(150 days)
Not Found
No
The document describes a standard steam sterilizer with automated control programs, but there is no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an autoclave designed for sterilizing medical and surgical goods, not for treating patients.
No
The device is described as a table-top autoclave designed for sterilizing medical and surgical goods. Its function is sterilization, not diagnosis.
No
The device description clearly outlines numerous hardware components including a pressure vessel, heating elements, pumps, and a physical display and keypad, indicating it is a hardware device with integrated software for control.
Based on the provided information, the ELARA-11" is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as sterilizing medical and surgical goods. This is a process performed on instruments and materials, not on biological samples taken from the human body for diagnostic purposes.
- Device Description: The description details a steam sterilizer (autoclave) with components designed for generating steam, creating vacuum, and controlling temperature and pressure. These are all functions related to sterilization, not to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of diseases based on the analysis of biological samples.
In summary, the ELARA-11" is a sterilization device used to prepare medical instruments and materials for use, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes
FLE
Device Description
General 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.
Design and Matcrials:
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.
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
ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K6 90783
pl 43
510(k) Summary
| Submitter: | Tuttnauer USA Co. Ltd.
25 Power Drive
Hauppauge, NY 11788
Phone: (631) 737-4850
Fax: (631) 737-0720 | | | | | AUG 20 2009 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|--|--|--|--|-------------|
| Contact Name: | Robert R. Basile, V.P. | | | | | |
| Date Prepared: | March 19, 2009 | | | | | |
| Common Name: | Electronic pre-vacuum autoclave, steam
sterilizer | | | | | |
| Trade Name: | Tuttnauer ELARA-11" Pre-vacuum Tabletop
Autoclave | | | | | |
| Classification Name: | Steam Sterilizer
Class 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:
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.
1
K090783
p2Jf3
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:
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.
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 | Recommended
Use | Maximum
Load
(kg/lbs) | Sterilization
Temperature
(°C/°F) | Sterilization
Time
(minutes) | Dry
Time | Max.
Cycle
Time | Ave.
Cycle
Time |
|---------------|--------------------------|-----------------------------|-----------------------------------------|------------------------------------|-------------|-----------------------|-----------------------|
| 1 (Flash 134) | unwrapped
instruments | 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))
2
| K090783 |
|---|
| p. 2 of 3 |
| | instruments,
wrapped
porous and
hollow A loads | porous -
2/4.4 | | | | | |
|--------------------------|-------------------------------------------------------------------------------|-------------------|---------|-----|----|----|----|
| 3 (NoDry 121) | unwrapped
instruments | solid -
8/17.6 | 121/250 | 20 | -- | 40 | 35 |
| 4 (WDry 121) | double-
wrapped
instruments,
wrapped
porous and
hollow A loads | solid -
8/17.6 | 121/250 | 20 | 20 | 70 | 60 |
| 5 (Delicate
121) | delicate
instruments
(porous
wrapped and
hollow 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:
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. It contains an electronic control system that makes the device automatic and fullyconfigurable.
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.
3
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.
4
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
5
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 | Recommended
Use | Maximum
Load
(kg/lbs) | Sterilization
Temperature
(°C/°F) | Sterilization
Time
(minutes) | Dry
Time | Max.
Cycle
Time | Ave.
Cycle
Time |
|--------------------------|-------------------------------------------------------------------------------|----------------------------------------|-----------------------------------------|------------------------------------|-------------|-----------------------|-----------------------|
| 1 (Flash 134) | unwrapped
instruments | solid -
8/17.6 | 134/273 | 4 | 1 | 25 | 15 |
| 2 (WDry 134) | double-
wrapped
instruments,
wrapped
porous and
hollow A loads | solid -
8/17.6
porous -
2/4.4 | 134/273 | 4 | 20 | 50 | 42 |
| 3 (NoDry 121) | unwrapped
instruments | solid -
8/17.6 | 121/250 | 20 | -- | 40 | 35 |
| 4 (WDry 121) | double-
wrapped
instruments,
wrapped
porous and
hollow A loads | solid -
8/17.6
porous -
2/4.4 | 121/250 | 20 | 20 | 70 | 60 |
| 5 (Delicate
121) | delicate
instruments
(porous
wrapped and
hollow 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 | | | | | | |
1
ELARA-11"
(sterilization chamber volume = 28.5 liters (7.5 gal))
6
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