(239 days)
No
The description focuses on the physical process of steam sterilization and does not mention any AI/ML components or functionalities.
No.
The device is an autoclave designed to sterilize medical instruments, not to provide therapy to patients.
No
The device is an autoclave, an instrument used for sterilization, not for diagnosing medical conditions. Its function is to kill bacteria on instruments, which is a treatment/preparation function, not a diagnostic one.
No
The device description clearly states it is a 120 volt autoclave, which is a hardware device used for sterilization.
Based on the provided information, the Revolutionary Science Saniclave 102 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to sterilize medical and dental instruments. This is a process performed on equipment, not on biological samples or specimens to diagnose a condition.
- Device Description: The device description clearly states it's an autoclave that uses steam to sterilize instruments. This is a sterilization process, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Saniclave 102's function is entirely focused on sterilizing reusable medical equipment.
N/A
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 |
Product codes
FLE
Device Description
The Saniclave 102 by Revolutionary Science (model number RS-SC-102) is a 120 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Physical and biological testing were performed in accordance with ANSI/AAMI ST55:2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
- 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. - We require an FDA cleared class 5
integrator be used for each cycle.
Class 5 integrators confirm that
pressure, temperature and time were
achieved. - 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 - 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. - We provide a recommended Saniclave
102 Cycle Documentation Table on N-
15 of 014_Proposed Labeling. - We require an FDA cleared class 5
integrator be used for each cycle.
Class 5 integrators confirm that
pressure, temperature and time were
achieved. - 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. | |
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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.
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