SANICLAVE 200 by ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT

The Revolutionary Science Saniclave 200 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 and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.

Device Description

The Saniclave 200 by Revolutionary Science (model number RS-SC-200) 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 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.

AI/ML Overview

Here's an analysis of the Revolutionary Science Saniclave 200 (RS-SC-200) based on the provided 510(k) summary, structured to address your specific points:

Since the device is a steam sterilizer (autoclave), the "acceptance criteria" and "device performance" are typically defined by demonstrating that the device effectively sterilizes according to established standards. The study mentioned is the validation testing against these standards.

Revolutionary Science Saniclave 200 (RS-SC-200) Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ANSI/AAMI ST55:2010)	Reported Device Performance (Saniclave 200)
Meets all requirements of ANSI/AAMI ST55:2010 for steam sterilization.	Testing showed that Saniclave 200 meets all requirements of this standard.
Specific Performance Parameters (for Recommended Use):
Sterilization Temperature: 121°C	Operates at 121°C for sterilization (for both wrapped and unwrapped).
Sterilization Time: 30 minutes	Operates for 30 minutes for sterilization (for both wrapped and unwrapped).
Ability to sterilize wrapped instruments (up to 4.5 lbs)	Validated for wrapped instruments (single pouching) up to 4.5 lbs.
Ability to sterilize unwrapped instruments (up to 4.5 lbs)	Validated for unwrapped instruments up to 4.5 lbs.
Effective sterilization of heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces).	Intended to sterilize these types of instruments. (Implicitly met by standard compliance.)

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

Sample Size for Test Set: The document does not specify the exact sample size (e.g., number of cycles, number of biological indicators, number of devices) used for the physical and biological testing. It only states that "physical and biological testing were performed."
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would be prospective and conducted by Revolutionary Science or a contracted testing facility.

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

For a steam sterilizer, "ground truth" related to sterilization efficacy is objectively established through physical measurements (temperature, pressure, time) and biological indicator (BI) kill-rates, which demonstrate the elimination of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores). This doesn't typically involve human expert consensus in the same way an AI diagnostic tool would.

Number of Experts: Not applicable in the context of expert consensus for ground truth. Testing is performed under controlled laboratory conditions, often overseen by engineers and microbiologists.
Qualifications of Experts: Not specified, but implied to be qualified personnel experienced in medical device sterilization validation according to ANSI/AAMI ST55.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Sterilization efficacy is assessed against pre-defined, objective chemical and biological indicators, not through human consensus or adjudication of subjective interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (AI vs. Without AI Assistance)

MRMC Comparative Effectiveness Study: No. This type of study is relevant for AI-powered diagnostic or interpretive tools that assist human readers (e.g., radiologists interpreting images). A steam sterilizer does not involve human "readers" or "AI assistance" in its direct function of sterilizing instruments.

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

Standalone Performance: Not applicable in the context of an algorithm. The device itself (the Saniclave 200) is a standalone physical product that performs sterilization. Its performance is evaluated based on its ability to meet the established physical and biological parameters for sterilization, independent of human intervention during the cycle.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for sterilization efficacy is established through:
- Physical Monitoring: Verification that physical parameters (temperature, pressure, time) achieve the specified sterilization conditions within the chamber.
- Biological Indicators (BIs): Use of biological indicators containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to confirm that all test microorganisms are destroyed, indicating a high probability of sterility. This represents a robust, objective measure of sterilization effectiveness.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The Saniclave 200 is a physical device, not an AI algorithm that undergoes "training" on a dataset. Its design and operational parameters are based on established scientific principles of steam sterilization, not machine learning from a training set.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the context of this device. The scientific and engineering principles of saturated steam sterilization (killing bacteria at 121°C for 30 minutes) are the foundational "ground truth" for the device's design, derived from decades of scientific research and validated standards like ANSI/AAMI ST55. The device is designed to execute these established principles to achieve sterility.

Summary

{0}------------------------------------------------

ﺒــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Revolutionary Science Saniclave 200 (RS-SC-200) 510(k)

K112811

510(k) Summary

JAN 1 1 2012

Submitted by:	Revolutionary Science17319 Lake Blvd.Shafer, MN 55074
Contact Person:	Isaac Erickson, Vice President651-373-7806
Date:	21 November 2011
Device Name:	Saniclave 200 (RS-SC-200)
Common Name:	Autoclave
Classification:	Steam Sterilizer (21 C.F.R. § 880.6880)Class II Device Product Code: FLE

Predicate Device: The Revolutionary Science Saniclave 200 (RS-SC-200) is claimed to be substantially equivalent to the FDA cleared B/T (Barnstead/Thermolyne) "Sterilemax" under the 510(k) number K953938.

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

Intended Use:

The Saniclave 200 by Revolutionary Science (model number RS-SC-200) is a Device Description: 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 121 degrees Celsius kills bacteria.

{1}------------------------------------------------

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: 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 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

Cycle Parameters:

	Recommended Use	Maximum Load	Sterilization Temperature	Sterilization Time	Dry Time
Wrapped	Instruments in pouches*	4.5 lbs	121°C	30	30
Unwrapped	Instruments intended to beused immediately uponsterilization	4.5 lbs	121°C	30	0

*Note-- This sterilizer has not been validated for double pouching.

Non-Clinical Testing:

Physical and biological testing were performed in accordance with ANSI/AAMI ST55:2010. Testing showed that Saniclave 200 meets all requirements of this standard.

Conclusion:

Revolutionary Science finds that the Saniclave 200 (RS-SC-200) is substantially equivalent to the legally marketed B/T (Barnstead/Thermolyne) "Sterilemax" cleared under the 510(k) number K953938.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and healing.

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

Alternative Pioneering Research and Development C/O Mr. Isaac Erickson Vice President Revolutionary Science 17319 Lake Boulevard Shafer, Minnesota 55074

JAN 1 1 2012

Re: K112811

Trade/Device Name: Saniclave 200 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 21, 2011 Received: December 22, 2011

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.

{3}------------------------------------------------

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Anthony D. wester

Inthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

KII 2811

510(k) Number (if known): unknown

Device Name: Saniclave 200

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use x_____x__ AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (QDE)

Elliott F. Lawrence-Willis

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

E-I 112811 510(k) Number:

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).