(103 days)
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 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.
The provided document outlines the acceptance criteria and performance data for the Tuttnauer T-Edge 10 & T-Edge 11 steam sterilizers, as submitted for FDA 510(k) clearance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance (Results) | Standard Used |
|---|---|---|---|---|
| Electrical Safety | Verifying device and components meet electrical safety requirements | Meeting standard specification | Pass | IEC 61010-1:2010, UL 61010-1:2012, IEC 61010-2-040:2015 |
| EMC | Verifying device meets EMC requirements | Meeting standard specification | Pass | EN 61326-1:2013 / IEC 61326-1:2012, FCC part 15, subpart B |
| Software Validation | Verifying SW used meets standard requirements | Meeting standard specification | Pass | EN 61326-1:2013 / IEC 61326-1:2012 |
| Pressure Vessel Testing | Verifying pressure vessel meets requirements and is safe for use | Meeting standard specification | Pass | ASME Boiler and pressure vessel code, Section VIII division 1 |
| Bowie & Dick Test | Verify air removal performance (for dynamic air removal sterilizers) | The Bowie-Dick test indicator sheet shall show a uniform color change | Pass | ANSI/AAMI ST-55 |
| 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. | Pass | ANSI/AAMI ST-55 |
| Empty Chamber Tests (250F/273F) - on wrapped and unwrapped load | To ensure sterilizer is capable of providing steady-state thermal conditions within chamber consistent with 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. | Pass | ANSI/AAMI ST-55 |
| Full Chamber Load Test (250F/273F) - on wrapped and unwrapped load | To ensure sterilizer is capable of providing steady-state thermal conditions within chamber consistent with 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. | Pass | ANSI/AAMI ST-55 |
| 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. | Pass | ANSI/AAMI ST-55 |
| 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. | Pass | ANSI/AAMI ST-55 |
| 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. | Pass | ANSI/AAMI ST-55 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of tests/runs) conducted for each performance test. It only provides a summary of the test purpose, acceptance criteria, and whether the device "Passed" or "No Pass."
Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It generally refers to "non-clinical tests conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are primarily engineering and microbiology validation tests against established standards (e.g., ANSI/AAMI ST-55, IEC 61010, ASME). These types of tests typically rely on objective measurements and adherence to specified protocols rather than expert consensus on ground truth in the way an imaging AI algorithm might.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective performance validations against technical standards, not subjective assessments requiring adjudication by multiple readers or experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the validation of a steam sterilizer, which is a medical device for sterilizing instruments, not an AI/imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or included.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI algorithm but a physical device. The performance tests evaluate the device's ability to sterilize effectively according to pre-defined parameters and standards.
7. Type of Ground Truth Used
The "ground truth" for the performance tests outlined is based on:
- Established Industry Standards: Such as ANSI/AAMI ST-55 for sterilization performance, IEC 61010 for electrical safety, ASME for pressure vessel codes, and EN/IEC 61326 for EMC.
- Physical Measurements/Observations: Including temperature readings, leak rates, color changes on indicators, and the absence/presence of microbial growth (for biological performance tests).
- Pre-defined Parameters: Sterilization temperature, time, and dry time, against which the device's actual performance is measured.
For biological performance tests, the "ground truth" for sterility is the absence of microbial growth (i.e., a 10-6 SAL or greater assurance of sterility), as determined by biological indicators (BIs) and process challenge devices (PCDs).
8. Sample Size for the Training Set
Not applicable. This is a medical device (steam sterilizer), not an AI/machine learning model that requires a training set. The device's operation is based on established physical principles and pre-programmed sterilization cycles, not on learned patterns from a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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
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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 (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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number
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 | Sterilizationtemperature[°F/°C] | Sterilizationtime [min] | Dry Time[min] | Max load10"[Kg] | Max load11"[Kg] |
|---|---|---|---|---|---|---|
| 1 | Unwrapped Instr.273F | 273.2°F(134°C) | 4 | 2 | 6 | 9 |
| 2 | Wrapped Pouches273F | 273.2°F(134°C) | 4 | 20 | Instruments - 3.6Textile - 1.5Handpieces - 1 units | Instruments - 5.4Textile - 2 |
| 3 | UnwrappedDelicate 250F | 250°F (121°C) | 20 | 2 | 6 | 9 |
| 4 | Wrapped Delicate250F | 250°F (121°C) | 20 | 30 | Instruments - 3.6Textile - 1.5 | Instruments - 5.4Textile - 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 | Sterilizationtemperature[°F/°C] | Sterilizationtime[min] | Dry Time[min] | Maxload 10"[Kg] | Maxload 11"[Kg] |
|---|---|---|---|---|---|---|
| 1 | Unwrapped instruments270F | 269.6°F (132°C) | 3 | 2 | 5 | 8 |
| 2 | Wrapped instrumentspouches 270F | 269.6°F (132°C) | 4 | 30 | 3.6 | 4.5 |
| 3 | Unwrapped delicateinstruments 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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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
| Predicatename | Product Code | RegulationNumber | RegulationName | Class | 510K no. |
|---|---|---|---|---|---|
| Elara 11 | FLE | 21CFR880.6880 | SteamSterilizer | Class II | K143311 |
| EZ11Plus | FLE | 21CFR880.6880 | SteamSterilizer | 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 | Sterilizationtemperature[°F/°C] | Sterilization time[min] | Dry Time[min] | Max load10"[Kg] | Max load11"[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 Delicate250F | 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 | Sterilizationtemperature[°F/°C] | Sterilizationtime[min] | Dry Time [min] | Max load10"[Kg] | Max load11"[Kg] |
|---|---|---|---|---|---|---|
| 1 | Unwrapped instruments 270F | 269.6°F (132°C) | 3 | 2 | 5 | 8 |
| 2 | Wrapped instruments pouches270F | 269.6°F (132°C) | 4 | 30 | 3.6 | 4.5 |
| 3 | Unwrapped delicateinstruments 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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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:
| 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) | |
| Maximumload 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"(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 trays | 5 | ||
| Mineral-free waterreservoir | Max. watervolume | Overflow (up to the float): ~128 Ounces (3.8 Lit) | |
| Min. watervolume | ~33.8 Ounces (1 Lit) | ||
| The volumeused by thesterilizationcycle/loadhaving thehigheststeamconsumption | Recorded 27 Ounces(800 ml)were required tosterilize full load ofporous type using"wrapped 121" | ~30 Ounces (~900 ml)forWrapped 273°F + virusprotect | |
| Used (waste) waterreservoir | Max. water volume | Max vol.: ~135 Ounces / (4 Lit)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).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).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).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).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).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).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).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 |
|---|---|---|---|---|
| Chambervolume | This device is asingle door table-top autoclavewith a chambervolume of 28.5L. | This device is asingle door table-top autoclavewith a chambervolume of 28.5L. | This device is asingle door table-top autoclave witha chamber volumeof: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 infirst aid rooms. | dental, medicalclinics, and infirst aid roomsand in smalllaboratories. | clinics, andmedical and dentaloffices). | ||
| Materials | The outer coverof the device ismade of metal(aluminum). | The outer coverof the device ismade of metal(aluminum). | The outer cover ofthe device is madeof polycarbonate. | Different |
| The chamber ismade of 316Lstainless steel. | The chamber ismade of 316Lstainless steel. | The chamber ismade of 316Lstainless steel. | Same | |
| The door is madeof 304L stainlesssteel. | The door is madeof 304L stainlesssteel. | The door is madeof 304L stainlesssteel. | Same | |
| Energy source | The device canbe operated onlywhile connectedto an electricalsource (theelectrical grid).It has no internalpower source(batteries). | The device canbe operated onlywhile connectedto an electricalsource (theelectrical grid).It has no internalpower source(batteries). | The device can beoperated onlywhile connected toan electricalsource (theelectrical grid).It has no internalpower source(batteries). | Same |
| Performance | The operationprinciple issterilization byheating acontrolledamount ofdemineralizedwater to generatesteam as thesterilizationreagent andmaintaining its | The operationprinciple issterilization byheating acontrolledamount ofdemineralizedwater to generatesteam as thesterilizationreagent andmaintaining its | The operationprinciple issterilization byheating acontrolled amountof demineralizedwater to generatesteam as thesterilizationreagent andmaintaining itstemperature by | Same |
| Parameter | Elara11 -K143311 | EZ11Plus -K111736 | T-Edge | Comparison |
| temperature byusing a heatingelementsurrounding thechamber. Thewater is drawnfrom a built-inwater reservoir. | temperature byusing a heatingelementsurrounding thechamber. Thewater is drawnfrom a built-inwater reservoir. | using a heatingelementsurrounding thechamber. Thewater is drawnfrom a built-inwater reservoir. | ||
| The heating ofthe water togenerate thesteam is done in asteam generatorand the heatingelement used ismetal band. | The heating ofthe water togenerate thesteam is done ina steam generatorand the heatingelement used ismetal band. | The heating of thewater to generatethe steam is doneby using a waterpipe heater and theheating elementused is siliconjacket. | ||
| The Elara11 has avacuummechanism toallow better airremoval of airpockets in theload for aneffectivesterilizationbefore the start ofthe sterilizationprocess (i.e., pre-vacuum) and toallow drying ofthe load at theend of thesterilizationprocess. | The EZ11Plushas no vacuummechanism | The T-Edge 10 &T-Edge 11 have avacuummechanism toallow better airremoval of airpockets in the loadfor an effectivesterilization (i.e.,pre-vacuum) andto allow drying ofthe load at the endof the sterilizationprocess. Thispossibility existsas the T-Edge 10& T-Edge 11 canbe switchedbetween S-classcycles and B-classcycles. | Same as theElara 11(primarypredicate). | |
| Parameter | Elara11 -K143311 | EZ11Plus -K111736 | T-Edge | Comparison |
| Sterilizationparameters | The Elara11 has6 key programsas a Class-Bdevice.The sterilizationparameters are asfollows:- Unwrappedinstruments:temp.$134°C/273°F$for 4 minutes.- Wrappedinstruments:temp.$134°C/273°F$for 4 minutes.- Unwrappeddelicateinstruments:temp.$121°C/250°F$for 20minutes.- Wrappeddelicateinstruments:temp.$121°C/250°F$for 20minutes. | The EZ11Plushas 4 keyprograms as aClass-S device.The sterilizationparameters are asfollows:- Unwrappedinstruments:temp. $132°C$for 3 minutes- Wrappedinstruments,pouches:temp. $132°C$for 4 minutes- Unwrappeddelicateinstruments:temp. $121°C$for 30minutes- Handpieces:temp. $132°C$for 4 minutes | The T-Edge 10 &T-Edge 11 haveboth Class-B andClass-S cycles andit can be switchedbetween modes.The sterilizationparameters for theClass-B cycles(see Table 1Section 4 in thisdocument):- Unwrappedinstruments:temp.$134°C/273.2°F$for 4 minutes.- Wrappedpouches1:temp.$134°C/273.2°F$for 4 minutes.- Unwrappeddelicate: temp.$121°C/249.8°F$for 20 minutes.- Wrappeddelicate: temp.$121°C/249.8°F$for 20 minutes.The sterilizationparameters for theClass-S cycles (seeTable 2 Section 4in this document): | Same for theElara11.Different forthe EZ11Plus. |
| Parameter | Elara11 -K143311 | EZ11Plus -K111736 | T-Edge | Comparison |
| - Unwrapped instruments:temp.132°C/269.6°Ffor 3 minutes- Wrapped pouches: temp.132°C/269.6°Ffor 4 minutes- Unwrapped delicate: temp.121°C/249.8°Ffor 20 minutes- Handpieces:temp.132°C/269.6°Ffor 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 thatdevice and itscomponents meetelectrical safetyrequirements | Meeting standardspecification | • IEC 61010-1:2010• UL 61010-1:2012• IEC 61010-2-040:2015 | Pass |
| EMC | Verifying that thedevice meets EMCrequirements | Meeting standardspecification | • EN 61326-1:2013 / IEC61326-1:2012• FCC part 15,subpart B | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass /No Pass) |
| Softwarevalidation | Verifying that theSW used meetsstandardrequirements | Meeting standardspecification | • EN 61326-1:2013 / IEC61326-1:2012 | Pass |
| Pressure vesseltesting | Verifying that thepressure vesselused for the T-Edge meets therequirements forpressure vessel andis safe for use. | Meeting standardspecification | • ASME Boilerand pressurevessel code,Section VIIIdivision 1 | Pass |
| Device performance tests | ||||
| Bowie & Dicktest | Verify air removalperformance (fordynamic airremoval sterilizers) | The Bowie-Dick testindicator sheet shallshow a uniformcolor change | • ANSI/AAMIST-55 | Pass |
| Air-leak-rate(vacuum) test | Verify air removalperformance (fordynamic airremoval sterilizers) | average leak rate of1 millimeter ofmercury(mmHg) (0.13 kPa)(0.019 psia) per minor less over themeasured timeinterval. | • ANSI/AAMIST-55 | Pass |
| Empty chambertests (250F/273F)- on wrapped andunwrapped load | to ensure thatthe sterilizer iscapable ofproviding steady-state thermalconditions withinthe chamberconsistent with thedesired sterilityassurance level(SAL) in the load | The temperatureshall not exceedmore than 3°C abovethe sterilizationtemperature.The temperatureshall not be belowthe sterilizationtemperatureActual exposuretime | • ANSI/AAMIST-55 | Pass |
| Full chamber loadtest (250F/273F)- on wrapped andunwrapped load | to ensure thatthe sterilizer iscapable ofproviding steady-state thermal | The temperatureshall not exceedmore than 3°C abovethe sterilizationtemperature. | • ANSI/AAMIST-55 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass /No Pass) |
| conditions withinthe chamberconsistent with thedesired sterilityassurance level(SAL) in the load | The temperatureshall not be belowthe sterilizationtemperatureActual exposuretime | |||
| Biologicalperformance witha textile PCD | Verifyingbiologicalperformance | Tested cycle has a10-6 SAL or an SALproviding a greaterassurance of sterilitywhen the textilePCD is used. | • ANSI/AAMIST-55 | Pass |
| Biologicalperformance withwrappedinstrument PCD | Verifyingbiologicalperformance | Tested cycle has a10-6 SAL or an SALproviding a greaterassurance of sterilitywhen the wrappedinstrument PCD isused. | • ANSI/AAMIST-55 | Pass |
| Biologicalperformance withdental handpieces | Verifyingbiologicalperformance | There shall be nogrowth observed inthe vials containingturbines or in theextraction of any ofthe turbines, exceptfor the positivecontrols. No growthshall be observedwith the BIs exceptthe positive controlBI. Growth shouldbe observed for thepositive controlturbines and BI. | • ANSI/AAMIST-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
§ 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).