T-Edge 10, T-Edge 11

K213080 · Tuttnauer , Ltd. · FLE · Jan 4, 2022 · General Hospital

Device Facts

• Record ID: K213080
• Device Name: T-Edge 10, T-Edge 11
• Applicant: Tuttnauer , Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Jan 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

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 Story

Table-top steam sterilizers (autoclaves) for medical/surgical goods. Inputs: demineralized water; medical/surgical loads. Operation: computerized control system (Linux-based) manages heating elements (silicon jacket) and vacuum pump for pre-vacuum air removal and post-vacuum drying. Produces: sterilized loads; cycle documentation (up to 999 cycles). Used in healthcare facilities by trained personnel. Output: touchscreen monitoring; USB data export; barcode printer connectivity. Benefits: efficient steam penetration; temperature uniformity; effective sterilization; reduced water/energy consumption. Safety features: door micro-switches; locking pin; safety thermostat; pressure relief valve; water quality sensor.

Clinical Evidence

Bench testing only. Performance validated per ANSI/AAMI ST-55, including Bowie & Dick test, air-leak-rate test, empty/full chamber thermal distribution tests, and biological performance testing (textile PCD, wrapped instrument PCD, and dental handpieces) achieving 10^-6 SAL.

Technological Characteristics

Chamber: 316L stainless steel. Door: 304L stainless steel. Outer covers: polycarbonate. Heating: silicon jacket heating element. Vacuum: built-in pump for pre/post-vacuum. Connectivity: USB, LAN. Standards: IEC 61010-1, IEC 61010-2-040, UL 61010-1, EN 61326-1, FCC Part 15, ASME Boiler and Pressure Vessel Code Section VIII, ANSI/AAMI ST-55.

Indications for Use

Indicated for sterilization of medical and surgical goods including wrapped and unwrapped solid, hollow, and porous loads in healthcare facilities such as hospitals, nursing homes, extended-care facilities, surgical centers, clinics, and medical/dental offices. Validated for fabric packs/textiles and dental handpieces.

Regulatory Classification

Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Predicate Devices

• Elara 11 (K143311)
• EZ11Plus (K111736)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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#### 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.

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Table 1: Class B key cycles

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

Table 2: Class S key cycles

| # | Cycle Name | Sterilization<br>temperature<br>[°F/°C] | Sterilization<br>time<br>[min] | Dry Time<br>[min] | Max<br>load 10"<br>[Kg] | Max<br>load 11"<br>[Kg] |
|---|----------------------------------------|-----------------------------------------|--------------------------------|-------------------|-------------------------|-------------------------|
| 1 | Unwrapped instruments<br>270F | 269.6°F (132°C) | 3 | 2 | 5 | 8 |
| 2 | Wrapped instruments<br>pouches 270F | 269.6°F (132°C) | 4 | 30 | 3.6 | 4.5 |
| 3 | Unwrapped delicate<br>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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# K213080 510(k) Summary Device name: T-Edge 10 & T-Edge 11

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### Date Prepared: August 4, 2021

# 1. SUBMITTER

Tuttnauer USA Co. Ltd. 25 Power Drive Hauppauge, NY 11788 Phone: [phone] Fax: [phone]

### Contact Person:

Robert Basile Sr. Vice President Tuttnauer USA Co. Ltd. Tel: [phone] Ext: 137 Fax: [phone] E-mail: [e-mail]

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

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# 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<br>temperature<br>[°F/°C] | Sterilization time<br>[min] | Dry Time<br>[min] | Max load<br>10"<br>[Kg] | Max load<br>11"<br>[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<br>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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#### Table 2: Class S key cycles

| # | Cycle Name | Sterilization<br>temperature<br>[°F/°C] | Sterilization<br>time<br>[min] | Dry Time [min] | Max load<br>10"<br>[Kg] | Max load<br>11"<br>[Kg] |
|---|----------------------------------------|-----------------------------------------|--------------------------------|----------------|-------------------------|-------------------------|
| 1 | Unwrapped instruments 270F | 269.6°F (132°C) | 3 | 2 | 5 | 8 |
| 2 | Wrapped instruments pouches<br>270F | 269.6°F (132°C) | 4 | 30 | 3.6 | 4.5 |
| 3 | Unwrapped delicate<br>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. .

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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:

| Property | | Value | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | | T-Edge 10 | T-Edge 11 |
| | Width | ~19" (48 cm) | ~19.7" (50 cm) |
| External size | Height | ~19.7" (50 cm) | |
| Property | Value | | |
| | T-Edge 10 | T-Edge 11 | |
| Chamber | Depth | ~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 space | 75% (~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 load | Solid /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<br>load per tray | Unwrapped | ~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"<br>(42.1 cm x 18.9 cm x 2.05 cm) | ~16.6" x ~8.14" x ~0.8"<br>(42.1 cm x 20.7 cm x 2.05 cm) |
| No. of trays | 5 | | |
| Mineral-free water<br>reservoir | Max. water<br>volume | Overflow (up to the float): ~128 Ounces (3.8 Lit) | |
| | Min. water<br>volume | ~33.8 Ounces (1 Lit) | |
| | The volume<br>used by the<br>sterilization<br>cycle/load<br>having the<br>highest<br>steam<br>consumption | Recorded 27 Ounces<br>(800 ml)<br>were required to<br>sterilize full load of<br>porous type using<br>"wrapped 121" | ~30 Ounces (~900 ml)<br>for<br>Wrapped 273°F + virus<br>protect |
| Used (waste) water<br>reservoir | Max. water volume | Max vol.: ~135 Ounces / (4 Lit)<br>Float: ~125 Ounces (3.7 Lit.) max allowed for | |
| Property | Value | | |
| | T-Edge 10 | T-Edge 11 | |
| Load No. counter | Counting 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 model | Device catalog no. | Device description |
|------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| T-Edge 10 230V | AMS10-230-T | An autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 230V/1Ph (50/60Hz).<br>The demineralized water is supplied by a manually filled reservoir. |
| T-Edge 10-W 230V | AMS10-230-W-T | An autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 230V/1Ph (50/60Hz).<br>The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply. |
| T-Edge 10 120V | AMS10-120-T | An autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 120V/1Ph (50/60Hz). |
| Device model | Device catalog no. | Device description |
| | | The demineralized water is supplied by a manually filled reservoir. |
| T-Edge 10-W 120V | AMS10-120-W-T | An autoclave with a 10" diameter chamber and with a volume of 23L (~778 Oz), operating in 120V/1Ph (50/60Hz).<br>The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply. |
| T-Edge 11 230V | AMS11-230-T | An autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 230V/1Ph (50/60Hz).<br>The demineralized water is supplied by a manually filled reservoir. |
| T-Edge 11-W 230V | AMS11-230-W-T | An autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 230V/1Ph (50/60Hz).<br>The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply. |
| T-Edge 11 120V | AMS11-120-T | An autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 120V/1Ph (50/60Hz).<br>The demineralized water is supplied by a manually filled reservoir. |
| Device model | Device catalog no. | Device description |
| T-Edge 11-W 120V | AMS11-120-W-T | An autoclave with a 11" diameter chamber and with a volume of 27.2L (~913 Oz), operating in 120V/1Ph (50/60Hz).<br>The demineralized water is supplied directly via dedicated inlet connected to a demineralized water supply. |

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Image /page/12/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name, the words "Innovation, Legacy, Partnership" are written in a smaller, gray font. Above the name is a gray, star-like symbol.

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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 -<br>K143311 | EZ11Plus -<br>K111736 | T-Edge | Comparison |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chamber<br>volume | This device is a<br>single door table-<br>top autoclave<br>with a chamber<br>volume of 28.5L. | This device is a<br>single door table-<br>top autoclave<br>with a chamber<br>volume of 28.5L. | This device is a<br>single door table-<br>top autoclave with<br>a chamber volume<br>of:<br>23L (~778 ounces)<br>for the T-Edge 10 | Different |
| Parameter | Elara11 -<br>K143311 | EZ11Plus -<br>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 -<br>K143311 | EZ11Plus -<br>K111736 | T-Edge | Comparison |
| | clinics, and in<br>first aid rooms. | dental, medical<br>clinics, and in<br>first aid rooms<br>and in small<br>laboratories. | clinics, and<br>medical and dental<br>offices). | |
| Materials | The outer cover<br>of the device is<br>made of metal<br>(aluminum). | The outer cover<br>of the device is<br>made of metal<br>(aluminum). | The outer cover of<br>the device is made<br>of polycarbonate. | Different |
| | The chamber is<br>made of 316L<br>stainless steel. | The chamber is<br>made of 316L<br>stainless steel. | The chamber is<br>made of 316L<br>stainless steel. | Same |
| | The door is made<br>of 304L stainless<br>steel. | The door is made<br>of 304L stainless<br>steel. | The door is made<br>of 304L stainless<br>steel. | Same |
| Energy source | The device can<br>be operated only<br>while connected<br>to an electrical<br>source (the<br>electrical grid).<br>It has no internal<br>power source<br>(batteries). | The device can<br>be operated only<br>while connected<br>to an electrical<br>source (the<br>electrical grid).<br>It has no internal<br>power source<br>(batteries). | The device can be<br>operated only<br>while connected to<br>an electrical<br>source (the<br>electrical grid).<br>It has no internal<br>power source<br>(batteries). | Same |
| Performance | The operation<br>principle is<br>sterilization by<br>heating a<br>controlled<br>amount of<br>demineralized<br>water to generate<br>steam as the<br>sterilization<br>reagent and<br>maintaining its | The operation<br>principle is<br>sterilization by<br>heating a<br>controlled<br>amount of<br>demineralized<br>water to generate<br>steam as the<br>sterilization<br>reagent and<br>maintaining its | The operation<br>principle is<br>sterilization by<br>heating a<br>controlled amount<br>of demineralized<br>water to generate<br>steam as the<br>sterilization<br>reagent and<br>maintaining its<br>temperature by | Same |
| Parameter | Elara11 -<br>K143311 | EZ11Plus -<br>K111736 | T-Edge | Comparison |
| | temperature by<br>using a heating<br>element<br>surrounding the<br>chamber. The<br>water is drawn<br>from a built-in<br>water reservoir. | temperature by<br>using a heating<br>element<br>surrounding the<br>chamber. The<br>water is drawn<br>from a built-in<br>water reservoir. | using a heating<br>element<br>surrounding the<br>chamber. The<br>water is drawn<br>from a built-in<br>water reservoir. | |
| | | The heating of<br>the water to<br>generate the<br>steam is done in a<br>steam generator<br>and the heating<br>element used is<br>metal band. | The heating of<br>the water to<br>generate the<br>steam is done in<br>a steam generator<br>and the heating<br>element used is<br>metal band. | The heating of the<br>water to generate<br>the steam is done<br>by using a water<br>pipe heater and the<br>heating element<br>used is silicon<br>jacket. |
| | The Elara11 has a<br>vacuum<br>mechanism to<br>allow better air<br>removal of air<br>pockets in the<br>load for an<br>effective<br>sterilization<br>before the start of<br>the sterilization<br>process (i.e., pre-<br>vacuum) and to<br>allow drying of<br>the load at the<br>end of the<br>sterilization<br>process. | The EZ11Plus<br>has no vacuum<br>mechanism | The T-Edge 10 &<br>T-Edge 11 have a<br>vacuum<br>mechanism to<br>allow better air<br>removal of air<br>pockets in the load<br>for an effective<br>sterilization (i.e.,<br>pre-vacuum) and<br>to allow drying of<br>the load at the end<br>of the sterilization<br>process. This<br>possibility exists<br>as the T-Edge 10<br>& T-Edge 11 can<br>be switched<br>between S-class<br>cycles and B-class<br>cycles. | Same as the<br>Elara 11<br>(primary<br>predicate). |
| Parameter | Elara11 -<br>K143311 | EZ11Plus -<br>K111736 | T-Edge | Comparison |
| Sterilization<br>parameters | The Elara11 has<br>6 key programs<br>as a Class-B<br>device.<br>The sterilization<br>parameters are as<br>follows:<br>- Unwrapped<br>instruments:<br>temp.<br>$134°C/273°F$<br>for 4 minutes.<br>- Wrapped<br>instruments:<br>temp.<br>$134°C/273°F$<br>for 4 minutes.<br>- Unwrapped<br>delicate<br>instruments:<br>temp.<br>$121°C/250°F$<br>for 20<br>minutes.<br>- Wrapped<br>delicate<br>instruments:<br>temp.<br>$121°C/250°F$<br>for 20<br>minutes. | The EZ11Plus<br>has 4 key<br>programs as a<br>Class-S device.<br>The sterilization<br>parameters are as<br>follows:<br>- Unwrapped<br>instruments:<br>temp. $132°C$<br>for 3 minutes<br>- Wrapped<br>instruments,<br>pouches:<br>temp. $132°C$<br>for 4 minutes<br>- Unwrapped<br>delicate<br>instruments:<br>temp. $121°C$<br>for 30<br>minutes<br>- Handpieces:<br>temp. $132°C$<br>for 4 minutes | The T-Edge 10 &<br>T-Edge 11 have<br>both Class-B and<br>Class-S cycles and<br>it can be switched<br>between modes.<br>The sterilization<br>parameters for the<br>Class-B cycles<br>(see Table 1<br>Section 4 in this<br>document):<br>- Unwrapped<br>instruments:<br>temp.<br>$134°C/273.2°F$<br>for 4 minutes.<br>- Wrapped<br>pouches1:<br>temp.<br>$134°C/273.2°F$<br>for 4 minutes.<br>- Unwrapped<br>delicate: temp.<br>$121°C/249.8°F$<br>for 20 minutes.<br>- Wrapped<br>delicate: temp.<br>$121°C/249.8°F$<br>for 20 minutes.<br>The sterilization<br>parameters for the<br>Class-S cycles (see<br>Table 2 Section 4<br>in this document): | Same for the<br>Elara11.<br>Different for<br>the EZ11Plus. |
| Parameter | Elara11 -<br>K143311 | EZ11Plus -<br>K111736 | T-Edge | Comparison |
| | | | - Unwrapped instruments:<br>temp.<br>132°C/269.6°F<br>for 3 minutes<br>- Wrapped pouches: temp.<br>132°C/269.6°F<br>for 4 minutes<br>- Unwrapped delicate: temp.<br>121°C/249.8°F<br>for 20 minutes<br>- Handpieces:<br>temp.<br>132°C/269.6°F<br>for 4 minutes | |

Table 5: Comparison of technological characteristics with predicate devices

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