(452 days)
Not Found
No
The device description mentions a microprocessor and software for controlling pre-programmed cycles, but there is no indication of AI or ML being used for learning, adaptation, or complex decision-making beyond these fixed parameters.
No.
The device is an autoclave used for sterilizing medical instruments, not for providing therapy or treatment to a patient.
No
The device is described as an autoclave, which is used for sterilization, not for diagnosing medical conditions. Its function is to clean and disinfect instruments.
No
The device is a table-top steam sterilizer with physical components like a chamber, heat source, and water reservoir. While it uses software for control, it is fundamentally a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the sterilization of medical instruments and materials. This is a process performed on items used in medical procedures, not on biological samples taken from a patient for diagnostic purposes.
- Device Description: The description details a steam sterilizer (autoclave) used for physical sterilization. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
- Generating diagnostic results
The device is clearly intended for sterilization, which is a process to make instruments safe for use, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Tuttnauer E Series Electronic Table-top Autoclave is intended to provide sterilization of medical and dental instruments (including dental handpieces) and to sterilize liquids for non-clinical applications.
Tuttnauer electronic controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). These cycles are preprogrammed and are recommended in the labeling.
Tuttnauer E Series Electronic Table-top 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.
Product codes
FLE
Device Description
The Tuttnauer Model E series autoclave is a table-top steam sterilizer that includes as its main components an electronic control, water reservoir, heat source and sealed chamber. The E has three pre-programmed sterilization cycles. The three pre-programmed cycles are for unwrapped instruments (134°C at 4 minutes), wrapped instruments (134°C at 8 minutes) and liquids (121°C at 30 minutes). Dental handpieces can be sterilized as unwrapped or wrapped instruments without modification to cycle times or temperatures.
The Model E autoclave is produced in four sizes, the 1730 with a chamber size of 7" x 12"; the 2340 with a chamber size of 9" x 18.5"; the 2540 with a chamber size of 10" x 18.7"; and the 3870, which has a chamber size of 15" x 27."
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.
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
ophthalmic, dental and medical clinics, first aid rooms, and small laboratories
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
Tuttnauer conducted validation studies on the E Series Electronic Table-top Autoclave to ensure effective handpiece sterilization. Representative handpieces from various manufacturers were inoculated in their most difficult to sterilize areas for the testing. Worst-case handpiece loads were then determined for the sterilizer. Three half-cycle tests were performed for each of unwrapped and wrapped methods of sterilization. The testing shows that dental handpieces may be effectively sterilized in the E Series Electronic Table-top Autoclave.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB - 9 2001
993856
510(K) SUMMARY
| Submitter: | Tuttnauer USA Co. Ltd.
33 Comac Loop, Equi-Park
Ronkonkoma, NY 11779 | | |
|----------------------|----------------------------------------------------------------------------|------------------------------------------------------------|--|
| | Phone: | 800-624-5836 | |
| | Fax: | 516-737-0720 | |
| Contact Name: | Robert R. Basile | | |
| Date Prepared: | October 25, 1999 | | |
| Common Name: | Electronic autoclave, table-top steam sterilizer | | |
| Trade Name: | Tuttnauer Electronic Autoclave Models (E, EA, EK, EP, EKA) | | |
| Classification Name: | | Steam Sterilizer
Class II Device - 21 C.F.R. § 880.6880 | |
Substantial Equivalence:
The modified Tuttnaver E Series Electronic Table-top Autoclave is substantially equivalent to the following currently cleared and legally marketed autoclave:
| Company | Product Name | 510(k) Clearance Number |
|---|---|---|
| Tuttnauer USA Co. Ltd. | E Series Electronic Autoclave | K920478 |
With the exception of changes to the automated program cycle times and the labeling to allow sterilization of dental handpieces, the modified devices are identical to the Model E cleared under K920478.
General Description:
The Tuttnauer Model E series autoclave is a table-top steam sterilizer that includes as its main components an electronic control, water reservoir, heat source and sealed chamber. The E has three pre-programmed sterilization cycles. The three pre-programmed cycles are for unwrapped instruments (134°C at 4 minutes), wrapped instruments (134°C at 8 minutes) and liquids (121°C at 30 minutes). Dental handpieces can be sterilized as unwrapped or wrapped instruments without modification to cycle times or temperatures.
The Model E autoclave is produced in four sizes, the 1730 with a chamber size of 7" x 12"; the 2340 with a chamber size of 9" x 18.5"; the 2540 with a chamber size of 10" x 18.7"; and the 3870, which has a chamber size of 15" x 27."
1
Tuttnauer E Series Dental Handpiece Modification 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 Tuttnauer E Series Electronic Table-top Autoclave is intended to provide sterilization of medical and dental instruments (including dental handpieces) and to sterilize liquids for non-clinical applications.
Technology Considerations:
The modified E Series exhibits the same technological characteristics as the Tuttnauer E Series Electronic Table top Autoclave, its predicate device. All of the components that may be found in the unmodified Model E are identical to those in the modified version.
Non-Clinical Testing:
Tuttnauer conducted validation studies on the E Series Electronic Table-top Autoclave to ensure effective handpiece sterilization. Representative handpieces from various manufacturers were inoculated in their most difficult to sterilize areas for the testing. Worst-case handpiece loads were then determined for the sterilizer. Three half-cycle tests were performed for each of unwrapped and wrapped methods of sterilization. The testing shows that dental handpieces may be effectively sterilized in the E Series Electronic Table-top Autoclave.
Conclusion:
It is Tuttnauer USA Co. Ltd.'s conclusion that the modified Tuttnauer E Series Electronic Table-top Autoclave is substantially equivalent to its predicate device. Based upon test data submitted, Tuttnauer E Series Table-top autoclaves effectively sterilize up to 5 dental handpieces contained within them during normal autoclave operation.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an abstract caduceus symbol, featuring three wavy lines that resemble a stylized human figure.
Public Health Service
.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2001
Tuttnauer USA Company Limited C/O Mr. Mark M. Yacura Buchanan Ingersoll, P.C. 1776 K Street, Northwest Suite 800 Washington, DC 20006-7910
Re: K993856 Tuttnauer Models 1730, 2340, 2540 and 3870 Trade Name: "E" Series Table-top Autoclave Regulatory Class: I Product Code: FLE Dated: January 26, 2001 Received: January 26, 2001
Dear Mr. Yacura:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beoced above and we have determined the market the device islarguivalent (for the indications for use device is bubbeanceary eqo legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the marketed in theorbeate of the Medical Device Amendments, or to devices enatement dace of the neved in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, the reactar rood, brag, and, subject to the general controls chercrore, marked one act. The general controls provisions of the provisions or the nec. If annual registration, listing of Act include requirements re practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II il your device ID Class III (Premarket Approval), it may be (Spectal Controlo) or Srabbrontrols. Existing major regulations subject to back device can be found in the Code of Federal arrecting your dover that 800 to 895. A substantially Reguiralent determination assumes compliance with the Current Good equivalence decormination abiaments, as set forth in the Quality
Manufacturing Practice requirements, as set forth in the publicition rundracearing Fring (QS) for Medical Devices: General regulation System Regulacion (20) 102 through periodic QS 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 regulatory accron. In a your device in the Federal Register. announcements this response to your premarket notification ricuse note. Enro respect any obligation you might have under sections 531 through 542 of the Act for devices under the
3
Page 2 — Mr. Yacura
Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as mis icece wour 510 (k) premarket notification. The FDA described in your 510 m provilence of your device to a legally marketed predicate device results in a classification for your marketed predicate device robates in proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice is additionally 809.00 for in regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (501) 32 resertising of your device, please contact che promocion and adversibling on July 2017 - 11so, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obcarned from the Drviber. 01 638-2041 or (301) 443-6597 or at its internet address
its incerner addroby/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Purpus
Timothy A.Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Tuttnauer Models 1730, 2340, 2540 and 3870 "E" Series Table-top Autoclave
Tuttnauer electronic controlled autoclaves are intended to be used for Indications For Use: sterilization of solid metal instruments, solid metal hinged instruments, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121℃ at 30 minutes and 16 psi). These cycles are preprogrammed and are recommended in the labeling.
Tuttnauer E Series Electronic Table-top 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)
Prescription Use __
Over -The-Counter Use
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
Qun S. Lim
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _