(58 days)
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.
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 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.
This document describes the premarket notification for Tuttnauer Pre-Vacuum Tabletop Autoclave (Model ELARA-11) and Tuttnauer Pre-Vacuum Horizontal Autoclave (Model 5075 HSG). The information provided is for regulatory clearance and focuses on substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria in the context of AI/ML.
Therefore, the requested information components related to acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance are not applicable to this document. This document primarily details the device's technical specifications and intended use, comparing them to existing cleared devices to establish substantial equivalence.
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity or specificity. Instead, it states that the devices meet the requirements of AAMI/ANSI ST55:2003, which is a standard for table-top steam sterilizers.
| Acceptance Criteria (AAMI/ANSI ST55:2003) | Reported Device Performance (ELARA-11 & 5075 HSG) |
|---|---|
| Physical performance requirements | Meets all aspects of the standard |
| Microbiological performance requirements | Meets all aspects of the standard |
| Validation testing of all sterilization cycles using biological indicator overkill method | Meets all AAMI/ANSI testing requirements |
2. Sample sized used for the test set and the data provenance
Not applicable. This is not a study involving a test set in the context of AI/ML performance. The testing performed is related to the physical and microbiological efficacy of the sterilizers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of expert consensus is not relevant here. The ground truth for sterilization efficacy is established through adherence to recognized standards (AAMI/ANSI ST55:2003) and biological indicator testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant to the type of testing described for steam sterilizers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to steam sterilizers, not AI/ML-driven diagnostic devices that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes mechanical/electrical steam sterilizers, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance testing is based on the established safety and efficacy requirements outlined in the AAMI/ANSI ST55:2003 standard, specifically through physical and microbiological performance assessments, including the biological indicator overkill method.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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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.
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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 (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
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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 | SterilizationTemperature(°C/°F) | SterilizationTime (minutes) | Dry Time(minutes) |
|---|---|---|---|---|
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| Unwrapped instruments | 134/273 | 4 | ||
|---|---|---|---|---|
| Wrapped instruments | 134/273 | 4 | 20 | |
| Unwrapped delicateinstruments | 121/250 | 20 | ||
| Wrapped delicateinstruments | 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 | SterilizationTemperature(°C/°F) | SterilizationTime(minutes) | Dry Time(minutes) | Max Load |
|---|---|---|---|---|---|
| 1 | Unwrappedinstruments | 134/273 | 4 | 1 | 15kg |
| 2 | Wrappedinstruments | 134/273 | 4 | 20 | 15kg |
| 3 | Unwrappeddelicateinstruments | 121/250 | 20 | 1 | 15kg |
| 4 | Wrapped delicateinstruments | 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.25 Power DriveHauppauge, NY 11788 | ||
|---|---|---|---|
| Phone: (631) 737-4850Fax: (631) 737-0720 | |||
| Contact Name: | Robert R. Basile, V.P. | ||
| Date Prepared: | January 5, 2015 | ||
| Common Name: | Electronic pre-vacuum autoclave, steamsterilizer | ||
| Trade Name: | Tuttnauer Pre-Vacuum Tabletop Autoclave (ModelELARA-11); Tuttnauer Pre-Vacuum HorizontalAutoclave (Model 5075 HSG) | ||
| Classification Name: | Steam SterilizerClass II Device - 21 C.F.R. § 880.6880Product 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 | TuttnauerELARA-11 | K111736:Tuttnauer EZPlus SeriesElectronicTabletopAutoclaves - | K090783:TuttnauerELARA-11Pre-vacuumTabletopAutoclave | K063711:TuttnauerElectronic Pre-vacuumAutoclaves | K050263:MOCOMMillennium BSeriesAutoclaves |
|---|---|---|---|---|---|
| Indications | The ELARA-11 is atabletop autoclavedesigned forsterilization ofmedical andsurgical goods,including bothwrapped andunwrapped, solid,hollow, porousproducts and tubesin ophthalmic,dental, and medicalclinics; and in firstaid rooms. | The EZ Plus Seriesautoclaves aretable-top autoclavedesigned forsterilizing medicaland surgical goods,including bothwrapped andunwrapped, solid,hollow, and porousproducts and goodsdefined as hollow A(e.g., dental handpieces; suctionpipes) inophthalmic, dental,and medical clinics;in first aid rooms;and in smalllaboratories. | The ELARA-11 is atable-top autoclavedesigned forsterilizing medicaland surgical goods,including bothwrapped andunwrapped, solid,hollow, and porousproducts and goodsdefined as hollow A(e.g., dental handpieces; suctionpipes) inophthalmic, dental,and medical clinics;in first aid rooms;and in smalllaboratories. | This Tuttnauerautoclave isdesigned for use inhealthcare settingsfor the sterilizationof heat stablemedical devices;wrapped solids,hollow and porousproducts.Sterilization ofliquid loads shouldonly be used in non-clinical applicationsin open or closed(but not sealed)containers. | The device isintended to be usedin medical anddental practices,hospitals, clinics,nursinghomes, laboratoriesand other facilitiesto sterilize re-usablesurgical instruments(includingdental hand-pieces)and medicalmaterials, heat andmoisture resistantand compatible withsteam sterilizationprocess. |
| OperatingPrinciple/Sterilization Method | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent |
| Sterilization CycleTypes | pre-vacuumsterilizer w/ post-vacuum drying | Steam-flushpressure-pulse(Dynamic airremoval); Gravity | Pre-vacuum;Gravity | Pre-vacuum;Gravity | pre-vacuumsterilizer w/ post-vacuum drying |
| GeneralSterilization Cycles | Unwrapped - 134Cfor 4 min.Wrapped - 134C for4 min.Wrapped/Delicateinstruments - 121Cfor 20 minutesWrapped/Delicateinstruments - 121Cfor 20 minutes anddry for 20 minutesAll cycles are pre-vacuum sterilizationcycles. | Unwrapped - 132Cfor 3 min.Wrapped - 132C for4 min.Unwrapped delicateinstruments - 121Cfor 30 minHandpieces - 132Cfor 4 minutes | Unwrapped - 134Cfor 4 min.Wrapped - 134C for4 min.Wrapped/Delicateinstruments - 121Cfor 20 minutes | Unwrapped - 132CUnwrapped - 121CWrapped - 132CWrapped - 134CLiquids - 121C | Porous - 134C for 4minutesPorous - 121C for20 minutesHollow - 134C for4 minutesHollow - 121C for20 minutesWrapped - 134Cfor 4 minutesWrapped - 121Cfor 20 minutesSolid - 134C for 4minutesSolid - 134C for 20minutes |
| ChamberDimensions | 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/waterpath Materials | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel |
| Controls | Electronic/computer | Electronic/computer | Electronic/computer | Electronic/computer | Electronic/computer |
ાં આવેલા
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| Device Features | TuttnauerModel 5075HSGAutoclave | K111736:Tuttnauer EZPlus SeriesElectronicTabletopAutoclaves - | K090783:TuttnauerELARA-11Pre-vacuumTabletopAutoclave | K063711:TuttnauerElectronic Pre-vacuumAutoclaves | K050263:MOCOMMillennium BSeriesAutoclaves |
|---|---|---|---|---|---|
| Indications | The Model 5075HSG-D is aautoclave designedfor sterilization bothwrapped andunwrappedinstruments andrelated items foundin dental, medical,and veterinaryclinics, first aidrooms, andhospitals. | The EZ Plus Seriesautoclaves aretable-top autoclavedesigned forsterilizing medicaland surgical goods,including bothwrapped andunwrapped, solid,hollow, and porousproducts and goodsdefined as hollow A(e.g., dental handpieces; suctionpipes) inophthalmic, dental,and medical clinics;in first aid rooms;and in smalllaboratories. | The ELARA-11" isa table-topautoclave designedfor sterilizingmedical andsurgical goods,including bothwrapped andunwrapped, solid,hollow, and porousproducts and goodsdefined as hollow A(e.g., dental handpieces; suctionpipes) inophthalmic, dental,and medical clinics;in first aid rooms;and in smalllaboratories. | This Tuttnauerautoclave isdesigned for use inhealthcare settingsfor the sterilizationof heat stablemedical devices;wrapped solids,hollow and porousproducts.Sterilization ofliquid loads shouldonly be used in non-clinical applicationsin open or closed(but not sealed)containers. | The device isintended to be usedin medical anddental practices,hospitals, clinics,nursinghomes, laboratoriesand other facilitiesto sterilize re-usablesurgical instruments(includingdental hand-pieces)and medicalmaterials, heat andmoisture resistantand compatible withsteam sterilizationprocess. |
| OperatingPrinciple/Sterilization Method | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent | Sterilization usingsteam as thesterilizing agent |
| Sterilization CycleTypes | pre-vacuumsterilizer w/ post-vacuum drying | Steam-flushpressure-pulse(Dynamic airremoval); Gravity | Pre-vacuum;Gravity | Pre-vacuum;Gravity | pre-vacuumsterilizer w/ post-vacuum drying |
| GeneralSterilization Cycles | Unwrapped - 134Cfor 4 min.Wrapped - 134C for4 min.Wrapped/Delicateinstruments - 121Cfor 20 minutesWrapped/Delicateinstruments - 121Cfor 20 minutes anddry for 20 minutesAll cycles are pre-vacuum sterilizationcycles. | Unwrapped - 132Cfor 3 min.Wrapped - 132C for4 min.Unwrapped delicateinstruments - 121Cfor 30 minHandpieces - 132Cfor 4 minutes | Unwrapped - 134Cfor 4 min.Wrapped - 134C for4 min.Wrapped/Delicateinstruments - 121Cfor 20 minutes | Unwrapped - 132CUnwrapped - 121CWrapped - 132CWrapped - 134CLiquids - 121C | Porous - 134C for 4minutesPorous -- 121C for20 minutesHollow - 134C for4 minutesHollow - 121C for20 minutesWrapped - 134Cfor 4 minutesWrapped - 121Cfor 20 minutesSolid - 134C for 4minutesSolid - 134C for 20minutes |
| ChamberDimensions | 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/waterpath Materials | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel | 316 or 304 gradestainless steel |
| Controls | Electronic/computercontrol | Electronic/computercontrol | Electronic/computercontrol | Electronic/computercontrol | Electronic/computercontrol |
း
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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:
:
. Based on the performance testing the subject device is substantially equivalent to the
predicate devices.
§ 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).