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.

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.

AI/ML Overview

The provided 510(k) summary for the Tuttnauer Model EPV Pre-vacuum Autoclave (K962282) states that "Evaluations have been completed to validate the safety and effectiveness of these devices." However, it does not provide specific numerical acceptance criteria for performance metrics, nor does it detail the results of a specific study in a quantifiable manner to demonstrate that these criteria were met.

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (Tuttnauer Model E series autoclave, K920478) and compliance with various safety standards. The performance aspects are described descriptively rather than with numerical targets and results.

Given the information provided, here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria were not explicitly stated in the provided text. The performance is described qualitatively.

Performance Metric	Acceptance Criteria (Implicit/Qualitative)	Reported Device Performance (Qualitative)
Sterilization Effectiveness	Render all recommended loads sterile; Effective sterilization of recommended loads within recommended cycles.	"The EPV rendered all recommended loads sterile on half-cycle and all other testing was completed successfully." "Based upon the test data submitted, the Model EPV provides effective sterilization of recommended loads within the recommended cycles."
Air Removal	Increased efficiency through removal of air pockets from packs and porous loads, allowing better steam penetration.	"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."
Drying Performance	Better drying of sterilized material at the end of the cycle.	"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."
Temperature Control	Narrowed chamber temperature control specifications.	"The software has also been modified to narrow the chamber temperature control specifications in line with European requirements."
Safety Standards Compliance	Compliance with domestic and international safety standards.	"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."

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

Sample Size for Test Set: Not specified. The document mentions "half-cycle and total kill endpoint analysis" and testing "under in-use, worst-case and simulated use conditions" but does not provide the number of sterilization cycles, loads, or biological indicators used in these tests.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Tuttnauer USA Co. LTD. is based in New York, and the device adheres to "domestic and international safety standards," it's highly likely that testing involved a combination of internal validation and compliance with specified standards, potentially involving recognized testing laboratories. The nature of sterilizer validation implies prospective testing.

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

Number of Experts: Not specified.
Qualifications of Experts: The document does not describe the use of human experts to establish "ground truth" for the test set in the context often seen with AI/clinical decision support devices. Sterilizer validation typically relies on standardized biological and chemical indicators, calibrated equipment, and established protocols rather than expert human interpretation of results in the same way clinical imaging or diagnostic devices might.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for this type of device. The "ground truth" for sterilization effectiveness is determined by objective measures like biological indicator kill, chemical indicator changes, and physical parameters rather than expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or clinical decision support devices where human readers (e.g., radiologists, pathologists) interpret data with and without AI assistance. The Tuttnauer Model EPV is a medical device for sterilization, not a diagnostic or AI-powered interpretative system.

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

Yes, a form of standalone performance evaluation was done. The device's "standalone" performance, in this context, refers to its ability to achieve sterilization outcomes independently without human intervention during the sterilization cycle itself. The testing described ("half-cycle and total kill endpoint analysis," "in-use, worst-case and simulated use conditions") evaluates the sterilizer's effectiveness on its own. The software controls the cycle parameters without human-in-the-loop decision-making during operation.

7. The Type of Ground Truth Used

The ground truth for sterilization efficacy is established through:

Biological Indicators (BI): These contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are killed only if proper sterilization conditions are met. A negative BI result (no growth) indicates sterilization. This is implicitly the "total kill endpoint analysis" mentioned.
Chemical Indicators (CI): These change color or form when exposed to specific sterilant parameters (e.g., steam, temperature, time). They provide immediate confirmation of exposure to sterilant.
Physical Monitoring: This involves monitoring and recording parameters directly from the sterilizer's sensors, such as temperature, pressure, and time.
Pathology/Outcomes Data: Not typically used as primary ground truth for sterilizer validation; rather, the successful kill of microorganisms (as determined by BIs) is the direct measure of effectiveness.

8. The Sample Size for the Training Set

Not applicable / Not specified. The Tuttnauer Model EPV is not an AI/machine learning device that requires a "training set" in the conventional sense. Its software controls predefined sterilization cycles based on fixed parameters, not adaptive learning from data. The software was "validated to ensure compliance with all applicable requirements," implying software testing and verification, but not machine learning training.

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

Not applicable. As the device does not employ machine learning with a distinct "training set," the concept of establishing ground truth for such a set is not relevant. The software logic and control parameters are based on established scientific principles of sterilization and engineering design, not on a data-driven training process.

Summary

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K962282

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 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)

.............................................................................................................................................................................. 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)

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).