The SteriCUBE 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 until used. The unit must be used with the SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks.

The SteriCUBE 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 SteriCUBE 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 SteriCUBE System.

Device Description

The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as the “SteriCUBE Systems” and include the SteriCUBE MTS225 System and the SteriCUBE MTS300 System. The SteriCUBE System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. An optional reusable ceramic drain filter and single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. The optional ceramic drain filter should be replaced every 6 months or after 160 uses, whichever comes first. 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 4 minutes and a dry cycle of a minimum of 5 minutes. Sterility is maintained for up to 30 days.

AI/ML Overview

The provided text describes the SteriCUBE® Multiple Tray Sterilization Systems and its equivalency to a predicate device. It indicates that performance data was generated but does not contain a detailed study report that includes specific acceptance criteria and outcome metrics in the format requested.

However, based on the information provided, we can infer some aspects related to acceptance criteria and the study's scope:

1. A table of acceptance criteria and the reported device performance

The document mentions validation of the SteriCUBE System. Based on the "Indications for Use" and "Comparison of Technological Characteristics," the following can be inferred as performance criteria and statements:

Acceptance Criteria (Inferred)	Reported Device Performance
Sterilization Efficacy: Achieve a 10⁻⁶ Sterility Assurance Level (SAL)	Achieved a 10⁻⁶ SAL when sterilizing rigid instruments containing lumens with an inner diameter of 0.7mm and overall length of 500mm, as well as lumens with an inner diameter of 1.0mm and overall length of 850mm.
Minimum Drying Time	Met the shorter minimum dry time of 5 minutes.
Sterility Maintenance Duration	Maintained sterility for 30 days.
Compatibility with specific lumen sizes	Tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and 500mm length, and 1.0mm and 850mm length.
Incompatibility with smaller/longer lumens	Not for use with instruments containing lumens with an inner diameter smaller than 0.7mm and overall length longer than 500mm, or lumens with an inner diameter smaller than 1.0mm and overall length longer than 850mm.
Use with prevacuum steam sterilizers	Intended for use in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes.
Load capacity per tray	No more than 3 trays per shelf or 25 lbs. per tray.
Volume-to-Vent Ratio	MTS300: 129.131; MTS225: 94.725 (Identical to predicate)
Cabinet Material	16 gauge stainless steel (Identical to predicate)
Filter Material	Heavy duty sterilization wrap by SPS Medical (Identical to predicate, with optional ceramic drain filter and paper filter separators also used effectively)

2. Sample size used for the test set and the data provenance

The document states, "Nonclinical data was generated to ensure the SteriCUBE System continues to meet the intended use. Sterilization efficacy verification studies were performed in accordance with the appropriate requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization."

Sample size: Not specified in the provided text.
Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). It is "nonclinical data."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a sterilization system and the performance data concerns sterilization efficacy and material properties, not diagnostic interpretation by human experts. The ground truth would be established through laboratory testing and physical measurements (e.g., sterility testing, temperature/pressure monitoring, material strength tests).

4. Adjudication method for the test set

This section is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, not for the technical validation of a sterilization device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool engaging human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a sterilization system and does not involve algorithms or human-in-the-loop performance in the context of an AI device. The "standalone" performance here refers to the device's ability to achieve sterilization and maintain sterility on its own, which is what the "Nonclinical data" and "Sterilization efficacy verification studies" would assess.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a sterilization system would be established through:

Biological Indicator (BI) testing: Using bacterial spores (e.g., Geobacillus stearothermophilus) to confirm a 10⁻⁶ SAL (Sterility Assurance Level) after the sterilization process.
Physical and Chemical Indicators: Monitoring temperature, pressure, and sterilant penetration within the system during the cycle.
Material Testing: Durability, integrity, and performance of the system's components (filters, cabinet, etc.) over time and repeated use.
Microbial Challenge Testing: Introducing known levels of microorganisms to device lumens to ensure effective sterilization.

The text explicitly mentions "Sterilization efficacy verification studies were performed in accordance with the appropriate requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization," which outlines methods for establishing such ground truth.

8. The sample size for the training set

This section is not applicable. The device is a physical sterilization system, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as #8.

Summary

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September 28, 2022

SteriCUBE, LLC % Annette Hillring President Hillring & Associates, Inc. 3012 St. Charles Drive Tampa, Florida 33618

Re: K222328

Trade/Device Name: SteriCUBE® Multiple Tray Sterilization Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 29, 2022 Received: August 2, 2022

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.

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

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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 (QS) 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

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K222328

Device Name SteriCUBE(R) Multiple Tray Sterilization Systems

Indications for Use (Describe)

The SteriCUBE 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 SteriCUBE 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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K222328 510(k) Summary

Submitter	SteriCUBE, LLC2701 Beach Boulevard SouthGulfport, FL 33707Contact person: Michele E. Mauzerall, CEOPhone: 908-300-7093Email: mem.pmbs@gmail.comDate prepared: September 27, 2022
Device	SteriCUBE® Multiple Tray Sterilization Systems
Predicate Device	MTS225 and MTS300 Multiple Tray Sterilization Systems (“MTS Systems”) cleared most recently November 5, 2019, via K190541
Device Description	The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as the “SteriCUBE Systems” and include the SteriCUBE MTS225 System and the SteriCUBE MTS300 System. The SteriCUBE System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. An optional reusable ceramic drain filter and single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. The optional ceramic drain filter should be replaced every 6 months or after 160 uses, whichever comes first. 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 4 minutes and a dry cycle of a minimum of 5 minutes. Sterility is maintained for up to 30 days.

Continued on next page

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Section 5: 510(k) Summary, continued

Indications forUse	The SteriCUBE Multiple Tray Sterilization System (SteriCUBE® System) isindicated for enclosing other medical devices that are to be sterilized by ahealthcare provider. It is intended to allow sterilization of the enclosedmaterials and maintain sterility for up to 30 days until used. The unit must beused with the SteriCUBE System Transfer Cart, SteriCUBE System Filtersand SteriCUBE System Integrity Locks.
	The SteriCUBE 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 SteriCUBE System was tested and validated with rigid instrumentscontaining lumens with an inner diameter of 0.7mm and an overall length of500mm as well as lumens with an inner diameter of 1.0mm and an overalllength of 850mm. Do not use with instruments containing lumens with aninner diameter smaller than 0.7mm and an overall length longer than 500mmor lumens with an inner diameter smaller than 1.0mm and an overall lengthlonger than 850mm.
	Use only uncovered, perforated or wire mesh general delivery trays within theSteriCUBE System.
Comparison ofTechnologicalCharacteristicswith thePredicateDevice	There are no new technological characteristics associated with the modifiedSteriCUBE System. A comparison of the technological characteristics of thesubject device, the SteriCUBE System (SteriCUBE MTS225 and SteriCUBEMTS300 Systems) to the predicate, the currently marketed MTS225 andMTS300 Systems, is provided in the table on the following pages.
	Continued on next page
Characteristic	Subject Device:	Predicate Device:
	SteriCUBE® Systems (SteriCUBE MTS225 and	MTS225 and MTS300 Systems
	SteriCUBE MTS300 Systems)	(K190541)
Indications for Use	The SteriCUBE Multiple Tray Sterilization System is indicatedfor enclosing other medical devices that are to be sterilized by ahealthcare provider. It is intended to allow sterilization of theenclosed materials and maintain sterility for up to 30 days untilused. The unit must be used with the SteriCUBE System TransferCart, SteriCUBE System Filters and SteriCUBE System IntegrityLocks.	The MTS System (Multiple Tray Sterilization System) is indicatedfor enclosing other medical devices that are to be sterilized by ahealthcare provider. It is intended to allow sterilization of theenclosed materials and maintain sterility for up to 30 days untilused. The unit must be used with the MTS System Transfer Cart,MTS System Filters and MTS System Integrity Locks.
	The SteriCUBE System is intended to be used in prevacuumsteam sterilizers with a prevacuum cycle of 270°F and exposuretime of 4 minutes. Use no more than 3 trays per shelf or 25 lbs.per tray.	The MTS System is intended to be used in prevacuum steamsterilizers with a prevacuum cycle of 270°F and exposure time of 4minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
	The SteriCUBE System was tested and validated with rigidinstruments containing lumens with an inner diameter of 0.7mmand an overall 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 MTS System was tested and validated with rigid instrumentscontaining lumens with an inner diameter of 0.7mm and an overalllength of 500mm as well as lumens with an inner diameter of1.0mm and an overall length of 850mm. Do not use with
	Use only uncovered, perforated or wire mesh general deliverytrays within the SteriCUBE System.	Use only uncovered, perforated or wire mesh general delivery trayswithin the MTS System.
	Sterilization	Prevacuum cycle of 270°F and exposure time of 4
Parameters	minutes	minutes
Minimum Drying	5 minutes	10 minutes
Time
Characteristic	Subject Device:SteriCUBE Systems (SteriCUBE MTS225 andSteriCUBE MTS300 Systems)	Predicate Device:MTS225 and MTS300 Systems(K190541)
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 (MTS300) and 185 lbs (MTS225)
Filter Material	Heavy duty sterilization wrap by SPS MedicalOptional ceramic drain filterOptional sterilization wrap filter separators	Heavy duty sterilization wrap by SPS Medical
Volume-to-VentRatio	129.131 (MTS300) and 94.725 (MTS225)	129.131 (MTS300) and 94.725 (MTS225)
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 SteriCUBE System	All makes and models with dimensions compatible withthe MTS System

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Section 5: 510(k) Summary, continued

Comparison of Technological Characteristics with the Predicate Device, continued

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Continued on next page

Section 5: 510(k) Summary, continued

Comparison of Technological Characteristics with the Predicate Device, continued

Continued on next page

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Section 5: 510(k) Summary, continued

Comparison ofTechnologicalCharacteristicswith thePredicateDevice,continued	Modifications introduced into the SteriCUBE® Multiple Tray SterilizationSystems do not affect the technological characteristics. The cabinet materialremains stainless steel and a filtration system utilizing disposable paper filtersof the same material from the same supplier is the method by whichsterilization is achieved and maintained. The optional reusable drain ceramicfilter and paper filter separators are available for user convenience andperformance data confirms their effectiveness. The cabinet continues to bedeployed into the sterilization chamber with an adjustable transfer cart. Thesterilization parameters and sterility maintenance specifications are identicalto the predicate device.
	The SteriCUBE Systems (both the SteriCUBE MTS225 and MTS300Systems) have demonstrated the ability to:achieve a 10-6 SAL when sterilizing longer and smaller lumen sizedinstruments (rigid instruments containing lumens with an innerdiameter of 0.7mm and an overall length of 500mm as well as lumenswith an inner diameter of 1.0mm and an overall length of 850mm), meet the shorter minimum dry time of 5 minutes, and maintain sterility for 30 days.
PerformanceData	Nonclinical data was generated to ensure the SteriCUBE System continues tomeet the intended use. Sterilization efficacy verification studies wereperformed in accordance with the appropriate requirements of ANSI/AAMIST77:2013 Containment devices for reusable medical device sterilization.
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, SteriCUBE, LLC, concludes that the subjectdevice, the SteriCUBE Systems (SteriCUBE MTS225 and MTS300 Systems)is as safe, as effective and perform as well as the predicate device, theMTS225 and MTS300 Multiple Tray Sterilization Systems (K190541).

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).