LogoFDA 510(k) Search
K Number
K213080
Device Name
T-Edge 10, T-Edge 11
Manufacturer
Tuttnauer Ltd.
Date Cleared
2022-01-04

(103 days)

Product Code
FLE
Regulation Number
880.6880
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.
More Information

K143311, K111736

Not Found

No
The description mentions a "computerized control system" based on Linux, but there is no mention of AI or ML capabilities for decision-making, pattern recognition, or learning from data. The system appears to be for automated cycle control, monitoring, and data recording.

No

This device is an autoclave designed for sterilizing medical and surgical goods, not for treating any medical conditions or patients directly.

No.

Explanation: The device is an autoclave designed for sterilizing medical and surgical goods. Its primary function is sterilization, not diagnosis.

No

The device is a tabletop autoclave, which is a physical piece of equipment used for sterilization. While it has a computerized control system and software, it is fundamentally a hardware device with integrated software, not a software-only medical device.

Based on the provided information, the T-Edge 10 & T-Edge 11 tabletop autoclaves are not In Vitro Diagnostic (IVD) devices.

Here's why:

  • Intended Use: The intended use is for the sterilization of medical and surgical goods. This is a process applied to instruments and materials used in patient care, not for testing samples from the human body.
  • Device Description: The device is a steam sterilizer (autoclave) designed to kill microorganisms on medical equipment. It does not perform any tests or analyses on biological samples.
  • Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue, etc.). There is no mention of reagents, assays, or diagnostic results.

In summary, the T-Edge 10 & T-Edge 11 are sterilization devices used to prepare medical equipment for use, which is distinct from the function of an In Vitro Diagnostic device that performs tests on biological samples.

N/A

Intended Use / Indications for 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

Product codes

FLE

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.

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

The T-Edge 10 & T-Edge 11 Table-Top autoclave are intended for use by trained personnel in hospital and healthcare settings.

All autoclave users must receive training in proper usage from an experienced employee. Every new employee must undergo a training period under an experienced employee.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The following non-clinical tests were conducted:

  • Electrical Safety: Verified that device and its components meet electrical safety requirements based on IEC 61010-1:2010, UL 61010-1:2012, and IEC 61010-2-040:2015. (Pass)
  • EMC: Verified that the device meets EMC requirements based on EN 61326-1:2013 / IEC 61326-1:2012 and FCC part 15, subpart B. (Pass)
  • Software validation: Verified that the SW used meets standard requirements based on EN 61326-1:2013 / IEC 61326-1:2012. (Pass)
  • Pressure vessel testing: Verified that the pressure vessel used for the T-Edge meets the requirements for pressure vessel and is safe for use based on ASME Boiler and pressure vessel code, Section VIII division 1. (Pass)
  • Bowie & Dick test: Verified air removal performance (for dynamic air removal sterilizers). Acceptance criterion: The Bowie-Dick test indicator sheet shall show a uniform color change based on ANSI/AAMI ST-55. (Pass)
  • Air-leak-rate (vacuum) test: Verified air removal performance (for dynamic air removal sterilizers). Acceptance criterion: average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less over the measured time interval based on ANSI/AAMI ST-55. (Pass)
  • Empty chamber tests (250F/273F) - on wrapped and unwrapped load: Ensured that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load. Acceptance criterion: The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time based on ANSI/AAMI ST-55. (Pass)
  • Full chamber load test (250F/273F) - on wrapped and unwrapped load: Ensured that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load. Acceptance criterion: The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time based on ANSI/AAMI ST-55. (Pass)
  • Biological performance with a textile PCD: Verified biological performance. Acceptance criterion: Tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility when the textile PCD is used based on ANSI/AAMI ST-55. (Pass)
  • Biological performance with wrapped instrument PCD: Verified biological performance. Acceptance criterion: Tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility when the wrapped instrument PCD is used based on ANSI/AAMI ST-55. (Pass)
  • Biological performance with dental handpieces: Verified biological performance. Acceptance criterion: There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines, except for the positive controls. No growth shall be observed with the BIs except the positive control BI. Growth should be observed for the positive control turbines and BI based on ANSI/AAMI ST-55. (Pass)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K143311, 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).

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 4, 2022

Tuttnauer Ltd. Robert Basile Official Correspondent Har-Tuv Industrial Zone Beit-Shemesh, Jerusalem 9910101 Israel

Re: K213080

Trade/Device Name: T-Edge 10, T-Edge 11 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 23, 2021 Received: September 23, 2021

Dear Robert Basile:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number

K213080

Device Name

T-Edge 10 & T-Edge 11

Indications for Use (Describe)

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

The following tables show the cycles that were validated for Class B, including sterilization temperature, sterilization time in minutes and dry time in minutes and maximum loads:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

Table 1: Class B key cycles

| # | Cycle Name | Sterilization
temperature
[°F/°C] | Sterilization
time [min] | Dry Time
[min] | Max load
10"
[Kg] | Max load
11"
[Kg] |
|---|----------------------------|-----------------------------------------|-----------------------------|-------------------|------------------------------------------------------------|----------------------------------|
| 1 | Unwrapped Instr.
273F | 273.2°F
(134°C) | 4 | 2 | 6 | 9 |
| 2 | Wrapped Pouches
273F | 273.2°F
(134°C) | 4 | 20 | Instruments - 3.6
Textile - 1.5
Handpieces - 1 units | Instruments - 5.4
Textile - 2 |
| 3 | Unwrapped
Delicate 250F | 250°F (121°C) | 20 | 2 | 6 | 9 |
| 4 | Wrapped Delicate
250F | 250°F (121°C) | 20 | 30 | Instruments - 3.6
Textile - 1.5 | Instruments - 5.4
Textile - 2 |
| 5 | B&D Test | 273.2°F
(134°C) | 3.5 | 2 | - | - |
| 6 | Vacuum Test | NA | NA | NA | - | - |

Table 2: Class S key cycles

| # | Cycle Name | Sterilization
temperature
[°F/°C] | Sterilization
time
[min] | Dry Time
[min] | Max
load 10"
[Kg] | Max
load 11"
[Kg] |
|---|----------------------------------------|-----------------------------------------|--------------------------------|-------------------|-------------------------|-------------------------|
| 1 | Unwrapped instruments
270F | 269.6°F (132°C) | 3 | 2 | 5 | 8 |
| 2 | Wrapped instruments
pouches 270F | 269.6°F (132°C) | 4 | 30 | 3.6 | 4.5 |
| 3 | Unwrapped delicate
instruments 250F | 249.8°F (121°C) | 20 | 2 | 5 | 8 |
| 4 | Handpieces 270F | 269.6°F (132°C) | 4 | 30 | 6 units | |

:

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Image /page/5/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller font. Above the company name is a gray, star-like shape.

K213080 510(k) Summary Device name: T-Edge 10 & T-Edge 11

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Image /page/6/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller, gray font. Above the company name is a gray, star-like symbol.

Date Prepared: August 4, 2021

1. SUBMITTER

Tuttnauer USA Co. Ltd. 25 Power Drive Hauppauge, NY 11788 Phone: (631) 737 4850 Fax: (631) 737 0720

Contact Person:

Robert Basile Sr. Vice President Tuttnauer USA Co. Ltd. Tel: 631 737 4850 Ext: 137 Fax: 631 737 1034 E-mail: bob@tuttnauerusa.com

2. DEVICE

Trade Name: T-Edge 10 & T-Edge 11 Common Name: Electronic autoclave Classification Name: Steam Sterilizer Classification: Product Code FLE

Regulatory Class: II Regulation Number: 21CFR 880.6880 Regulation Name: Steam Sterilizer

3. PREDICATE DEVICES

Primary predicate: Tuttnauer's Elara 11 autoclave Secondary predicate: Tuttnauer's EZ11Plus autoclaves

| Predicate
name | Product Code | Regulation
Number | Regulation
Name | Class | 510K no. |
|-------------------|--------------|----------------------|---------------------|----------|----------|
| Elara 11 | FLE | 21CFR
880.6880 | Steam
Sterilizer | Class II | K143311 |
| EZ11Plus | FLE | 21CFR
880.6880 | Steam
Sterilizer | Class II | K111736 |

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Image /page/7/Picture/1 description: The image shows the logo for Tuttnauer. The logo features the company name in bold, red letters. Below the name, in smaller letters, are the words "Innovation, Legacy, Partnership."

4. 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 following tables show the cycles that were validated for Class-S and Class-B, including sterilization temperature, sterilization time in minutes and dry time in minutes:

| # | Cycle Name | Sterilization
temperature
[°F/°C] | Sterilization time
[min] | Dry Time
[min] | Max load
10"
[Kg] | Max load
11"
[Kg] |
|---|----------------------------|-----------------------------------------|-----------------------------|-------------------|-------------------------|-------------------------|
| 1 | Unwrapped Instr. 273F | 273.2°F (134°C) | 4 | 2 | 6 | 9 |
| 2 | Wrapped Pouches 273F | (134°C) 273.2°F | 4 | 20 | Instruments – 3.6 | Instruments – 5.4 |
| | | | | | Textile – 1.5 | Textile – 2 |
| | | | | | Handpieces – 1 units | |
| 3 | Unwrapped Delicate
250F | 250°F (121°C) | 20 | 2 | 6 | 9 |
| 4 | Wrapped Delicate 250F | 250°F (121°C) | 20 | 30 | Instruments – 3.6 | Instruments – 5.4 |
| | | | | | Textile – 1.5 | Textile – 2 |
| 5 | B&D Test | 273.2°F (134°C) | 3.5 | 2 | - | - |
| 6 | Vacuum Test | NA | NA | NA | - | - |

Table 1: Class B key cycles

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Image /page/8/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name, there is a tagline that reads "Innovation, Legacy, Partnership" in a smaller, gray font. Above the company name, there is a gray, star-like symbol.

Table 2: Class S key cycles

| # | Cycle Name | Sterilization
temperature
[°F/°C] | Sterilization
time
[min] | Dry Time [min] | Max load
10"
[Kg] | Max load
11"
[Kg] |
|---|----------------------------------------|-----------------------------------------|--------------------------------|----------------|-------------------------|-------------------------|
| 1 | Unwrapped instruments 270F | 269.6°F (132°C) | 3 | 2 | 5 | 8 |
| 2 | Wrapped instruments pouches
270F | 269.6°F (132°C) | 4 | 30 | 3.6 | 4.5 |
| 3 | Unwrapped delicate
instruments 250F | 249.8°F (121°C) | 20 | 2 | 5 | 8 |
| 4 | Handpieces 270F | 269.6°F (132°C) | 4 | 30 | | 6 units |

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. .

9

Image /page/9/Picture/1 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller font. Above the company name is a gray, star-like shape.

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.

The properties of the T-Edge 10 & T-Edge 11 are as described in the following table:

PropertyValue
T-Edge 10T-Edge 11
Width~19" (48 cm)~19.7" (50 cm)
External sizeHeight~19.7" (50 cm)
PropertyValue
T-Edge 10T-Edge 11
ChamberDepth~22.8" (58 cm) (supporting common install base carry a ~23" (60 cm) countertop)
Diameter~10" (25 cm)~11" (28 cm)
Depth~18" (46 cm)
Volume~778 Ounces (23 Lit)~913 Ounces (27.2 Lit)
Usable chamber space75% (~575 Ounces/~17 Lit)75% (~685 Ounces/~20.5 Lit)
Max. Allowable Working pressure (MAWP)~40.6 PSI (2.8 bar)
Safety relief valve~40 PSI (2.8 bar)
Net weight~117 lbs (53 kg)~124 lbs (56 kg)
Shipping weight~145 lbs (66 kg)~152 lbs (69 kg)
Floor loading requirements~165 lbs (75 kg)
Max loadSolid /Unwrapped~13 lbs (6 kg)~19.8 lbs (9 kg)
Solid /Wrapped~7.7 lbs (3.5 kg)~11.9 lbs (5.4 kg)
Textile~3.3 lbs (1.5 kg)~4.4 lbs (2 kg)
Maximum
load per trayUnwrapped~2.67 lbs (1.2 kg)~4 lbs (1.8 kg)
Wrapped~1.6 lbs (0.72 kg)~2.4 lbs (1.08 kg)
Tray dimensions~16.6" x ~7.4" x ~0.8"
(42.1 cm x 18.9 cm x 2.05 cm)~16.6" x ~8.14" x ~0.8"
(42.1 cm x 20.7 cm x 2.05 cm)
No. of trays5
Mineral-free water
reservoirMax. water
volumeOverflow (up to the float): ~128 Ounces (3.8 Lit)
Min. water
volume~33.8 Ounces (1 Lit)
The volume
used by the
sterilization
cycle/load
having the
highest
steam
consumptionRecorded 27 Ounces
(800 ml)
were required to
sterilize full load of
porous type using
"wrapped 121"~30 Ounces (~900 ml)
for
Wrapped 273°F + virus
protect
Used (waste) water
reservoirMax. water volumeMax vol.: ~135 Ounces / (4 Lit)
Float: ~125 Ounces (3.7 Lit.) max allowed for
PropertyValue
T-Edge 10T-Edge 11
Load No. counterCounting from 0 to 999 and nullifies

Table 3: T-Edge 10 & T-Edge 11 properties

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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.

5. LIST OF DEVICES

The following table is a list of devices models for which this 510(k) clearance is requested in this submission:

Table 4: List of devices models in the current submission

Device modelDevice catalog no.Device description
T-Edge 10 230VAMS10-230-TAn autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 230V/1Ph (50/60Hz).
The demineralized water is supplied by a manually filled reservoir.
T-Edge 10-W 230VAMS10-230-W-TAn autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 230V/1Ph (50/60Hz).
The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply.
T-Edge 10 120VAMS10-120-TAn autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 120V/1Ph (50/60Hz).
Device modelDevice catalog no.Device description
The demineralized water is supplied by a manually filled reservoir.
T-Edge 10-W 120VAMS10-120-W-TAn autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 120V/1Ph (50/60Hz).
The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply.
T-Edge 11 230VAMS11-230-TAn autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 230V/1Ph (50/60Hz).
The demineralized water is supplied by a manually filled reservoir.
T-Edge 11-W 230VAMS11-230-W-TAn autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 230V/1Ph (50/60Hz).
The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply.
T-Edge 11 120VAMS11-120-TAn autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 120V/1Ph (50/60Hz).
The demineralized water is supplied by a manually filled reservoir.
Device modelDevice catalog no.Device description
T-Edge 11-W 120VAMS11-120-W-TAn autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 120V/1Ph (50/60Hz).
The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply.

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6. INDICATION FOR USE

The T-Edge 10 & T-Edge 11 table-top autoclaves are designed for 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

Intended user

The T-Edge 10 & T-Edge 11 Table-Top autoclave are intended for use by trained personnel in hospital and healthcare settings.

All autoclave users must receive training in proper usage from an experienced employee. Every new employee must undergo a training period under an experienced employee.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following technological characteristics will be compared between the T-Edge family (T-Edge 10 & T-Edge 11) and the cleared predicate devices, the Elara11 (the primary predicate) and the EZ11Plus (The secondary predicate):

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  • General design of device: chamber volume, control system; ●
  • . Indication for use and intended users
  • Materials; ●
  • Energy source: .
  • Performance: .
  • . Sterilization parameters

Reason for the 510(k):

The T-Edge 10 & T-Edge 11 are class II device, equivalent to the predicate cleared devices, Elara11 (K143311) and EZ11plus (K111736) but changes made exceeds the limitations for a special 510(k) and thus the device requires a traditional 510(k):

  • . The Operating system of T-Edge devices is based on Linux (using Java as the programing language) compared to Windows (using C# as the programing language) in the predicate devices.
  • The sterilization time for the Unwrapped delicate cycle in the T-Edge 10 & T-Edge 11 is 10 ● minutes shorter than its equivalent in the EZ11 (20 minutes as compared to 30 minutes).
  • The chamber volume of the T-Edge 10 corresponds to the 10" chamber. It differs in 23L . compared to 28.5L. The chamber volume of the T-Edge 11 corresponds to the 11" chamber. It differs slightly in 27.2L compared to 28.5L.

| Parameter | Elara11 -
K143311 | EZ11Plus -
K111736 | T-Edge | Comparison |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chamber
volume | This device is a
single door table-
top autoclave
with a chamber
volume of 28.5L. | This device is a
single door table-
top autoclave
with a chamber
volume of 28.5L. | This device is a
single door table-
top autoclave with
a chamber volume
of:
23L (~778 ounces)
for the T-Edge 10 | Different |
| Parameter | Elara11 -
K143311 | EZ11Plus -
K111736 | T-Edge | Comparison |
| | | | 27.2L (~913 ounces) for the T-Edge11. | |
| Control system | The device is software controlled with electronic control panel that permits automatic usage. | The device is software controlled with electronic control panel that permits automatic usage. | The device is software controlled with electronic control panel that permits automatic usage. | Same |
| | The device is non-programmable. | The device is non-programmable. | The device is non-programmable. | Same |
| | The Operating system is Windows (programing language is C#). | The Operating system is Windows (programing language is C#). | The Operating system is Linux (programing language is Java). | Different |
| Indication for use | The Elara11 is a tabletop autoclave designed for the sterilization of 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 | The EZ11Plus is a tabletop autoclave designed for the sterilization of 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. | The T-Edge 10 & T-Edge 11 are tabletop autoclaves 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. | Different |
| Parameter | Elara11 -
K143311 | EZ11Plus -
K111736 | T-Edge | Comparison |
| | clinics, and in
first aid rooms. | dental, medical
clinics, and in
first aid rooms
and in small
laboratories. | clinics, and
medical and dental
offices). | |
| Materials | The outer cover
of the device is
made of metal
(aluminum). | The outer cover
of the device is
made of metal
(aluminum). | The outer cover of
the device is made
of polycarbonate. | Different |
| | The chamber is
made of 316L
stainless steel. | The chamber is
made of 316L
stainless steel. | The chamber is
made of 316L
stainless steel. | Same |
| | The door is made
of 304L stainless
steel. | The door is made
of 304L stainless
steel. | The door is made
of 304L stainless
steel. | Same |
| Energy source | The device can
be operated only
while connected
to an electrical
source (the
electrical grid).
It has no internal
power source
(batteries). | The device can
be operated only
while connected
to an electrical
source (the
electrical grid).
It has no internal
power source
(batteries). | The device can be
operated only
while connected to
an electrical
source (the
electrical grid).
It has no internal
power source
(batteries). | Same |
| Performance | The operation
principle is
sterilization by
heating a
controlled
amount of
demineralized
water to generate
steam as the
sterilization
reagent and
maintaining its | The operation
principle is
sterilization by
heating a
controlled
amount of
demineralized
water to generate
steam as the
sterilization
reagent and
maintaining its | The operation
principle is
sterilization by
heating a
controlled amount
of demineralized
water to generate
steam as the
sterilization
reagent and
maintaining its
temperature by | Same |
| Parameter | Elara11 -
K143311 | EZ11Plus -
K111736 | T-Edge | Comparison |
| | temperature by
using a heating
element
surrounding the
chamber. The
water is drawn
from a built-in
water reservoir. | temperature by
using a heating
element
surrounding the
chamber. The
water is drawn
from a built-in
water reservoir. | using a heating
element
surrounding the
chamber. The
water is drawn
from a built-in
water reservoir. | |
| | | The heating of
the water to
generate the
steam is done in a
steam generator
and the heating
element used is
metal band. | The heating of
the water to
generate the
steam is done in
a steam generator
and the heating
element used is
metal band. | The heating of the
water to generate
the steam is done
by using a water
pipe heater and the
heating element
used is silicon
jacket. |
| | The Elara11 has a
vacuum
mechanism to
allow better air
removal of air
pockets in the
load for an
effective
sterilization
before the start of
the sterilization
process (i.e., pre-
vacuum) and to
allow drying of
the load at the
end of the
sterilization
process. | The EZ11Plus
has no vacuum
mechanism | The T-Edge 10 &
T-Edge 11 have a
vacuum
mechanism to
allow better air
removal of air
pockets in the load
for an effective
sterilization (i.e.,
pre-vacuum) and
to allow drying of
the load at the end
of the sterilization
process. This
possibility exists
as the T-Edge 10
& T-Edge 11 can
be switched
between S-class
cycles and B-class
cycles. | Same as the
Elara 11
(primary
predicate). |
| Parameter | Elara11 -
K143311 | EZ11Plus -
K111736 | T-Edge | Comparison |
| Sterilization
parameters | The Elara11 has
6 key programs
as a Class-B
device.
The sterilization
parameters are as
follows:

  • Unwrapped
    instruments:
    temp.
    $134°C/273°F$
    for 4 minutes.
  • Wrapped
    instruments:
    temp.
    $134°C/273°F$
    for 4 minutes.
  • Unwrapped
    delicate
    instruments:
    temp.
    $121°C/250°F$
    for 20
    minutes.
  • Wrapped
    delicate
    instruments:
    temp.
    $121°C/250°F$
    for 20
    minutes. | The EZ11Plus
    has 4 key
    programs as a
    Class-S device.
    The sterilization
    parameters are as
    follows:
  • Unwrapped
    instruments:
    temp. $132°C$
    for 3 minutes
  • Wrapped
    instruments,
    pouches:
    temp. $132°C$
    for 4 minutes
  • Unwrapped
    delicate
    instruments:
    temp. $121°C$
    for 30
    minutes
  • Handpieces:
    temp. $132°C$
    for 4 minutes | The T-Edge 10 &
    T-Edge 11 have
    both Class-B and
    Class-S cycles and
    it can be switched
    between modes.
    The sterilization
    parameters for the
    Class-B cycles
    (see Table 1
    Section 4 in this
    document):
  • Unwrapped
    instruments:
    temp.
    $134°C/273.2°F$
    for 4 minutes.
  • Wrapped
    pouches1:
    temp.
    $134°C/273.2°F$
    for 4 minutes.
  • Unwrapped
    delicate: temp.
    $121°C/249.8°F$
    for 20 minutes.
  • Wrapped
    delicate: temp.
    $121°C/249.8°F$
    for 20 minutes.
    The sterilization
    parameters for the
    Class-S cycles (see
    Table 2 Section 4
    in this document): | Same for the
    Elara11.
    Different for
    the EZ11Plus. |
    | Parameter | Elara11 -
    K143311 | EZ11Plus -
    K111736 | T-Edge | Comparison |
    | | | | - Unwrapped instruments:
    temp.
    132°C/269.6°F
    for 3 minutes
  • Wrapped pouches: temp.
    132°C/269.6°F
    for 4 minutes
  • Unwrapped delicate: temp.
    121°C/249.8°F
    for 20 minutes
  • Handpieces:
    temp.
    132°C/269.6°F
    for 4 minutes | |

Table 5: Comparison of technological characteristics with predicate devices

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Notes:

  • The Wrapped pouches cycle in the T-Edge is equivalent to the Wrapped instruments cycle in 1. the Elara11.

8. PERFORMANCE TESTING

The following shows the non-clinical tests conducted:

| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------|
| Electrical Safety | Verifying that
device and its
components meet
electrical safety
requirements | Meeting standard
specification | • IEC 61010-
1:2010
• UL 61010-
1:2012
• IEC 61010-2-
040:2015 | Pass |
| EMC | Verifying that the
device meets EMC
requirements | Meeting standard
specification | • EN 61326-
1:2013 / IEC
61326-1:2012
• FCC part 15,
subpart B | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
| Software
validation | Verifying that the
SW used meets
standard
requirements | Meeting standard
specification | • EN 61326-
1:2013 / IEC
61326-1:2012 | Pass |
| Pressure vessel
testing | Verifying that the
pressure vessel
used for the T-
Edge meets the
requirements for
pressure vessel and
is safe for use. | Meeting standard
specification | • ASME Boiler
and pressure
vessel code,
Section VIII
division 1 | Pass |
| Device performance tests | | | | |
| Bowie & Dick
test | Verify air removal
performance (for
dynamic air
removal sterilizers) | The Bowie-Dick test
indicator sheet shall
show a uniform
color change | • ANSI/AAMI
ST-55 | Pass |
| Air-leak-rate
(vacuum) test | Verify air removal
performance (for
dynamic air
removal sterilizers) | average leak rate of
1 millimeter of
mercury
(mmHg) (0.13 kPa)
(0.019 psia) per min
or less over the
measured time
interval. | • ANSI/AAMI
ST-55 | Pass |
| Empty chamber
tests (250F/273F)

  • on wrapped and
    unwrapped load | to ensure that
    the sterilizer is
    capable of
    providing steady-
    state thermal
    conditions within
    the chamber
    consistent with the
    desired sterility
    assurance level
    (SAL) in the load | The temperature
    shall not exceed
    more than 3°C above
    the sterilization
    temperature.
    The temperature
    shall not be below
    the sterilization
    temperature
    Actual exposure
    time | • ANSI/AAMI
    ST-55 | Pass |
    | Full chamber load
    test (250F/273F)
  • on wrapped and
    unwrapped load | to ensure that
    the sterilizer is
    capable of
    providing steady-
    state thermal | The temperature
    shall not exceed
    more than 3°C above
    the sterilization
    temperature. | • ANSI/AAMI
    ST-55 | Pass |
    | Test name | Purpose | Acceptance criteria | Standards used | Results
    (Pass /
    No Pass) |
    | | conditions within
    the chamber
    consistent with the
    desired sterility
    assurance level
    (SAL) in the load | The temperature
    shall not be below
    the sterilization
    temperature

Actual exposure
time | | |
| Biological
performance with
a textile PCD | Verifying
biological
performance | Tested cycle has a
10-6 SAL or an SAL
providing a greater
assurance of sterility
when the textile
PCD is used. | • ANSI/AAMI
ST-55 | Pass |
| Biological
performance with
wrapped
instrument PCD | Verifying
biological
performance | Tested cycle has a
10-6 SAL or an SAL
providing a greater
assurance of sterility
when the wrapped
instrument PCD is
used. | • ANSI/AAMI
ST-55 | Pass |
| Biological
performance with
dental handpieces | Verifying
biological
performance | There shall be no
growth observed in
the vials containing
turbines or in the
extraction of any of
the turbines, except
for the positive
controls. No growth
shall be observed
with the BIs except
the positive control
BI. Growth should
be observed for the
positive control
turbines and BI. | • ANSI/AAMI
ST-55 | Pass |

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9. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device, T-Edge 10 & T-Edge 11, are as safe, as effective, and performs as well as or better than the legally marketed device