TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
Device Facts
| Record ID | K063711 |
|---|---|
| Device Name | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA |
| Applicant | Tuttnauer Co. , Ltd. |
| Product Code | FLE · General Hospital |
| Decision Date | Feb 2, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
Indications for Use
This Tuttnauer autoclave is designed for use in healthcare settings for the sterilization of heat stable medical devices; wrapped solids, hollow and porous products. Sterilization of liquid loads should only be used in non-clinical applications in open or closed (but not sealed) containers. Because of the difficulty to standardize the liquid cycle load. This cycle in not intended for sterilization of materials that come into contact with patients and should only be used for non-clinical applications only.
Device Story
Prevacuum steam-heated autoclaves; utilize saturated steam for sterilization of heat-stable medical devices, wrapped solids, hollow/porous products, and non-clinical liquids. Device comprises pressure vessel, steam jacket, heating elements, water reservoir, water/vacuum pumps, and electronic control panel. Operator selects pre-programmed cycles via control panel; microcomputer manages cycle parameters (time, temperature, pressure) automatically. Includes Bowie & Dick and Air Leakage test programs. Used in healthcare settings; operated by clinical staff. Provides automated sterilization cycle; ensures consistent sterilization parameters; benefits patient by ensuring sterile medical devices.
Clinical Evidence
Bench testing only. Validation studies conducted in accordance with ANSI/AAMI ST8 (2001) confirmed compliance with physical and microbiological performance requirements. Successful sterilization achieved in all tests.
Technological Characteristics
Steam sterilizer; pressure vessel with steam jacket, heating elements, water reservoir, water pump, vacuum pump. Electronic control panel with microcomputer. Twelve pre-programmed cycles plus two test programs (Bowie & Dick, Air Leakage). Automatic shutdown capability. Pneumatic or hydraulic door operation depending on model.
Indications for Use
Indicated for sterilization of heat-stable medical devices, wrapped solids, hollow, and porous products in healthcare settings. Liquid loads are indicated for non-clinical applications only in open or closed (non-sealed) containers. Not indicated for sterilization of patient-contact materials in liquid cycles.
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
- K850264 (non-computer controlled autoclaves)
- K850264A (non-computer controlled autoclaves)
- K032192 (computer controlled autoclaves)
Submission Summary (Full Text)
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K063711
## 510(k) Summary
FEB - 2 2007
Tuttnauer USA Co. Ltd. 25 Power Drive Hauppauge, NY 11788 Phone: 631-737-4850 Fax: 631-737-0720
Robert R. Basile, V.P.
November 21, 2006
Electronic pre-vacuum autoclave, steam sterilizer
Tuttnauer Prevacuum Steam Heated Autoclave with Automatic Hinged Door (Model 6990 SP-1A)
Tuttnauer Prevacuum Steam Heated Autoclave with Automatic Hinged Door (Model 66120 SP-1A)
Tuttnauer Prevacuum Steam Heated Autoclave with Two Automatic Hinged Doors (Model 69150 SP-2A)
Tuttnauer Prevacuum Steam Heated Autoclave Equipped with Two Automatic Hinged Doors (Model 69120 L USA SP-2A)
Tuttnauer Steam-Heated Prevacuum Autoclave with Two Horizontal Sliding Doors (Model 69180 SP-2HA)
Tuttnauer Prevacuum Steam Heated Autoclave Equipped with Vertical Sliding Door (Model 6690 L USA SP-1V)
Steam Sterilizer Class II Device - 21 C.F.R. § 880.6880
Submitter:
Contact Name:
Date Prepared:
Common Name (for all):
Trade Names:
Classification Name (for all):
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### Substantial Equivalence:
All six Tuttnauer autoclave models referenced above (Models 6990 SP-1A; 66120 SP-1 A: 69150 SP-2A: 69120 L USA SP-2A: 69180 SP-2HA; and 6690 L USA SP-1V) are claimed to be substantially equivalent to the autoclaves cleared under the following 510(k) numbers:
K850264 (non-computer controlled autoclaves) K850264A (non-computer controlled autoclaves) K032192 (computer controlled autoclaves)
The six Tuttnauer autoclave models covered by this 510(k) notification differ in the size of their chambers (dimensions and volume) and in their door configurations. All six models have been previously cleared by FDA in their manual form; the six models covered herein only differ from these previously cleared devices in that they contain electronic control panels to allow for automatic usage. As there is no change to factors affecting sterilization, such as cycle time, temperature, or pressure, these six devices should be equivalent to the predicate devices cleared under the three 510(k) numbers listed above.
### General Description:
Tuttnauer autoclave models 6990 SP-1A: 66120 SP-1A: 69150 SP-2A: 69120 L USA SP-2A; 69180 SP-2HA; and 6690 L USA SP-1V are all prevacuum autoclaves that utilize saturated steam as the sterilizing agent. Each of these autoclaves is 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 key differences between the six models covered by this 510(k) notification are (1) chamber dimensions/chamber volume, and door configuration. These differences are summarized here:
| Model | Chamber Dim. (w x h x d) | Chamber Volume | Door Configuration |
|-------------------|--------------------------|----------------|--------------------------------------------------------------------|
| 6990 SP-1A | 24" x 36" x 36" | 21 ft. 3 | automatic hinged door<br>driven by pneumatic<br>drive |
| 66120 SP-1A | 26" x 26" x 50" | 21.2 ft. 3 | automatic hinged door<br>driven by pneumatic<br>drive |
| 69150 SP-2A | 24" x 36" x 60" | 33 ft. 3 | two automatic hinged<br>doors driven by<br>pneumatic drive |
| 69120 L USA SP-2A | 24" x 36" x 48" | 750 l. 3 | two automatic hinged<br>doors driven by<br>pneumatic drive |
| 69180 SP-2HA | 24" x 36" x 83" | 1165 l. 3 | two horizontal sliding<br>doors operated by<br>hydraulic operators |
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through an oil cylinder
## 6690 L USA SP-1 V 26" x 26" x 39"
450 1. 3
one vertical sliding door operated by hydraulic system through two oil cylinders mounted laterally on both sides of door
The six Tuttnauer models covered herein are substantially the same as models cleared under 510(k) numbers K850264 and K850264A. Both of these 510(k) notifications and clearances cover the manual versions of the automatic autoclaves subject to this 510(k) application. Tuttnauer has modified the control panel of the manual autoclaves, replacing the current manual control panel with an electronic control panel. CDRH has already cleared a similar manual-toelectronic change in 510(k) number K032192. Therefore, all three of these 510(k) notifications and subsequent clearances are claimed as predicate devices for all six of the autoclaves in this 510(k) application.
### Design and Materials:
Each of the six Tuttnauer autoclave models is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a water reservoir, a water pump, and a vacuum pump, Each autoclave is pre-programmed with twelve sterilization cycles, and each has two test programs: (1) a "Bowie & Dick Test," and (2) an "Air Leakage Test." The six autoclaves are equipped with the capability to shut down automatically. An emergency stop push button that is mounted on the front panel is an available option for customers with specific needs.
The control software, which is identical to that used in the autoclayes cleared under K032192, allows for automatic operation of all six autoclaves. The microcomputer technology employed in the autoclaves ensures that the entire cycle will operate on a fully-automatic basis. Therefore, no further intervention is necessary after setting the pre-selected parameters and starting operation of the autoclaye.
### Comparison to Cleared Devices:
The only material component that is being changed on these six devices is the substitution of a manual control panel with an electronic control panel, including operational software. This electronic control panel/operational software package was previously cleared as a modification to two existing Tuttnauer autoclaves under 510(k) number K032192. This control panel/software substitution does not affect the intended use of the six devices included in this notification, and the fundamental scientific technology of the six devices is not altered.
### Intended Use:
All six Tuttnauer autoclave models referenced above (Models 6990 SP-1A; 66120 SP-1A; 69150 SP-2A; Model 69120 L USA SP-2A; 69180 SP-2HA; and Model 6690 L USA SPl V) are designed for sterilization of heat stable medical devices; wrapped solids, hollow and
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porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers. Indication for use statement is attached
Because of the difficulty to standardize the liquid cycle load. This cycle in not intended for sterilization of materials that come into contact with patients and should only be used for non-clinical applications only.
### Technology Considerations:
Each of the six Tuttnauer autoclave models is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a water reservoir, a water pump, and a vacuum pump.
### Non-Clinical Testing:
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.
### Conclusion:
For all of the foregoing reasons, Tuttnauer believes that the six Tuttnauer autoclave models described in this 510(k) notification may be safely marketed in the United States.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tuttnauer Company Limited C/O Mr. Mark Yacura Buchanan Ingersoll, P.C. 1776 K Street N.W., Suite 300 Washington, DC 20006-2365
FEB - 2 2007
Re: K063711
Trade/Device Name: Tuttnauer Prevacuum Steam Heated Autoclaves Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA, 6690 L USA SP-1V Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 13, 2006 Received: December 14, 2006
Dear Mr. Yacura:
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.
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 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.
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Page 2 - Mr. Yackura
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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), please contact the Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu 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
### 510(k) Number: K063711
Device Name: Tuttnauer Prevacuum Steam Heated Autoclaves models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA, 6690 L USA SP-1V
Indications for Use: This Tuttnauer autoclave is designed for use in healthcare settings for the sterilization of heat stable medical devices; wrapped solids, hollow and porous products. Sterilization of liquid loads should only be used in non-clinical applications in open or closed (but not sealed) containly si
Maximum loads depend upon the chamber size, and are listed below.
## MODEL NUMBER 6990 SP-1A
#### Cycle Program Temperature Maximum Maximum Number ofi Load (Ibs) Trays 01.02 . Unwrapped 250 72 2 03, 04 Unwrapped 270/274 72 2 05, 06, 08 Wrapped 270 72 2 07 Wrapped 274 72 2 09, 10, 11, 12 Liquids 250 72 2 13 B & D test 274 72 2 14 Air leak test . .
## CHAMBER (inches) 24x36x36
Maximum load for one tray may not exceed the maximum load for the autoclave
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (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)
Shule M. Maugham K.D.
Manager, General Manager
and all Associates
Page 1 of 4
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# MODEL NUMBER 66120 SP-1A
## CHAMBER (inches) 26x26x50
| Cycle<br>Number | Program | Temperature<br>°F | Maximum<br>Load (lbs) | Maximum<br>Trays |
|-----------------|---------------|-------------------|-----------------------|------------------|
| 01, 02 | Unwrapped | 250 | 96 | 2 |
| 03, 04 | Unwrapped | 270/274 | 96 | 2 |
| 05, 06, 08 | Wrapped | 270 | 96 | 2 |
| 07 | Wrapped | 274 | 96 | 2 |
| 09, 10, 11, 12 | Liquids | 250 | 96 | 2 |
| 13 | B & D test | 274 | 96 | 2 |
| 14 | Air leak test | - | - | - |
Maximum load for one tray may not exceed the maximum load for the autoclave
## MODEL NUMBER 69150 SP-2A
## CHAMBER (inches) 24x36x60
| Cycle<br>Number | Program | Temperature<br>°F | Maximum<br>Load (lbs) | Maximum<br>Trays |
|-----------------|---------------|-------------------|-----------------------|------------------|
| 01, 02 | Unwrapped | 250 | 192 | 2 |
| 03, 04 | Unwrapped | 270/274 | 192 | 2 |
| 05, 06, 08 | Wrapped | 270 | 192 | 2 |
| 07 | Wrapped | 274 | 192 | 2 |
| 09, 10, 11, 12 | Liquids | 250 | 192 | 2 |
| 13 | B & D test | 274 | 192 | 2 |
| 14 | Air leak test | - | - | - |
Maximum load for one tray may not exceed the maximum load for the autoclave
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# MODEL NUMBER 69120 SP-2A
## CHAMBER (inches) 24x36x48
| Cycle<br>Number | Program | Temperature<br>°F | Maximum<br>Load (lbs) | Maximum<br>Trays |
|-----------------|---------------|-------------------|-----------------------|------------------|
| 01, 02 | Unwrapped | 250 | 192 | 2 |
| 03, 04 | Unwrapped | 270/274 | 192 | 2 |
| 05, 06 | Wrapped | 270 | 192 | 2 |
| 07 | Wrapped | 274 | 192 | 2 |
| 08 | Wrapped | 250 | 192 | 2 |
| 09, 10, 11, 12 | Liquids | 250 | 192 | 2 |
| 13 | B & D test | 274 | 192 | 2 |
| 14 | Air leak test | - | - | - |
Maximum load for one tray may not exceed the maximum load for the autoclave
## MODEL NUMBER 69180 SP-2HA
## CHAMBER (inches) 24x36x83
:
:
| Cycle<br>Number | Program | Temperature<br>°F | Maximum<br>Load (lbs) | Maximum<br>Trays |
|-----------------|---------------|-------------------|-----------------------|------------------|
| 01, 02 | Unwrapped | 250 | 256 | 2 |
| 03, 04 | Unwrapped | 270/274 | 256 | 2 |
| 05, 06 | Wrapped | 270 | 256 | 2 |
| 07 | Wrapped | 274 | 256 | 2 |
| 08 | Wrapped | 250 | 256 | 2 |
| 09, 10, 11, 12 | Liquids | 250 | 256 | 2 |
| 13 | B & D test | 274 | 256 | 2 |
| 14 | Air leak test | - | - | - |
Maximum load for one tray may not exceed the maximum load for the autoclave
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## MODEL NUMBER 6690 SP-1V
# CHAMBER (inches) 26x26x39
| Cycle<br>Number | Program | Temperature<br>°F | Maximum<br>Load (lbs) | Maximum<br>Trays |
|-----------------|---------------|-------------------|-----------------------|------------------|
| 01, 02 | Unwrapped | 250 | 144 | 2 |
| 03, 04 | Unwrapped | 270/274 | 144 | 2 |
| 05, 06, 08 | Wrapped | 270 | 144 | 2 |
| 07 | Wrapped | 274 | 144 | 2 |
| 09, 10, 11, 12 | Liquids | 250 | 144 | 2 |
| 13 | B & D test | 274 | 144 | 2 |
| 14 | Air leak test | - | - | - |
Maximum load for one tray may not exceed the maximum load for the autoclave
:
