(147 days)
The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.
The Soniquence RF Generators® are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutuallyexclusive use with the Soniquence® line of generators.
All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.
Soniquence Electrodes are used with the Soniquence RF Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Soniquence family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).
These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
This document, an FDA 510(k) submission summary for the Soniquence RF Generator and Soniquence Electrodes, does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance on a test set, expert ground truth establishment, or clinical effectiveness studies with human readers.
The document states:
- "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." (Page 11)
- The non-clinical testing listed primarily focuses on electrical safety, EMC, Usability Engineering, sterilization, biocompatibility, and software verification and validation. It also includes "Energy output verification of each of the five modes and comparison to predicate" and "Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue." (Page 11)
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for AI/algorithm performance characteristics. The device appears to be a traditional electrosurgical unit, not an AI/algorithm-driven diagnostic or therapeutic device.
If you are looking for information about the performance of the Soniquence RF Generator and Soniquence Electrodes, the document primarily relies on substantial equivalence to predicate devices (Surgi-Max® Ultra (K170107), Bovie® IDS-310 Electrosurgical Generator (K134054), Elliquence Electrodes (K142410), and Cobbra RF™ Tissue Dissector (K160041)) based on technological characteristics and intended use.
Here's a summary of the performance testing mentioned, which is non-clinical and geared towards safety and functional equivalence, not AI performance characteristics.
Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):
| Acceptance Criteria Category | Specific Tests/Performance Metrics Mentioned (Non-AI) | Reported Device Performance |
|---|---|---|
| Electrical Safety | AAMI ANSI ES60601-1 | Successfully performed |
| IEC 60601-1-2 (EMC) | Successfully performed | |
| IEC 60601-2-2 | Successfully performed | |
| Usability | IEC 62366 (Usability Engineering) | Successfully performed |
| Sterilization | ISO 11135 (EO sterilization) | Successfully performed |
| ISO 11737-1 (Microbiological methods: population) | Successfully performed | |
| ISO 11737-2 (Microbiological methods: sterility tests) | Successfully performed | |
| ISO 11138-1 (Biological indicators) | Successfully performed | |
| Biocompatibility | ISO 10993-1 (Risk management) | Successfully performed |
| ISO 10993-5 (Cytotoxicity) | Successfully performed | |
| ISO 10993-7 (EO residuals) | Successfully performed | |
| ISO 10993-10 (Irritation/sensitization) | Successfully performed | |
| ISO 10993-11 (Systemic toxicity) | Successfully performed | |
| Shelf Life | ASTM F1980-07 (Accelerated Aging of Barrier Systems) | Successfully performed |
| Software | IEC 62304 / FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation successfully performed |
| Functional Performance | Energy output verification of each of the five modes | Comparison to Predicate |
| Thermal effect comparison (ex-vivo bovine tissue) | Comparison to Predicate |
Since the requested information pertains to an AI/algorithm-driven device, and this document describes a traditional electrosurgical unit without AI components, the following points cannot be answered from the provided text:
- Sample size used for the test set and data provenance: No test set (in the AI sense) is mentioned.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 22, 2019
Soniquence, LLC Suzanne Lucas Regulatory Affairs 2473 Grand Avenue Baldwin, New York 11510
Re: K183611
Trade/Device Name: Soniquence RF Generator and Soniquence Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 22, 2019 Received: March 25, 2019
Dear Suzanne Lucas:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Jennifer R. Stevenson Acting Division 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
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Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K183611
Device Name
Soniquence RF Generator and Soniquence Electrodes
Indications for Use (Describe)
The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Soniquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.
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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Image /page/3/Picture/0 description: The image shows the first page of a document, as indicated by the text "Page 1 of 9" in the upper right corner. The document number, "K183611", is printed at the top center of the page. The page features a blue graphic on the left and the word "Soniquence" in blue on the right.
Exhibit 4. 510(k) SUMMARY
(As required by 21 CFR 807.92(a))
Date Prepared
May 22, 2019
Submitter's Information (807.92(a)(1))
Company Name and Address:
Soniquence, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: (516) 654-4000 www.soniquence.com
Establishment Registration for Soniquence, LLC will be completed once this 510(k) has been FDA cleared.
Contact Information:
Suzanne Lucas - Regulatory Affairs Phone: (516) 654-8017 Fax: (516) 654-8000 Email: slucas@soniquence.com
Paul D. Buhrke IV- QA/RA Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@soniquence.com
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Device Information (807.92(a)(2))
Trade Name: Soniquence RF Generator and Soniquence Electrodes
Common/Usual Name
Electrosurgical unit and accessories, electrosurgical cutting and coagulation device and accessories
Classification Name and Requlation
Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400
Classification Panel
General and Plastic Surgery Device
Device Class/Product Code
FDA Classification: Class II FDA Product Code: GEI
Predicate Devices (807.92(a)(3))
- Surgi-Max® Ultra (K170107) o
- Bovie® IDS-310 Electrosurgical Generator (K134054) ●
- Elliquence Electrodes (K142410) o
- Cobbra RF™ Tissue Dissector (K160041) o
Device Description (807.92(a)(4))
The Soniquence RF Generators® are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutuallyexclusive use with the Soniquence® line of generators.
All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.
Soniquence Electrodes are used with the Soniquence RF Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The
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Soniquence family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).
These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
Intended Use:
The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures
Substantial Equivalence Comparison (807.92(a)(6))
The Soniquence RF Generator is substantially equivalent in both intended use and technological characteristics to the Surgi-Max® Ultra (K170107), as well as the Bovie® IDS-310 Electrosurgical Generator (K134054). An extensive comparison chart concerning key characteristics is provided on the following pages (Table 1.1).
Table 1.1 Substantial Equivalence Comparison Chart (RF Generator)
| Predicateinformation | Soniquence RF GeneratorPROPOSED DEVICE | Surgi-Max® Ultra(K170107)PREDICATE | Bovie® IDS-310ElectrosurgicalGenerator (K134054)PREDICATE | Principle ofOperation | Identical to predicates | Conversion of electricalenergy to high-frequencyRF energy(monopolar and bipolar) | Conversion of electricalenergy to high-frequency RF energy(monopolar and bipolar) |
|---|---|---|---|---|---|---|---|
| Manufacturer | Soniquence, LLC | elliquence, LLC | Bovie Medical Corp. | Modes ofoperation | Identical to elliquenceK170107 | CutBlendHemoBipolarBipolar Turbo | 9 Monopolar and 4bipolar modes |
| Productcode | GEI | GEI | GEI | Outputfrequency | Identical to elliquenceK170107 | 4 MHz (monopolar)1.7 MHz (bipolar) | 350 - 490 kHz(monopolar)490 kHz (bipolar) |
| Regulationnumber | Identical to predicates | 21 CFR 878.4400 | 21 CFR 878.4400 | Maximumpower output | Identical to elliquenceK170107 | 170W | 300W |
| Regulationname | Identical to predicates | Electrosurgical Cutting andCoagulation Device andaccessories | Electrosurgical Cuttingand Coagulation Deviceand accessories | Voltage(peak-to-peak) | Identical to elliquenceK170107 | 1,200V | 8,000V |
| Indicationsfor use | The Soniquence RFGenerator is intended toprovide high frequency energyfor resection, ablation, andcoagulation of soft tissues andhemostasis of blood vesselsduring surgical proceduresand is used to deliver RFenergy via an assortment ofsurgical devices to cut and | Orthopedic, arthroscopic,spinal, and neurologicalFor resection, ablation, andcoagulation of soft tissuesand hemostasis of bloodvessels in orthopedic,arthroscopic, spinal andneurological procedures. Forsoft tissue resection andablation during arthroscopicsurgical procedures of knee, | The IDS-310 HighFrequency ElectrosurgicalGenerator is used todeliver RF energy via anassortment of surgicaldevices to cut andcoagulate different kindsof tissue. | Duty Cycle | Identical to elliquenceK170107 | 10 sec On / 30 sec OFF | 10 sec On / 30 sec OFF |
| coagulate different kinds oftissue. | shoulder, ankle, elbow, hipand wrist.CuttingSnoring, Submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy with effectivehemorrhage control, epistaxistreatment, and turbinateshrinkage, skin incisions,biopsy, cysts, abscesses,tumors, cosmetic repairs,development of skin flaps,skin tags, Blepharoplasty.Blended Cutting andCoagulationSnoring, Submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy with effectivehemorrhage control, epistaxistreatment, and turbinateshrinkage, skin tags,papilloma Keloids, Keratosis,Verrucae, Basal CellCarcinoma, Nevi, Fistulas,Epithelioma, CosmeticRepairs, Cysts, Abscesses,Development of skin flaps.Hemostasis andNonablative CoagulationControl of bleeding, Epilation,TelangiectasiaBipolarPinpoint, PreciseCoagulation, PinpointHemostasis, in any field (wetor dry), snoring, submucosalpalatal shrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy with effectivehemorrhage control, epistaxistreatment, and turbinateshrinkage. | Supply inputpower | Identical to elliquenceK170107 | 100 VAC - 240 VAC,50/60 Hz | 100 VAC - 240 VAC,50/60 Hz | ||
| Prescriptiondevice(21 CFR801.109) | Identical to predicates | Yes | Yes | Poweractivationcontrol | Identical to predicates | Footswitch and/orfingerswitch | Footswitch and/orfingerswitch |
| Electricalsafety andEMC testingstandards | Identical to elliquenceK170107 | AAMI ANSI ES60601-1IEC 60601-1-2IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | ||||
| Applied parttype | Identical to elliquenceK170107 | CF | CF |
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Table 1.2 – Substantial equivalence comparison table (Electrodes)
| PredicateInformation | Soniquence ElectrodesPROPOSED DEVICE | Elliquence Electrodes(K142410)PREDICATE | Cobbra™ RF TissueDissector (K160041)PREDICATE |
|---|---|---|---|
| Intended Use | The SoniquenceElectrodes are intended foruse by a physician familiarwith resection, dissection,incision, and hemostasis insoft tissue surgicalprocedures. | The ElliquenceElectrodes are intendedfor use by a physicianfamiliar with resection,dissection, incision, andhemostasis in softtissue surgicalprocedures. The types | Intended for use by aphysician familiar withresection, dissection,incision, and hemostasis insoft tissue surgicalprocedures. Generalsurgery, laparoscopic,procedures, endoscopicprocedures, open |
| of surgery intended are:General surgery,Laparaoscopicprocedures, Endoscopicprocedures, Openabdominal, Orthopediccoagulation,Thorascopiccoagulation,Neurosurgicalcoagulation,Gynecologicalcoagulation, (except foruse in femalesterilization), Ear, Nose,Throat coagulation. | abdominal, orthopediccoagulation, thorascopiccoagulation, neurosurgicalcoagulation, gynecologicalcoagulation, and ENTcoagulation are the typesof intended surgeries. | ||
| Product Code | Identical to predicates | GEI | GEI |
| Device Classification | Identical to predicates | Class II | Class II |
| Functions | Identical to predicates | Cutting/coagulation | Cutting/coagulation |
| Energy type/operating principle | Identical to predicates | Monopolar | Monopolar |
| Design Specifications | Identical to predicates | Integrated sterilecomponents; handle,cable, connector, shaft,monopolar electrode | Integrated sterilecomponents; handle,cable, connector, shaft,monopolar electrode |
| Shaft forms | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | Straight, Bayonet,angled, and curved | Straight |
| Shaft malleability | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | Fixed and malleablemodels | Fixed models only |
| Shaft lengths | Identical to predicate | 1.9 - 60 cm | electrode shaft: 12.7 cmhandpiece shaft: 18.55 cm |
| Shaft diameter | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | 1/16" and 3/32" | electrode shaft: 6.0 mmhandpiece shaft: 21.7 mm |
| Tip Configurations | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | Loop (round, diamond),ball, and blade (needle,fine wired, spatula) | Spatula |
| Material Composition | |||
| Handle | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | Molded Plastic | Molded plastic |
| Shaft | Surgical StainlessSteel/Brass | Surgical stainless steel | |
| Electrode | Surgical Stainless Steel/Tungsten/Brass | Surgical stainless steel /PFA insulation | |
| Patient contactingmaterials | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | Medical grade stainlesssteel, brass, tungsten,Loctite, PFA, and PTFE | Medical grade stainlesssteel and PFA |
| Coating | Identical to predicates | None | None |
| Biocompatibility | Identical to predicates | ISO 10993 | ISO 10993 |
| Sterilization Methods | Identical to predicates | Gamma or EthyleneOxide | Gamma or Ethylene Oxide |
| Expiration Dating | Identical to predicates | Yes | Yes |
| Packaging | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | Sterile, Blister TraySterile, Peel Pouch | Sterile, Blister Tray |
| Activation Method | Identical to predicates | Fingerswitch/Footswitch | Fingerswitch/Footswitch |
| Manual Controls | Identical to predicates | None, all power settingsestablished ongenerator | None, all power settingsestablished on generator |
| Internal Memory/circuitry for generatorrecognition | Identical to predicates | None | None |
| Min., Max., Defaultoutput Values(Wattage) | Identical to predicates | 0-170 | 0-170 |
| Patient Leakagecurrent | Identical to predicates | Type CF | Type CF |
| Cable Length (m) | Cobbra models identical toCobbra predicateAll others are identical toElliquence Electrodespredicate | 3 | 3 |
| Temperature Probe | Identical to predicates | No | No |
| Cooling Function | Identical to predicates | None | None |
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Non-Clinical Testing (807.92(b)(1))
The Soniquence RF Generator and Soniquence Electrodes will be manufactured in accordance with the design control requirements of 21 CFR 820.30. Appropriate nonclinical verification and validation activities were planned and conducted in order to address identified risks and ensure the safety and effectiveness of the device. The following tests were successfully performed:
- AAMI ANSI ES60601-1 Medical Electrical Equipment, Part I: General 0 requirements for basic safety and essential performance
- . IEC 60601-1-2 - Medical Electrical Equipment, Part I-2: General requirements for basic safety and essential performance. Collateral Standard : Electromagnetic Compatibility
- . IEC 60601-2-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 62366 Medical devices Application of usability engineering to medical ● devices.
- ISO 11135 Sterilization of health-care products ethylene oxide requirements ● for the development, validation and routine control of a sterilization process for medical devices
- ISO 11737-1 Sterilization of health care products Microbiological methods o Part 1: Determination of a population of microorganisms on products
- 0 ISO 11737-2:2009 - Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process /
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- o ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and 0 testing within a risk management process
- ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity
- . ISO 10993-7 - Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for 0 irritation and skin sensitization
- ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for 0 systemic toxicity
- ASTM F1980-07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- 0 Software verification and validation in accordance with IEC 62304 and the FDA Final Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- o Energy output verification of each of the five modes and comparison to predicate.
- . Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue.
Technological Characteristics
The devices are substantially equivalent to the predicate devices based on a comparison of physical and performance characteristics.
Clinical Testing (807.92(b)(2))
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion (807.92(b)(3))
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate devices in terms of technology, performance, and indications for use, Soniquence, LLC concludes that the Soniquence RF Generator and Soniquence Electrodes are substantially equivalent to the predicate devices as described above.
§ 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.