTS300 System
(K152014) |
|---------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Sterility
Maintenance | 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-Vent
Ratio | 129.131 (MTS300) and 94.725 (MTS225) | 129.131 |
| Deployment into
Sterilization
Chamber | Adjustable transfer cart | Adjustable transfer cart |
| Recommended
Sterilization Trays | All manufacturers' trays – uncovered, perforated or
wire mesh general delivery trays | All manufacturers' trays - uncovered, perforated or wire
mesh general delivery trays |
| Recommended
Sterilizers | All makes and models with dimensions compatible
with the MTS System | All makes and models with dimensions compatible with
the MTS300 System |
7
| Comparison of
Technological
Characteristics
with the
Predicate
Device | Modifications introduced into the MTS300 Multiple Tray Sterilization
Systems do not affect the technological characteristics. The cabinet material
remains stainless steel and a filtration system utilizing disposable filters of the
same material from the same supplier is the method by which sterilization is
achieved and maintained. The cabinet continues to be deployed into the
sterilization chamber with an adjustable transfer cart. The sterilization
parameters and sterility maintenance specifications are identical to the
predicate device. |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical
Testing | Nonclinical data was generated to ensure the MTS Systems meet the intended
use. Sterilization efficacy verification studies were performed in accordance
with the requirements of ANSI/AAMI ST77:2013 Containment devices for
reusable medical device sterilization.
The smaller modified MTS300 System (the MTS225 System) is
dimensionally smaller in height and lighter weight. Because of its smaller
size, the Volume-to-Vent ratio is less than the MTS300 System.
The MTS Systems (both the MTS225 and MTS300 Systems) have
demonstrated 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 Multiple
Tray Sterilization Systems are as safe, as effective, and perform as well as or
better than the legally marketed device, the MTS300 Multiple Tray
Sterilization System (K152014). |