← Product Code [KCT](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT) · K152014 # MTS300 Multiple Tray Sterilization System (K152014) _Pmbs, LLC · KCT · Oct 20, 2015 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K152014 ## Device Facts - **Applicant:** Pmbs, LLC - **Product Code:** [KCT](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT.md) - **Decision Date:** Oct 20, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6850 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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 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. ## Device Story MTS300 Multiple Tray Sterilization System; stainless steel sterilization cabinet and adjustable transfer cart. Used by healthcare providers to enclose medical devices for steam sterilization. Inputs: medical instruments placed in uncovered, perforated, or wire mesh trays. Process: cabinet loaded onto transfer cart, deployed into prevacuum steam sterilizer (270°F, 4-minute cycle), followed by 30-minute drying. System uses disposable filters and integrity locks with sterilization indicator dots to maintain sterility for 30 days. Optional STEAMPlus tray record card/integrator may be used. Output: sterilized, protected instrument trays ready for clinical use. Benefits: enables organized, sterile storage and transport of surgical instruments; maintains sterility post-processing. ## Clinical Evidence Bench testing only. Sterilization efficacy verification performed per ANSI/AAMI ST77:2013 and FDA guidance for sterilization packaging. Stability demonstrated via engineering analysis and usability study. No clinical data. ## Technological Characteristics 16-gauge stainless steel cabinet; adjustable transfer cart; disposable heavy-duty sterilization wrap filters; integrity locks with indicator dots. Sterilization via prevacuum steam (270°F). Compatible with all uncovered, perforated, or wire mesh general delivery trays. Dimensions/volume-to-vent ratio specified. Mechanical containment device; no software or electronic components. ## Regulatory 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. ## Predicate Devices - S.C.O.R.E.S. Units, Self Contained Operating Room Equipment Sterilization Containers ([K110898](/device/K110898.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement. 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) K152014 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 | | | 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}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K152014](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K152014) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com