Pre-vacuum Tabletop Autoclave

K143311 · Tuttnauer U.S.A Co, Ltd. · FLE · Jan 15, 2015 · General Hospital

Device Facts

• Record ID: K143311
• Device Name: Pre-vacuum Tabletop Autoclave
• Applicant: Tuttnauer U.S.A Co, Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

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.

Device Story

Steam sterilizers (autoclaves) for medical/surgical instruments; utilize pre-vacuum air removal and post-vacuum drying; inputs include water (mineral-free/distilled) and load items; electronic control system manages sterilization cycles (temperature, time, pressure); outputs include sterilized instruments and printed cycle reports; operated by clinical staff in clinics/hospitals; benefits include effective sterilization of lumened, solid, and porous goods; safety features include manual door with double-locking mechanism and automatic shutoff.

Clinical Evidence

Bench testing only. Validation studies conducted per AAMI/ANSI ST55:2003. Testing included physical and microbiological performance requirements and biological indicator overkill method for all sterilization cycles.

Technological Characteristics

Steam sterilizer; pressure vessel (stainless/carbon steel); vacuum pump; water pump; electronic control system; automatic/fully-configurable; display screen, keypad, and printer interface. Sterilization agent: steam.

Indications for Use

Indicated for sterilization of wrapped/unwrapped medical/surgical goods, including solid, hollow, and porous items (e.g., dental handpieces, suction pipes) in dental, medical, and veterinary clinics, hospitals, and first aid rooms.

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

• Tuttnauer EZ Plus Series (K111736)
• Tuttnauer ELARA-11 Pre-vacuum Tabletop Autoclave (K090783)
• Tuttnauer Electronic Pre-vacuum Autoclaves (K063711)
• MOCOM Millennium B Series Autoclaves (K050263)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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<br>Temperature<br>(°C/°F) | Sterilization<br>Time (minutes) | Dry Time<br>(minutes) |
|---------|-------------|-----------------------------------------|---------------------------------|-----------------------|
| | | | | |

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| | Unwrapped instruments | 134/273 | 4 | |
|--------|-----------------------------------|---------|----------------|-----|
| | Wrapped instruments | 134/273 | 4 | 20 |
| | Unwrapped delicate<br>instruments | 121/250 | 20 | |
| | Wrapped delicate<br>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<br>Temperature<br>(°C/°F) | Sterilization<br>Time<br>(minutes) | Dry Time<br>(minutes) | Max Load |
|---------|--------------------------------------|-----------------------------------------|------------------------------------|-----------------------|----------|
| 1 | Unwrapped<br>instruments | 134/273 | 4 | 1 | 15kg |
| 2 | Wrapped<br>instruments | 134/273 | 4 | 20 | 15kg |
| 3 | Unwrapped<br>delicate<br>instruments | 121/250 | 20 | 1 | 15kg |
| 4 | Wrapped delicate<br>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

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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)

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# 510(k) Summary - K143311

| Submitter: | Tuttnauer USA Co. Ltd.<br>25 Power Drive<br>Hauppauge, NY 11788 | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|--|--|
| | Phone: [phone]<br>Fax: [phone] | | |
| Contact Name: | Robert R. Basile, V.P. | | |
| Date Prepared: | January 5, 2015 | | |
| Common Name: | Electronic pre-vacuum autoclave, steam<br>sterilizer | | |
| Trade Name: | Tuttnauer Pre-Vacuum Tabletop Autoclave (Model<br>ELARA-11); Tuttnauer Pre-Vacuum Horizontal<br>Autoclave (Model 5075 HSG) | | |
| Classification Name: | Steam Sterilizer<br>Class II Device - 21 C.F.R. § 880.6880<br>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

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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

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| Device Features | Tuttnauer<br>ELARA-11 | K111736:<br>Tuttnauer EZ<br>Plus Series<br>Electronic<br>Tabletop<br>Autoclaves - | K090783:<br>Tuttnauer<br>ELARA-11<br>Pre-vacuum<br>Tabletop<br>Autoclave | K063711:<br>Tuttnauer<br>Electronic Pre-<br>vacuum<br>Autoclaves | K050263:<br>MOCOM<br>Millennium B<br>Series<br>Autoclaves |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The ELARA-11 is a<br>tabletop autoclave<br>designed for<br>sterilization of<br>medical and<br>surgical goods,<br>including both<br>wrapped and<br>unwrapped, solid,<br>hollow, porous<br>products and tubes<br>in ophthalmic,<br>dental, and medical<br>clinics; and in first<br>aid rooms. | The EZ Plus Series<br>autoclaves are<br>table-top autoclave<br>designed for<br>sterilizing medical<br>and surgical goods,<br>including both<br>wrapped and<br>unwrapped, solid,<br>hollow, and porous<br>products and goods<br>defined as hollow A<br>(e.g., dental hand<br>pieces; suction<br>pipes) in<br>ophthalmic, dental,<br>and medical clinics;<br>in first aid rooms;<br>and in small<br>laboratories. | The ELARA-11 is a<br>table-top autoclave<br>designed for<br>sterilizing medical<br>and surgical goods,<br>including both<br>wrapped and<br>unwrapped, solid,<br>hollow, and porous<br>products and goods<br>defined as hollow A<br>(e.g., dental hand<br>pieces; suction<br>pipes) in<br>ophthalmic, dental,<br>and medical clinics;<br>in first aid rooms;<br>and in small<br>laboratories. | This Tuttnauer<br>autoclave is<br>designed for use in<br>healthcare settings<br>for the sterilization<br>of heat stable<br>medical devices;<br>wrapped solids,<br>hollow and porous<br>products.<br>Sterilization of<br>liquid loads should<br>only be used in non-<br>clinical applications<br>in open or closed<br>(but not sealed)<br>containers. | The device is<br>intended to be used<br>in medical and<br>dental practices,<br>hospitals, clinics,<br>nursing<br>homes, laboratories<br>and other facilities<br>to sterilize re-usable<br>surgical instruments<br>(including<br>dental hand-pieces)<br>and medical<br>materials, heat and<br>moisture resistant<br>and compatible with<br>steam sterilization<br>process. |
| Operating<br>Principle/Sterilizati<br>on Method | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent |
| Sterilization Cycle<br>Types | pre-vacuum<br>sterilizer w/ post-<br>vacuum drying | Steam-flush<br>pressure-pulse<br>(Dynamic air<br>removal); Gravity | Pre-vacuum;<br>Gravity | Pre-vacuum;<br>Gravity | pre-vacuum<br>sterilizer w/ post-<br>vacuum drying |
| General<br>Sterilization Cycles | Unwrapped - 134C<br>for 4 min.<br>Wrapped - 134C for<br>4 min.<br>Wrapped/Delicate<br>instruments - 121C<br>for 20 minutes<br>Wrapped/Delicate<br>instruments - 121C<br>for 20 minutes and<br>dry for 20 minutes<br>All cycles are pre-<br>vacuum sterilization<br>cycles. | Unwrapped - 132C<br>for 3 min.<br>Wrapped - 132C for<br>4 min.<br>Unwrapped delicate<br>instruments - 121C<br>for 30 min<br>Handpieces - 132C<br>for 4 minutes | Unwrapped - 134C<br>for 4 min.<br>Wrapped - 134C for<br>4 min.<br>Wrapped/Delicate<br>instruments - 121C<br>for 20 minutes | Unwrapped - 132C<br>Unwrapped - 121C<br>Wrapped - 132C<br>Wrapped - 134C<br>Liquids - 121C | Porous - 134C for 4<br>minutes<br>Porous - 121C for<br>20 minutes<br>Hollow - 134C for<br>4 minutes<br>Hollow - 121C for<br>20 minutes<br>Wrapped - 134C<br>for 4 minutes<br>Wrapped - 121C<br>for 20 minutes<br>Solid - 134C for 4<br>minutes<br>Solid - 134C for 20<br>minutes |
| Chamber<br>Dimensions | 11"(d) x 19.8"(1) | 9"(d) x 19.8"(1)<br>11"(d) x 19.8"(1)<br>15"(d) x 30"(1) | 11" (d) x 19.8"(1) | 24" x 36" x 36"<br>26" x 26" x 50"<br>24" x 36" x 60"<br>24" x 36" x 48"<br>24" x 36" x 83"<br>26" x 26" x 39" | |
| Chamber/water<br>path Materials | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel |
| Controls | Electronic/computer | Electronic/computer | Electronic/computer | Electronic/computer | Electronic/computer |

ાં આવેલા

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| Device Features | Tuttnauer<br>Model 5075<br>HSG<br>Autoclave | K111736:<br>Tuttnauer EZ<br>Plus Series<br>Electronic<br>Tabletop<br>Autoclaves - | K090783:<br>Tuttnauer<br>ELARA-11<br>Pre-vacuum<br>Tabletop<br>Autoclave | K063711:<br>Tuttnauer<br>Electronic Pre-<br>vacuum<br>Autoclaves | K050263:<br>MOCOM<br>Millennium B<br>Series<br>Autoclaves |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Model 5075<br>HSG-D is a<br>autoclave designed<br>for sterilization both<br>wrapped and<br>unwrapped<br>instruments and<br>related items found<br>in dental, medical,<br>and veterinary<br>clinics, first aid<br>rooms, and<br>hospitals. | The EZ Plus Series<br>autoclaves are<br>table-top autoclave<br>designed for<br>sterilizing medical<br>and surgical goods,<br>including both<br>wrapped and<br>unwrapped, solid,<br>hollow, and porous<br>products and goods<br>defined as hollow A<br>(e.g., dental hand<br>pieces; suction<br>pipes) in<br>ophthalmic, dental,<br>and medical clinics;<br>in first aid rooms;<br>and in small<br>laboratories. | The ELARA-11" is<br>a table-top<br>autoclave designed<br>for sterilizing<br>medical and<br>surgical goods,<br>including both<br>wrapped and<br>unwrapped, solid,<br>hollow, and porous<br>products and goods<br>defined as hollow A<br>(e.g., dental hand<br>pieces; suction<br>pipes) in<br>ophthalmic, dental,<br>and medical clinics;<br>in first aid rooms;<br>and in small<br>laboratories. | This Tuttnauer<br>autoclave is<br>designed for use in<br>healthcare settings<br>for the sterilization<br>of heat stable<br>medical devices;<br>wrapped solids,<br>hollow and porous<br>products.<br>Sterilization of<br>liquid loads should<br>only be used in non-<br>clinical applications<br>in open or closed<br>(but not sealed)<br>containers. | The device is<br>intended to be used<br>in medical and<br>dental practices,<br>hospitals, clinics,<br>nursing<br>homes, laboratories<br>and other facilities<br>to sterilize re-usable<br>surgical instruments<br>(including<br>dental hand-pieces)<br>and medical<br>materials, heat and<br>moisture resistant<br>and compatible with<br>steam sterilization<br>process. |
| Operating<br>Principle/Sterilizati<br>on Method | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent | Sterilization using<br>steam as the<br>sterilizing agent |
| Sterilization Cycle<br>Types | pre-vacuum<br>sterilizer w/ post-<br>vacuum drying | Steam-flush<br>pressure-pulse<br>(Dynamic air<br>removal); Gravity | Pre-vacuum;<br>Gravity | Pre-vacuum;<br>Gravity | pre-vacuum<br>sterilizer w/ post-<br>vacuum drying |
| General<br>Sterilization Cycles | Unwrapped - 134C<br>for 4 min.<br>Wrapped - 134C for<br>4 min.<br>Wrapped/Delicate<br>instruments - 121C<br>for 20 minutes<br>Wrapped/Delicate<br>instruments - 121C<br>for 20 minutes and<br>dry for 20 minutes<br>All cycles are pre-<br>vacuum sterilization<br>cycles. | Unwrapped - 132C<br>for 3 min.<br>Wrapped - 132C for<br>4 min.<br>Unwrapped delicate<br>instruments - 121C<br>for 30 min<br>Handpieces - 132C<br>for 4 minutes | Unwrapped - 134C<br>for 4 min.<br>Wrapped - 134C for<br>4 min.<br>Wrapped/Delicate<br>instruments - 121C<br>for 20 minutes | Unwrapped - 132C<br>Unwrapped - 121C<br>Wrapped - 132C<br>Wrapped - 134C<br>Liquids - 121C | Porous - 134C for 4<br>minutes<br>Porous -- 121C for<br>20 minutes<br>Hollow - 134C for<br>4 minutes<br>Hollow - 121C for<br>20 minutes<br>Wrapped - 134C<br>for 4 minutes<br>Wrapped - 121C<br>for 20 minutes<br>Solid - 134C for 4<br>minutes<br>Solid - 134C for 20<br>minutes |
| Chamber<br>Dimensions | 26"(d) x 29.5"(1) | 9"(d) x 19.8"(1)<br>11"(d) x 19.8"(1)<br>15"(d) x 30"(1) | 11" (d) x 19.8"(1) | 24" x 36" x 36"<br>26" x 26" x 50"<br>24" x 36" x 60"<br>24" x 36" x 48"<br>24" x 36" x 83"<br>26" x 26" x 39" | 24" x 36" x 36"<br>26" x 26" x 50"<br>24" x 36" x 60"<br>24" x 36" x 48"<br>24" x 36" x 83"<br>26" x 26" x 39" |
| Chamber/water<br>path Materials | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel | 316 or 304 grade<br>stainless steel |
| Controls | Electronic/computer<br>control | Electronic/computer<br>control | Electronic/computer<br>control | Electronic/computer<br>control | Electronic/computer<br>control |

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## 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:

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:

. Based on the performance testing the subject device is substantially equivalent to the
predicate devices.