Who is the manufacturer of Soniquence RF Generator and Soniquence Electrodes?

Soniquence, LLC filed the 510(k) submission for Soniquence RF Generator and Soniquence Electrodes (K183611).

What is the FDA product code for Soniquence RF Generator and Soniquence Electrodes?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Soniquence RF Generator and Soniquence Electrodes?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Soniquence RF Generator and Soniquence Electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Soniquence RF Generator and Soniquence Electrodes

Q: What are the predicate devices for Soniquence RF Generator and Soniquence Electrodes?

Surgi-Max® Ultra (K170107); Bovie® IDS-310 Electrosurgical Generator (K134054); Elliquence Electrodes (K142410); Cobbra RF™ Tissue Dissector (K160041).

K183611 · Soniquence, LLC · GEI · May 22, 2019 · General, Plastic Surgery

Device Facts

Record ID	K183611
Device Name	Soniquence RF Generator and Soniquence Electrodes
Applicant	Soniquence, LLC
Product Code	GEI · General, Plastic Surgery
Decision Date	May 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

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

Device Story

The Soniquence RF Generator is a compact electrosurgical unit providing high-frequency RF energy for soft tissue cutting, coagulation, and hemostasis. It operates in monopolar and bipolar modes. The system includes a generator and various electrodes (tungsten, brass, stainless steel). The operator selects waveforms and power levels via front-panel push buttons; digital displays provide status feedback and self-test monitoring. Power activation is controlled by foot or hand switches. The generator delivers time-varying voltage to the surgical site via the electrode to achieve the desired tissue effect. Used in clinical surgical settings by physicians, the device assists in surgical procedures by enabling precise tissue management. The system includes interlocks to prevent operation during failure states. It is designed to comply with international electrical safety standards.

Clinical Evidence

No clinical data was provided. Substantial equivalence is supported by bench testing, including electrical safety (AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2), usability engineering (IEC 62366), sterilization validation (ISO 11135, ISO 11737, ISO 11138), biocompatibility (ISO 10993), and software verification/validation (IEC 62304). Performance was verified via energy output testing and ex-vivo bovine tissue thermal effect comparisons against predicate devices.

Technological Characteristics

RF electrosurgical generator and electrodes. Materials: Tungsten, brass, stainless steel, PFA, PTFE. Energy: High-frequency RF (monopolar/bipolar). Output: 170W max, 1,200V peak-to-peak. Standards: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993, ISO 11135, ASTM F1980-07. Connectivity: Standalone. Sterilization: Ethylene Oxide or Gamma. Software: IEC 62304 compliant.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures. Intended for use by physicians familiar with soft tissue surgical procedures.

Regulatory Classification

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.

Predicate Devices

Surgi-Max® Ultra (K170107)
Bovie® IDS-310 Electrosurgical Generator (K134054)
Elliquence Electrodes (K142410)
Cobbra RF™ Tissue Dissector (K160041)

Related Devices

K100390 — SURGIMAX/ SURGIMAX PLUS · Elliquence, LLC · Aug 25, 2010
K202562 — Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set · Ellusa, LLC · Nov 2, 2020
K061174 — SURGI-MAX · Ellman Int'L, Inc. · Jun 28, 2006
K251813 — CURIS II RF Generator (REF 360100-05) · Sutter Medizintechnik GmbH · Feb 11, 2026
K082834 — ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC · Ellman Int'L, Inc. · May 7, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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. 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/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 {4}------------------------------------------------ #### 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 {5}------------------------------------------------ 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) | Predicate information | Soniquence RF Generator PROPOSED DEVICE | Surgi-Max® Ultra (K170107) PREDICATE | Bovie® IDS-310 Electrosurgical Generator (K134054) PREDICATE | Principle of Operation | Identical to predicates | Conversion of electrical energy to high-frequency RF energy (monopolar and bipolar) | Conversion of electrical energy to high- frequency RF energy (monopolar and bipolar) | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Manufacturer | Soniquence, LLC | elliquence, LLC | Bovie Medical Corp. | Modes of operation | Identical to elliquence K170107 | Cut Blend Hemo Bipolar Bipolar Turbo | 9 Monopolar and 4 bipolar modes | | Product code | GEI | GEI | GEI | Output frequency | Identical to elliquence K170107 | 4 MHz (monopolar) 1.7 MHz (bipolar) | 350 - 490 kHz (monopolar) 490 kHz (bipolar) | | Regulation number | Identical to predicates | 21 CFR 878.4400 | 21 CFR 878.4400 | Maximum power output | Identical to elliquence K170107 | 170W | 300W | | Regulation name | Identical to predicates | Electrosurgical Cutting and Coagulation Device and accessories | Electrosurgical Cutting and Coagulation Device and accessories | Voltage (peak-to- peak) | Identical to elliquence K170107 | 1,200V | 8,000V | | Indications for 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 | Orthopedic, arthroscopic, spinal, and neurological For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, | The IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. | Duty Cycle | Identical to elliquence K170107 | 10 sec On / 30 sec OFF | 10 sec On / 30 sec OFF | | | coagulate different kinds of tissue. | shoulder, ankle, elbow, hip and wrist. Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty. Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps. Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage. | | Supply input power | Identical to elliquence K170107 | 100 VAC - 240 VAC, 50/60 Hz | 100 VAC - 240 VAC, 50/60 Hz | | Prescription device (21 CFR 801.109) | Identical to predicates | Yes | Yes | Power activation control | Identical to predicates | Footswitch and/or fingerswitch | Footswitch and/or fingerswitch | | Electrical safety and EMC testing standards | Identical to elliquence K170107 | AAMI ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 | | | | | | Applied part type | Identical to elliquence K170107 | CF | CF | | | | | {6}------------------------------------------------ {7}------------------------------------------------ # Table 1.2 – Substantial equivalence comparison table (Electrodes) | Predicate Information | Soniquence Electrodes PROPOSED DEVICE | Elliquence Electrodes (K142410) PREDICATE | Cobbra™ RF Tissue Dissector (K160041) PREDICATE | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. | The Elliquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. The types | Intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. General surgery, laparoscopic, procedures, endoscopic procedures, open | | | | of surgery intended are: General surgery, Laparaoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation. | abdominal, orthopedic coagulation, thorascopic coagulation, neurosurgical coagulation, gynecological coagulation, and ENT coagulation are the types of 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 sterile components; handle, cable, connector, shaft, monopolar electrode | Integrated sterile components; handle, cable, connector, shaft, monopolar electrode | | Shaft forms | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | Straight, Bayonet, angled, and curved | Straight | | Shaft malleability | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | Fixed and malleable models | Fixed models only | | Shaft lengths | Identical to predicate | 1.9 - 60 cm | electrode shaft: 12.7 cm handpiece shaft: 18.55 cm | | Shaft diameter | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | 1/16" and 3/32" | electrode shaft: 6.0 mm handpiece shaft: 21.7 mm | | Tip Configurations | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | Loop (round, diamond), ball, and blade (needle, fine wired, spatula) | Spatula | | Material Composition | | | | | Handle | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | Molded Plastic | Molded plastic | | Shaft | | Surgical Stainless Steel/Brass | Surgical stainless steel | | Electrode | | Surgical Stainless Steel/ Tungsten/Brass | Surgical stainless steel / PFA insulation | | Patient contacting materials | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | Medical grade stainless steel, brass, tungsten, Loctite, PFA, and PTFE | Medical grade stainless steel and PFA | | Coating | Identical to predicates | None | None | | Biocompatibility | Identical to predicates | ISO 10993 | ISO 10993 | | Sterilization Methods | Identical to predicates | Gamma or Ethylene Oxide | Gamma or Ethylene Oxide | | Expiration Dating | Identical to predicates | Yes | Yes | | Packaging | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | Sterile, Blister Tray Sterile, Peel Pouch | Sterile, Blister Tray | | Activation Method | Identical to predicates | Fingerswitch/Footswitch | Fingerswitch/Footswitch | | Manual Controls | Identical to predicates | None, all power settings established on generator | None, all power settings established on generator | | Internal Memory/ circuitry for generator recognition | Identical to predicates | None | None | | Min., Max., Default output Values (Wattage) | Identical to predicates | 0-170 | 0-170 | | Patient Leakage current | Identical to predicates | Type CF | Type CF | | Cable Length (m) | Cobbra models identical to Cobbra predicate All others are identical to Elliquence Electrodes predicate | 3 | 3 | | Temperature Probe | Identical to predicates | No | No | | Cooling Function | Identical to predicates | None | None | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## 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 / {11}------------------------------------------------ - 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.