(58 days)
Not Found
No
The description focuses on standard autoclave technology and control systems, with no mention of AI or ML capabilities.
No.
The device is an autoclave designed for sterilizing medical and surgical goods and instruments, not for diagnosing, curing, mitigating, treating, or preventing disease, which is the definition of a therapeutic device.
No
The devices described (ELARA-11 and Model 5075 HSG) are autoclaves designed for sterilizing medical and surgical goods and instruments. Their function is to clean and prepare items for use, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components like pressure vessels, heating elements, pumps, and a manual safety door, indicating it is a hardware device with integrated software for control.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of both the ELARA-11 and the Model 5075 HSG is to sterilize medical and surgical goods, instruments, and related items. This is a process performed on medical devices and materials, not on biological specimens or samples taken from the human body for diagnostic purposes.
- Device Description: The device descriptions detail the components and function of autoclaves, which are sterilization devices. They do not describe any components or processes 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 substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Reagents, calibrators, or controls used in diagnostic testing
The devices are clearly intended for the sterilization of medical equipment, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
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; and in first aid rooms.
The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4.
The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals.
The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3.
The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.
Product codes
FLE
Device Description
The ELARA-11 is a tabletop autoclave designed for sterilization of medical and surgical goods, including both wrapped and unwrapped, solid, hollow, porous products and tubes in ophthalmic, dental, and medical clinics; and in first aid rooms. The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals. These two devices are pre-vacuum and post-vacuum sterilizers that have 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 a single manual safety door with a double-safety 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 six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of varying grades of stainless steel.
The 5075 HSG model is a steam sterilizer composed of a pressure vessel, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including a single manual safety door containing a double-safety locking mechanism, an automatic safety valve to protect personnel and equipment against build-up of high pressure, and a pressure gauge that indicates when there has been a failure in operation. The front panel of the device consists of a display screen, a keypad, and a printer. The 5075 HSG model electronic control system is automatic, fully-configurable, and has a total of six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of varying grades of stainless steel and carbon 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, medical clinics; first aid rooms; hospitals; medical and veterinary clinics.
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
Non-Clinical and Performance Testing: Tuttnauer conducted validation studies in accordance with AAMI/ANSI ST55:2003. Testing shows that the ELARA-11 and Model 5075 HSG meet all aspects of the standard, including physical and microbiological performance requirements. This testing included validation testing of all sterilization cycles using the biological indicator overkill method. The sterilizers meet all AAMI/ANSI testing requirements.
Key Metrics
Not Found
Predicate Device(s)
K090783, K063711, K050263, K111736
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Tuttnauer USA Co. Ltd. C/O Mr. Theodore Sullivan Official Correspondent Buchanan, Ingersoll, & Rooney PC 1700 K Street NW Washington, DC 20006
Re: K143311
Trade/Device Name: Tuttnauer Pre-Vacuum Tabletop Autoclave (Model ELARA-11); Tuttnauer Pre-Vacuum Horizontal Autoclave (Model 5075 HSG) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: November 18, 2014
Received: November 18, 2014
Dear Mr. Theodore 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K143311 510(k) Number:
Device Name: Tuttnauer ELARA-11 Pre-vacuum Tabletop Autoclave; Tuttnauer Prevacuum Horizontal Autoclave Model 5075 HSG
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, medical clinics; and in first aid rooms.
The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4.
The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals.
The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3.
The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.
Programs:
Key program features, including cycle times, temperature, dry times, and descriptions of each program for each device are listed in the following charts:
ELARA-11
Chamber Diameter 280 mm (11") Chamber Depth 504 mm (19.8") 28.5 liters (7.5 gal) Chamber Volume Maximum load 8.0 kg (17.6 lbs)
| Program | Description | Sterilization
Temperature
(°C/°F) | Sterilization
Time (minutes) | Dry Time
(minutes) |
|---------|-------------|-----------------------------------------|---------------------------------|-----------------------|
| | | | | |
3
| Unwrapped instruments | 134/273 | 4 | ||
|---|---|---|---|---|
| Wrapped instruments | 134/273 | 4 | 20 | |
| Unwrapped delicate | ||||
| instruments | 121/250 | 20 | ||
| Wrapped delicate | ||||
| instruments | 121/250 | 20 | 20 | |
| Test 1 | Bowie & Dick | 134/273 | 3.5 | 9 |
| Test 2 | Vacuum Test | N/A | Test time 5+10 | N/A |
Sterilization programs 2 and 4 can be used for sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm.
Sterilization programs 2 and 4 can be used in sterilizing fabric packs/textiles.
Sterilization programs 2 and 4 can be used in sterilizing up to six dental handpieces.
All sterilization programs utilize a pre-vacuum step
Model 5075 HSG
(Chamber Diameter 49.4 cm (26.0") Chamber Depth 75.0 cm (29.5") Chamber Volume 160 liters (42.3 gal) Maximum Load 15 kg (33 lbs)
| Program | Description | Sterilization
Temperature
(°C/°F) | Sterilization
Time
(minutes) | Dry Time
(minutes) | Max Load |
|---------|--------------------------------------|-----------------------------------------|------------------------------------|-----------------------|----------|
| 1 | Unwrapped
instruments | 134/273 | 4 | 1 | 15kg |
| 2 | Wrapped
instruments | 134/273 | 4 | 20 | 15kg |
| 3 | Unwrapped
delicate
instruments | 121/250 | 20 | 1 | 15kg |
| 4 | Wrapped delicate
instruments | 121/250 | 20 | 20 | 15kg |
| Test 1 | Bowie & Dick | 134/273 | 3.5 | 2 | -- |
| Test 2 | Vacuum Test | N/A | Test time 5+10 | N/A | -- |
Sterilization programs 2 and 3 can be used in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm.
Sterilization programs 2 and 4 can be used in sterilizing fabric packs/textiles.
All sterilization programs utilize a pre-vacuum step
4
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)
5
510(k) Summary - K143311
| Submitter: | Tuttnauer USA Co. Ltd.
25 Power Drive
Hauppauge, NY 11788 | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|--|--|
| | Phone: (631) 737-4850
Fax: (631) 737-0720 | | |
| Contact Name: | Robert R. Basile, V.P. | | |
| Date Prepared: | January 5, 2015 | | |
| Common Name: | Electronic pre-vacuum autoclave, steam
sterilizer | | |
| Trade Name: | Tuttnauer Pre-Vacuum Tabletop Autoclave (Model
ELARA-11); Tuttnauer Pre-Vacuum Horizontal
Autoclave (Model 5075 HSG) | | |
| Classification Name: | Steam Sterilizer
Class II Device - 21 C.F.R. § 880.6880
Product Code - FLE | | |
| Subotantial Equivalance: | | | |
Substantial Equivalence:
The ELARA-11 and Model 5075 HSG are claimed to be substantially equivalent to the autoclaves cleared under K090783 and K063711. Like these autoclaves, the ELARA-11 and Model 5075 HSG contain an electronic control panel that permits automatic usage, and contains software equivalent to that in autoclaves cleared under K090783 and K063711. The ELARA-11 is a smaller model than the models cleared under K063711 (i.e. it is designed for a countertop), but is nearly identical in size to the model previously cleared under K090783. The Model 5075 HSG is larger than the previously cleared models. The nominal parameters (e.g., sterilization temperature and time; and dry time are also different for the ELARA-11 and Model 5075 HSG than for the devices under K063711, but are identical to the parameters for the previously cleared ELARA-11 model (K090783). Further, all devices use steam as the sterilization agent.
The autoclaves are substantially equivalent to the Millennium B pre-vacuum autoclave cleared under K050263 based on general principles of operation as a steam sterilizer, and specifically for the device's electronic control, pre-vacuum operation, and post-vacuum drying stage.
The autoclaves substantially equivalent to the Tuttnauer EZ series autoclaves cleared under K111736. This is based on general principles of operation as a a steam sterilizer, and specifically for the device's electronic control and software which are almost identical to those
6
found in the ELARA-11 and Model 5075 HSG (the only changes being those required due to mechanical differences and software version)..
Specific substantial equivalence to the predicate models is described in the comparison tables below.
Comparison Tables
ను
7
| Device Features | Tuttnauer
ELARA-11 | K111736:
Tuttnauer EZ
Plus Series
Electronic
Tabletop
Autoclaves - | K090783:
Tuttnauer
ELARA-11
Pre-vacuum
Tabletop
Autoclave | K063711:
Tuttnauer
Electronic Pre-
vacuum
Autoclaves | K050263:
MOCOM
Millennium B
Series
Autoclaves |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The ELARA-11 is a
tabletop autoclave
designed for
sterilization of
medical and
surgical goods,
including both
wrapped and
unwrapped, solid,
hollow, porous
products and tubes
in ophthalmic,
dental, and medical
clinics; and in first
aid rooms. | The EZ Plus Series
autoclaves are
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. | 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. | This Tuttnauer
autoclave is
designed for use in
healthcare settings
for the sterilization
of heat stable
medical devices;
wrapped solids,
hollow and porous
products.
Sterilization of
liquid loads should
only be used in non-
clinical applications
in open or closed
(but not sealed)
containers. | The device is
intended to be used
in medical and
dental practices,
hospitals, clinics,
nursing
homes, laboratories
and other facilities
to sterilize re-usable
surgical instruments
(including
dental hand-pieces)
and medical
materials, heat and
moisture resistant
and compatible with
steam sterilization
process. |
| Operating
Principle/Sterilizati
on Method | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent |
| Sterilization Cycle
Types | pre-vacuum
sterilizer w/ post-
vacuum drying | Steam-flush
pressure-pulse
(Dynamic air
removal); Gravity | Pre-vacuum;
Gravity | Pre-vacuum;
Gravity | pre-vacuum
sterilizer w/ post-
vacuum drying |
| General
Sterilization Cycles | Unwrapped - 134C
for 4 min.
Wrapped - 134C for
4 min.
Wrapped/Delicate
instruments - 121C
for 20 minutes
Wrapped/Delicate
instruments - 121C
for 20 minutes and
dry for 20 minutes
All cycles are pre-
vacuum sterilization
cycles. | Unwrapped - 132C
for 3 min.
Wrapped - 132C for
4 min.
Unwrapped delicate
instruments - 121C
for 30 min
Handpieces - 132C
for 4 minutes | Unwrapped - 134C
for 4 min.
Wrapped - 134C for
4 min.
Wrapped/Delicate
instruments - 121C
for 20 minutes | Unwrapped - 132C
Unwrapped - 121C
Wrapped - 132C
Wrapped - 134C
Liquids - 121C | Porous - 134C for 4
minutes
Porous - 121C for
20 minutes
Hollow - 134C for
4 minutes
Hollow - 121C for
20 minutes
Wrapped - 134C
for 4 minutes
Wrapped - 121C
for 20 minutes
Solid - 134C for 4
minutes
Solid - 134C for 20
minutes |
| Chamber
Dimensions | 11"(d) x 19.8"(1) | 9"(d) x 19.8"(1)
11"(d) x 19.8"(1)
15"(d) x 30"(1) | 11" (d) x 19.8"(1) | 24" x 36" x 36"
26" x 26" x 50"
24" x 36" x 60"
24" x 36" x 48"
24" x 36" x 83"
26" x 26" x 39" | |
| Chamber/water
path Materials | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel |
| Controls | Electronic/computer | Electronic/computer | Electronic/computer | Electronic/computer | Electronic/computer |
ાં આવેલા
8
| Device Features | Tuttnauer
Model 5075
HSG
Autoclave | K111736:
Tuttnauer EZ
Plus Series
Electronic
Tabletop
Autoclaves - | K090783:
Tuttnauer
ELARA-11
Pre-vacuum
Tabletop
Autoclave | K063711:
Tuttnauer
Electronic Pre-
vacuum
Autoclaves | K050263:
MOCOM
Millennium B
Series
Autoclaves |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Model 5075
HSG-D is a
autoclave designed
for sterilization both
wrapped and
unwrapped
instruments and
related items found
in dental, medical,
and veterinary
clinics, first aid
rooms, and
hospitals. | The EZ Plus Series
autoclaves are
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. | 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. | This Tuttnauer
autoclave is
designed for use in
healthcare settings
for the sterilization
of heat stable
medical devices;
wrapped solids,
hollow and porous
products.
Sterilization of
liquid loads should
only be used in non-
clinical applications
in open or closed
(but not sealed)
containers. | The device is
intended to be used
in medical and
dental practices,
hospitals, clinics,
nursing
homes, laboratories
and other facilities
to sterilize re-usable
surgical instruments
(including
dental hand-pieces)
and medical
materials, heat and
moisture resistant
and compatible with
steam sterilization
process. |
| Operating
Principle/Sterilizati
on Method | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent | Sterilization using
steam as the
sterilizing agent |
| Sterilization Cycle
Types | pre-vacuum
sterilizer w/ post-
vacuum drying | Steam-flush
pressure-pulse
(Dynamic air
removal); Gravity | Pre-vacuum;
Gravity | Pre-vacuum;
Gravity | pre-vacuum
sterilizer w/ post-
vacuum drying |
| General
Sterilization Cycles | Unwrapped - 134C
for 4 min.
Wrapped - 134C for
4 min.
Wrapped/Delicate
instruments - 121C
for 20 minutes
Wrapped/Delicate
instruments - 121C
for 20 minutes and
dry for 20 minutes
All cycles are pre-
vacuum sterilization
cycles. | Unwrapped - 132C
for 3 min.
Wrapped - 132C for
4 min.
Unwrapped delicate
instruments - 121C
for 30 min
Handpieces - 132C
for 4 minutes | Unwrapped - 134C
for 4 min.
Wrapped - 134C for
4 min.
Wrapped/Delicate
instruments - 121C
for 20 minutes | Unwrapped - 132C
Unwrapped - 121C
Wrapped - 132C
Wrapped - 134C
Liquids - 121C | Porous - 134C for 4
minutes
Porous -- 121C for
20 minutes
Hollow - 134C for
4 minutes
Hollow - 121C for
20 minutes
Wrapped - 134C
for 4 minutes
Wrapped - 121C
for 20 minutes
Solid - 134C for 4
minutes
Solid - 134C for 20
minutes |
| Chamber
Dimensions | 26"(d) x 29.5"(1) | 9"(d) x 19.8"(1)
11"(d) x 19.8"(1)
15"(d) x 30"(1) | 11" (d) x 19.8"(1) | 24" x 36" x 36"
26" x 26" x 50"
24" x 36" x 60"
24" x 36" x 48"
24" x 36" x 83"
26" x 26" x 39" | 24" x 36" x 36"
26" x 26" x 50"
24" x 36" x 60"
24" x 36" x 48"
24" x 36" x 83"
26" x 26" x 39" |
| Chamber/water
path Materials | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel | 316 or 304 grade
stainless steel |
| Controls | Electronic/computer
control | Electronic/computer
control | Electronic/computer
control | Electronic/computer
control | Electronic/computer
control |
း
9
General Description:
The ELARA-11 is a tabletop autoclave designed for sterilization of medical and surgical goods, including both wrapped and unwrapped, solid, hollow, porous products and tubes in ophthalmic, dental, and medical clinics; and in first aid rooms. The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals. These two devices are pre-vacuum and post-vacuum sterilizers that have 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.
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
Design and Materials:
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 a single manual safety door with a double-safety 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 six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of yarying grades of stainless steel.
The 5075 HSG model is a steam sterilizer composed of a pressure vessel, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including a single manual safety door containing a double-safety locking mechanism, an automatic safety valve to protect personnel and equipment against build-up of high pressure, and a pressure gauge that indicates when there has been a failure in operation. The front panel of the device consists of a display screen, a keypad, and a printer. The 5075 HSG model electronic control system is automatic, fully-configurable, and has a total of six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of varying grades of stainless steel and carbon steel.
Comparison to Cleared Devices:
Although the ELARA-11 and Model 5075 HSG, and the models cleared under K063711 and K090783 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.
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Intended 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; and in first aid rooms.
The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4.
The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals.
The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3.
The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.
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.
The Model 5075 HSG is a steam sterilizer composed of a pressure vessel, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. They contain an electronic control system that makes the device automatic and fullyconfigurable.
Non-Clinical and Performance Testing:
Tuttnauer conducted validation studies in accordance with AAMI/ANSI ST55:2003. Testing shows that the ELARA-11 and Model 5075 HSG meet all aspects of the standard, including physical and microbiological performance requirements. This testing included validation testing of all sterilization cycles using the biological indicator overkill method. The sterilizers meet all AAMI/ANSI testing requirements.
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Conclusion:
:
. Based on the performance testing the subject device is substantially equivalent to the
predicate devices.