(392 days)
Not Found
No
The description focuses on the mechanical and operational aspects of a steam sterilizer (autoclave) and its pre-programmed sterilization cycles. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an autoclave, used for sterilizing medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
This device is an autoclave, which is used for sterilization of medical devices and other materials. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components like a pressure vessel, heating elements, pumps, and a steam jacket, indicating it is a hardware device with integrated software for control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing sterilization of heat stable medical devices, wrapped products, and liquids (for non-clinical applications). This is a sterilization function, not a diagnostic function.
- Device Description: The device description details the components of a steam sterilizer, which is used for sterilization, not for performing tests on biological samples to diagnose conditions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the Tuttnauer Model 4472 EP-1V and 5596 EP-1V Autoclaves are sterilizers, not IVDs.
N/A
Intended Use / Indications for 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.
The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow 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) For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 270°F with drying cycle.
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.
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.
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.
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FLE
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.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
K 032192
AUG 1 2 2004
510(k) Summary
| Submitter: | Tuttnauer USA Co. Ltd.
25 Power Drive
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
generator, Models 4472 EP-1V and 5596 EP-1V | | |
| Classification Name: | Steam Sterilizer
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.
1
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
and 5596 EP-1V
Autoclaves | EHS Series
(K003470) |
|------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Labeling/Intended
Use | Auto Steam
Autoclave | Auto Steam
Autoclave |
| Process Parameters | Sterilization cycle
defined by time, temp.
and pressure | Sterilization cycle
defined by time, temp.
and pressure |
| Process Monitors | Temp. and pressure
gauges, digital display
screen, and printer | Temp. and pressure
gauges, digital display
screen, and printer |
| Pre-Vacuum | Yes | Yes |
| On-Board Steam
Generation | Yes | Yes |
| Control | Cycle time, temp.,
pressure, and user
interface controlled by
microprocessor | Cycle time, temp.,
pressure, and user
interface controlled by
microprocessor |
| Program Comparison | Wrapped, unwrapped,
liquids, and dry | Wrapped, unwrapped,
and dry |
| Process Equivalent
Times | Sterilization times of
3, 4, 10 or 30 minutes
depending upon
program selected | Sterilization times of
3.5, 8, or 30 minutes
depending upon
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.
2
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.
3
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
4
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) .
5
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) .
6
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) .
7
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) .
8
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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