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.

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.

AI/ML Overview

The provided document describes a 510(k) submission for a corrective action to a previously cleared device, not a new device or an AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design for performance, MRMC studies, standalone performance, and extensive details about ground truth and training sets for an AI/software product is not applicable.

This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Tuttnauer Manual Autoclave Models M, MK, MP) to its predicate device, primarily due to a change in a single mechanical component: the door closure mechanism's thrust bearing.

Here's an attempt to answer the questions based on the available information, noting where sections are not applicable:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for a Mechanical Modification)	Reported Device Performance
Safety:
- Maintain safety profile equivalent to predicate device.	- "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." - "Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices."
- Conformance to relevant safety and pressure vessel standards (UL 544, CSA, TUV, Japanese safety standards, ASME, CRN).	- Explicitly stated compliance: UL 544, CSA, European TUV, Japanese safety standards. - Pressure chamber complies with ASME standards and Canadian CRN requirements.
- Safe operation of the door closure assembly.	- "Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices."
Effectiveness:
- Maintain sterilization effectiveness equivalent to predicate device.	- "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." - Maintans ability to sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes), and liquids (121°C at 30 minutes).
Substantial Equivalence:
- Demonstrate substantial equivalence to the predicate device (Tuttnauer Model M series autoclave, K833837).	- "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." - "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." - "The modified Model M exhibits the same technological characteristics as the Model M, its predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable in the context of an AI/software device performance study. This submission is for a physical device modification.
The document mentions "individually tested for conformance prior to release" for each pressure vessel, implying a manufacturing quality control process, but not a formal clinical or performance study with a defined sample size for a "test set" in the sense of evaluating an algorithm. The evidence presented appears to be based on engineering calculations and ASME testing of the door closure assembly, and the assumption that changing one mechanical component (the thrust bearing) does not alter the fundamental sterilization parameters of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/software device requiring expert-established ground truth for a diagnostic performance evaluation. The "ground truth" for a sterilizer is its ability to effectively sterilize, which is evaluated through physical and microbiological validation methods, not expert consensus on images or data. The document does not detail specific microbiological validation studies for this modification, relying instead on the argument that the mechanical change does not affect sterilization parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned or relevant for this type of submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of an AI/software device. For this mechanical modification, the "ground truth" for safety and effectiveness is implicitly based on adherence to engineering principles, material specifications, and the established physical and biological performance characteristics of the predicate device. The claim is that the modification does not alter these established characteristics.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/software device.

9. How the ground truth for the training set was established

Not applicable. There is no training set as this is not an AI/software device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as presented for this 510(k) submission):

The "study" or evidence provided to support the substantial equivalence claim for the modified Tuttnauer M series autoclaves is based on:

Engineering Evaluation: The core argument is that the change from a "ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism" is a minor modification that "does not effect the autoclave's sterilization parameters." This implies an engineering assessment that the mechanical change does not impart new risks or alter the fundamental function related to sterilization.
Compliance with Established Standards: The device's safety is supported by its compliance with various domestic and international safety standards (UL 544, CSA, European TUV, Japanese safety standards) and pressure vessel standards (ASME, Canadian CRN). The submission asserts that the modification does not compromise this compliance.
Individual Testing: Each pressure vessel is "individually tested for conformance prior to release."
Reference to Predicate Device: The modified device is declared "identical to the Model M cleared under K833837" with the single exception of the thrust bearing, and it "exhibits the same technological characteristics." The performance of the predicate device (K833837) implicitly forms the benchmark for the modified device's expected safety and effectiveness, which is claimed to be unchanged.

Essentially, the "study" is a justification that the specific, limited mechanical change does not negate the established safety and effectiveness profile of the original device, relying on engineering principles and continued adherence to standards rather than new performance testing for sterilization efficacy.

Summary

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Special 510(k) - Corrective Action Being Taken Door Closure Modification

510(K) Summarv

K973550

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 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.

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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.

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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

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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

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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)

Regulation Number and Section

§ 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).