(91 days)
Not Found
No
The device description and performance studies focus on the physical sterilization system and its efficacy, with no mention of AI or ML components.
No
The device is a sterilization system for other medical devices, not a device used for treating a disease or condition in a patient.
No
The device is a sterilization system intended for enclosing other medical devices to be sterilized, not for diagnosing medical conditions.
No
The device description clearly states it includes a stainless steel sterilization cabinet and adjustable transfer cart, which are hardware components.
Based on the provided text, the MTS300 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "enclosing other medical devices that are to be sterilized by a healthcare provider." This is a sterilization and containment system for medical devices, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a sterilization cabinet, transfer cart, filters, and integrity locks. These are components of a sterilization system, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
The MTS300 System is a device used in the process of preparing other medical devices for use, specifically through sterilization. This falls under the category of medical device sterilization equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 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 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 MTS300 System.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The MTS300 Multiple Tray Sterilization System (also referred to as the MTS300 System) includes 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 TM tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. The MTS System is intended to sterilize a maximum weight of 300 pounds of devices and instruments for a single patient surgery. The loaded cabinet is deployed from the adjustable transfer cart and processed in a pre-vacuum steam sterilizer and then dried for 30 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 MTS300 Multiple Tray Sterilization System continues to 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 and the recommendations of Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Healthcare Facilities, Draft Guidance for Industry and FDA, March 7, 2002, and included all of the studies performed on the predicate device. Stability of the system (cabinet on transfer cart) was demonstrated by an engineering analysis and within a usability study. The usability study demonstrated that the modified cabinet and adjustable transfer cart will continue to meet user needs and intended use.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2015
PMBS, LLC c/o Ms. Annette Hillring President Hillring & Associates, Inc. 3012 St. Charles Dr. Tampa, FL 33618
Re: K152014
Trade/Device Name: MTS300 Multiple Tray Sterilization System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 16, 2015 Received: September 17, 2015
Dear Ms. 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. The general controls provisions of the Act include requirements for annual registration. Iisting 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
Page 2 - Ms. Hillring
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MTS300 Multiple Tray Sterilization System
Indications for Use (Describe)
The MTS300 System is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterlization 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 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 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 MTS300 System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Date Prepared | September 16, 2015 |
|---|---|
| Submitter | Michele E. Mauzerall |
| PMBS, LLC | |
| 40 Milltown Road | |
| Stockton, New Jersey 08559 | |
| Phone: 908-300-7093 | |
| Email: mem.pmbs@gmail.com | |
| Device | Trade Name: MTS300 Multiple Tray Sterilization SystemCommon Name: Sterilization Container and AccessoriesClassification Name: Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesProduct Code: KCTClassification Regulation: 21 CFR 880.6850 Sterilization wrap, Class II |
| Predicate Device | AmMed Surgical Equipment, LLC, S.C.O.R.E.S. Units, Self Contained Operating Room Equipment Sterilization Containers cleared via Premarket Notification 510(k) K110898 on July 26, 2012 |
| Device Description | The MTS300 Multiple Tray Sterilization System (also referred to as the MTS300 System) includes 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 TM tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. The MTS System is intended to sterilize a maximum weight of 300 pounds of devices and instruments for a single patient surgery. The loaded cabinet is deployed from the adjustable transfer cart and processed in a pre-vacuum steam sterilizer and then dried for 30 minutes. Sterility is maintained for up to 30 days. |
| Indications for Use | 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 |
Continued on next page
4
| Indications for
Use, continued | unit must be used with the MTS300 Transfer Cart, MTS300 filters and
integrity locks. | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 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
MTS300 System. | |
| Comparison of
Technological
Characteristics
with the
Predicate
Device | There are no new technological characteristics associated with the MTS300
Multiple Tray Sterilization System as compared to the predicate device, the
S.C.O.R.E.S. Units, Self Contained Operating Room Equipment Sterilization
Container. A comparison of the technological characteristics of the subject
device, the MTS300 Multiple Tray Sterilization System, to the predicate
device, the S.C.O.R.E.S. Units, Self Contained Operating Room Equipment
Sterilization Container is provided in the table on the following page. | |
| Characteristic | Subject Device:
MTS300 Multiple Tray Sterilization System
("MTS300 System")
K152015 | Predicate Device:
S.C.O.R.E.S. Units, Self Contained Operating
Room Equipment Sterilization Container
K110898 |
| Indications for Use | 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 SCORES Sterilization Container 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 SCORES Transfer Cart, SCORES filters
and integrity locks. |
| | 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 unit 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 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. | The SCORES Unit 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 MTS300 System. | Use only uncovered, perforated or wire mesh general
delivery trays within the SCORES Sterilization
Container. |
| Characteristic | Subject Device:
MTS300 Multiple Tray Sterilization System
("MTS300 System")
K152015 | Predicate Device:
S.C.O.R.E.S. Units, Self Contained Operating
Room Equipment Sterilization Container
K110898 |
| 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 | 30 minutes | 30 minutes |
| Sterility | 30 days | 30 days |
| Maintenance | | |
| Cabinet Material | 16 gauge stainless steel | 12 and 14 gauge stainless steel |
| Weight w/ Shelves | 212 lbs. | 214 lbs. |
| Filter Material | Heavy duty sterilization wrap by SPS Medical | Heavy duty sterilization wrap by SPS Medical |
| Volume-to-Vent
Ratio | 129.131 | 192.22 |
| 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 | Three Steris models |
| Comparison of
Technological
Characteristics
with the
Predicate
Device,
continued | Modifications introduced into the MTS300 Multiple Tray Sterilization
System 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 (with only dimensional changes) 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, drying time and sterility
maintenance specifications are identical to the predicate device along with the
indications for use. | |
| Performance
Data | Nonclinical data was generated to ensure the MTS300 Multiple Tray
Sterilization System continues to 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 and the recommendations of Premarket Notification [510(k)]
Submissions for Medical Sterilization Packaging Systems in Healthcare
Facilities, Draft Guidance for Industry and FDA, March 7, 2002, and
included all of the studies performed on the predicate device. Stability of the
system (cabinet on transfer cart) was demonstrated by an engineering analysis
and within a usability study. The usability study demonstrated that the
modified cabinet and adjustable transfer cart will continue to meet user needs
and intended use. | |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR
807, and based upon the information and scientifically valid data provided in
this premarket notification, PMBS, LLC, concludes that the subject device,
the MTS300 Multiple Tray Sterilization System is as safe, as effective and
performs as well as the predicate device, the S.C.O.R.E.S. Units, Self
Contained Operating Room Equipment Sterilization Container (K110898). | |
5
omparison of Technological Characteristics with the Predicate Device, continu
6
omparison of Technological Characteristics with the Predicate Device, continu
7