SANICLAVE 200

K112811 · Alternative Pioneering Research and Development · FLE · Jan 11, 2012 · General Hospital

Device Facts

• Record ID: K112811
• Device Name: SANICLAVE 200
• Applicant: Alternative Pioneering Research and Development
• Product Code: FLE · General Hospital
• Decision Date: Jan 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

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 Story

Saniclave 200 is a 120V front-loading tabletop steam sterilizer; used in medical/dental clinics and hospitals to sterilize reusable solid instruments. Device operates by boiling water in a pressurized chamber; saturated steam at 121°C kills bacteria on instruments. User places instruments in chamber; initiates cycle; device manages preheat, sterilization, and dry modes via internal tubular heating element. Output is sterile instruments; enables safe reuse of medical equipment. System includes stainless steel chamber, silicone seals, and electronic circuit board for cycle control.

Clinical Evidence

Bench testing only. Physical and biological testing performed in accordance with ANSI/AAMI ST55:2010. Results confirmed the device meets all requirements of the standard for steam sterilization cycles.

Technological Characteristics

120V front-loading steam sterilizer. Materials: stainless steel chamber/door, galvanized steel base, silicone seals/tubing, cast brass/plastic solenoid valve, Incoloy-sheathed nichrome tubular heater. Dimensions: 16"x13.5"x21" (external), 9" diameter x 10.5" deep (internal). Operates via saturated steam at 121°C. Includes circuit board with surface mount electronics for cycle control. Complies with ANSI/AAMI ST55:2010.

Indications for Use

Indicated for sterilization of wrapped and unwrapped heat/moisture stable solid instruments, mated surfaces, knurled and hinged devices in medical/dental clinics and hospitals. Excludes lumened devices and dental hand pieces. Compatible with saturated steam at 121°C for 30 minutes.

Regulatory Classification

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.

Predicate Devices

• B/T (Barnstead/Thermolyne) Sterilemax (K953938)

Submission Summary (Full Text)

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

K112811

## 510(k) Summary

JAN 1 1 2012

| Submitted by: | Revolutionary Science<br>17319 Lake Blvd.<br>Shafer, MN 55074 |
|-----------------|------------------------------------------------------------------------------|
| Contact Person: | Isaac Erickson, Vice President<br>651-373-7806 |
| Date: | 21 November 2011 |
| Device Name: | Saniclave 200 (RS-SC-200) |
| Common Name: | Autoclave |
| Classification: | Steam Sterilizer (21 C.F.R. § 880.6880)<br>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 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.

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.

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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 be<br>used immediately upon<br>sterilization | 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.

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## 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.

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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 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 [phone] or [phone] 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

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Indications for Use

KII 2811

510(k) Number (if known): unknown

Device Name: Saniclave 200

Indications For Use:

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.

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: