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510(k) Data Aggregation
K Number
K222608Device Name
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Manufacturer
Tuttnauer LTD.
Date Cleared
2022-12-16
(109 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
Tuttnauer LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pre-vacuum steam sterilizer models 3870HSG and 3870HSG-WS are in hospitals and other healthcare facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
Device Description
The autoclave models 3870HSG-WS and the 3870HSG are dynamic-air-removal steam-heated sterilizers that are using steam as the sterilizing agent, which are suitable for large medical centers, dental clinics and operating rooms for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
The model 3870HSG-WS has an automatic door and is designed to be a fast cycle sterilizer that is mobile and can operate independent of building utilities due to its internal water reservoirs. The autoclave includes the option of water recycling, which allows the operator to manually fill the tap water reservoir with water that will be reused for 10 cycles, after which the reservoir is automatically drained and, in case the device is connected to a water inlet connection, be refilled automatically.
The model 3870HSG has an automatic door and is designed to be a fast cycle sterilizer. Contrary to the 3870HSG-WS, the 3870HSG need to be connected to the building utilities system (the water system). For both autoclave configurations (HSG/HSG-WS) a 9kW built-in steam generator is used to supply the steam for the sterilization process.
The autoclaves are Class B devices equipped with a vacuum system that allows:
- . Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
- . Better steam penetration into the load; resulting in effective sterilization.
- . Better temperature uniformity.
- . Post sterilization drying phase - during the drying stage draws air through a HEPA filter (0.2um) and pushes that air through the heated chamber to remove moisture and facilitate the drying operation. Drying is performed with the door closed.
The autoclave models 3870HSG-WS and 3870HSG are stand-alone devices that do not need to interact with other devices or to interact with any person(s) or patient(s) besides the current device operator.
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K Number
K221227Device Name
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
Manufacturer
Tuttnauer Ltd.
Date Cleared
2022-09-20
(145 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
Tuttnauer Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices that are intended to provide sterilization of heat stable medical devices: wrapped (IUSS) solids, hollow and porous products.
Device Description
The Tuttnauer horizontal autoclave series models 4472, 5596 and 6690 are dynamic-air-removal autoclaves that are designed for sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products. 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 autoclave operates in a temperature range of up to 137 C (279°F) and pressure up to 2.3 bar (34psi).
Each of the mentioned models differ from each other in chamber size and include different 1 or 2 door configurations. The models can come with onboard steam generation capability, but other configurations are used with external steam sources.
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K Number
K213080Device Name
T-Edge 10, T-Edge 11
Manufacturer
Tuttnauer Ltd.
Date Cleared
2022-01-04
(103 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
Tuttnauer Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-Edge 10 & T-Edge 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices).
The T-Edge 10 & T-Edge 11 are validated for use in:
- · Sterilizing fabric packs / textiles
- · Sterilizing dental handpieces
Device Description
The T-Edge 10 & T-Edge 11 are Table-Top steam sterilizers (autoclave) that use steam as the sterilizing agent. The autoclaves are fully automated device with a computerized control system, which is based on Linux Operating system. that ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle, including the ability of recording the sterilization parameters (with a built-in memory to store history of up-to 999 cycles). A graphical touchscreen is used for monitoring and control purposes.
The T-Edge 10 & T-Edge 11 are Class-B and Class-S devices. They are designed for repeated use of sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities.
The T-Edge 10 & T-Edge 11 are validated for use in:
- Sterilizing fabric packs / textiles
- . Sterilizing dental handpieces
The steam for the sterilization process is produced by warming up a controlled amount of demineralized water that is inserted into a pipe heating element and then flows into the chamber as steam. This technique is used as a way of reducing water consumption and saving energy. The autoclave is equipped with a heating element wrapped around the chamber to maintain the required temperatures and steam for the sterilization process. All of these processes are done via the computerized control system of the device.
The T-Edge 10 & T-Edge 11 autoclaves are equipped with a built-in vacuum pump used for fractionated pre-vacuum air removal at the first stage of the cycle, eliminating air pockets from all load types, including porous load and most kinds of tubes (rubber, plastic etc.). This is maximizing efficient steam penetration throughout the entire load, resulting in temperature uniformity and an effective sterilization. After the sterilization stage the vacuum pump is used for post-vacuum drying, performed with the door closed.
The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.
The chamber door has the following features protecting personnel from hazards:
- . Two door micro-switches that indicate that the door is closed and locked. Without this indication steam is not introduced into the chamber. These micro-switches prevent opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
- An electrical door locking pin that blocks door opening during operation. .
In addition, the following safety devices are installed in the autoclave to optimize its safe operation:
- A safety thermostat to prevent over-heating of the chamber heating elements. .
- . A safety cut-off switch to prevent over heating of the pipe heating element.
- . A pressure safety valve to prevent over-pressurizing of the chamber.
The T-Edge 10 & T-Edge 11 autoclaves have two optional configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The demineralized water overflow outlet is located on the rear cover, demineralized water overflow, and wastewater outlet on the rear cover. Built-in system for checking water quality Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water.
The T-Edge 10 & T-Edge 11 feature a built-in memory to record up to 999 sterilization cycles. The T-Edge 10 & T-Edge 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC.
The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine. The device also has a built-in network port (LAN) for use with optional Tuttnauer's R.PC.R software.
The chamber is made of a corrosion-resistant 316L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.
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K Number
K181456Device Name
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
Manufacturer
Tuttnauer Ltd.
Date Cleared
2019-07-08
(399 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
Tuttnauer Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves that are intended for use by a health care r no rathant nealized products by means of pressurized steam. The devices are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products.
Device Description
Tuttnauer Horizontal Models: 4472, 5596, 6690, 66120, 69120 and 69180 autoclaves
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