The ELARA-11" is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.

Device Description

The automated Tuttnauer ELARA-11" is a table-top steam sterilizer (i.e., autoclave) designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories. This device is a pre-vacuum and post-vacuum sterilizer that has an air removal stage (i.e., pre-vacuum) before the start of the sterilization stage, as well as a post-sterilization drying stage that is based upon the combined operation of heat plus vacuum with air inlet pulses. The sterilizing agent is steam that is electrically-generated from either mineral-free or distilled water that is added to the built-in reservoir.

The ELARA-11" is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including an automated safety door with a doublesafety locking mechanism and an automatic safety shutoff. The front panel of the device consists of a display screen, a keypad, and a printer. The ELARA-11" electronic control system is automatic, fully-configurable, and has a total of seven (7) programs: five (5) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the VacTest program). The components are made of varying grades of stainless steel.

AI/ML Overview

The Elara-11" Pre-vacuum Tabletop Autoclave is a medical device designed for sterilizing medical and surgical goods. The device underwent non-clinical testing to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document refers to the acceptance criteria established by AAMI/ANSI ST55:2003 for tabletop steam sterilizers. The document states that the ELARA-11" meets "all aspects of the standard, including physical and microbiological performance requirements."

However, specific numerical performance metrics from the study are not provided in the summary. For example, details like the specific biological indicator kill rates, physical parameter tolerances, or dry times for various load types, which would be part of AAMI/ANSI ST55:2003, are not explicitly stated as results. The table below represents the available information:

Acceptance Criteria (AAMI/ANSI ST55:2003)	Reported Device Performance (ELARA-11")
Physical performance requirements	Met all aspects of the standard
Microbiological performance requirements	Met all aspects of the standard

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set. It mentions "validation studies" and "testing shows," implying multiple trials or conditions were tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given that this is a 510(k) submission for a new device, it is highly likely that the "validation studies" were prospectively conducted by Tuttnauer USA Co. Ltd. to demonstrate the device's efficacy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide details on the number of experts, if any, used to establish ground truth. For sterilization validation, ground truth is typically established through established testing protocols and methodologies (e.g., biological indicators, thermocouples, chemical indicators) as defined by standards like AAMI/ANSI ST55:2003, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

Not applicable. As described in point 3, ground truth in sterilization validation is established through objective measurements and accepted testing methodologies, not through expert adjudication of subjective results.

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 a sterilization device, not an AI-powered diagnostic or imaging device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a sterilization device. There is no "algorithm only" performance concept in this context. The "device" itself performs the sterilization process automatically.

7. The Type of Ground Truth Used:

The ground truth for evaluating the ELARA-11" would have been established through objective measurements and validated methods as specified by AAMI/ANSI ST55:2003. This would include:

Microbiological data: Use of Biological Indicators (BIs) to demonstrate a sufficient kill (e.g., 6-log reduction) of resistant microorganisms (e.g., Geobacillus stearothermophilus spores).
Physical data: Monitoring of temperature, pressure, and time throughout the sterilization cycle using calibrated sensors.
Chemical data: Use of Chemical Indicators (CIs) to provide immediate visual confirmation of exposure to sterilant conditions.
Load testing: Verification of sterility and drying for various load types (e.g., wrapped instruments, porous loads, hollow A items) and maximum load configurations.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set. Its operational parameters are based on scientific principles of steam sterilization and validated through non-clinical testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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K6 90783

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510(k) Summary

Submitter:	Tuttnauer USA Co. Ltd.25 Power DriveHauppauge, NY 11788Phone: (631) 737-4850Fax: (631) 737-0720					AUG 20 2009
Contact Name:	Robert R. Basile, V.P.
Date Prepared:	March 19, 2009
Common Name:	Electronic pre-vacuum autoclave, steamsterilizer
Trade Name:	Tuttnauer ELARA-11" Pre-vacuum TabletopAutoclave
Classification Name:	Steam SterilizerClass II Device - 21 C.F.R. § 880.6880

Substantial Equivalence:

The ELARA-11" is claimed to be substantially equivalent to the autoclaves cleared under K063711. Like these autoclaves, the ELARA-11" contains an electronic control panel that permits automatic usage, and it contains identical software to the autoclaves cleared under K063711. The ELARA-11" is a smaller models to which substantial equivalence is claimed (i.e., it is designed for a countertop). The nominal parameters (e.g., sterilization temperature and time; dry time; and maximum/average cycle times) are also different for the ELARA-11" than for the devices under K063711; however, all devices use steam as the sterilization agent.

General Description:

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K090783
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Only United States Food and Drug Administration cleared accessories such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes should be used with this autoclave. Sterilization programs 1, 2, 3, 4, and 5 are not considered by the Food and Drug Administration to be standard sterilization cycles. There are currently no stcrilization wraps, sterilization pouches, chemical indicators, biological indicators, or sterilization cassettes cleared for use by the Food and Drug Administration for the specific sterilization parameters of sterilizer programs 1, 2, 3, 4, or 5.

Design and Matcrials:

Comparison to Cleared Devices:

Although the ELARA-11" and the six (6) models cleared under K063711 differ in device size and program cycles, they all operate with an electronic control panel that permits automated usage, and all models utilize the same operational software. Furthermore, they all use steam as the sterilization agent.

The ELARA-11" is a table-top autoclave designed for sterilizing medical Indications for Use: and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.

Key program features, including cycle times, temperature, maximum load sizes, and recommended use of each program are listed in the following chart:

Program	RecommendedUse	MaximumLoad(kg/lbs)	SterilizationTemperature(°C/°F)	SterilizationTime(minutes)	DryTime	Max.CycleTime	Ave.CycleTime
1 (Flash 134)	unwrappedinstruments	solid -8/17.6	134/273	4	1	25	15
2 (WDry 134)	double-wrapped	solid -8/17.6	134/273	4	20	50	42

ELARA-11" (sterilization chamber volume = 28.5 liters (7.5 gal))

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K090783
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	instruments,wrappedporous andhollow A loads	porous -2/4.4
3 (NoDry 121)	unwrappedinstruments	solid -8/17.6	121/250	20	--	40	35
4 (WDry 121)	double-wrappedinstruments,wrappedporous andhollow A loads	solid -8/17.6	121/250	20	20	70	60
5 (Delicate121)	delicateinstruments(porouswrapped andhollow A)	solid -8/17.6	121/250	20	--	55	45
Test 1 (Bowie& Dick)	--	--	134 C	3.5	1	30	25
Test 2(VacTest)	Cycle time - 20 min

Technology:

Non-Clinical Testing:

Tuttnauer conducted validation studies in accordance with AAMI/ANSI ST55:2003. Testing shows that the ELARA-11" meets all aspects of the standard, including physical and microbiological performance requirements.

Conclusion:

For all of the foregoing reasons, Tuttnauer believes that the ELARA-11" autoclave model described in this 510(k) notification may be safely marketed in the United States.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing snakes intertwined around a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 9 0 2009

Tuttnauer USA Company, Limited C/O Mr. Theodore Sullivan Buchanan Ingersoll and Rooney, LLP 1700 K Street, N.W., Suite 300 Washington, District of Columbia 20006

Re: K090783

Trade/Device Name: Tuttnauer ELARA-11" Pre-Vacuum Tabletop Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: July 24, 2009 Received: July 28, 2009

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, 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 controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Sullivan

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Anzelone

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

Device Name : Tuttnauer ELARA-11" Pre-vacuum Tabletop Autoclave

Indications for Use: The ELARA-11" is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.

Key program features, including cycle times, temperature, maximum load sizes, and recommended use of each program are listed in the following chart:

Program	RecommendedUse	MaximumLoad(kg/lbs)	SterilizationTemperature(°C/°F)	SterilizationTime(minutes)	DryTime	Max.CycleTime	Ave.CycleTime
1 (Flash 134)	unwrappedinstruments	solid -8/17.6	134/273	4	1	25	15
2 (WDry 134)	double-wrappedinstruments,wrappedporous andhollow A loads	solid -8/17.6porous -2/4.4	134/273	4	20	50	42
3 (NoDry 121)	unwrappedinstruments	solid -8/17.6	121/250	20	--	40	35
4 (WDry 121)	double-wrappedinstruments,wrappedporous andhollow A loads	solid -8/17.6porous -2/4.4	121/250	20	20	70	60
5 (Delicate121)	delicateinstruments(porouswrapped andhollow A)	solid -8/17.6	121/250	20	--	55	45
Test 1 (Bowie& Dick)		--	134 C	3.5	1	30	25
Test 2(VacTest)	Cycle time - 20 min

ELARA-11"

(sterilization chamber volume = 28.5 liters (7.5 gal))

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Prescription Use (21 C.F.R. 801 Subpart D)

AND/OR

Over-the-Counter Use X (21 C.F.R. 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule T. Murphy MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K040783

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).