Tecno-Gaz ANDROMEDA VACUUM CS Autoclave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, and other facilities to sterilize heat and moisture-stable, reusable items (including dental hand pieces and and lumened devices ) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

Device Description

The Tecno-Gaz ANDROMEDA VACUUM CS autoclave is a table-top Steam Sterilizer and uses saturated steam at high pressures and temperatures to kill infectious bio-organisms. The steam is generated in the sterilization chamber by an electric heating clement surrounding the chamber. Sterilization cycles are preprogrammed to complete each sterilization cycle according to the established times, temperature, and pressure parameter. These sterilization cycles are selected by an operator depending on the type of items to be sterilized.

The sterilizer automatically admits a controlled volume of water into the chamber, start heating process and steam generation, sterilizes the items. At the end of sterilization process the autoclave automatically vents the steam and dries the items.

AI/ML Overview

The provided text describes the Tecno-Gaz ANDROMEDA VACUUM CS Autoclave, a steam sterilizer, and reports on its substantial equivalence to predicate devices, but it does not detail specific acceptance criteria for a device's performance in a diagnostic or AI context, nor does it describe a study using a test set with expert adjudication.

Instead, the document focuses on the sterilizer's operational parameters and its intended use, with a statement that its processes and cycles are validated according to a specific standard.

Therefore, many of the requested elements for describing acceptance criteria and a study proving performance are not applicable or cannot be extracted from this document, as it is related to a sterilization device and not a diagnostic AI system or a device requiring such performance criteria.

However, I can extract information related to the device's operational parameters which could be considered its performance characteristics.

Here's a breakdown of what can be inferred or stated as "not applicable" based on the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are framed as the "Standard Cycle Parameters" that the device is designed to meet for effective sterilization. The document states that all process parameters and cycles are validated to ensure the sterilization process is safe and effective.

Acceptance Criterion (Cycle Parameter)	Reported Device Performance (as stated in the "Standard Cycle Parameters" table)
C1 Not wrapped 134°C (273°F)	Time of Sterilization: 6 minutesTime of Drying: 17 minutesWorking Pressure: 220 kPa (32 psi)Materials: Metallic instruments, Unwrapped textileMax. Load (Metallic instruments): 0.75 Kg (1.65 lb) every tray, at maximum 4 trays; 2.8 kg (6.17 lb) Whole full loadMax. Load (Unwrapped textile): 0.5 Kg (1.1 lb) Whole full load
C2 Wrapped 134°C (273°C)	Time of Sterilization: 11 minutesTime of Drying: 17 minutesWorking Pressure: 220 kPa (32 psi)Materials: Metallic instruments, Dental handpieces, Wrapped textileMax. Load (Metallic instruments): 0.75 Kg (1.65 lbs) every tray, at maximum 4 trays; 2.8 kg (6.17 lbs) Whole full loadMax. Load (Dental handpieces): One handpiece per tray and no more than 3 trays as whole full loadMax. Load (Wrapped textile): 0.5 Kg (1.1 lb) Whole full load
C3 Not wrapped 122°C (252°F)	Time of Sterilization: 18 minutesTime of Drying: 17 minutesWorking Pressure: 120 kPa (17 psi)Materials: Metallic instruments, Rubber or plastic devices (including lumened devices), Unwrapped textileMax. Load (Metallic instruments): 0.75 Kg (1.65lbs) every tray, at maximum 4 trays; 2.8 kg (6.17lbs) Whole full loadMax. Load (Rubber or plastic devices): 0.5 Kg (1.1 lbs) every tray, at maximum 4 trays; 1.36 kg (2.99 lbs) Whole full loadMax. Load (Unwrapped textile): 0.5 Kg (1.1 lb) Whole full load
C4 Wrapped 122°C (252°F)	Time of Sterilization: 21 minutesTime of Drying: 17 minutesWorking Pressure: 120 kPa (17 psi)Materials: Metallic instruments, Dental handpieces, Rubber or plastic devices (including lumened devices), Wrapped textileMax. Load (Metallic instruments): 0.75 Kg (1.65 lb) every tray, at maximum 4 trays; 2.8 kg (6.17 lb) Whole full loadMax. Load (Dental handpieces): One handpiece per tray and no more than 3 trays as whole full loadMax. Load (Rubber or plastic devices): 0.5 Kg (1.1 lbs) every tray, at maximum 4 trays; 1.36 kg (2.99 Ibs) Whole full loadMax. Load (Wrapped textile): 0.5 Kg (1.1 lb) Whole full load
C5 Not wrapped 134°C (273°F)	Time of Sterilization: 6 minutesTime of Drying: 2 minutesWorking Pressure: 220 kPa (32 psi)Materials: Metallic instrumentsMax. Load (Metallic instruments): 0.75 Kg (1.65 lb) every tray, at maximum 4 trays; 2.8 kg (6.17 lb) Whole full load

Study Details:

Sample size used for the test set and the data provenance: Not applicable. This device is a sterilizer, not a diagnostic tool requiring a "test set" of patient data. The validation refers to performance tests of the sterilization cycles.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a sterilizer is established by demonstrating the destruction of microorganisms, typically through standardized biological indicator tests, rather than expert interpretation of images or patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 standalone sterilization device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device operates in a standalone capacity to perform sterilization. Its performance is evaluated based on its ability to meet the specified cycle parameters and effectively sterilize items. The document states: "All process parameters and cycles are validated with performance tests according to the AAMI/ANSI ST55:2003 standards to assure that sterilization process is safe and effective." This indicates a standalone performance evaluation against a recognized standard.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a sterilizer would be the complete inactivation or destruction of microorganisms. This is typically established through biological indicators (BIs) or chemical indicators (CIs) and confirmed by microbiological laboratory testing, demonstrating a specified Sterility Assurance Level (SAL). The document mentions validation against "AAMI/ANSI ST55:2003 standards," which implies adherence to these methods for determining sterilization efficacy.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

Summary

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K063681

SECTION 3:

JUN 2 9 2007

510(K) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter: Mediline Italia Srl Via 8 Marzo, 4 - CorteTegge 42025 Cavriago (Reggio Emilia) -ITALY Tel: +39 0522 942996 Fax:+39 0522 944798 Email: aq.mediline@tecnogaz.com Contact Person: Pantaleoni Maurizio (Consultant) I.SE.NET Via Emilia, 418, 40068 - San Lazzaro di Savena (Bologna) - Italy

Contact Person:

Summary Preparation Date:

December 7, 2006

Tel: +39 051 6257315 Fax: +39 051 6284344

Email: m pantaleoni@libero.it

Device Names

Device Name: Tecno-Gaz ANDROMEDA VACUUM CS Autoclave

Classification Name: Sterilizer, Steam, Classified as Class II Regulation number: 21 CFR 880.6880

Product Code: FLE

Predicate Devices

The Tecno-Gaz ANDROMEDA VACUUM CS Autoclave is substantially equivalent to the following devices:

V Midmark M9 Ultraclave Steam Sterilizer (K023348),
Tuttnauer EHS Series Table top autoclave (K003470)
Prestige Medical Series 2100 Clinical Autoclave (K962903)

Page 4 of 38 CONFIDENTIAL

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Device Description

Intended Use

CYCLES	TIME OFSTERILIZATION	TIME OFDRYING	WORKINGPRESSURE	MATERIALS	MAX.LOAD
C1Not wrapped134°C273°F	6minutes	17minutes	220 kPa (32psi)	- Metallicinstruments	- 0.75 Kg (1.65 lb)every tray, atmaximum 4 trays- 2.8 kg (6.17 lb)Whole full load
				- Unwrappedtextile	- 0.5 Kg (1.1 lb)Whole full load
C2Wrapped134°C273°C	11minutes	17minutes	220 kPa (32psi)	- Metallicinstruments	- 0.75 Kg (1.65 lbs)every tray, atmaximum 4 trays- 2.8 kg (6.17 lbs)Whole full load
				- Dentalhandpieces	One handpiece pertray and no more than3 trays as whole fullload
				- Wrapped textile	- 0.5 Kg (1.1 lb)Whole full load
C3Not wrapped122°C252°F	18minutes	17minutes	120 kPa (17psi)	- Metallicinstruments	- 0.75 Kg (1.65lbs)every tray, atmaximum 4 trays- 2.8 kg (6.17lbs)Whole full load
				- Rubber orplastic devices(includinglumened devices)	- 0.5 Kg (1.1 labs)every tray, atmaximum 4 trays- 1.36 kg (2.99 lbs)Whole full load
				- Unwrappedtextile	- 0.5 Kg (1.1 lb)Whole full load

Standard Cycle Parameters

Page 5 of 38 CONFIDENTIAL

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C4 Wrapped122°C252°F	21minutes	17minutes	120 kPa (17psi)	- Metallicinstruments	- 0.75 Kg (1.65 lb)every tray, atmaximum 4 trays- 2.8 kg (6.17 lb )Whole full load
				- Dentalhandpieces	One handpiece pertray and no more than3 trays as whole fullload
				- Rubber orplastic devices(includinglumened devices)	- 0.5 Kg (1.1 lbs)every tray, atmaximum 4 trays- 1,36 kg (2.99 lbs)Whole full load
	- Wrapped textile	- 0.5 Kg (1.1 lb)Whole full load
C5Not wrapped134°C273°F	6minutes	2minutes	220 kPa (32psi)	- Metallicinstruments	- 0.75 Kg (1.65 lb)every tray, atmaximum 4 trays- 2.8 kg (6.17 lb )Whole full load

Comparison to Predicate Devices

The substantial equivalence comparison has been performed comparing the intended use, the technological characteristics and the cycle characteristics of the Tecno-Gaz Andromeda Vacuum CS to the predicate devices.

The intended use and the technological characteristics of the Tecno-Gaz Andromeda Vacuum CS and Midmark M9 Ultraclave Steam Sterilizer (K023348) are very similar, and both autoclaves conform to the same industrial standards.

Minor difference between Tecno-Gaz Andromeda Vacuum CS and predicate devices is further discussed in detail in Section 6. All process parameters and cycles are validated with performance tests according to the AAMI/ANSI ST55:2003 standards to assure that sterilization process is safe and effective.

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Image /page/3/Picture/11 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body. The text is in all capital letters and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Mediline Italia S.r.l. C/O Mr. Maurizio Pantaleoni Consultant Alta Consulting LLC 6512 Bannockburn Drive Bethesda, MD 20817

Re: K063681

Trade/Device Name: Tecno-Gaz ANDROMEDA VACCUM CS Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 15, 2007 Received: June 25, 2007

Dear Mr. Pantaleoni:

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 such 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. Pantaleoni

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Susan Rumores

Chiu Lin, Ph.D. 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 (if known): K063681

Tecno-Gaz ANDROMEDA VACUUM CS Device Name:

Indications For Use:

Tecno-Gaz ANDROMEDA VACUUM CS Autoclave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, and other facilities to sterilize heat and moisture-stable, reusable items (including dental hand pieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stark H. Murphy, M.D.

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

Page 1 of

510(k) Number: / K06318/

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CYCLES	TIME OFSTERILIZATION	TIME OFDRYING	WORKINGPRESSURE	MATERIALS	MAX.LOAD
C1Not wrapped134°C273°F	6minutes	17minutes	220 kPa (32psi)	- Metallicinstruments- Unwrappedtextile	- 0.75 Kg (1.65lb) every tray, atmaximum 4 trays- 2.8 kg (6.17 lb)Whole full load- 0.5 Kg (1.1 lb)Whole full load
C2Wrapped134°C273°C	11minutes	17minutes	220 kPa (32psi)	- Metallicinstruments- Dentalhandpieces- Wrapped textile	- 0.75 Kg (1.65lbs) every tray, atmaximum 4 trays- 2.8 kg (6.17 lbs)Whole full loadOne handpieceper tray and nomore than 3 traysas whole full load- 0.5 Kg (1.1 lb)Whole full load
C3Not wrapped122°C252°F	18minutes	17minutes	120 kPa (17psi)	- Metallicinstruments- Rubber orplastic devices(includinglumened devices)- Unwrappedtextile	- 0.75 Kg (1.65lbs) everytray, at maximum4 trays- 2.8 kg (6.17lbs)Whole full load- 0.5 Kg (1.1labs) every tray,at maximum 4trays- 1,36 kg (2.99lbs)Whole full load- 0.5 Kg (1.1 lb)Whole full load
C4 Wrapped122°C252°F	21minutes	17minutes	120 kPa (17psi)	- Metallicinstruments- Dentalhandpieces- Rubber orplastic devices(includinglumened devices)- Wrapped textile	- 0.75 Kg (1.65lb) every tray, atmaximum 4 trays- 2.8 kg (6.17 lb )Whole full loadOne handpieceper tray and nomore than 3 traysas whole full load- 0.5 Kg (1.1labs) every tray,at maximum 4trays- 1,36 kg (2.99Ibs)Whole full load- 0.5 Kg (1.1 lb)Whole full load
C5Not wrapped134°C273°F	6minutes	2minutes	220 kPa (32psi)	- Metallicinstruments	- 0.75 Kg (1.65lb) every tray, atmaximum 4 trays- 2.8 kg (6.17 lb )Whole full load

Standard Cycle Parameters

Page 2 of _ 2

、

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).