Who is the manufacturer of SANICLAVE 102, MODEL RS-SC-102?

Alternative Pioneering Research and Development filed the 510(k) submission for SANICLAVE 102, MODEL RS-SC-102 (K122978).

What is the FDA product code for SANICLAVE 102, MODEL RS-SC-102?

FLE. It is classified under 21 CFR 880.6880 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for SANICLAVE 102, MODEL RS-SC-102?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SANICLAVE 102, MODEL RS-SC-102?

Revolutionary Science Saniclave 200 (K112811).

Who can help prepare an FDA 510(k) submission like SANICLAVE 102, MODEL RS-SC-102?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SANICLAVE 102, MODEL RS-SC-102

K122978 · Alternative Pioneering Research and Development · FLE · May 23, 2013 · General Hospital

Device Facts

Record ID	K122978
Device Name	SANICLAVE 102, MODEL RS-SC-102
Applicant	Alternative Pioneering Research and Development
Product Code	FLE · General Hospital
Decision Date	May 23, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6880
Device Class	Class 2

Intended Use

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 Story

Saniclave 102 is a 120V tabletop gravity displacement steam sterilizer for medical/dental clinics. Device uses a pressurized chamber to boil water, generating saturated steam at 121°C to kill bacteria on unwrapped instruments. Operation involves manual water filling, manual draining, and manual drying of the chamber post-cycle. A microprocessor-based circuit board monitors temperature and cycle time, displaying status on a digital screen. Users must employ an FDA-cleared Class 5 chemical integrator per cycle to confirm sterilization parameters (time, temperature, pressure) were achieved, as the device lacks a pressure transducer and printer. Benefits include effective immediate-use sterilization of solid instruments in clinical settings.

Clinical Evidence

Bench testing only. Physical and biological testing performed in accordance with ANSI/AAMI ST55:2010. Thermal profile testing results were similar to the predicate device.

Technological Characteristics

Gravity displacement steam sterilizer; 8L chamber volume. Materials: 300 series stainless steel chamber/door, injection-molded ABS exterior, silicone seal, galvanized steel base. 1250W tubular heating element. Microprocessor-based control for time/temperature. Dimensions: 14.5" x 13.5" x 12.5". Manual drainage/drying. No pressure transducer. Class II device (Product Code: FLE).

Indications for Use

Indicated for use in medical/dental clinics and hospitals to sterilize unwrapped, heat/moisture-stable solid instruments, mated surfaces, knurled and hinged devices. Excludes lumened devices and dental handpieces. For immediate use sterilization only.

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

Revolutionary Science Saniclave 200 (K112811)

Reference Devices

Prestige 2100 (K962903)
Tuttnauer 1730M (K973550)

Related Devices

K180272 — Saniclave 250 · Revolutionary Science · Jul 26, 2018
K112811 — SANICLAVE 200 · Alternative Pioneering Research and Development · Jan 11, 2012
K111736 — TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES · Tuttnauer Co. , Ltd. · Dec 8, 2011
K021504 — TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 · Tuttnauer U.S.A Co, Ltd. · Jul 25, 2002
K962179 — STAT IM 5000 CASSETTE AUTOCLAVE · Scican · Jan 13, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Revolutionary Science Saniclave 102 510(k) K122978 #### 510(k)Summary # MAY 2 3 2013 | Submitted by: | Revolutionary Science 17319 Lake Blvd. Shafer, MN 55074 | |-----------------|------------------------------------------------------------------------------| | Contact Person: | Isaac Erickson, Vice President 651-353-7806 | | 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: 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. 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 | 1 {1}------------------------------------------------ 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. {2}------------------------------------------------ ## Non-Clinical Testing: Physical and biological testing were performed in accordance with ANSI/AAMI ST55:2010. | Feature | Predicate Device: Revolutionary Science Saniclave200(RS-SC-200) | Revolutionary Science Saniclave102(RS-SC- 102) | Justification | | |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | FDA 510(K) number | K112811 | K122978 | | | | EPA registered component? Y/N | N | N | | | | Labeling/ 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 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. 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 Unwrapped Recommended Use - Instruments intended to be used immediately upon sterilization Maximum load: 4.5 lbs Sterilization Temperature: 121C Sterilization time: 30 Dry time: 0 | | | | Type | Gravity Displacement Steam Sterilizer | Gravity Displacement Steam Sterilizer | | | | Overall Size | 16" (L), 13.5" (W), 21" (H) | 14.5" (L), 13.5" (W), 12.5" (H) | | | | Internal Chamber Size Construction | 9" diameter x 10.5" deep (including door) Draw formed 300 series stainless steel | 9" diameter x 8.25" deep (including door) Draw formed 300 series stainless steel | | | | Door Construction | Draw formed 300 series stainless steel 9" diameter x 2.5" deep | Draw formed 300 series stainless steel 9" 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 the chamber. For this reason a user can clean the inside of the chamber, since the heater is not visible. The predicate has a 500 watt internal heater. The chamber is a little more difficult to clean around this heater. Both heaters are CE approved for safety and serve the same purpose during preheat and sterilizing modes. The thermal profile testing results are similar for both the predicate and subject device. | | | Process Parameters Time Temperature Pressure | 30 minutes 121°C 15psi | 30 minutes 121°C 15psi | | | | Process Monitors: recorders, gauges, printouts | Pressure Gauge: Digital display indicates pressure Temperature Gauge: Digital display indicates current temperature, pressure and cycle time remaining in sterilization mode Printouts: prints process parameters including highest and lowest temperature achieved in sterilization mode (printer is optional) | Temperature: Digital display indicates current temperature (in degrees C) and cycle time remaining in sterilization mode | See below | | | Software/Firmware Controlled | Yes - Integrated chip controls time and temperature. | Yes -Integrated chip controls time and temperature. | | | | Cycle(s) Comparison | wrapped: 121°C for 30 min, plus 30 min dry mode unwrapped: 121°C for 30 min (no dry mode) | Unwrapped only: 121°C for 30 min | | | | Process Equivalent Time (F₀) | Greater than or equal to 30 minutes | Greater than or equal to 30 minutes | | | | Solenoid, plumbing and water exhaust tank. | These parts work in conjunction with each other to automatically drain the used water from the chamber at the end of the cycle. Dry mode is initiated after the chamber water is drained. | These parts are not employed on the subject device. | The reason that these parts are absent in the subject device is because 1. Water must be drained manually. The following statement is found on page N-17 on 014_Proposed Labeling "NEVER reuse water left in the chamber. Re-used water may contain endotoxins. Drain used water from the chamber and refill chamber with clean, distilled water before each cycle." 2. Only unwrapped instruments may be sterilized according to the intended use statement. Unwrapped instruments do not require a dry mode. 3. The FDA cleared Prestige 2100 | | | | | | | | | | | | a means to expel the used water from the chamber. The user must manually drain the water after each cycle. | | | Pressure transducer | The predicate device has a pressure transducer. Pressure is recorded and displayed on the digital display/printout. | The subject device does not employ a pressure transducer. | The reason the pressure transducer is absent is because 1. Pressure is controlled mechanically: The ZPD valve lets cold air release until the temperature is sufficient to build pressure. Then the ZPD seals shut and the pressure builds. The Pressure Relief valve will release excess pressure if chamber pressure is too high (24psi). The temperature probe works in conjunction with the microprocessor to regulate the temperature of the chamber. 2. We require an FDA cleared class 5 integrator be used for each cycle. Class 5 integrators confirm that pressure, temperature and time were achieved. 3. The FDA cleared Prestige 2100 autoclave (K962903) does not contain a pressure transducer or pressure monitoring system. | | | Printer connection or storage device | The predicate has a printer connection in accordance to ST55. Memory for printout will only store one cycle until reset by the user. Only 'CC' or error mode is stored until it is reset by the user at cycle end. | The subject device does not contain a printer connection or printer. It does contain memory storage for one cycle. Only 'CC' or error mode is stored until it is reset by the user at cycle end. | The reason the printer connection is absent is because 1. It does contain memory storage for one cycle. Only 'CC' or error mode is stored until it is reset by the user at cycle end. 2. We provide a recommended Saniclave 102 Cycle Documentation Table on N- 15 of 014_Proposed Labeling. 3. We require an FDA cleared class 5 integrator be used for each cycle. Class 5 integrators confirm that pressure, temperature and time were achieved. 4. The FDA cleared Prestige 2100 autoclave (K962903) and the Tuttnauer 1730M autoclave (K973550) do not contain a printer, printer connection or comprehensive data storage capability. | | . ധ {3}------------------------------------------------ 4 . ・ : : · י , . ・ . : : . {4}------------------------------------------------ ### 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. {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. ## 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 {6}------------------------------------------------ ## 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 {7}------------------------------------------------ Indications for Use 510(k) Number (if known): K122978 Device Name: Saniclave 102 Indications For Use: 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. 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 | 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

SANICLAVE 102, MODEL RS-SC-102

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

SANICLAVE 102, MODEL RS-SC-102

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!