(41 days)
Not Found
No
The description focuses on manual and pre-programmed sterilization cycles based on fixed parameters (temperature, pressure, time) and does not mention any adaptive or learning capabilities.
No.
The device is an autoclave intended for sterilizing medical instruments and materials, not for treating patients.
No
The device is an autoclave, used for sterilization of instruments, not for diagnosing medical conditions.
No
The device description clearly outlines physical hardware components such as a multi-valve control assembly, timer, water reservoir, heat source, and sealed chamber, indicating it is a hardware device with potentially some software control, not a software-only 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 outside the human body to make them safe for use, not a test performed on samples taken from the human body to diagnose a condition.
- Device Description: The description details a steam sterilizer (autoclave), which is a piece of equipment used for sterilization, not for performing diagnostic tests.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
The device falls under the category of a sterilizer, specifically regulated under 21 C.F.R. § 880.6880, which is for "Sterilizers, steam, hospital." This regulation is for devices used to sterilize medical equipment, not for in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Model M is intended to provide sterilization of medical and dental instruments and to sterilize liquids for non-clinical applications.
Tuttnauer electronic and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the "E" Series; these cycles are pre-programmed, whereas in the "M" Series the user must manually set the parameters, however, these parameters are recommended in the labeling.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Tuttnauer Model M series autoclave is a table-top steam sterilizer that includes as its main components a multi-valve control assembly & timer, water reservoir, heat source and sealed chamber. The M can sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes).
The Model M 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" and the 2540 with a chamber size of 10" x 18.7". The 3870, which has a chamber size of 15" x 27", is not subject to this corrective action.
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.
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
These 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.
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)
Not Found
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
Special 510(k) - Corrective Action Being Taken Door Closure Modification
510(K) Summarv
OCT 2 9 1997
Submitter:
Tuttnauer USA Co. LTD. 33 Comac Loop Equi Park Ronkonkoma, New York 11779
Phone (516) 737-4850 Fax (516) 737-0720
Contact Name: Robert R. Basile, V.P.
Date Prepared: September 18, 1997
Common Name: Autoclave, table-top steam sterilizer
Trade Name: Tuttnauer Manual Autoclave Models (M, MK, MP).
Classification Name:
Steam Sterilizer Class II Device - 21 C.F.R. § 880.6880
Substantial Equivalence:
The Modified Tuttnauer Model M series autoclave is claimed to be substantially equivalent in safety and effectiveness to the Tuttnauer Model M series autoclave that is currently cleared and legally marketed under 510(k) number K833837. With the exception of the change from a ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism, the modified devices are identical to the Model M cleared under K833837.
General Description:
The Tuttnauer Model M series autoclave is a table-top steam sterilizer that includes as its main components a multi-valve control assembly & timer, water reservoir, heat source and sealed chamber. The M can sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes).
The Model M 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" and the 2540 with a chamber size of 10" x 18.7". The 3870, which has a chamber size of 15" x 27", is not subject to this corrective action.
1
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.
Intended Use:
The Model M is intended to provide sterilization of medical and dental instruments and to sterilize liquids for non-clinical applications.
Technology Considerations:
The modified Model M exhibits the same technological characteristics as the Model M, its predicate device. With the exception of a solid thrust bearing, all of the components that may be found in the unmodified Model M are identical to those in the modified version.
Safety and Effectiveness:
Because modification of the thrust bearing on the door closure mechanism does not effect the autoclave's sterilization parameters, the modified Model M series presents an identical sterilization profile.
The Tuttnauer Model M complies with domestic and international safety standards including Underwriter's Laboratories UL 544, Canadian Standards Association (CSA) medical device standards, European TUV standards and Japanese safety standards. The pressure chamber complies with ASME standards for pressure vessels and Canadian CRN requirements. Additionally, each pressure vessel is individually tested for conformance prior to release.
Conclusion:
It is Tuttnauer USA Co. Ltd.'s conclusion that the modified Model M series autoclave is substantially equivalent to its predicate device, the Tuttnauer Model M series autoclave, 510(k) number K833837. Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices.
2
DEPARTMENT OF HEALTH & HUMAN-SERVICES --------
Image /page/2/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1997
Tuttnauer USA Company, Ltd. C/O Mr. Mark M. Yacura Akin, Gump, Strauss, Hauer & Feld, L.L.P. 1333 New Hampshire Avenue, N.W., Suite 400 Washington, DC 20036
Re : K973550 Tuttnauer Table-Top Autoclaves, Models 1730, Trade Name: 2340 and 2540 "M" and "E" Series Regulatory Class: II Product Code: FLE == ========================================================================================================================================================= September 18, 1997 Dated: September 18, -1997 --------------------Received:
Dear Mr. Yacura:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531
3
Page 2 - Mr. Yacura
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely Yours,
Ky Celatrust
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
.Enclosure
4
PAGE 002 OF 002
510(k) Number: K973550
Tuttnauer Models 1730, 2340 and 2540 "M" and "E" Series Table-top Device Name: Autoclave
Indications For Use: Tuttnauer electronic and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the "E" Series; these cycles are pre-programmed, whereas in the "M" Series the user must manually set the parameters, however, these parameters are recommended in the labeling.
These 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)
Qhin S. Lin
(Division Sign-510(k) Num
Prescription Use
OR Over-The-Counter Use X
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)