The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids (for non-clinical application only) in open or closed containers. It has the following automated program sterilization cycles: Program 1 (Flash - Porous), Program 2 (Flash - Nonporous), Program 3 (Wrapped - 270°F), Program 4 (Wrapped - 270°F), Program 5 (Wrapped 275°F), Program 6 (Wrapped - 250°F), Program 7 (Liquids - 250°F) For non-clinical applications only, Program 8 (Bowie-Dick Test), Program 9 (Air Leakage Test).

Device Description

The Tuttnauer Model 4472 EP-1V and 5596 EP-1V Autoclaves are steam sterilizers that provide onboard steam generation capability. They are designed for sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The Tuttnauer Model 4472 EP-1V and 5596 EP-1V autoclaves are steam sterilizers that include as main components: a pressure vessel with steam jacket, heating elements, a chamber water reservoir, a water pump and a vacuum pump.

AI/ML Overview

The provided text is for a 510(k) summary for a steam sterilizer (autoclave), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Below is a summary of the acceptance criteria and study information provided for the Tuttnauer Autoclaves.

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from ANSI/AAMI ST-8)	Reported Device Performance (Tuttnauer 4472 EP-1V & 5596 EP-1V)
General Sterilization Efficacy	Meets all aspects of ANSI/AAMI ST-8, including physical and microbiological performance requirements for steam sterilization.	"Tuttnauer conducted validation studies in accordance with ANSI/AAMI ST8 (2001). Testing showed that the sterilizers meet all aspects of the standard, including physical and microbiological performance requirements. Successful sterilization was accomplished in all tests performed." The device provides effective sterilization of instruments.
Program 1 (Flash - Porous)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 270°F (270-276°F)Sterilization Time: 3 minutesPressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig)Maximum Load: two (2) 16 lb. unwrapped trays
Program 2 (Flash - Nonporous)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 270°F (270-276°F)Sterilization Time: 10 minutesPressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig)Maximum Load: two (2) 16 lb. unwrapped trays
Program 3 (Wrapped - 270°F)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 270°F (270-276°F)Sterilization Time: 4 minutesDry Time: 30 minutesPressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig)Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs
Program 4 (Wrapped - 270°F)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 270°F (270-276°F)Sterilization Time: 10 minutesDry Time: 20 minutesPressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig)Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs
Program 5 (Wrapped - 275°F)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 275°F (275-281°F)Sterilization Time: 3 minutesDry Time: 20 minutesPressure & Range: 214 kPa (214-245 kPa); 16.3 psig (16.3-20.8 psig)Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs
Program 6 (Wrapped - 250°F)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 250°F (250-256°F)Sterilization Time: 30 minutesDry Time: 45 minutesPressure & Range: 103 kPa (103-128 kPa); 0.2 psig (0.2-3.9 psig)Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs
Program 7 (Liquids - 250°F)	Per ANSI/AAMI ST8:2001	Sterilization Temperature & Range: 250°F (250-256°F)Sterilization Time: 30 minutesPressure & Range: 103 kPa (103-128 kPa); 0.2 psig (0.2-3.9 psig)Maximum Load: three (3) 1 liter flasks
Program 8 (Bowie-Dick Test)	Fixed sterilization parameters for Bowie-Dick Test	Sterilization Temperature & Range: 273°F (273-274°F)Sterilization Time: 3.5 minutesDry Time: 2 minutesPressure & Range: 207 kPa (207 kPa); 15.3 psig (15.3 psig)
Program 9 (Air Leakage Test)	Test for air leakage to the chamber through door seal or other seals in vacuum phase	This test is intended to test air leakage to the chamber through the door seal or any other seals. This test is performed in vacuum phase.

(Note: The "acceptance criteria" for the specific programs are implied by successful demonstration of meeting the program parameters as part of the overall ANSI/AAMI ST-8 compliance.)

Study Details (as they pertain to an AI/ML context, if applicable):

Sample size used for the test set and the data provenance:
- The document refers to "validation studies" and "all tests performed" in accordance with ANSI/AAMI ST-8. It does not specify a distinct "test set" in the context of AI/ML data, but rather the performance of the physical sterilizer under various load and cycle conditions as defined by the standard.
- No specific sample sizes (e.g., number of sterilization cycles, number of biological indicators) are provided, nor is the country of origin of the data explicitly stated (though it's a US company seeking US clearance, implying US-based testing or compliance with US standards).
- The studies were "validation studies," which are prospective in nature for a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device sterilizer, not an AI/ML diagnostic or predictive tool requiring expert ground truth for image or data interpretation. Ground truth for sterilization efficacy is typically established through established microbiological and physical testing standards (e.g., biological indicators, thermocouples).
Adjudication method for the test set:
- Not applicable. This is a physical device sterilizer.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical device sterilizer.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device sterilizer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for sterilizers is established by established microbiological destruction criteria (e.g., 10^-6 sterility assurance level for biological indicators) and physical parameters (temperature, pressure, time) as defined by standards like ANSI/AAMI ST-8.
The sample size for the training set:
- Not applicable. This is a physical device sterilizer, not an AI/ML device trained on data. The "training" for such a device involves engineering design, manufacturing protocols, and internal testing to ensure it meets its design specifications before formal validation.
How the ground truth for the training set was established:
- Not applicable. This is a physical device sterilizer.

Summary

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K 032192

AUG 1 2 2004

510(k) Summary

Submitter:	Tuttnauer USA Co. Ltd.25 Power DriveHauppauge, NY 11788
Phone:	631-737-4850
Fax:	631-737-1034
Contact Name:	Robert R. Basile
Date Prepared:	July 15, 2003
Common Name:	Electronic pre-vacuum autoclave
Trade Name:	Tuttnauer pre-vacuum autoclave with vertical sliding door and steamgenerator, Models 4472 EP-1V and 5596 EP-1V
Classification Name:	Steam SterilizerClass II Device - 21 C.F.R. § 880.6880

Substantial Equivalence:

The Tuttnauer Model 4472 EP-1V and 5596 EP-1 V autoclaves are substantially equivalent to the following currently marketed sterilizer (which meets ANSI/AAMI ST-8):

Company	Product Name	510(k) Clearance Number
Tuttnauer USA Co. Ltd.	EHS Series Pre-vacuum Autoclaves	K003470

General Description:

Intended Use:

The Tuttnauer Model 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers.

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Technological Characteristics:

The Tuttnauer Model 4472 EP-1V and 5596 EP-1V autoclaves are steam sterilizers that include as main components: a pressure vessel with steam jacket, heating elements, a chamber water reservoir, a water pump and a vacuum pump.

Characteristic	Models 4472 EP-1Vand 5596 EP-1VAutoclaves	EHS Series(K003470)
Labeling/IntendedUse	Auto SteamAutoclave	Auto SteamAutoclave
Process Parameters	Sterilization cycledefined by time, temp.and pressure	Sterilization cycledefined by time, temp.and pressure
Process Monitors	Temp. and pressuregauges, digital displayscreen, and printer	Temp. and pressuregauges, digital displayscreen, and printer
Pre-Vacuum	Yes	Yes
On-Board SteamGeneration	Yes	Yes
Control	Cycle time, temp.,pressure, and userinterface controlled bymicroprocessor	Cycle time, temp.,pressure, and userinterface controlled bymicroprocessor
Program Comparison	Wrapped, unwrapped,liquids, and dry	Wrapped, unwrapped,and dry
Process EquivalentTimes	Sterilization times of3, 4, 10 or 30 minutesdepending uponprogram selected	Sterilization times of3.5, 8, or 30 minutesdepending uponprogram selected

Non-Clinical Testing:

Tuttnauer conducted validation studies in accordance with ANSVAAMI ST8 (2001). Testing showed that the sterilizers meet all aspects of the standard, including physical and microbiological performance requirements. Successful sterilization was accomplished in all tests performed.

Conclusion:

It is Tuttnauer USA Co. Ltd.'s conclusion that the Tuttnauer Models 4472 EP-1V and 5596 EP-1 V Autoclaves are substantially equivalent to its predicate device. Based upon test data submitted, the Models 4472 EP-1V and 5596 EP-1V Autoclaves provide effective sterilization of instruments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2004

Tuttnauer USA Company Limited C/O Mr. Mark M. Yacura Buchanan Ingersoll P.C. 1776 K Street, N.W. Suite 800 Washington, DC 20006-2365

Re: K032192

K032172
Trade/Device Name: Tuttnauer Pre-Vacuum Autoclave with Vertical Sliding Door and Steam Generator, Models 4472 EP-1V and 5596 EP-1V Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 18, 2004 Received: June 18, 2004

Dear Mr. Yacura:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases of 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls provisions of 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (I WAY, it may of suchose of Federal Regulations, Title 21, Parts 800 to 898. In your device of the rannouncements concerning your device in the Federal Register.

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Page 2 - Mr. Yacura

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 mean that FDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and reguirements, including, but not limited to: registration You must comply with an the Here Progent ..................................................................................................................................... and ilsung (21 CFR Part 067), labeling (21 CFR Part (QS) regulation (21 CFR Part 820); and if requirements as Sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgan mailioning your substantial equivalence of your device to a premarket notification. The PDF midning of backing of 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), If you desire specific advice to: Jour de at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general miernational and Consumer Assistance at its toll-free Driston (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Chin Lin, Ph.D.

Chiu Lin, Ph.D. 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

K032192 510(k) Number (if known):

Tuttnauer Pre-Vacuum Autoclave with Vertical Sliding Door and Device Name: Steam Generator, Models 4472 EP-1V and 5596 EP-1V

Indications For Use: The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow inkonded to products, as well as liquids (for non-clinical application only) in open or and products, a somainers. It has the following automated program sterilization cycles:

Program 1 (Flash - Porous)

Parameters:

Sterilization temperature & Range: 270°F (270 276°F) .
Sterilization time: 3 minutes .
Pressure & Range: 186 Kpa (186 220 kPa); 12.3 psig (12.3 17.2 psig) .
Maximum load: two (2) 16 lb. unwrapped trays (per ST8:2001) .

Program 2 (Flash - Nonporous)

Sterilization temperature & Range: 270°F (270 276°F) .
Sterilization time: 10 minutes .
Pressure & Range: 186 kPa (186 -220 kPa); 12.3 psig (12.3 17.2 psig) .
Maximum load: two (2) 16 lb. unwrapped trays (per ST8:2001) .

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Program 3 (Wrapped - 270°F)

For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 270°F with drying cycle.

Parameters:

Sterilization temperature & Range: 270°F (270 276°F) .
Sterilization time: 4 minutes .
Dry time: 30 minutes .
Pressure & Range: 186 kPa (186 220 kPa); 12.3 psig (12.3 17.2 psig) .
Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001) .

Program 4 (Wrapped - 270°F)

For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 270°F with drying cycle.

Sterilization temperature & Range: 270°F (270 276°F) .
Sterilization time: 10 minutes .
. Dry time: 20 minutes
Pressure & Range: 186 kPa (186 220 kPa); 12.3 psig (12.3-17.2 psig) t
Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001) .

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Program 5 (Wrapped 275°F)

For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 275°F with drying cycle.

Parameters:

Sterilization temperature & Range: 275°F (275 281°F) .
Sterilization time: 3 minutes .
Dry time: 20 minutes .
Pressure & Range: 214 kPa (214 245 kPa); 16.3 psig (16.3 20.8 psig) .
Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001) .

Program 6 (Wrapped - 250°F)

For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 250°F with drying cycle.

Sterilization temperature & Range: 250°F (250 256°F) .
Sterilization time: 30 minutes .
Dry time: 45 minutes .
Pressure & Range: 103 kPa (103-128 kPa); 0.2 psig (0.2 3.9 psig) .
Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001) .

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Program 7 (Liquids - 250°F) For non-clinical applications only

For sterilization of liquids which the manufacturer recommends autoclaving at temperatures of up to 250°F. For non-clinical applications only.

Parameters:

Sterilization temperature & Range: 250°F (250 256°F) .
Sterilization time: 30 minutes .
Pressure & Range: 103 kPa (103 128 kPa); 0.2 psig (0.2 3.9 psig) .
Maximum load: three (3) 1 liter flasks (per ST8:2001) .

Program 8 (Bowie-Dick Test)

This is a test program, with fixed sterilization parameters of 273°F and 3.5 minutes which cannot be modified by the operator.

Sterilization temperature & Range: 273°F (273-274°F) .
Sterilization time: 3.5 minutes .
Dry time: 2 minutes .
Pressure & Range: 207 kPa (207 Kpa); 15.3 psig (15.3 psig) .

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Program 9 (Air Leakage Test)

This test is intended to test air leakage to the chamber through the door seal or any other seals. This test is performed in vacuum phase.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 (ODE)

Kein Mulvey

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:

Page 1 of

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).