The Revolutionary Science Saniclave 102 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize unwrapped heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes. Unwrapped instruments that were sterilized should be used immediately after sterilization is completed (immediate use sterilization). The chamber must be manually drained and wiped dry after each cycle.

Device Description

The Saniclave 102 by Revolutionary Science (model number RS-SC-102) is a 120 volt autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121 degrees Celsius kills bacteria.

AI/ML Overview

The Revolutionary Science Saniclave 102 is a steam sterilizer (autoclave) intended for use in medical and dental clinics, hospitals, and other facilities for sterilizing unwrapped heat and moisture-stable solid instruments.

Here's an analysis of its acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of quantitative measures like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "acceptance criteria" are implied through substantial equivalence to a predicate device and adherence to industry standards for sterilizers.

The core performance requirement for a sterilizer is to achieve sterilization. This is demonstrated by meeting specific thermal and time parameters.

Feature	Acceptance Criteria (Implied / Predicate Device)	Reported Device Performance (Saniclave 102)
Sterilization Temperature	121°C	121°C
Sterilization Time	30 minutes	30 minutes
Pressure	15 psi	15 psi (controlled mechanically via ZPD valve and pressure relief valve)
Process Equivalent Time (F₀)	Greater than or equal to 30 minutes	Greater than or equal to 30 minutes
Sterilization Efficacy	Achieve sterilization	Demonstrated by physical and biological testing in accordance with ANSI/AAMI ST55:2010
Intended Use Compatibility	Steam sterilizer for unwrapped instruments	Steam sterilizer for unwrapped instruments

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

The document states that "Physical and biological testing were performed in accordance with ANSI/AAMI ST55:2010." However, it does not specify the sample size used for these tests (e.g., number of cycles, number of biological indicators).

The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Revolutionary Science, the manufacturer, in support of their 510(k) submission to the FDA (USA). The nature of the testing is prospective, as it's an evaluation of the device's performance against a standard.

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

This is not applicable in the context of device sterilization testing. The "ground truth" for a sterilizer's performance isn't established by human experts in the same way as, for example, image interpretation.

Instead, the ground truth for sterilization efficacy is established by:

Physical measurements: Verifying that temperature, time, and pressure parameters are met throughout the cycle.
Biological indicators: Using standardized biological indicators (e.g., spore strips) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to confirm spore inactivation. A successful test (ground truth) is no growth of microorganisms after incubation.

The study refers to using "Class 5 integrators" which "confirm that pressure, temperature and time were achieved," and implies their use for each cycle. These integrators serve as a chemical indication of whether the critical sterilization parameters were met, further supporting the "ground truth" that sterilization conditions were achieved.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1 consensus) are typically used for subjective assessments, such as expert review of medical images or clinical outcomes. This is not applicable to the objective physical and biological testing of a sterilizer. The results of biological indicator tests (growth/no growth) and physical parameter measurements are objective.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not applicable to this device. MRMC studies are used to evaluate the diagnostic accuracy of AI systems in combination with human readers, typically for image interpretation tasks. The Saniclave 102 is a physical sterilization device, not a diagnostic tool that involves human interpretation of output.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

While the device incorporates a microprocessor-based circuit board (software/firmware controlled), a "standalone performance" study in the context of AI algorithms is not applicable. The device's function is automated sterilization. The non-clinical testing performed (physical and biological testing per ANSI/AAMI ST55:2010) inherently assesses the "standalone" performance of the device and its control system in achieving sterilization parameters. There is no human "in the loop" required beyond operating the device.

7. Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on:

Objective Physical Parameters: Confirmation that the specified sterilization temperature (121°C), time (30 minutes), and pressure (15 psi) are consistently achieved and maintained within the chamber during the sterilization cycle.
Biological Inactivation (Biological Indicators): Absence of growth from highly resistant bacterial spores after exposure to the sterilization cycle and subsequent incubation.
Chemical Integration (Class 5 Integrators): Confirmation by Class 5 chemical integrators that all critical parameters (time, temperature, and steam) for sterilization have been met.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. The Saniclave 102 is a physical device, not an AI model that learns from data. Its operational parameters (time, temperature, pressure) are pre-programmed and fixed, not learned from a training dataset.

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

As there is no "training set" in the context of this physical device, this question is not applicable.

Summary

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Revolutionary Science Saniclave 102 510(k) K122978

510(k)Summary

MAY 2 3 2013

Submitted by:	Revolutionary Science17319 Lake Blvd.Shafer, MN 55074
Contact Person:	Isaac Erickson, Vice President651-353-7806
Date:	September, 24th, 2012
Device Name:	Saniclave 102
Common Name:	Autoclave
Classification:	Steam Sterilizer (21 C.F.R. § 880.6880)Class II Device Product Code: FLE

Predicate Device: Revolutionary Science claims substantial equivalence to the FDA cleared Revolutionary Science Saniclave 200 device cleared under the 510(k) number K112811.

Technical Characteristics, Intended use and cycle parameters are all similar to the predicate device.

Intended Use:

Indications For Use:

Outside dimensions: 14.5" (L), 13.5" (W), 12.5" (H)

Internal chamber dimensions (including door): 9" diameter x 8.25" deep Chamber volume: 8 liters

Cycle Parameters

	Recommended Use	MaximumLoad	SterilizationTemperature	SterilizationTime	Dry Time
Unwrapped	Instrumentsintended to be usedimmediately uponsterilization	4.5 lbs	121°C	30	0

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Device Description: The Saniclave 102 by Revolutionary Science (model number RS-SC-102) is a i 20 volt autoclave.

Explanation of how the device functions: The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside.

Scientific concepts that form the basis for the device: The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121degrees Celsius kills bacteria.

Significant physical performance characteristics:

Device design:

Material used: The following materials were used in the Construction of the Saniclave:

	Chamber (including door):	Drawformed 300 series stainless steel
Exterior enclosure:	Injection molded ABS
Base plate:	Galvanized steel
Seal:	Injection molded silicone
Heater:	Tubular heating element
Microprocessor based circuit board

Basic physical properties: The single heating element

(affixed to the bottom of the chamber) generates all heat for the autoclave, including preheat and sterilization. When the cycle is initiated the heater turns on and boils the water.

Outside dimensions: 14.5" (L), 13.5" (W), 12.5" (H) Internal chamber dimensions (including door): 9" diameter x 8.25" deep Chamber volume: 8 liters

Cycle Parameters:

Recommended Use	Maximum Load	Sterilization Temperature	Sterilization Time	Dry Time
Unwrapped Instruments intended to be used immediately upon sterilization	4.5 lbs	121°C	30	0

Note-- This sterilizer has not been validated for wrapped instruments.

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Non-Clinical Testing:

Physical and biological testing were performed in accordance with ANSI/AAMI ST55:2010.

Feature	Predicate Device:Revolutionary ScienceSaniclave200(RS-SC-200)	Revolutionary ScienceSaniclave102(RS-SC-102)	Justification
FDA 510(K) number	K112811	K122978
EPA registeredcomponent? Y/N	N	N
Labeling/ Intended Use	The Revolutionary ScienceSaniclave 200 is designed to beused in medical and dentalclinics, hospitals and otherfacilities where reusable sterileequipment is used. It is intendedto sterilize wrapped andunwrapped heat and moisturestable solid instruments, matedsurfaces, knurled and hingeddevices (excluding lumeneddevices and dental hand pieces)that are compatible withsaturated steam sterilization at121 degrees Celsius for 30minutes.	The Revolutionary ScienceSaniclave 102 is designed to beused in medical and dentalclinics, hospitals and otherfacilities where reusable sterileequipment is used. It isintended to sterilize unwrappedheat and moisture stable solidinstruments, mated surfaces,knurled and hinged devices(excluding lumened devicesand dental hand pieces) that arecompatible with saturatedsteam sterilization at 121degrees Celsius for 30 minutes.Unwrapped instruments thatwere sterilized should be usedimmediately after sterilization iscompleted (immediate usesterilization). The chambermust be manually drained andwiped dry after each cycle.Outside dimensions: 14.5" (L),13.5" (W), 12.5" (H)Internal chamber dimensions(including door): 9" diameter x8.25" deepChamber volume: 8 litersCycle ParametersUnwrappedRecommended Use -Instruments intended to beused immediately uponsterilizationMaximum load: 4.5 lbsSterilization Temperature:121CSterilization time: 30Dry time: 0
Type	Gravity Displacement SteamSterilizer	Gravity Displacement SteamSterilizer
Overall Size	16" (L), 13.5" (W), 21" (H)	14.5" (L), 13.5" (W), 12.5" (H)
Internal Chamber SizeConstruction	9" diameter x 10.5" deep (includingdoor)Draw formed 300 series stainlesssteel	9" diameter x 8.25" deep(including door)Draw formed 300 series stainlesssteel
Door Construction	Draw formed 300 series stainlesssteel9" diameter x 2.5" deep	Draw formed 300 series stainlesssteel9" diameter x 0.25" deep
Tray Size	8.6"x 8.2"	8" diameter (round)
Construction	Stainless Steel	Stainless steel
Heater	500 Watt	1250 Watt	The 1250 heater is on the underside of thechamber. For this reason a user can clean theinside of the chamber, since the heater is notvisible. The predicate has a 500 watt internalheater. The chamber is a little more difficult toclean around this heater.Both heaters are CE approved for safety and servethe same purpose during preheat and sterilizingmodes. The thermal profile testing results aresimilar for both the predicate and subject device.
Process ParametersTimeTemperaturePressure	30 minutes121°C15psi	30 minutes121°C15psi
Process Monitors:recorders, gauges,printouts	Pressure Gauge:Digital display indicates pressureTemperature Gauge:Digital display indicates currenttemperature, pressure and cycletime remaining in sterilizationmodePrintouts: prints process parametersincluding highest and lowesttemperature achieved insterilization mode (printer isoptional)	Temperature:Digital display indicates currenttemperature (in degrees C) andcycle time remaining insterilization mode	See below
Software/FirmwareControlled	Yes - Integrated chip controls timeand temperature.	Yes -Integrated chip controls timeand temperature.
Cycle(s) Comparison	wrapped: 121°C for 30 min, plus30 min dry modeunwrapped: 121°C for 30 min (nodry mode)	Unwrapped only: 121°C for 30min
Process Equivalent Time(F₀)	Greater than or equal to 30 minutes	Greater than or equal to 30 minutes
Solenoid, plumbing andwater exhaust tank.	These parts work in conjunctionwith each other to automaticallydrain the used water from thechamber at the end of the cycle.Dry mode is initiated after thechamber water is drained.	These parts are not employed onthe subject device.	The reason that these parts are absent in thesubject device is because1.Water must be drained manually. Thefollowing statement is found on pageN-17 on 014_Proposed Labeling"NEVER reuse water left in thechamber. Re-used water may containendotoxins. Drain used water from thechamber and refill chamber withclean, distilled water before eachcycle."2.Only unwrapped instruments may besterilized according to the intendeduse statement. Unwrappedinstruments do not require a dry mode.3. The FDA cleared Prestige 2100

			a means to expel the used water fromthe chamber. The user must manuallydrain the water after each cycle.
Pressure transducer	The predicate device has a pressuretransducer. Pressure is recordedand displayed on the digitaldisplay/printout.	The subject device does notemploy a pressure transducer.	The reason the pressure transducer is absent isbecause1. Pressure is controlled mechanically:The ZPD valve lets cold air releaseuntil the temperature is sufficient tobuild pressure. Then the ZPD sealsshut and the pressure builds. ThePressure Relief valve will releaseexcess pressure if chamber pressure istoo high (24psi). The temperatureprobe works in conjunction with themicroprocessor to regulate thetemperature of the chamber.2. We require an FDA cleared class 5integrator be used for each cycle.Class 5 integrators confirm thatpressure, temperature and time wereachieved.3. The FDA cleared Prestige 2100autoclave (K962903) does not containa pressure transducer or pressuremonitoring system.
Printer connection orstorage device	The predicate has a printerconnection in accordance to ST55.Memory for printout will only storeone cycle until reset by the user.Only 'CC' or error mode is storeduntil it is reset by the user at cycleend.	The subject device does not containa printer connection or printer. Itdoes contain memory storage forone cycle. Only 'CC' or error modeis stored until it is reset by the userat cycle end.	The reason the printer connection is absent isbecause1. It does contain memory storage forone cycle. Only 'CC' or error mode isstored until it is reset by the user atcycle end.2. We provide a recommended Saniclave102 Cycle Documentation Table on N-15 of 014_Proposed Labeling.3. We require an FDA cleared class 5integrator be used for each cycle.Class 5 integrators confirm thatpressure, temperature and time wereachieved.4. The FDA cleared Prestige 2100autoclave (K962903) and theTuttnauer 1730M autoclave(K973550) do not contain a printer,printer connection or comprehensivedata storage capability.

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Conclusion:

Based on a comparison of technologies, indications for use, and process parameters Revolutionary Science finds that the Saniclave 102 (RS-SC-102) is substantially equivalent to the legally marketed Revolutionary Science Saniclave 200 device cleared under the 510(k) number K112811.

Revolutionary Science claims that the subject device is substantial equivalence to the FDA cleared Revolutionary Science Saniclave 200 device cleared under the 510(k) number K112811.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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May 23, 2013

Alternative Pioneering Research and Development, Inc. Mr. Isaac Erickson Vice President Revolutionary Science Division 17319 Lake Boulevard SHAFER MN 55074

Re: K122978

Trade/Device Name: Saniclave 102 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 8, 2013 Received: May 14, 2013

Dear Mr. Erickson:

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, 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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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Page 2 -- Mr. Erickson

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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Image /page/6/Picture/8 description: The image contains a logo or signature on the left side, which appears to be stylized and possibly handwritten. To the right of the logo, there is some text that reads "Tejashri", "Clinical D", and "DAGRID". The text is aligned vertically, with "Tejashri" at the top and "DAGRID" at the bottom.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

FOR

Anthony D. Watson, B.S., M.S., M.B.A. 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): K122978

Device Name: Saniclave 102

Indications For Use:

Outside dimensions: 14.5" (L), 13.5" (W), 12.5" (H)

Internal chamber dimensions (including door): 9" diameter x 8.25" deep Chamber volume: 8 liters

Cycle Parameters

Recommended Use	Maximum Load	Sterilization Temperature	Sterilization Time	Dry Time
UnwrappedInstrumentsintended to beusedimmediatelyuponsterilization	4.5 lbs	121°C	30	0

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x x =' (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Elizabeth F. Claverie Concurrence of CDRH, Office of Device Evaluation (ODE 2013.05.22 17:36:41 -04'00'

E-I

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number K122

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).