PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V

K032192 · Tuttnauer U.S.A Co, Ltd. · FLE · Aug 12, 2004 · General Hospital

Device Facts

• Record ID: K032192
• Device Name: PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
• Applicant: Tuttnauer U.S.A Co, Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

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.

Device Story

Steam sterilizer with onboard steam generation; utilizes pressure vessel, steam jacket, heating elements, water reservoir, water pump, and vacuum pump. Operates by introducing steam directly into chamber to eliminate boil-time. Controlled by microprocessor; user selects from 9 automated programs (flash, wrapped, liquid, test cycles). Monitors include temperature/pressure gauges, digital display, and printer. Used in clinical settings for instrument sterilization; operated by healthcare staff. Provides effective sterilization of heat-stable medical devices; benefits patient by ensuring sterile instruments for procedures.

Clinical Evidence

Bench testing only. Validation studies conducted in accordance with ANSI/AAMI ST-8 (2001). Testing confirmed compliance with physical and microbiological performance requirements for all sterilization programs.

Technological Characteristics

Steam sterilizer; pressure vessel with steam jacket, heating elements, water reservoir, water pump, vacuum pump. Microprocessor-controlled cycle parameters (time, temperature, pressure). Connectivity via digital display and printer. Sterilization via steam. Complies with ANSI/AAMI ST-8.

Indications for Use

Indicated for sterilization of heat-stable medical devices, including wrapped solids, hollow and porous products, and non-clinical liquids in open or closed (unsealed) containers. Not for sealed containers.

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

• EHS Series Pre-vacuum Autoclaves (K003470)

Submission Summary (Full Text)

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K 032192

AUG 1 2 2004

#### 510(k) Summary

| Submitter: | Tuttnauer USA Co. Ltd.<br>25 Power Drive<br>Hauppauge, 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 steam<br>generator, Models 4472 EP-1V and 5596 EP-1V | | |
| Classification Name: | Steam Sterilizer<br>Class 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:

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.

#### 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-1V<br>and 5596 EP-1V<br>Autoclaves | EHS Series<br>(K003470) |
|------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Labeling/Intended<br>Use | Auto Steam<br>Autoclave | Auto Steam<br>Autoclave |
| Process Parameters | Sterilization cycle<br>defined by time, temp.<br>and pressure | Sterilization cycle<br>defined by time, temp.<br>and pressure |
| Process Monitors | Temp. and pressure<br>gauges, digital display<br>screen, and printer | Temp. and pressure<br>gauges, digital display<br>screen, and printer |
| Pre-Vacuum | Yes | Yes |
| On-Board Steam<br>Generation | Yes | Yes |
| Control | Cycle time, temp.,<br>pressure, and user<br>interface controlled by<br>microprocessor | Cycle time, temp.,<br>pressure, and user<br>interface controlled by<br>microprocessor |
| Program Comparison | Wrapped, unwrapped,<br>liquids, and dry | Wrapped, unwrapped,<br>and dry |
| Process Equivalent<br>Times | Sterilization times of<br>3, 4, 10 or 30 minutes<br>depending upon<br>program selected | Sterilization times of<br>3.5, 8, or 30 minutes<br>depending upon<br>program 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 [phone]. 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 [phone] or [phone] 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:

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