(147 days)
Not Found
No
The description focuses on standard electrosurgical generator technology, waveforms, power levels, and safety standards. There is no mention of AI, ML, or any features that would suggest adaptive learning or data-driven decision making.
Yes
The device is described as an RF generator for resection, ablation, and coagulation, and its intended use directly involves surgical procedures to treat soft tissues and blood vessels. These actions are therapeutic in nature, aimed at treating or alleviating a condition.
No
The device is described as an RF generator for surgical procedures (resection, ablation, coagulation, hemostasis) and does not mention any diagnostic capabilities.
No
The device description clearly details hardware components like an RF generator, push buttons, lamps, digital displays, and electrodes made of classic alloys. While software is mentioned for verification and validation, the core functionality and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details an "electrosurgical generator" that delivers "high-frequency RF energy" to "cut and coagulate different kinds of tissue." This is consistent with surgical equipment used for tissue manipulation and hemostasis.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of patient specimens or diagnostic purposes.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, usability, sterilization, biocompatibility, and energy output verification on ex-vivo tissue. These are typical tests for surgical devices, not IVDs which would involve analytical and clinical performance studies related to specimen analysis.
In summary, the Soniquence RF Generator and Electrodes are designed for direct surgical intervention on the patient's body, which is the defining characteristic of a surgical device, not an IVD.
N/A
Intended Use / 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 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.
Product codes
GEI
Device Description
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 mutually-exclusive 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures) / Not Found
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)
Non-Clinical Testing:
- 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
- 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 /
- 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
- 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"
- 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.
Clinical Testing was not performed as part of this submission.
Key Results: The devices are substantially equivalent to the predicate devices based on a comparison of physical and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K170107, K134054, K142410, K160041
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 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.