(200 days)
Not Found
No
The description details a standard steam sterilization process with preprogrammed cycles and automatic functions based on established parameters, with no mention of AI or ML.
No
The device is an autoclave used for sterilizing medical instruments, not for directly treating a condition or disease in a patient.
No
This device is a sterilizer that uses steam to kill bio-organisms on reusable items, not to diagnose medical conditions.
No
The device description clearly states it is a "table-top Steam Sterilizer" and describes physical components like an "electric heating element" and a "sterilization chamber," indicating it is a hardware device with integrated software for control.
Based on the provided information, the Tecno-Gaz ANDROMEDA VACUUM CS Autoclave is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to sterilize reusable items (medical and dental instruments) to kill infectious bio-organisms. This is a sterilization process for instruments, not a diagnostic test performed on biological samples from a patient.
- Device Description: The device description clearly states it's a "table-top Steam Sterilizer" that uses heat and pressure to sterilize items. It does not mention any function related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is a medical device used for sterilization, which is a critical process in healthcare settings, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental offices, hospitals, clinics, nursing homes, and other facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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
STERILIZATION | TIME OF
DRYING | WORKING
PRESSURE | MATERIALS | MAX.
LOAD |
|-------------------------------------|--------------------------|-------------------|---------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| C1
Not wrapped
134°C
273°F | 6
minutes | 17
minutes | 220 kPa (32
psi) | - Metallic
instruments | - 0.75 Kg (1.65 lb)
every tray, at
maximum 4 trays
- 2.8 kg (6.17 lb)
Whole full load |
| | | | | - Unwrapped
textile | - 0.5 Kg (1.1 lb)
Whole full load |
| C2
Wrapped
134°C
273°C | 11
minutes | 17
minutes | 220 kPa (32
psi) | - Metallic
instruments | - 0.75 Kg (1.65 lbs)
every tray, at
maximum 4 trays - 2.8 kg (6.17 lbs)
Whole full load |
| | | | | - Dental
handpieces | One handpiece per
tray and no more than
3 trays as whole full
load |
| | | | | - Wrapped textile | - 0.5 Kg (1.1 lb)
Whole full load |
| C3
Not wrapped
122°C
252°F | 18
minutes | 17
minutes | 120 kPa (17
psi) | - Metallic
instruments | - 0.75 Kg (1.65lbs)
every tray, at
maximum 4 trays - 2.8 kg (6.17lbs)
Whole full load |
| | | | | - Rubber or
plastic devices
(including
lumened devices) | - 0.5 Kg (1.1 labs)
every tray, at
maximum 4 trays - 1.36 kg (2.99 lbs)
Whole full load |
| | | | | - Unwrapped
textile | - 0.5 Kg (1.1 lb)
Whole full load |
Standard Cycle Parameters
Page 5 of 38 CONFIDENTIAL
2
| C4 Wrapped
122°C
252°F | 21
minutes | 17
minutes | 120 kPa (17
psi) | - Metallic
instruments | - 0.75 Kg (1.65 lb)
every tray, at
maximum 4 trays
- 2.8 kg (6.17 lb )
Whole full load |
|-------------------------------------|-------------------|--------------------------------------|---------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | | | | - Dental
handpieces | One handpiece per
tray and no more than
3 trays as whole full
load |
| | | | | - Rubber or
plastic devices
(including
lumened devices) | - 0.5 Kg (1.1 lbs)
every tray, at
maximum 4 trays - 1,36 kg (2.99 lbs)
Whole full load |
| | - Wrapped textile | - 0.5 Kg (1.1 lb)
Whole full load | | | |
| C5
Not wrapped
134°C
273°F | 6
minutes | 2
minutes | 220 kPa (32
psi) | - Metallic
instruments | - 0.75 Kg (1.65 lb)
every tray, at
maximum 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.
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 (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
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
STERILIZATION | TIME OF
DRYING | WORKING
PRESSURE | MATERIALS | MAX.
LOAD |
|-------------------------------------|--------------------------|-------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C1
Not wrapped
134°C
273°F | 6
minutes | 17
minutes | 220 kPa (32
psi) | - Metallic
instruments
- Unwrapped
textile | - 0.75 Kg (1.65
lb) every tray, at
maximum 4 trays - 2.8 kg (6.17 lb)
Whole full load - 0.5 Kg (1.1 lb)
Whole full load |
| C2
Wrapped
134°C
273°C | 11
minutes | 17
minutes | 220 kPa (32
psi) | - Metallic
instruments - Dental
handpieces - Wrapped textile | - 0.75 Kg (1.65
lbs) every tray, at
maximum 4 trays - 2.8 kg (6.17 lbs)
Whole full load
One handpiece
per tray and no
more than 3 trays
as whole full load - 0.5 Kg (1.1 lb)
Whole full load |
| C3
Not wrapped
122°C
252°F | 18
minutes | 17
minutes | 120 kPa (17
psi) | - Metallic
instruments - Rubber or
plastic devices
(including
lumened devices) - Unwrapped
textile | - 0.75 Kg (
1.65lbs) every
tray, at maximum
4 trays - 2.8 kg (6.17lbs)
Whole full load - 0.5 Kg (1.1
labs) every tray,
at maximum 4
trays - 1,36 kg (2.99
lbs)
Whole full load - 0.5 Kg (1.1 lb)
Whole full load |
| C4 Wrapped
122°C
252°F | 21
minutes | 17
minutes | 120 kPa (17
psi) | - Metallic
instruments - Dental
handpieces - Rubber or
plastic devices
(including
lumened devices) - Wrapped textile | - 0.75 Kg (1.65
lb) every tray, at
maximum 4 trays - 2.8 kg (6.17 lb )
Whole full load
One handpiece
per tray and no
more than 3 trays
as whole full load - 0.5 Kg (1.1
labs) every tray,
at maximum 4
trays - 1,36 kg (2.99
Ibs)
Whole full load - 0.5 Kg (1.1 lb)
Whole full load |
| C5
Not wrapped
134°C
273°F | 6
minutes | 2
minutes | 220 kPa (32
psi) | - Metallic
instruments | - 0.75 Kg (1.65
lb) every tray, at
maximum 4 trays - 2.8 kg (6.17 lb )
Whole full load |
Standard Cycle Parameters
Page 2 of _ 2
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