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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.

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.

The automated Tuttnauer ELARA-11" is a table-top steam sterilizer (i.e., autoclave) designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories. This device is a pre-vacuum and post-vacuum sterilizer that has an air removal stage (i.e., pre-vacuum) before the start of the sterilization stage, as well as a post-sterilization drying stage that is based upon the combined operation of heat plus vacuum with air inlet pulses. The sterilizing agent is steam that is electrically-generated from either mineral-free or distilled water that is added to the built-in reservoir. The ELARA-11" is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including an automated safety door with a doublesafety locking mechanism and an automatic safety shutoff. The front panel of the device consists of a display screen, a keypad, and a printer. The ELARA-11" electronic control system is automatic, fully-configurable, and has a total of seven (7) programs: five (5) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the VacTest program). The components are made of varying grades of stainless steel.

The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids (for non-clinical application only) in open or closed containers. It has the following automated program sterilization cycles: Program 1 (Flash - Porous), Program 2 (Flash - Nonporous), Program 3 (Wrapped - 270°F), Program 4 (Wrapped - 270°F), Program 5 (Wrapped 275°F), Program 6 (Wrapped - 250°F), Program 7 (Liquids - 250°F) For non-clinical applications only, Program 8 (Bowie-Dick Test), Program 9 (Air Leakage Test).

The Tuttnauer Model 4472 EP-1V and 5596 EP-1V Autoclaves are steam sterilizers that provide onboard steam generation capability. They are designed for sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The Tuttnauer Model 4472 EP-1V and 5596 EP-1V autoclaves are steam sterilizers that include as main components: a pressure vessel with steam jacket, heating elements, a chamber water reservoir, a water pump and a vacuum pump.

The Tuttnauer 2540 EHS Series Table-top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped) including complex lumened devices such as dental handpieces, porous, hollow loads and to sterilize liquids for non-clinical applications. Cycle parameters are as follows: | Cycle | Ste. Temp & Range<br>(°F) | Press. &<br>Range (Kpa) | Time<br>(min) | Vacuum<br>(kPa.) | Dry Time<br>(min) | Load<br>Configuration | |--------------------------------------------------|---------------------------|-------------------------|---------------|------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------| | 1. Unwrapped<br>273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | --- | Single,<br>unwrapped<br>instrument in<br>center of lowest<br>tray | | 2. Wrapped 273<br>(complex/<br>lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. | | 3. Wrapped 250<br>(for instruments<br>onliquida) | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments<br>4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. | | 4. Wrapped 273<br>(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. | | 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack in<br>otherwise empty<br>chamber | | 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.<br>Containers<br>made of heat<br>proof glass,<br>each filled up to<br>2/3 capacity. | Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.

The Tuttnauer 2540 EHS Table-top Autoclave is a steam sterilizer that provides an onboard steam generation capability. It is designed for sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous, hollow loads and to sterilize liquids for non-clinical applications. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The Tuttnauer EHS Series Electronic Table-top Autoclave is a steam sterilizer that includes as its main components: a pressure vessel with steam jacket, heating elements, a dualchamber water reservoir, a water pump and a vacuum pump. The device is identical to the predicate device, with the exception of the proposed modification to the labeling that would authorize sterilization of wrapped, non-lumened devices at 273° for four (4) minutes.

Tuttnauer electronic controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121℃ at 30 minutes and 16 psi). These cycles are preprogrammed and are recommended in the labeling. Tuttnauer E Series Electronic Table-top Autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.

The Tuttnauer Model E series autoclave is a table-top steam sterilizer that includes as its main components an electronic control, water reservoir, heat source and sealed chamber. The E has three pre-programmed sterilization cycles. The three pre-programmed cycles are for unwrapped instruments (134°C at 4 minutes), wrapped instruments (134°C at 8 minutes) and liquids (121°C at 30 minutes). Dental handpieces can be sterilized as unwrapped or wrapped instruments without modification to cycle times or temperatures. The Model E autoclave is produced in four sizes, the 1730 with a chamber size of 7" x 12"; the 2340 with a chamber size of 9" x 18.5"; the 2540 with a chamber size of 10" x 18.7"; and the 3870, which has a chamber size of 15" x 27." The pressure chamber, door and locking device are constructed from stainless steel. The pressure chamber, and components are designed, tested and stamped for conformance to ASME code. A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the device within its desired parameters. The software has been validated to ensure compliance with all applicable requirements.

The Tuttnauer Mini Container and Standard Case Cassettes are general dental/medical instrument cassettes intended to hold instruments and accessories in place during the sterilization cycle. The devices are indicated for use in both gravity and pre-vacuum steam sterilization.

The Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette are sterilization cassettes that are designed to allow steam to pass through the device to ensure effective sterilization. The Mini Container and Standard Case Cassettes are small to medium-sized trays with silicone mats that are useful in the organization, containment and transport of medical and dental instruments. An array of Mini Container sizes are available to accommodate various instrument sizes. The Mini Container also offers an integrated instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter.

Tuttnauer electronic controlled pre-vacuum autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 5 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); liquids (121°C at 30 minutes and 16 psi); Bowie Dick test program (134°C at 3.5 minutes and 29 psi); and a free program with adjustable sterilization times and temperatures. With the exception of the free program, all of these cycles are pre-programmed, requiring no user input. The free program allows the user to select their own sterilization parameters, however, the operations manual warns that sterilization has not been validated for user selected settings, and cautions the user that they must validate sterilization. These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.

The Tuttnauer Model EPV series autoclave is a table-top steam sterilizer that includes as its main components a vacuum pump, water reservoir, heat source and sealed chamber. As with the predicate device, the EPV has three pre-programmed sterilization cycles, one user definable cycle and a Bowie-Dick test cycle. The three pre-programmed cycles are for unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes). The Model EPV autoclave is produced in two sizes, the 2340EPV with a chamber size of 9" x 18.5" and the 2540EPV with a chamber size of 10" x 18.7". The pressure chamber, door and locking device are constructed from stainless steel. The pressure chamber, and components are designed, tested and stamped for conformance to ASME code. A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the device within its desired parameters. The software has been validated to ensure compliance with all applicable requirements.

Tuttnauer electronic and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the "E" Series; these cycles are pre-programmed, whereas in the "M" Series the user must manually set the parameters, however, these parameters are recommended in the labeling. These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.

The Tuttnauer Model M series autoclave is a table-top steam sterilizer that includes as its main components a multi-valve control assembly & timer, water reservoir, heat source and sealed chamber. The M can sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes). The Model M autoclave is produced in four sizes, the 1730 with a chamber size of 7" x 12"; the 2340 with a chamber size of 9" x 18.5" and the 2540 with a chamber size of 10" x 18.7". The 3870, which has a chamber size of 15" x 27", is not subject to this corrective action.