TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE

K063681 · Mediline Italia S.R.L. · FLE · Jun 29, 2007 · General Hospital

Device Facts

• Record ID: K063681
• Device Name: TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
• Applicant: Mediline Italia S.R.L.
• Product Code: FLE · General Hospital
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended 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 and and lumened devices ) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

Device Story

Table-top steam sterilizer; uses saturated steam at high pressure/temperature to kill bio-organisms. Electric heating element generates steam within sterilization chamber. Operator selects preprogrammed cycles based on item type; device automatically admits water, heats, sterilizes, vents steam, and dries items. Used in medical/dental offices, hospitals, clinics, and nursing homes. Output is sterilized reusable medical/dental instruments. Benefits patient by ensuring effective sterilization of reusable devices, reducing infection risk.

Clinical Evidence

Bench testing only. Sterilization cycles and process parameters validated according to AAMI/ANSI ST55:2003 standards to ensure safety and effectiveness.

Technological Characteristics

Table-top steam sterilizer; electric heating element; saturated steam sterilization; preprogrammed cycles (122°C/120 kPa and 134°C/220 kPa).

Indications for Use

Indicated for sterilization of heat and moisture-stable, reusable items, including dental handpieces and lumened devices, in medical, dental, and clinical settings.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone] Fax:[phone] Email: [e-mail] 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: [phone] Fax: [phone]

Email: m [e-mail]

#### 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

000012

{1}------------------------------------------------

#### 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.

#### Intended 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 and and lumened devices ) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

| CYCLES | TIME OF<br>STERILIZATION | TIME OF<br>DRYING | WORKING<br>PRESSURE | MATERIALS | MAX.<br>LOAD |
|-------------------------------------|--------------------------|-------------------|---------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| C1<br>Not wrapped<br>134°C<br>273°F | 6<br>minutes | 17<br>minutes | 220 kPa (32<br>psi) | - Metallic<br>instruments | - 0.75 Kg (1.65 lb)<br>every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lb)<br>Whole full load |
| | | | | - Unwrapped<br>textile | - 0.5 Kg (1.1 lb)<br>Whole full load |
| C2<br>Wrapped<br>134°C<br>273°C | 11<br>minutes | 17<br>minutes | 220 kPa (32<br>psi) | - Metallic<br>instruments | - 0.75 Kg (1.65 lbs)<br>every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lbs)<br>Whole full load |
| | | | | - Dental<br>handpieces | One handpiece per<br>tray and no more than<br>3 trays as whole full<br>load |
| | | | | - Wrapped textile | - 0.5 Kg (1.1 lb)<br>Whole full load |
| C3<br>Not wrapped<br>122°C<br>252°F | 18<br>minutes | 17<br>minutes | 120 kPa (17<br>psi) | - Metallic<br>instruments | - 0.75 Kg (1.65lbs)<br>every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17lbs)<br>Whole full load |
| | | | | - Rubber or<br>plastic devices<br>(including<br>lumened devices) | - 0.5 Kg (1.1 labs)<br>every tray, at<br>maximum 4 trays<br>- 1.36 kg (2.99 lbs)<br>Whole full load |
| | | | | - Unwrapped<br>textile | - 0.5 Kg (1.1 lb)<br>Whole full load |

Standard Cycle Parameters

Page 5 of 38 CONFIDENTIAL

{2}------------------------------------------------

| C4 Wrapped<br>122°C<br>252°F | 21<br>minutes | 17<br>minutes | 120 kPa (17<br>psi) | - Metallic<br>instruments | - 0.75 Kg (1.65 lb)<br>every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lb )<br>Whole full load |
|-------------------------------------|-------------------|--------------------------------------|---------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | | | | - Dental<br>handpieces | One handpiece per<br>tray and no more than<br>3 trays as whole full<br>load |
| | | | | - Rubber or<br>plastic devices<br>(including<br>lumened devices) | - 0.5 Kg (1.1 lbs)<br>every tray, at<br>maximum 4 trays<br>- 1,36 kg (2.99 lbs)<br>Whole full load |
| | - Wrapped textile | - 0.5 Kg (1.1 lb)<br>Whole full load | | | |
| C5<br>Not wrapped<br>134°C<br>273°F | 6<br>minutes | 2<br>minutes | 220 kPa (32<br>psi) | - Metallic<br>instruments | - 0.75 Kg (1.65 lb)<br>every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lb )<br>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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

#### 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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/

{6}------------------------------------------------

| CYCLES | TIME OF<br>STERILIZATION | TIME OF<br>DRYING | WORKING<br>PRESSURE | MATERIALS | MAX.<br>LOAD |
|-------------------------------------|--------------------------|-------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C1<br>Not wrapped<br>134°C<br>273°F | 6<br>minutes | 17<br>minutes | 220 kPa (32<br>psi) | - Metallic<br>instruments<br>- Unwrapped<br>textile | - 0.75 Kg (1.65<br>lb) every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lb)<br>Whole full load<br>- 0.5 Kg (1.1 lb)<br>Whole full load |
| C2<br>Wrapped<br>134°C<br>273°C | 11<br>minutes | 17<br>minutes | 220 kPa (32<br>psi) | - Metallic<br>instruments<br>- Dental<br>handpieces<br>- Wrapped textile | - 0.75 Kg (1.65<br>lbs) every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lbs)<br>Whole full load<br>One handpiece<br>per tray and no<br>more than 3 trays<br>as whole full load<br>- 0.5 Kg (1.1 lb)<br>Whole full load |
| C3<br>Not wrapped<br>122°C<br>252°F | 18<br>minutes | 17<br>minutes | 120 kPa (17<br>psi) | - Metallic<br>instruments<br>- Rubber or<br>plastic devices<br>(including<br>lumened devices)<br>- Unwrapped<br>textile | - 0.75 Kg (<br>1.65lbs) every<br>tray, at maximum<br>4 trays<br>- 2.8 kg (6.17lbs)<br>Whole full load<br>- 0.5 Kg (1.1<br>labs) every tray,<br>at maximum 4<br>trays<br>- 1,36 kg (2.99<br>lbs)<br>Whole full load<br>- 0.5 Kg (1.1 lb)<br>Whole full load |
| C4 Wrapped<br>122°C<br>252°F | 21<br>minutes | 17<br>minutes | 120 kPa (17<br>psi) | - Metallic<br>instruments<br>- Dental<br>handpieces<br>- Rubber or<br>plastic devices<br>(including<br>lumened devices)<br>- Wrapped textile | - 0.75 Kg (1.65<br>lb) every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lb )<br>Whole full load<br>One handpiece<br>per tray and no<br>more than 3 trays<br>as whole full load<br>- 0.5 Kg (1.1<br>labs) every tray,<br>at maximum 4<br>trays<br>- 1,36 kg (2.99<br>Ibs)<br>Whole full load<br>- 0.5 Kg (1.1 lb)<br>Whole full load |
| C5<br>Not wrapped<br>134°C<br>273°F | 6<br>minutes | 2<br>minutes | 220 kPa (32<br>psi) | - Metallic<br>instruments | - 0.75 Kg (1.65<br>lb) every tray, at<br>maximum 4 trays<br>- 2.8 kg (6.17 lb )<br>Whole full load |

# Standard Cycle Parameters

Page 2 of _ 2

、

.