(122 days)
Not Found
No
The document describes a system combining electrosurgery and cryosurgery for tissue ablation, cutting, and coagulation. It details the components, their functions, and how they interact. There is no mention of AI, ML, or any related concepts like algorithms for image processing, data analysis, or predictive modeling. The system operates based on pre-programmed electrical waveforms and parameters, and regulated gas flow, not learning or adaptive processes.
Yes
The devices deliver electrical current or extreme cold for cutting, coagulation, and ablation of tissue, which are direct therapeutic actions.
No
The device description clearly states that the VIO 3, ERBECRYO 2, and HybridTherm ablation probes are intended for therapeutic procedures such as cutting, coagulation, and ablation of tissue, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including an electrosurgical unit (ESU), a cryosurgical unit, ablation probes, footswitches, and cables. While software is involved in controlling these units, the device is fundamentally a system of interconnected hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "cutting and/or coagulation of tissue, including ablation" and "cryoadhesion (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation." These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details an electrosurgical unit, a cryosurgical unit, and ablation probes used for direct interaction with tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is an electrosurgical and cryosurgical system used for therapeutic and surgical interventions directly on the patient.
N/A
Intended Use / Indications for Use
Indications for Use - VIO 3
The Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation.
Indications for use - ERBECRYO 2
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation.
Indications for use - HybridTherm ablation probes
The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.
Product codes
GEI, JOS, GEH
Device Description
The HybridTherm system consists of the electrosurgical unit (ESU) Model VIO 3, the cryosurgical unit Model ERBECRYO 2, the HybridTherm ablation probes and accessories.
HybridTherm ablation probes
The HybridTherm probes are a product family consisting of 8 probes to offer the user a range of instruments based upon the physician's preference. There are 4 monopolar and 4 bipolar ablation probes, which differ in the function of the distal end: with and without a monopolar cutting tip (eTip), as well as in their shape (i.e. straight or angulated/curved).
The HybridTherm probes combine high-frequency (HF) technology with cryotechnology. The HF technology is used for cutting (only variants with eTip), coagulation, and ablation of tissue. To reduce tissue desiccation and to increase the ablation zone, the probes are cooled. Cooling also minimizes tissue adhesion to the electrode. The primary function of the cooling is to support the ablation process.
VIO 3
The ESU Model VIO 3 delivers high frequency (HF) electrical current for cutting, coagulation and ablation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different Footswitches are available for activating the ESU and as applicable to change modes of the ESU (Remode feature). The ESU Model VIO 3 has several clearly defined cutting, coagulation and ablation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle.
ERBECRYO 2
The cryosurgical unit Model ERBECRYO 2 is connected to an electrical power source and a carbon dioxide (CO2) source. Upon activation, the Unit delivers a regulated CO2flow to the end of the connected instrument for cooling. The CO2 returning from the probe to the ERBECRYO 2 exists via the exhaust gas hose. Appropriate gas cylinder adapters are available for the various international gas cylinder connections.
HybridTherm System
The HybridTherm probes are connected to the units (VIO 3 and ERBECRYO 2) via respective plugs. The units are connected to each other via an Erbe Communication Bus (ECB) cable, whereby the user only interacts with the ESU Model VIO 3 (master-slave technology: the cryosurgical unit is controlled via the VIO 3). The ERBECRYO 2 additionally requires a CO2 gas cylinder. A footswitch is connected to the ESU, with which the activation of the available modes is started. The ESU supplies the HF current which is needed for cutting (only HybridTherm probe variants with eTip), coagulation and ablation of tissue. The ERBECRYO 2 supplies CO2 gas which is needed for cooling via the Joule-Thomson-effect to support the ablation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Side-by-side tissue testing was performed in compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", to validate the cutting, coagulation and ablation performance compared to the predicate device(s).
Electromagnetic compatibility (EMC) was tested in compliance with IEC 60601-1-2 and FDA Guidance "Electromagnetic Compatibility (EMC) of Medical Devices".
Electrical safety of the subject device was tested in compliance with, IEC 60601-1; IEC 60601-2-2 and IEC 60601-2-18, as applicable.
Software verification and documentation for cybersecurity was provided in compliance with IEC 62304 and FDA Guidance Documents "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility of the materials with tissue contact.
Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" showing an SAL of 10-6. EO residual testing and limits comply with ISO 10993-7.
Packaging and shelf-life validation was performed in compliance with ISO 11607-1, ISO 11607-2 and accelerated aged devices (ASTM F 1980).
Key results: Side-by-side tissue testing against the respective predicate device(s) shows that the performance (i.e. cutting, coagulation and ablation) is as good as the performance of the predicate device(s). The non-clinical testing described below shows that the different technological characteristics do not negatively affect the safety and effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K181249, K163450, K190823, K192542, K190651
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 5, 2024
Erbe Elektromedizin GmbH Matthias Kollek Regulatory Affairs Specialist Waldhoernlestrasse 17 Tuebingen, 72072 Germany
Re: K240932
Trade/Device Name: HybridTherm System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, JOS, GEH Dated: July 22, 2024 Received: July 22, 2024
Dear Matthias Kollek:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Long H. Chen -> Digitally signed by Long H. Chen-S
Date: 2024.08.05 13:39:20 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K240932
Device Name HybridTherm System
Indications for Use (Describe)
Indications for Use - VIO 3
The Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation.
Indications for use - ERBECRYO 2
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation.
Indications for use - HybridTherm ablation probes The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Traditional 510(k) for HybridTherm System
510(k) SUMMARY
| Applicant | Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
72072 Tuebingen
Germany
Tel: 0049-7071-755-0
Fax: 0049-7071-755-179 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Dr. Matthias Kollek |
| | Regulatory Affairs Specialist |
| | E-Mail: Matthias.Kollek@erbe-med.com |
| Date Prepared | July 22, 2024 |
| Device Information | |
| Trade/Proprietary Name: | HybridTherm System |
| Common Name: | Electrosurgical cutting and coagulation device |
| | and accessories |
| Classification Name | Electrosurgical cutting and coagulation device |
| | and accessories |
| Regulation Number: | 21 CFR 878.4400, |
| | 21 CFR 878.4350 |
| Class: | II |
| Product Code: | GEI & JOS |
| | GEH |
| Legally Marketed Predicate Devices | Primary |
| | EUSRA RF Electrode - K181249 |
| | Additional predicate devices |
| | VIVA combo RF System - K163450 |
| | Erbe ESU Model VIO 3 - K190823 |
| | Single Use Electrosurgical pencil - K192542 |
| | ERBECRYO 2 - K190651 |
5
Device Description
The HybridTherm system consists of the electrosurgical unit (ESU) Model VIO 3, the cryosurgical unit Model ERBECRYO 2, the HybridTherm ablation probes and accessories.
HybridTherm ablation probes
The HybridTherm probes are a product family consisting of 8 probes to offer the user a range of instruments based upon the physician's preference. There are 4 monopolar and 4 bipolar ablation probes, which differ in the function of the distal end: with and without a monopolar cutting tip (eTip), as well as in their shape (i.e. straight or angulated/curved).
The HybridTherm probes combine high-frequency (HF) technology with cryotechnology. The HF technology is used for cutting (only variants with eTip), coagulation, and ablation of tissue. To reduce tissue desiccation and to increase the ablation zone, the probes are cooled. Cooling also minimizes tissue adhesion to the electrode. The primary function of the cooling is to support the ablation process.
VIO 3
The ESU Model VIO 3 delivers high frequency (HF) electrical current for cutting, coagulation and ablation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different Footswitches are available for activating the ESU and as applicable to change modes of the ESU (Remode feature). The ESU Model VIO 3 has several clearly defined cutting, coagulation and ablation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle.
ERBECRYO 2
The cryosurgical unit Model ERBECRYO 2 is connected to an electrical power source and a carbon dioxide (CO2) source. Upon activation, the Unit delivers a regulated CO2flow to the end of the connected instrument for cooling. The CO2 returning from the probe to the ERBECRYO 2 exists via the exhaust gas hose. Appropriate gas cylinder adapters are available for the various international gas cylinder connections.
HybridTherm System
The HybridTherm probes are connected to the units (VIO 3 and ERBECRYO 2) via respective plugs. The units are connected to each other via an Erbe Communication Bus (ECB) cable, whereby the user only interacts with the ESU Model VIO 3 (master-slave technology: the cryosurgical unit is controlled via the VIO 3). The ERBECRYO 2 additionally requires a CO2 gas cylinder. A footswitch is connected to the ESU, with which the activation of the available modes is started. The ESU supplies the HF current which is needed for cutting (only HybridTherm probe variants with eTip), coagulation and ablation of tissue. The ERBECRYO 2 supplies CO2 gas which is needed for cooling via the Joule-Thomson-effect to support the ablation.
6
Indications for Use
HybridTherm probes
The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.
VIO 3
The Erbe electrosurgical unit (ESU/Generator) Model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation.
ERBECRYO 2
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion, devitalization (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation.
Compared to the predicate device(s), the VIO 3 and the HybridTherm probes have the same intended use. All devices are intended for the application of high frequency (HF) electrical energy in interventional/surgical procedures to thermally effect or destroy tissue.
Compared to the previously cleared cryosurgical unit (ERBECRYO 2), the ERBECRYO 2 that is part of the HybridTherm System has an extended Indications for Use statement (i.e. cooling of tissue during radiofrequency ablation). However, the intended use of both devices is the supply of CO2 to a connected instrument for cooling via the Joule-Thomson effect. This function is the same for the predicate system. The VIVA Combo RF Generator in combination with the EUSRA RF Electrode uses a peristaltic pump with chilled water to cool the probe/tissue during the application. Therefore, the intended use is essentially the same.
7
Comparison to predicate devices
VIO 3
| Characteristics | Subject Device
HybridTherm System (VIO 3) | Primary Predicate
Erbe ESU Model VIO 3 with
Accessories | Secondary Predicate
VIVA Combo RF System | Discussion |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Erbe Elektromedizin GmbH
(Germany) | Erbe Elektromedizin GmbH
(Germany) | STARmed Co., Ltd. | N/A |
| 510(k) | K240932 | K190823 | K163450 | N/A |
| Trade/
Proprietary Name | Erbe ESU Model VIO® 3 | Erbe ESU Model VIO® 3 with
Accessories | VIVA combo RF System | N/A |
| Classification Name | Electrosurgical, Cutting &
Coagulation & Accessories | Electrosurgical, Cutting &
Coagulation & Accessories | Electrosurgical, Cutting &
Coagulation & Accessories | Same |
| Classification Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product Code | GEI | GEI | GEI | Same |
| Device Class | II | II | II | Same |
| Indications for Use | The Erbe electrosurgical unit
(ESU/Generator) model VIO 3
with instruments and
accessories is intended to
deliver high frequency (HF)
electrical current for the cutting
and/or coagulation of tissue,
including ablation. | The Erbe Electrosurgical Unit
(ESU/Generator) Model VIO® 3
with Accessories is intended to
deliver High Frequency (HF)
electrical current for the cutting
and/or coagulation of tissue. | The VIVA combo RF Ablation
System is intended for use in
percutaneous and
intraoperative coagulation and
ablation of tissue. | Same |
| Prescription or OTC | Prescription | Prescription | Prescription | Same |
| Dimensions | Width x Height x Depth
415 x 215 x 375 mm
16.3" x 8.5" x 14.8" | Width x Height x Depth
415 x 215 x 375 mm
16.3" x 8.5" x 14.8" | Width x Height x Depth
260 x 115 x 348 mm
10.2" x 4.5" x 13.7" | Same as Primary
Predicate |
| Characteristics | Subject Device
HybridTherm System (VIO 3) | Primary Predicate
Erbe ESU Model VIO 3 with
Accessories | Secondary Predicate
VIVA Combo RF System | Discussion |
| Weight | 12 kg/26.7 lbs | 12 kg/26.7 lbs | 6 kg / 13.2 lbs | Same as Primary
Predicate |
| | Mains voltage 100 - 120 VAC
(±10%) / 220 - 240 VAC (±10%) | Mains voltage 100 - 120 VAC
(±10%) / 220 - 240 VAC (±10%) | Mains voltage 100 - 240 V | Same as Primary
Predicate |
| | Mains current max. 6.3A | Mains current max. 6.3A | Not known | Same as Primary
Predicate |
| Technical/
Performance Data | Mains frequency 50 Hz / 60 Hz | Mains frequency 50 Hz / 60 Hz | Mains frequency 50 Hz / 60 Hz | Same |
| | Frequency 350 kHz | Frequency 350 kHz | Frequency 480 kHz | Same as Primary
Predicate |
| | Maximum Power Output 400
watts | Maximum Power Output 400
watts | Maximum Power Output 200
watts | Same as Primary
Predicate |
| WiFi connection | Available
(deactivated by default,
no HF-activation possible if WiFi
is enabled) | Available
(deactivated by default,
no HF-activation possible if WiFi
is enabled) | Not available | Same as Primary
Predicate |
| Output Modules/
Receptacles | 4 HF instrument sockets
1 Neutral electrode socket
2 Footswitch sockets | 4 HF instrument sockets
1 Neutral electrode socket
2 Footswitch sockets | 1 HF Cable socket
2 Neutral electrode sockets
2 Footswitch sockets | Same as Primary
Predicate |
| Software Version | V1.1.x | V2.0.x | 1.10 | Different Software
Version |
| Accessories | One- and two- pedal Foot
switches | One- and two- pedal Foot
switches | One- and two- pedal Foot
switches | Same |
| | Connection cables | Connection cables | Connection cables | Same |
| | Neutral Electrodes | Neutral Electrodes | Neutral Electrodes | Same |
| | VIO-Cart, System Carrier
compact and System Carrier
compact plus | VIO-Cart | N/A | New system
Carriers |
| Characteristics | Subject Device
HybridTherm System (VIO 3) | Primary Predicate
Erbe ESU Model VIO 3 with
Accessories | Secondary Predicate
VIVA Combo RF System | Discussion |
| | N/A | N/A | Peristaltic Pump | Secondary predicate
device uses a
peristaltic pump for
cooling of the
connected ablation
electrode. |
| Condition provided / Use
condition | Non-sterile / reusable | Non-sterile / reusable | Non-sterile / reusable | Same |
8
9
HybridTherm Probes
| Characteristics | Subject Device
HybridTherm probes | Primary Predicate
EUSRA RF Electrode | Secondary Predicate
Single Use Electrosurgical
pencil | Discussion | |
|---------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| 510(k) Number | K240932 | K181249 | K192542 | N/A | |
| Trade/Proprietary Name | HybridTherm Probes | EUSRA RF Electrode | Single Use Electrosurgical
pencil with non-coated and
non-stick electrode (Non-sterile
and sterile) | N/A | |
| Manufacturer | Erbe Elektromedizin GmbH | STARmed Co., Ltd. | Modern Medical Equipment
Manufacturing, LTD. | N/A | |
| Classification Name | Electrosurgical Cutting and
Coagulation Device and
Accessories | Electrosurgical Cutting and
Coagulation Device and
Accessories | Electrosurgical Cutting and
Coagulation Device and
Accessories | Same | |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery | Same | |
| Classification Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | |
| Product Code | GEI, JOS | GEI, JOS | GEI | Same | |
| Characteristics | | Subject Device
HybridTherm probes | Primary Predicate
EUSRA RF Electrode | Secondary Predicate
Single Use Electrosurgical
pencil | Discussion |
| | Device Class | Class II | Class II | Class II | Same |
| | Indications for Use | The HybridTherm probes are
intended for ablation and
coagulation of soft tissue. The
following probes can also be
used for cutting tissue:
HybridTherm monopolar, eTip
and HybridTherm bipolar, eTip. | The EUSRA RF Electrode is
indicated for coagulation and
ablation of soft tissue when used
in conjunction with compatible
radio frequency generator. | The devices are used to cut
and coagulate soft tissue by
means of high frequency
electrical current during an
electrosurgical procedure. | Same |
| | Energy Used | HF electrical current | HF electrical current | HF electrical current | Same |
| | Operating Principle | Monopolar and Bipolar | Monopolar | Monopolar | Similar |
| | Cooling Technology | CO2 (Joule-Thompson Effect) | Cooled Water | N/A | Similar |
| Physical
Specifications | Tip Length | Monopolar variants: 9.05mm
(active electrode)
Bipolar variants: 2x 9,05mm +
1,2mm Isolator = 19,3mm | 5, 7, 10, 15, 20mm | 69mm, 102mm, 152mm (blade
electrode) | Within dimensions of
primary predicate |
| | Tip
Diameters | 1.9mm | 19 Gauge (1.06mm) | 2.36mm | Within dimensions of
primary and
secondary predicate |
| | Flexible
Shaft | 1250mm | 1393mm | N/A | Similar to primary
predicate |
| Patient Contacting Materials | | Stainless Steel, Gold, Plastics | Stainless Steel, Plastics | Plastics, Stainless steel, Teflon
one coat | Similar |
| Condition provided / Use
condition | | Sterile, single use | Sterile, single use | Sterile, single use | Same |
| Sterilization method | | EO Sterilization | EO Sterilization | EO Sterilization | Same |
| Extensible Tip Length | | Not extensible | Extensible Tip Length | Not extensible | Same as secondary
predicate |
10
11
ERBECRYO 2
| Characteristics | Subject Device
HybridTherm System (ERBECRYO 2) | Predicate Device
ERBECRYO 2 Cryosurgical Unit and
Accessories | Discussion |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510(k) Number | K240932 | K190651 | Different |
| Model Name | ERBECRYO® 2 Cryosurgical Unit
and Accessories | ERBECRYO® 2 Cryosurgical Unit
and Accessories | Same |
| Manufacturer | Erbe Elektromedizin GmbH | Erbe Elektromedizin GmbH | Same |
| Common Name | Cryosurgical Unit and Accessories | Cryosurgical Unit and Accessories | Same |
| Classification Regulation | 21 CFR 878.4350 | 21 CFR 878.4350 | Same |
| Product Code | GEH | GEH | Same |
| Device Class | II | II | Same |
| Indications for Use | The ERBECRYO 2 cryosurgical unit and
accessories are intended for cryoadhesion,
devitalization (destruction) of tissue by the
application of extreme cold, and cooling of
tissue during radiofrequency ablation. | The ERBECRYO® 2 cryosurgical unit and
accessories are intended for cryoadhesion
and devitalization (destruction) of tissue by
the application of extreme cold. | Equivalent, extended Indications
for Use fall within the intended
use |
| Intended Use | Supply of CO2 to a connected instrument
for cooling via the Joule-Thompson effect. | Supply of CO2 to a connected instrument
for cooling via the Joule-Thompson effect. | Same |
| Prescription or OTC | Prescription | Prescription | Same |
| Materials | Metal sheet, aluminum, copper pipes,
plastics and wiring, electronic components | Metal sheet, aluminum, copper pipes,
plastics and wiring, electronic components | Same |
| Type, Dimensional, and Physical Attributes as well as Performance and Other Specifications | | | |
| Dimensions
of Unit | 16.1"x5.1"x14.6" 410x130x370mm) | 16.1"x5.1"x14.6" 410x130x370mm) | Same |
| Weight of Unit | 14.8lbs (6.7kg) | 14.8lbs (6.7kg) | Same |
| Characteristics | Subject Device
HybridTherm System (ERBECRYO 2) | Predicate Device
ERBECRYO 2 Cryosurgical Unit and
Accessories | Discussion |
| Technical Data of Unit | Rated supply voltage:
100 - 240V (±10%) | Rated supply voltage:
100 - 240V (±10%) | Same |
| | Rated supply frequency: 50 - 60Hz | Rated supply frequency: 50 - 60Hz | Same |
| | Line current: 0.4 - 0.8A | Line current: 0.4 - 0.8A | Same |
| Software Version | 2.0.0 | 1.0.3 | Different |
| Remote control by VIO 3 | Yes | No | Different |
| Performance Data of Unit | No. of effect levels: 1 - 5 (depending on
instrument) | No. of effect levels: 1 - 5 (depending on
instrument) | Same |
| | Activation: via footswitch | Activation: via footswitch | Same |
| | Cooling gas used: CO2 | Cooling gas used: CO2 | Same |
| | Input Pressure:
653 - 943psi (45 - 65bar) | Input Pressure:
653 - 943psi (45 - 65bar) | Same |
| Other Compatible
Equipment | ERBECRYO 2 Cart, VIO Cart, cable, gas
hoses, gas bottle adapter | ERBECRYO 2 Cart, VIO Cart, cable, gas
hoses, gas bottle adapter | Same |
| Provided Condition | Non-sterile, reusable | Non-sterile, reusable | Same |
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Comparison of Technological Characteristics
Differences of the ESU Model VIO 3 compared to the previously cleared device is an updated software mainly to introduce new modes for cutting, coagulation and ablation of tissue, remote control of the cryosurgical unit ERBECRYO 2 and operation/control of the HybridTherm probes.
Compared to the primary predicate device EUSRA RF Electrode the HybridTherm probes have an additional bipolar variant, a monopolar cutting tip (only variants with eTip) and a lateral and distal coagulation feature. The HybridTherm probes are cooled via CO2 compared to cooling via chilled water which is employed by the predicate probes. In addition, the HybridTherm probes have different materials and different physical specifications which are, however, within the specifications of the respective predicate devices.
Difference of the ERBECRYO 2 compared to the predicate device is an updated software for remote control via the VIO 3 and operation/control of the HybridTherm probes.
The subject device system and the predicate device(s) use the same enerqy (HF electrical current) and principles of operation. Both the monopolar and bipolar technology are established and routinely adopted in interventional procedures for many years. Compared to the monopolar variant, the bipolar variant does not raise different issues of safety and effectiveness. The cooling technology of the subject device by means of CQ2 is the same compared to the previously cleared ERBECRYO 2. Although the predicate system uses a different cooling technology (chilled water), the purpose of the same and the cooling is only used to support the ablation process.
Side-by-side tissue testing against the respective predicate device(s) shows that the performance (i.e. cutting, coagulation and ablation) is as good as the performance of the predicate device(s). The non-clinical testing described below shows that the different technological characteristics do not negatively affect the safety and effectiveness of the subject device.
Non-clinical performance testing
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new or different issues of safety or effectiveness of the subject device compared to the predicate devices.
Functional testing and design controls to verify both safety and performance of the subject device was performed in compliance with 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.
Side-by-side tissue testing was performed in compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", to validate the cutting, coagulation and ablation performance compared to the predicate device(s).
Electromagnetic compatibility (EMC) was tested in compliance with IEC 60601-1-2 and FDA Guidance "Electromagnetic Compatibility (EMC) of Medical Devices".
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Electrical safety of the subject device was tested in compliance with, IEC 60601-1; IEC 60601-2-2 and IEC 60601-2-18, as applicable.
Software verification and documentation for cybersecurity was provided in compliance with IEC 62304 and FDA Guidance Documents "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility of the materials with tissue contact.
Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" showing an SAL of 10-6. EO residual testing and limits comply with ISO 10993-7.
Packaging and shelf-life validation was performed in compliance with ISO 11607-1, ISO 11607-2 and accelerated aged devices (ASTM F 1980).
Conclusion
The subject device has the same intended use, the same fundamental design, substantially equivalent performance characteristics, and the same energy source as the predicate devices. The subject device was tested as described above and the minor differences in technological characteristics were assessed with regards to safety and effectiveness. Taken together, the subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate devices for the requested indications for use.