(518 days)
Not Found
No
The description mentions a microprocessor and software controlling pre-programmed and user-definable cycles based on fixed parameters (temperature, time, pressure). There is no mention of AI or ML capabilities for learning, adapting, or making decisions beyond these pre-set or user-defined parameters.
No.
This device is an autoclave, which is used for sterilization of instruments and materials, not for direct therapeutic treatment of patients.
No
The device is a sterilizer, not a diagnostic device. Its purpose is to sterilize instruments and materials, as explicitly stated in the "Intended Use / Indications for Use" section and throughout the "Device Description".
No
The device description clearly states it is a table-top steam sterilizer with physical components like a vacuum pump, water reservoir, heat source, and sealed chamber. While it uses a microprocessor and software to control parameters, it is fundamentally a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the sterilization of instruments and materials used in medical, dental, and laboratory settings. Sterilization is a process applied to objects, not to biological samples for diagnostic purposes.
- Device Description: The description details a steam sterilizer (autoclave) with components like a vacuum pump, water reservoir, heat source, and sealed chamber. These are typical components of a sterilization device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Reagents or assays.
The device's purpose is to render instruments and materials sterile, which is a crucial step in preventing the spread of infection in healthcare and laboratory environments. This is a different function than an in vitro diagnostic device, which is used to perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
Tuttnauer electronic controlled pre-vacuum autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 5 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); liquids (121°C at 30 minutes and 16 psi); Bowie Dick test program (134°C at 3.5 minutes and 29 psi); and a free program with adjustable sterilization times and temperatures. With the exception of the free program, all of these cycles are pre-programmed, requiring no user input. The free program allows the user to select their own sterilization parameters, however, the operations manual warns that sterilization has not been validated for user selected settings, and cautions the user that they must validate sterilization.
These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Tuttnauer Model EPV series autoclave is a table-top steam sterilizer that includes as its main components a vacuum pump, water reservoir, heat source and sealed chamber. As with the predicate device, the EPV has three pre-programmed sterilization cycles, one user definable cycle and a Bowie-Dick test cycle. The three pre-programmed cycles are for unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes).
The Model EPV autoclave is produced in two sizes, the 2340EPV with a chamber size of 9" x 18.5" and the 2540EPV with a chamber size of 10" x 18.7".
The pressure chamber, door and locking device are constructed from stainless steel. The pressure chamber, and components are designed, tested and stamped for conformance to ASME code.
A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the device within its desired parameters. The software has been validated to ensure compliance with all applicable requirements.
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
ophthalmic, dental and medical clinics, first aid rooms, and small laboratories
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
Evaluations have been completed to validate the safety and effectiveness of these devices. Testing was completed using half-cycle and total kill endpoint analysis. The sterilizers were also tested under in-use, worst-case and simulated use conditions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EPV rendered all recommended loads sterile on half-cycle and all other testing was completed successfully.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
Submitter:
Tuttnauer USA Co. LTD. 33 Comac Loop Equi Park Ronkonkoma, New York 11779 NOV 1 2 1997
Phone (516) 737-4850 Fax (516) 737-0720
Contact Name: Robert R. Basile, V.P.
Date Prepared: June 13, 1997
Common Name: Pre-Vacuum autoclave, table-top steam sterilizer
Trade Name: Tuttnauer Model EPV Pre-vacuum Autoclave
Classification Name:
Steam Sterilizer Class II Device - 21 C.F.R. § 880.6880
Substantial Equivalence:
The Tuttnauer Model EPV series Pre-vacuum autoclave is claimed to be substantially equivalent in safety and effectiveness to the Tuttnauer Model E series autoclave that is currently approved and legally marketed under 510(k) number K920478. The Model EPV series is an improvement of the basic E Model through incorporation of a vacuum pump and minor modification of the software driver to narrow the sterilization temperature control range.
General Description:
The Tuttnauer Model EPV series autoclave is a table-top steam sterilizer that includes as its main components a vacuum pump, water reservoir, heat source and sealed chamber. As with the predicate device, the EPV has three pre-programmed sterilization cycles, one user definable cycle and a Bowie-Dick test cycle. The three pre-programmed cycles are for unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes).
The Model EPV autoclave is produced in two sizes, the 2340EPV with a chamber size of 9" x 18.5" and the 2540EPV with a chamber size of 10" x 18.7".
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Tuttnauer Model EPV 510(k) Summary Page 2
Design and Materials:
The pressure chamber, door and locking device are constructed from stainless steel. The pressure chamber, and components are designed, tested and stamped for conformance to ASME code.
A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the device within its desired parameters. The software has been validated to ensure compliance with all applicable requirements.
Intended Use:
The Model EPV is intended to provide sterilization of medical and dental instruments and to sterilize liquids for non-clinical applications.
Technology Considerations:
With the exception of the addition of a vacuum pump, the Model EPV series exhibits the same technological characteristics as the Model E, its predicate device. All of the components that may be found in the Model E are present in the Model EPV.
The addition of a pre-vacuum cycle to the sterilization program increases the efficiency of the device through removal of air pockets from packs and porous loads, allowing better steam penetration into the packs. The addition of a vacuum pump also provides better drying of sterilized material at the end of the cycle by creating a vacuum in the chamber to increase evaporation.
The software driver for the EPV has been modified in relation to the code for the Model E to take into account the addition of a pre-sterilization vacuum stage and post-sterilization vacuum drying. The software has also been modified to narrow the chamber temperature control specifications in line with European requirements.
Safety and Effectiveness:
Evaluations have been completed to validate the safety and effectiveness of these devices. Testing was completed using half-cycle and total kill endpoint analysis. The sterilizers were also tested under in-use, worst-case and simulated use conditions. The EPV rendered all recommended loads sterile on half-cycle and all other testing was completed successfully.
The Tuttnauer Model EPV complies with domestic and international safety standards including Underwriter's Laboratories UL 544, Canadian Standards Association (CSA) medical device standards, European TUV standards and Japanese safety standards. The pressure chamber complies with ASME standards for pressure vessels and Canadian CRN requirements.
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Tuttnauer Model EPV 510(k) Summary Page 3
Conclusion:
It is Tuttnauer USA Co. Ltd.'s conclusion that the Model EPV series autoclave is substantially equivalent to its predicate device, the Tuttnauer Model E series autoclave, 510(k) number K920478. Based upon the test data submitted, the Model EPV provides effective sterilization of recommended loads within the recommended cycles.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 2 1997
Mr. Robert R. Basile ·Vice President Tuttnauer USA Co. Ltd. 33 Comac Loop, Equi-Park Ronkonkoma, New York 11779
Re: K962282 Trade Name: Tuttnauer Prevacuum Table Autoclave Requlatory Class: II Product Code: FLE October 31, 1997 Dated: October 31, 1997 Received:
Dear Mr. Basile:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Basile
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K962282
Tuttnauer Models 2340 and 2540 "EPV" Series Table-top Pre-Vacuum Device Name: Autoclave
Indications For Use: Tuttnauer electronic controlled pre-vacuum autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 5 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); liquids (121°C at 30 minutes and 16 psi); Bowie Dick test program (134°C at 3.5 minutes and 29 psi); and a free program with adjustable sterilization times and temperatures. With the exception of the free program, all of these cycles are pre-programmed, requiring no user input. The free program allows the user to select their own sterilization parameters, however, the operations manual warns that sterilization has not been validated for user selected settings, and cautions the user that they must validate sterilization.
These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number_
Prescription Use
Over -The-Counter Use _ OR
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)