The Revolutionary Science Saniclave 250 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 wrapped heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.

Device Description

The Saniclave 250 by Revolutionary Science (model number RS-SC-250) is a 120 volt front loading 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 121degrees Celsius kills bacteria.

AI/ML Overview

The provided text describes the Saniclave 250, a steam sterilizer, and its comparison to a predicate device for 510(k) clearance. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Objective)	Reported Device Performance (Saniclave 250)
Sterility Assurance Level (SAL): 10⁻⁶	Achieved 10⁻⁶ SAL for all tested cycles and loads.
Sterilization Temperature for all cycles	121°C
Sterilization Time for all cycles	30 minutes
Dry Time (Gravity, small load, wrapped)	30 minutes
Dry Time (Gravity, small load, unwrapped)	N/A
Dry Time (Gravity, large load, unwrapped)	N/A
Maximum Load (Gravity, small load, wrapped)	1 tray, 4.5 lbs
Maximum Load (Gravity, small load, unwrapped)	1 tray, 4.5 lbs
Maximum Load (Gravity, large load, unwrapped)	3 trays, 8.0 lbs
Compatibility with Instruments	Heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens > 3mm ID and < 70mm length, excluding dental handpieces).
Temperature and Pressure inside chamber	Within operating parameters (121°C for 30 min, 15 psi).
Electromagnetic Compatibility (EMC)	Compliance to EN 60601-1-2
Electrical Safety	Compliance to EN 60601-1-1, EN 60601-1, EN 61010-2-040, EN 61010-1
Compliance to Sterilizer Standard	ANSI/AAMI ST55:2016

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

Sample Size: The document does not specify a numerical sample size for the biological indicators or instruments used in the sterilization efficacy tests. It mentions "a loaded test" and "a separate test" with "the inoculum tested." For physical testing, it indicates "Five precalibrated temperature sensors" and "One precalibrated pressure transducer."
Data Provenance: The document does not explicitly state the country of origin of the data. The tests were performed in accordance with ANSI/AAMI ST55:2016 and EN standards, suggesting international applicability. The studies appear to be prospective as they were conducted as part of the device's validation.

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

The document does not mention the use of human experts to establish ground truth for the sterilization efficacy tests. The "ground truth" for these tests is based on the biological indicator's (G. Bacillus Stearothermophilus) growth or lack thereof, which is a direct, objective measure of sterility.

4. Adjudication Method for the Test Set:

Not applicable. The primary method for determining sterilization efficacy relies on biological indicators, which provide an objective "growth/no growth" result. There is no mention of a subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a sterilizer, and its performance is evaluated through physical and biological efficacy tests, not human interpretation of medical images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

This device is a physical steam sterilizer, not an AI algorithm. Its performance is inherently "standalone" in the sense that its sterilization process operates independently once initiated. The testing described (physical and biological) evaluates the device's inherent capability to sterilize without human intervention affecting the outcome of the sterilization cycle itself.

7. The Type of Ground Truth Used:

The primary ground truth used for sterilization efficacy was biological indicators (G. Bacillus Stearothermophilus in an artificial soil), which provides objective evidence of microbial kill (or lack thereof).
For physical parameters (temperature and pressure), the ground truth was established by precalibrated sensors and transducers, providing objective measurements against predefined operating parameters.

8. The Sample Size for the Training Set:

Not applicable. The Saniclave 250 is a physical device, a steam sterilizer, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development.

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

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alternative Pioneering Research and Development Revolutionary Science Isaac Erickson Chief Technology Officer 17319 Lake Blvd Shafer, Minnesota 55074

Re: K180272

Trade/Device Name: Saniclave 250 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: June 22, 2018 Received: June 29, 2018

Dear Isaac 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.

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180272

Device Name

Saniclave 250

Indications for Use (Describe)

Cycle	SterilizationTemperature	SterilizeTime	DryTime	Recommended Load
Gravity,small load,wrapped*	121°C	30minutes	30minutes	1 tray, wrapped* instruments, maximum weight 4.5 lbsHeat and moisture stable solid instruments, mated surfaces,knurled, hinged devices, including lumened devices and trocars
Gravity,small load,unwrapped*	121°C	30minutes	N/A	1 tray, unwrapped* instruments, maximum weight 4.5 lbsHeat and moisture stable solid instruments, mated surfaces,knurled, hinged devices, including lumened devices and trocars
Gravity,large load,unwrapped*	121°C	30minutes	N/A	3 trays, unwrapped* loaded evenly, maximum weight 8.0 lbsHeat and moisture stable solid instruments, lumened devices andtrocars only

The Saniclave 250 has 3 factory-programmed cycles:

A wrapped load is wrapped or pouched in autoclave packaging that is FDA cleared for 30 min at 121°C. An unwrapped load is not wrapped or pouched and is intended for immediate use.

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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Revolutionary Science Saniclave 250 (RS-SC-250) 510(k): K180272 510(k) Summary

Submitted by:	Alternative Pioneering Research and DevelopmentRevolutionary Science17319 Lake Blvd.Shafer, MN 55074
Contact Person:	Isaac Erickson, Chief Technology Officer651-353-7806
Date:	23 July 2018
Device Name:	Saniclave 250 (RS-SC-250)
Model Number:	RS-SC-250
Common Name:	Steam Sterilizer
Classification:	Steam Sterilizer (21 C.F.R. § 880.6880)Class II Device Product Code: FLE

Predicate Device: The Revolutionary Science Saniclave 250 (RS-SC-250) is claimed to be substantially equivalent to the FDA cleared Saniclave 200 under the 510(k) number K112811.

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

Intended Use:

The Revolutionary Science Saniclave 250 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 wrapped and unwrapped heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.

The Saniclave 250 has 3 factory-programmed cycles:

Cycle	SterilizationTemperature	Sterilize Time	Dry Time	Recommended Load
Gravity,small load,wrapped*	121°C	30minutes	30minutes	1 tray, wrapped* instruments, maximum weight 4.5 lbsHeat and moisture stable solid instruments, mated surfaces, knurled,hinged devices, including lumened devices and trocars
Gravity,small load,unwrapped*	121°C	30minutes	N/A	1 tray, unwrapped* instruments, maximum weight 4.5 lbsHeat and moisture stable solid instruments, mated surfaces, knurled,hinged devices, including lumened devices and trocars
Gravity,large load,unwrapped*	121°C	30minutes	N/A	3 trays, unwrapped* loaded evenly, maximum weight 8.0 lbsHeat and moisture stable solid instruments, lumened devices andtrocars only

*A wrapped load is wrapped or pouched in autoclave packaging that is FDA cleared for 30 min at 121°C. An unwrapped

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load is not wrapped or pouched and is intended for immediate use.

Device Description: The Saniclave 250 by Revolutionary Science (model number RS-SC-250) is a 120 volt front loading 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): Draw formed stainless steel Exterior enclosure: ABS thermoformed plastic Base plate: Galvanized steel Seal: Injection molded silicone Plumbing: extruded silicone tubing Solenoid valve: Cast brass and plastic Heater: Tubular heating element, nichrome wire and Incoloy sheathe. Circuit board with surface mount electronics This device has no direct or indirect patient contact.

Basic physical properties: The single heating element (permantently affixed to the bottom inside the chamber with bulkhead fittings) generates all heat for the autoclave, including preheat, sterilization and dry modes. It is immersed in the water of the chamber. When the cycle is initiated, the heater turns on and boils the water.

Outside dimensions: 16"x13.5"x21" Internal chamber dimensions (including door): 9" diameter x 10.5" deep

Comparison to Predicate Device:

The Saniclave 250 employs the same materials in construction as the Saniclave 200. It has the same factoryprogrammed cycle parameters. The only two significant differences between these two machines are: 1. A large unwrapped cycle has been added to accommodate 3 trays and 8lbs of trocars, lumened devices and solid instruments evenly distributed among the trays. This cycle is initiated with the same button as the smaller 4.5 Ibs unwrapped cycle but has been tested with the larger load. 2. Lumened devices of 3mm inner and 70mm in length are claimed in the indications for use.

These differences do not raise new questions for safety or effectiveness. The additional weight and trocars were tested and support a 10 6 SAL for the full sterilization cycle following the gravity steam sterilization half-cycle of 121 degrees C for 15 minutes.

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Technological Characteristics Comparison Table

Description	K112811200 Saniclave	K180272250 Saniclave	Comparison
Indications for Use	The Revolutionary ScienceSaniclave 200 is designed to beused in medical and dental clinics,hospitals and other facilities wherereusable sterile equipment is used.It is intended to sterilize wrappedand unwrapped heat and moisturestable solid instruments, matedsurfaces, knurled, hinged devices,(excluding lumened devices anddental handpieces) that arecompatible with saturated steamsterilization at 121 degrees Celsiusfor 30 minutes.	The Revolutionary ScienceSaniclave 250 is designed to beused in medical and dental clinics,hospitals and other facilities wherereusable sterile equipment is used.It is intended to sterilize wrappedand unwrapped heat and moisturestable solid instruments, matedsurfaces, knurled, hinged devices,including lumened devices andtrocars (lumens greater than 3mminner diameter and less than 70mmin length, excluding dentalhandpieces) that are compatiblewith saturated steam sterilizationat 121 degrees Celsius for 30minutes.	Similar
Chamber Size	9" diameter x 10.5" deep(including door)	9" diameter x 10.5" deep(including door)	Same
Sterilization cycles	Gravity, small load, wrapped: 121°Cfor 30 minutes with 30 minutes ofdry time. 1 tray, wrappedinstruments, maximum weight 4.5lbs: Heat and moisture stable solidinstruments, mated surfaces,knurled, hinged devices, excludinglumened devices and dental handpieces.Gravity, small load, unwrapped:121°C for 30 minutes with no drytime. 1 tray, unwrappedinstruments, maximum weight 4.5lbs: Heat and moisture stable solidinstruments, mated surfaces,knurled, hinged devices, excludinglumened devices and dental handpieces.	Gravity, small load, wrapped: 121°Cfor 30 minutes with 30 minutes ofdry time. 1 tray, wrappedinstruments, maximum weight 4.5lbs: Heat and moisture stable solidinstruments, mated surfaces,knurled, hinged devices, includinglumened devices and trocarsGravity, small load, unwrapped:121°C for 30 minutes with no drytime. 1 tray, unwrappedinstruments, maximum weight 4.5lbs: Heat and moisture stable solidinstruments, mated surfaces,knurled, hinged devices, includinglumened devices and trocarsGravity, large load, unwrapped:121°C for 30 minutes with no drytime. 3 trays, unwrapped loadedevenly, maximum weight 8.0 lbs:Heat and moisture stable solidinstruments, lumened devices andtrocars only	Different
Materials used in thesterilizer	Chamber (including door): Drawformed stainless steel (316 grade)Exterior enclosure: ABSthermoformed plastic	Chamber (including door): Drawformed stainless steel (316 grade)Exterior enclosure: ABSthermoformed plastic	Same
	Base plate: Galvanized steelSeal: Injection molded siliconePlumbing: extruded siliconetubingSolenoid valve: Cast brass andplasticHeater: Tubular heating element,nichrome wire and Incoloysheathe.Circuit board with surface mountelectronics	Base plate: Galvanized steelSeal: Injection molded siliconePlumbing: extruded siliconetubingSolenoid valve: Cast brass andplasticHeater: Tubular heating element,nichrome wire and Incoloysheathe.Circuit board with surface mountelectronics
Built according to standard	ANSI/AAMI ST55	ANSI/AAMI ST55	Same
Physical Testing	Parametric testing of temperature(121 ℃ for 30 min) and pressure(15 psi)	Parametric testing of temperature(121 ℃ for 30 min) and pressure(15 psi)	Same
Biological Testing	Sterilization validation with worstcase load	Sterilization validation with worstcase load, including lumeneddevices	Similar
Sterility Assurance Level	10-6	10-6	Same
Biocompatibility	No patient contacting components	No patient contacting components	Same
EMC and Electrical Safety	EMC and Electrical SafetyCompliance to EN 61010-2-040,EN 61010-1, EN 60601-1-2, EN60601-1-1, EN 60601-1	EMC and Electrical SafetyCompliance to EN 61010-2-040,EN 61010-1, EN 60601-1-2, EN60601-1-1, EN 60601-1	Same
Electrically generatedsteam	Yes	Yes	Same
Multiple Safety features	Yes	Yes	Same
Spring loaded safetyrelease valve	Yes	Yes	Same
Digital display	Yes	Yes	Same
Optional printer	Yes	Yes	Same
Plastic enclosure	Yes	Yes	Same
120 VAC input	Yes	Yes	Same

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Substantial Equivalence of the new claims are discussed below.

Non-Clinical Testing:

Physical and biological testing were performed in accordance with ANSVAAMI ST55:2016. Testing showed that Saniclave 250 meets all applicable requirements of this standard. Physical testing measured pressure and temperature inside the chamber in an empty and fully loaded state. Five precalibrated temperature sensors were placed inside the chamber measuring temperature in the front, back, upper, lower, and middle of the chamber so as to provide a good understanding of the temperature distribution in the chamber. One precalibrated pressure

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transducer was used to monitor pressure. Temperature and pressure was found to be within operating parameters. A loaded test with one tray and 4.5 lbs was performed with instruments (including hinged and knurled devices but not lumens) and inoculated with G. Bacillus Stearothermophilus in an artificial soil so as to present the greatest challenge to sterilization. A cycle was run and the inoculum tested. No growth was observed.

A separate test was also performed with the additional trocars (with lumens measuring 3mm inner diameter and 70mm in length) using 3 trays and 8.0 lbs inoculated with G. Bacillus Stearothermophilus in an artificial soil so as to present the greatest challenge to sterilization. A cycle was run and the inoculum tested. No growth was observed.

Electromagnetic Compatibility (EMC) and Safety Compliance: The Saniclave 250 was tested to the following standards.

EMC:	EN 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERALREQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD:ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
Safety:	EN 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERALREQUIREMENTS FOR SAFETY 1: COLLATERAL STANDARD:SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
	EN 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERALREQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
	EN 61010-2-040 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENTFOR MEASUREMENT, CONTROL AND LABORATORY USE – PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS
	EN 61010-1 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT,CONTROL, AND LABORATORY USE. GENERAL REQUIREMENTS

Clinical Data:

No clinical data was needed for this device. This device has no direct patient contact.

Conclusion:

Based on a comparison of technologies, indications for use, and process parameters the Saniclave 250 (RS-SC-250) is as safe, as effective, and performs as well or better than the legally marketed predicate device, Saniclave 200 (RS-SC-200), cleared under 510k number K112811.

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).