(57 days)
The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurgically.
The HF SURGERY GENERATOR 400KHZ is used for electrosurgical cutting and coagulation of living human tissue. For this purpose, electrical energy from the power supply network is transformed into high frequency current which allows this surgical property. The device offers a multitude of different profiled current forms which are optimized for the different surgical requirements. It is equipped for monopolar and bipolar cutting and coagulation in micro- and macrosurgical operations.
Here's a breakdown of the acceptance criteria and the study information for the HF SURGERY GENERATOR 400KHZ, based on the provided FDA 510(k) summary.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it primarily reports on comparative testing and compliance with standards rather than detailed acceptance criteria and specific performance metrics of a novel algorithm or AI.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific acceptance criteria in numerical terms (e.g., minimum accuracy, sensitivity, or specificity) nor does it provide a numerical "performance" for such criteria. Instead, the acceptance criteria are largely implied by compliance with safety and performance standards, and comparison to the predicate device.
The "reported device performance" is primarily that the device meets relevant standards and is substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Essential Performance: | |
| - Electrical safety requirements (IEC 60601-2-2) | Device fulfills electrical safety requirements of IEC 60601-2-2. |
| - Electromagnetic compatibility (IEC 60601-1-2) | Device fulfills electromagnetic compatibility requirements of IEC 60601-1-2. |
| - Basic safety (IEC 60601-1) | Device fulfills basic safety requirements of IEC 60601-1. |
| - Overall design meets requirements and specifications | Verification and validation testing confirms product meets all requirements and specifications. |
| Functional Equivalence to Predicate: | |
| - Ability to generate high-frequency current for electrosurgery | Yes, fundamental frequencies are comparable and substantially equivalent to predicate. |
| - Monopolar and bipolar cutting and coagulation | Yes, provides monopolar and bipolar high-frequency current modes. |
| - Comparable maximum power output | Yes, both subject and predicate generators feature a maximum power output of 400 W. |
| - Software functions and performance | Performance testing was done due to different software functions. |
| - Performance on tissue | Validation of performance on tissue was conducted. |
| - Waveform comparison | Validation of performance based on waveform comparison was conducted. |
| Other: | |
| - Transportation validation | Transportation validation was performed. |
| - Cleaning and reprocessing effectiveness | Methods of cleaning and reprocessing are detailed in the Instruction for Use. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of AI or diagnostic device performance based on patient data. The performance testing conducted for the HF SURGERY GENERATOR 400KHZ is primarily bench testing and animal testing.
- Sample Size for Test Set: Not applicable in the context of patient data for AI. For bench and animal testing, specific sample sizes are not detailed in this summary.
- Data Provenance: Not applicable for patient data. The testing involves engineering verification and validation.
- One test mentioned is "Validation of the performance on tissue (Section 19 Performing Testing Animal)". This suggests animal models were used, but details on the number of animals or specific data are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an electrosurgical generator, which is a therapeutic device, not a diagnostic device that requires expert interpretation for a "ground truth" to evaluate an algorithm's performance.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an electrosurgical generator, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device contains software classified as a "Major Level of Concern." While "Software Verification and Validation" was performed, the document does not describe a standalone algorithm-only performance study in the way this question typically refers to AI performance (e.g., classifying images without human input). The software's role is in controlling the electrosurgical generator's functions, not performing diagnostic interpretations.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the "Validation of the performance on tissue (Section 19 Performing Testing Animal)" and "Validation of the performance based on waveform comparison," the "ground truth" would be established through:
- Bench Test Results: Measured electrical outputs (power, voltage, frequency, crest factor) compared against engineering specifications and predicate device characteristics.
- Animal Tissue Response: Observation and potentially histological analysis of tissue effects (cutting, coagulation) in animal models, likely assessed against expected outcomes for electrosurgery.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML-driven diagnostic or image analysis device that requires a training set of data. The software is likely rule-based or control-loop based, validated against specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is described for this type of device.
In summary, the provided FDA 510(k) substantial equivalence summary for the HF SURGERY GENERATOR 400KHZ focuses on demonstrating that the device is safe and effective by:
- Compliance with recognized electrical safety and EMC standards.
- Comparison of technological characteristics to a legally marketed predicate device.
- Performance testing: This includes bench testing of electrical outputs, waveform comparison, animal tissue testing, software verification/validation, and transportation validation.
It is crucial to understand that the questions posed are typically relevant to AI/ML-enabled diagnostic medical devices, which this electrosurgical generator is not.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 22, 2023
Richard Wolf Medical Instruments Corporation Mike Mcandrew US Head of Regulatory - OA/OC 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K230194
Trade/Device Name: HF Surgery Generator 400KHZ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 23, 2023 Received: January 24, 2023
Dear Mike Mcandrew:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.03.22
15:31:45 -04'00'
Mark Trumbore, 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
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) To be determined
Device Name HF SURGERY GENERATOR 400KHZ
Indications for Use (Describe)
The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurgically.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in black, while the word "WOLF" is in a dark red color. To the right of the text is a logo featuring a stylized dog standing next to a vertical line with a small object at the top and a paw print at the bottom, all enclosed in a rounded square.
510(k) Summary 5
Submitter l
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061
Phone: 847-913-1113, ext. 380 Mobile: 847-636-0887 Fax: 847-913-1489 E-Mail: MMcAndrew@richardwolfusa.com
Contact Person, Mike McAndrew, US Head of Regulatory – QA/QC Date Prepared: March 21, 2023
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen
ll Device
| ProductSpecification | RegulationNumber and | ProductCode | DeviceClass |
|---|---|---|---|
| -------------------------- | -------------------------- | ----------------- | ----------------- |
Table 5-1: Device classification
| Brand name | Trade name | Model Number | Productclassificationname | RegulationNumber andName | ProductCode | DeviceClass | ReviewPanel |
|---|---|---|---|---|---|---|---|
| 2260 | HF SURGERYGENERATOR400KHZ | 2260003 | Electrosurgical, Cutting &Coagulation &Accessories | 878.4400Electrosurgicalcutting andcoagulationdevice andaccessories | GEI | Class II | Generaland PlasticSurgery |
| N/A | FOOTSWITCH 2PEDALS L 5M | 2260021 |
Document 001 510(k) Summary
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in black, while the word "WOLF" is in red. To the right of the words is a logo of a dog with a rod through its mouth, inside of a rounded square.
| N/AHF CONNECTIONCABLE BIPO L 5M | N/AHF CONNECTIONCABLE BIPO L 3M |
|---|---|
| 8108253 | 8108233 |
��� Predicate Device
Trade name of Predicate Device: ARC 400 510(k) Number: K193591 Requlatory Class: Class II Product Code: GEI Manufacturer: BOWA-Electronics GmbH & Co. KG
The predicate has not been subject to a design-related recall. No reference devices were used in this submission.
Subject Device Description 5.1
5.1.1 Device Identification
Table 5-2: Device identification
| Brandname | ModelNumber | Trade name | Package unit |
|---|---|---|---|
| 2260 | 2260003 | HF SURGERY GENERATOR 400KHZ | 1 |
| N/A | 2260021 | FOOTSWITCH 2 PEDALS L 5M | 1 |
| N/A | 8108233 | HF CONNECTION CABLE BIPO L 3M | 1 |
| N/A | 8108253 | HF CONNECTION CABLE BIPO L 5M | 1 |
5.1.2 Device characteristics
Delivered sterile / non-sterile
The HF SURGERY GENERATOR 400KHZ is delivered non-sterilization is not required.
Single use / reusable
The devices are reusable and do require cleaning and reprocessing during their use-life, i.e., users are required to clean and disinfect the device before every application and before returning for repairs. Methods of cleaning and reprocessing are detailed in the Instruction for Use.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in black, while the word "WOLF" is in a dark red color. To the right of the text is a logo featuring a stylized image of a wolf's head with a nail through it, enclosed in a rounded square.
Software
The HF SURGERY GENERATOR 400KHZ contains software. The software is classified as a Major Level of Concern.
Materials with patient contact
The HF SURGERY GENERATOR 400KHZ is not intended to contact the patient directly or indirectly.
5.1.3 Brief written description of the Device
The HF SURGERY GENERATOR 400KHZ is used for electrosurgical cutting and coagulation of living human tissue. For this purpose, electrical energy from the power supply network is transformed into high frequency current which allows this surgical property. The device offers a multitude of different profiled current forms which are optimized for the different surgical requirements. It is equipped for monopolar and bipolar cutting and coagulation in micro- and macrosurgical operations.
Image /page/5/Figure/8 description: The image shows a Richard Wolf HF-GENERATOR 2260. The device has a screen that displays the settings for different modes, including "M" and "B". The screen also shows that the device is currently "ON" and set to "Laparoscopy - Standard" mode, with options for "Mode" and "Menu".
Figure 05-1: Richard Wolf HF SURGERY GENERATOR 400KHZ
5.1.4 Materials of Use
The HF SURGERY GENERATOR 400KHZ consists of a metal housing which does not have any patient contact.
5.2 Indications for Use
Statement
The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurqically.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, black font above the word "WOLF", which is in a larger, red font. To the right of the text is a logo featuring a dog's head next to a vertical line with a small hand at the bottom, all enclosed in a rounded square.
User
This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
Patient population
The product is intended for adult patients.
The patient group intended for the application of the medical product herein described is not limited with regard to ethnicity, gender, body height, Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient.
Explanation on differences to the predicate device
In comparison to the predicate device, the usage of the subject device is further restricted to adults. However, the full indication of use for the subject device is covered by the predicate device and reducing the scope does not lead to new questions regarding safety and effectiveness.
Comparison of Technological Characteristics with the Predicate Device 5.3
5.3.1 Overview Table
Table 5-3: Comparison of technical characteristics
| ltem | Subject device | Predicate devices | Comparison | |||
|---|---|---|---|---|---|---|
| General information | ||||||
| Product name | HF SURGERYGENERATOR 400KHZ | ARC 400 ElectrosurgicalUnit | N/A | |||
| Brand name | 2260 | N/A | N/A | |||
| Type No. | 2260003 | 900400 | N/A | |||
| 510(k) number | TBD / subject device | K193591 | N/A | |||
| Manufacturer | Richard Wolf GmbH | BOWA-electronics GmbH& Co. KG | N/A | |||
| Product Code | GEI | GEI | Same | |||
| RegulationNumber | 878.4400 | 878.4400 | Same | |||
| Indications forUse | The product is used forgenerating high frequencyelectrical current forcutting and coagulatingtissue electrosurgically. | The HF device is intendedexclusively for thegeneration of electricalpower for monopolar andbipolar cutting andcoagulation on tissuestructures in surgicaloperations. | Equivalent | |||
| Contraindications | Contraindications directlyrelated to the product arepresently unknown. Ifmedical contraindicationsfor the mentionedindications are known, theuse of the products is notpermitted.On the basis of thepatient's general conditionthe doctor in charge mustdecide whether or not theplanned use is possible. | Do not use the HF deviceif, in the opinion of anexperienced physician oraccording to currentprofessional literature,such use would endangerthe patient, due forexample to the generalcondition of the patient, orif other contraindicationsare present. | Equivalent | |||
| Prescription/over-the-counter-use | RX only | RX only | Same |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, sans-serif font above the word "WOLF", which is in a larger, blocky, red font. To the right of the text is a logo featuring a stylized drawing of a wolf's head with a vertical line through it, enclosed in a rounded square.
| Item | Subject device | Predicate devices | Comparison |
|---|---|---|---|
| Sterile/Non-steriledevice | Non-sterile device | Non-sterile device | Same |
| Single use/Reusable | Reusable device | Reusable device | Same |
| Sterilizationmethod | Non-sterile device | Non-sterile device | Same |
| Reprocessing | Cleaning and disinfectionsolution/wipes for lowlevel should be based onalcohol. Examples forsuitable substances forcleaning and disinfectionof surfaces:• Propanol• Ethanol• Didecyldimethylammoniumchloride• Dimethylbenzylammoniumchloride | Apply the cleaning agentand disinfectant.Wipe down the HF deviceonly with cleaning agentsand disinfectants that areapproved in the country ofuse for surface cleaning. | Equivalent |
| Maintenanceintervals | 12 months | 12 months | Same |
| OperatingCondition | Ambient temperature +10°C to +40 °CRelative humidity 30% to75% (non-condensing)Atmospheric pressure 700hPa to 1060 hPa | Temperature: +10 °C to+40 °CRelative humidity: 30 to75%, non-condensingAtmospheric pressure:700 to 1600 hPaOperating altitude (max.)4000 m above sea level | Equivalent |
| Storage andTransportConditions | Ambient temperature -20°C to +60 °CRelative humidity 10% to90% (non-condensing)Atmospheric pressure 700hPa to 1060 hPa | Temperature: -20 °C to+50 °CRelative humidity 0 to 75%, non-condensingAtmospheric pressure:500 to 1600 hPa | Equivalent |
| Operational modes / settings | |||
| Mode: Monopolar cutting | |||
| Modes | 12 | 12 | Same |
| Max. Power | 400 W (at 500 Ω) | 400 W (at 200 Ω) | Same |
| Output Frequency | 403 - 500 kHz | 350 kHz | Different |
| Max. VoltageOutput | 3150 Vp | 1600 Vp | Different |
| Crest Factor | 1.4 - 4.4 | 1.5, 3.5 | Different |
| Wave Forms | Sinusoidal ConstantSinusoidal ModulatedSinusoidal Alternating | Sinusoidal ConstantSinusoidal ModulatedSinusoidal AlternatingCut/Coag/Pause Phases | Equivalent |
| Mode: Monopolar coagulation | |||
| Modes | 15 | 9 | Different |
| Max. Power | 200 W (at 350 Ω) | 250 W (at 500 Ω) | Different |
| Output Frequency | 375 - 500 kHz | 350 kHz | Different |
| Max. VoltageOutput | 5000 Vp | 5000 Vp | Equivalent |
| Crest Factor | 1.4 - 7.6 | 1.6 - 7.4 | Different |
| Wave Forms | Sinusoidal ConstantSinusoidal ModulatedPulse Modulated | Sinusoidal ConstantSinusoidal ModulatedPulse Modulated | Same |
| Item | Subject device | Predicate devices | Comparison |
| Modes | 8 | 4 | Different |
| Max. Power | 300 W (at 100 Ω) | 400W (at 75 Ω) | Different |
| Output Frequency | 355 - 381 kHz | 350 kHz | Different |
| Max. Voltage | 750 Vp | 500 Vp | Different |
| Output | |||
| Crest Factor | 1.4 - 2.3 | 1.5 - 1.6 | Different |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant | Same |
| Mode: Bipolar coagulation | |||
| Modes | 9 | 9 | Equivalent |
| Max. Power | 250 W (at 75 Ω) | 350 W (at 25 Ω) | Different |
| Output Frequency | 338 - 381 kHz | 350 kHz | Different |
| Max. Voltage | 425 Vp | 550 Vp | Different |
| Output | |||
| Crest Factor | 1.4 - 1.7 | 1.5 - 3.8 | Different |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant | Same |
| Pulse Modulated | Pulse Modulated | ||
| Technological characteristics | |||
| Standard | IEC 60601-1:2005 (19-4) | IEC 60601-1: 2005 (19-4) | Same |
| compliance | IEC 60601-1-2:2014 (19-8) | IEC 60601-1-2: 2014 (19-8) | |
| IEC 60601-2-2:2017 (6-389) | IEC 60601-2-2:2017 (6-389) | ||
| Voltage [V] | 100-240 V | 230 V | Equivalent |
| Frequency [Hz] | 50/60 Hz | 50/60 Hz | Same |
| Power | 45 without HF output | 85 power consumption in | Equivalent |
| consumption [VA] | 650 at max. output power | standby mode | |
| / Current rating | 975 maximum power | ||
| [A] | consumption with 300 WHF output power | ||
| Protection class | I | I | Same |
| to EN/IEC 60601-1;(UL 2601-1/CSAC22.2 No.601.1 -for USA) | |||
| Protection against | CF applied part,defibrillator-proof | CF | Same |
| electric shock | |||
| Degree of | IPX0 | IP 21 | Equivalent |
| protection against | |||
| liquids | |||
| Weight [kg] | 10.2 kg (22.4 lbs) | approx. 12.5 kg | Different |
| Dimensions | 300 x 160 x 402 mm | 430 x 180 x 475 mm | Different |
| Material | Metal & plastics | Metal & plastics | Equivalent |
| Single-Use | No | No | Same |
| Light Source | No | No | Same |
| Battery Operated | No | No | Same |
| AC Powered | Yes | Yes | Same |
| Software version | 1.4.3 | 1.0.0.6.17.9 | Different |
| USB Port | Yes | Yes | Same |
| Potential | Yes | Yes | Same |
| equalization | |||
| connector | |||
| LAN (Ethernet)Network | Yes | Yes | Same |
| Item | Subject device | Predicate devices | Comparison |
| Foot switchsocket connector | Yes | Yes | Same |
| Control elements/ user interface | Touchscreen | Touchscreen | Same |
| Materials with patient contact | |||
| Materials withdirect patientcontact | N/A - no materials withdirect patientcontact | N/A - no materials withdirect patientcontact | Same |
| Materials withindirect patientcontact | N/A - no materials withindirect patientcontact | N/A - no materials withindirect patientcontact | Same |
| Instruction for use | |||
| Version | GA-A339 / en / US / V0.6 | 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN | Different |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the text is a square with rounded corners containing a stylized image of a wolf's head and a medical instrument. The logo is simple and modern, with a clear focus on the company name.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, sans-serif font above the word "WOLF", which is in a larger, bolder, red font. To the right of the text is a logo featuring a stylized wolf head with a nail through it, enclosed in a rounded square.
5.3.2 Discussion
The subject device and the predicate device share the same fundamental technology. They both convert electrical energy from the grid into a high-frequency current which provides the surgical property. For that purpose, monopolar and bipolar high frequency current modes were provided to the corresponding socket module. The fundamental frequencies of about 400 kHz provided by the subject and the predicate device are comparable and substantial equivalent. Both generators feature a maximum power output of 400 W.
The general and technical characteristics that differ between the predicate and the subject device are differences in PCB layouts, software including the graphical user interface, number of output sockets and other technical characteristics such as power consumption and weight, dimensions. These differences do not question safety and effectiveness of the subject devices, several performance tests were performed, such as:
-
a. Validation of the electromagnetic compatibility and electrical safety (Section 17 -
Electromagnetic Compatibility and Electrical Safety) -
b. Validation of the performance on tissue (Section 19 Performing Testing Animal)
-
Validation of the performance based on waveform comparison and the tissue study (Section C. 18 - Performance Testing Bench)
-
ರ. Performance testing due to the different software functions, the change in power consumption, cooling method, and the "Dialog" function (Section 18 - Performance Testing Bench)
-
e. Transportation validation (Section 18 Performance Testing Bench)
Performance Testing 5.4
- 5.4.1 Sterilization N/A
5.4.2 Biocompatibility
N/A
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image contains the words "RICHARD WOLF" in a logo format. The word "RICHARD" is in a smaller, sans-serif font above the word "WOLF", which is in a larger, bolder, red font. To the right of the words is a logo of a wolf with a medical device. The logo is contained within a rounded square.
5.4.3 Electromaqnetic Compatibility and Electrical Safety
The predicate device and the device covered by this registration are classified in protection class I according to 60601-1. They both fulfil the electrical safety requirements of IEC 60601-2-2 and IEC 60601-1-2. Based on that, the devices are considered to be comparable in terms of electromagnetic compatibility and electrical safety.
5.4.4 Performance and Operational testing
The efficacy and safety of the HF SURGERY GENERATOR 400KHZ is documented by the verification and validation testing which confirms that the product meets all the requirements and specifications for overall design, basic safety, essential performance, and that the design inputs and specifications are met.
રે. રે Conclusions
The HF SURGERY GENERATOR 400KHZ has the same intended use and field of application as the legally marketed predicate device named in this submission.
The same performance tests were concluded for the subject device as for the predicate device. Therefore, no comparison testing was performed. Non-clinical performance testing, including Electromagnetic Compatibility. Electrical Safety, and Software Verification and Validation. demonstrated that the safety and performance of the device is equivalent to the predicate device. Differences in characteristics described in Section 12.2 do not raise any new questions regarding the safety and effectiveness of the HF SURGERY GENERATOR 400KHZ compared to the predicate device.
The HF SURGERY GENERATOR 400KHZ is substantially equivalent to the legally marketed predicate device ARC 400 (K193591).
§ 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.