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℃ 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.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Tuttnauer E Series Electronic Table-top Autoclave are implicit in its intended use and the validation studies performed. Since this is a 510(k) submission for a modification to an already cleared device, the primary acceptance criterion is substantial equivalence to the predicate device, specifically regarding the ability to sterilize dental handpieces effectively.

The reported device performance, based on the non-clinical testing, directly addresses this criterion.

Acceptance Criterion (Implicit)	Reported Device Performance and Evidence
Effective sterilization of dental handpieces (as unwrapped or wrapped instruments)	"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.""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."
Maintenance of pre-programmed sterilization cycle parameters (134°C at 4 minutes for unwrapped, 134°C at 8 minutes for wrapped, 121°C at 30 minutes for liquids)	"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 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."
Conformance to ASME code (for pressure chamber, door, and locking device)	"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."
Functional equivalence to predicate device (K920478), with the change being labeling and ability to sterilize dental handpieces.	"The modified Tuttnaver E Series Electronic Table-top Autoclave is substantially equivalent to the following currently cleared and legally marketed autoclave: 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.""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."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document mentions "Representative handpieces from various manufacturers were inoculated" and "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." It also states, "effectively sterilize up to 5 dental handpieces contained within them during normal autoclave operation."
- Interpretation: While a precise number isn't given for "various manufacturers," it implies a selection. For the actual testing, it specifies 3 half-cycle tests for unwrapped handpieces and 3 half-cycle tests for wrapped handpieces. The device demonstrated the ability to sterilize "up to 5 dental handpieces" in a single cycle.
Data Provenance: This was a prospective non-clinical validation study conducted by Tuttnauer USA Co. Ltd. The country of origin of the data is implicitly the USA, where Tuttnauer USA Co. Ltd. is located and where the testing was likely performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not provided in the given text. For sterilization validation, the "ground truth" is typically established through microbiological testing (e.g., spore strips, biological indicators) which demonstrates the killing of resilient microorganisms, rather than expert consensus on visual assessment. The text states "inoculated in their most difficult to sterilize areas," implying a microbiological challenge.

4. Adjudication method for the test set

This is not applicable and not mentioned in the provided text, as the validation of a sterilizer's effectiveness relies on objective microbiological and physical parameters (temperature, pressure, time), not on human interpretation or adjudication of images or clinical diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This is not applicable and not mentioned. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and their performance with and without AI assistance is compared. This document concerns a sterilizer, where the "outcome" is sterility, measured objectively.

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

This is not applicable in the context of a sterilizer. The device itself is the "algorithm," controlling the physical process. Its performance is evaluated directly through its ability to achieve sterility without human intervention in the sterilization process itself (beyond loading and operating the machine). The validation studies described are effectively "standalone" in this regard for the device's function.

7. The type of ground truth used

The ground truth used for the validation studies was likely microbiological sterility, demonstrated by challenging the device with microorganisms ("inoculated in their most difficult to sterilize areas") and subsequently verifying their inactivation. While not explicitly stated as "microbiological testing," the context strongly implies this by using terms like "inoculated" and "effective sterilization."

8. The sample size for the training set

This is not applicable and not provided. This device is a physical sterilizer and its control system is described as a microprocessor with validated software. It is not an AI/ML device that requires a "training set" in the conventional sense. The "training" for such a system would be the design, programming, and rigorous testing of the software itself against engineering specifications.

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

This is not applicable for the reasons stated in point 8. The validation of the software (mentioned as "The software has been validated to ensure compliance with all applicable requirements") would typically involve testing against predefined engineering requirements and safety standards, not against a "ground truth" derived from data in the way an AI/ML model would be trained.

Summary

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FEB - 9 2001

993856

510(K) SUMMARY

Submitter:	Tuttnauer USA Co. Ltd.33 Comac Loop, Equi-ParkRonkonkoma, 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 SterilizerClass 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:

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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.

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.

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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

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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

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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

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _

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).