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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MTS300 Multiple Tray Sterilization System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it often references studies done to meet existing standards or guidance documents rather than detailing a single, comprehensive study testing a device against specific, novel acceptance criteria. The information below reflects what is extractable from this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Claimed	Reported Device Performance (from studies/validation)
Sterilization Efficacy	Demonstrated through verification studies in accordance with ANSI/AAMI ST77:2013 and FDA Draft Guidance (2002).
Sterility Maintenance Duration	Up to 30 days
Compatibility with Prevacuum Steam Sterilizers	Prevacuum cycle of 270°F, 4 minutes exposure time
Maximum Tray Load per Shelf	No more than 3 trays per shelf
Maximum Weight per Tray	25 lbs. per tray
Lumen Instrument Compatibility	Rigid instruments with inner diameter ≥ 3.8mm and overall length ≤ 370mm
Tray Type Compatibility	Uncovered, perforated, or wire mesh general delivery trays
System Stability (Cabinet on Transfer Cart)	Stable during deployment and use.
User Needs/Intended Use (Usability)	Meets user needs and intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" of items tested for the sterilization efficacy studies (e.g., number of sterilization cycles, number of biological indicators). It refers to "sterilization efficacy verification studies" performed.

Data Provenance: The studies were performed in accordance with ANSI/AAMI ST77:2013 and the recommendations of the Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Healthcare Facilities, Draft Guidance for Industry and FDA, March 7, 2002. This implies that the testing methodologies would follow standard industry practices and regulatory guidance, likely conducted in a controlled laboratory or healthcare setting. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's for a 510(k) submission, it would typically involve prospective testing conducted by the manufacturer or a contract research organization.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number or qualifications of experts used to establish ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods (e.g., culturing biological indicators to confirm sterility), not usually by expert consensus in the typical sense of reading medical images.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are typically used for interpreting results from human readers (e.g., radiologists) in diagnostic studies, not for the technical performance testing of a sterilization system. The verification studies follow established protocols where results (e.g., growth/no growth of biological indicators) are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The MTS300 is a sterilization system, not an imaging or diagnostic device involving human interpretation in that manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "sterilization efficacy verification studies" and "engineering analysis" are standalone performance evaluations of the device itself (the "algorithm" in this context refers to the device's functional performance). There isn't an "AI algorithm" involved in the way typically discussed in diagnostic imaging. The device is intended to perform its function without constant human intervention during the sterilization cycle. The "usability study" involves human interaction but evaluates the system's ease of use and ability to meet human needs, not human diagnostic performance.

7. The Type of Ground Truth Used

For sterilization efficacy, the ground truth is primarily based on microbiological testing (e.g., culturing biological indicators to confirm the absence of viable microorganisms after the sterilization process). For stability and usability, the ground truth would be based on engineering analysis (meeting design specifications) and potentially user feedback/observation in the usability study demonstrating successful and safe operation.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI in a way that requires a "training set." Its performance is based on physical and chemical principles and validated through engineered design and testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K152014

Device Name MTS300 Multiple Tray Sterilization System

Indications for Use (Describe)

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.

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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510(k) Summary

Date Prepared	September 16, 2015
Submitter	Michele E. MauzerallPMBS, LLC40 Milltown RoadStockton, New Jersey 08559Phone: 908-300-7093Email: 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

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Indications forUse, continued	unit must be used with the MTS300 Transfer Cart, MTS300 filters andintegrity locks.
	The MTS300 System is intended to be used in prevacuum steam sterilizerswith a prevacuum cycle of 270°F and exposure time of 4 minutes. Use nomore than 3 trays per shelf or 25 lbs. per tray.
	The MTS300 System was tested and validated with rigid instrumentscontaining lumens with an inner diameter of 3.8mm and an overall length of370mm. Do not use with instruments containing lumens with an innerdiameter smaller than 3.8mm and an overall length longer than 370mm.
	Use only uncovered, perforated or wire mesh general delivery trays within theMTS300 System.
Comparison ofTechnologicalCharacteristicswith thePredicateDevice	There are no new technological characteristics associated with the MTS300Multiple Tray Sterilization System as compared to the predicate device, theS.C.O.R.E.S. Units, Self Contained Operating Room Equipment SterilizationContainer. A comparison of the technological characteristics of the subjectdevice, the MTS300 Multiple Tray Sterilization System, to the predicatedevice, the S.C.O.R.E.S. Units, Self Contained Operating Room EquipmentSterilization 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 OperatingRoom Equipment Sterilization ContainerK110898
Indications for Use	The MTS300 System is indicated for enclosing othermedical devices that are to be sterilized by a healthcareprovider. It is intended to allow sterilization of theenclosed materials and maintain sterility for up to 30 daysuntil used. The unit must be used with the MTS300Transfer Cart, MTS300 filters and integrity locks.	The SCORES Sterilization Container is indicated forenclosing other medical devices that are to be sterilizedby a healthcare provider. It is intended to allowsterilization of the enclosed materials and maintainsterility for up to 30 days until used. The unit must beused with the SCORES Transfer Cart, SCORES filtersand integrity locks.
	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 unit is intended to be used in prevacuum steamsterilizers with a prevacuum cycle of 270°F and exposuretime of 4 minutes. Use no more than 3 trays per shelf or25 lbs. per tray.
	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 diametersmaller than 3.8mm and an overall length longer than370mm.	The SCORES Unit 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 diametersmaller than 3.8mm and an overall length longer than370mm.
	Use only uncovered, perforated or wire mesh generaldelivery trays within the MTS300 System.	Use only uncovered, perforated or wire mesh generaldelivery trays within the SCORES SterilizationContainer.
Characteristic	Subject Device:MTS300 Multiple Tray Sterilization System("MTS300 System")K152015	Predicate Device:S.C.O.R.E.S. Units, Self Contained OperatingRoom Equipment Sterilization ContainerK110898
SterilizationParameters	Prevacuum cycle of 270°F and exposure time of 4minutes	Prevacuum cycle of 270°F and exposure time of 4minutes
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-VentRatio	129.131	192.22
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 orwire mesh general delivery trays
RecommendedSterilizers	All makes and models with dimensions compatiblewith the MTS System	Three Steris models
Comparison ofTechnologicalCharacteristicswith thePredicateDevice,continued	Modifications introduced into the MTS300 Multiple Tray SterilizationSystem 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 (with only dimensional changes) is themethod by which sterilization is achieved and maintained. The cabinetcontinues to be deployed into the sterilization chamber with an adjustabletransfer cart. The sterilization parameters, drying time and sterilitymaintenance specifications are identical to the predicate device along with theindications for use.
PerformanceData	Nonclinical data was generated to ensure the MTS300 Multiple TraySterilization System continues to meet the intended use. Sterilization efficacyverification studies were performed in accordance with the requirements ofANSI/AAMI ST77:2013 Containment devices for reusable medical devicesterilization and the recommendations of Premarket Notification [510(k)]Submissions for Medical Sterilization Packaging Systems in HealthcareFacilities, Draft Guidance for Industry and FDA, March 7, 2002, andincluded all of the studies performed on the predicate device. Stability of thesystem (cabinet on transfer cart) was demonstrated by an engineering analysisand within a usability study. The usability study demonstrated that themodified cabinet and adjustable transfer cart will continue to meet user needsand intended use.
Conclusions	In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR807, and based upon the information and scientifically valid data provided inthis premarket notification, PMBS, LLC, concludes that the subject device,the MTS300 Multiple Tray Sterilization System is as safe, as effective andperforms as well as the predicate device, the S.C.O.R.E.S. Units, SelfContained Operating Room Equipment Sterilization Container (K110898).

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omparison of Technological Characteristics with the Predicate Device, continu

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omparison of Technological Characteristics with the Predicate Device, continu

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Regulation Number and Section

§ 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).