(413 days)
No
The description focuses on the electrosurgical functions and button controls, with no mention of AI or ML.
No
The device is an accessory to an RF Generator used in surgical procedures and does not directly provide therapy. It facilitates the activation of different modes for resection, incision, and hemostasis during surgery.
No
The device is described as an accessory for an RF Generator used for surgical procedures (resection, incision, and hemostasis), not for diagnosis. It activates different surgical modes (CUT, BLEND, HEMO).
No
The device is a physical wand with buttons and electrical connections, clearly indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection, incision, and hemostasis in soft tissue surgical procedures." This describes a surgical tool used directly on a patient's tissue, not a device used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a handpiece that connects to an RF generator and electrodes for surgical procedures. It controls the output of the generator for cutting, blending, and hemostasis. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Soniquence Reusable 3 Button Fingerswitch Wand is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, incision, and hemostasis in soft tissue surgical procedures.
Product codes
GEI
Device Description
The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Soniquence SmoothWave RF Generator. It is connected to a High Frequency Generator via the male end, and the female end termination connects to the Monopolar Electrode. This device will be provided non-sterile and is intended to be used with Soniquence Monopolar Electrodes.
The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows:
a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates.
b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue surgical procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Non-Clinical Testing:
Electrical Safety -The following tests were successfully performed:
-
IEC 60601-1: 3ª edition, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surgical accessories
Biocompatibility:
The device was subjected to the following biocompatibility tests which passed all tests.
-
Intracutaneous Reactivity Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization
- Skin Sensitization Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part A 10: Tests for irritation and skin sensitization
-
In Vitro Cytotoxicity, ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
Sterilization Validation: The device has undergone sterilization reprocessing with passing results according to the requirements of:
- ISO 14937:2009 Sterilization of health care products General requirements for A characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
- AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by A health care facilities: A quide for device manufacturers
- A ASTM E1766-15 - Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
Key Metrics
Not Found
Predicate Device(s)
Soniquence Disposable 3 Button Fingerswitch Handpiece (K183611)
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
September 2, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo, featuring an abstract eagle emblem encircled by the department's name. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" in bold blue letters, and "ADMINISTRATION" in smaller blue letters below.
Soniquence. LLC Ms. Suzanne Lucas, B.A Sr. Regulatory Affairs Specialist 2477 Grand Avenue Baldwin, New York 11510
Re: K212222
Trade/Device Name: Soniquence Reusable 3 Button Fingerswitch Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 3, 2022 Received: August 8, 2022
Dear Ms. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 medical devices and radiation-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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212222
Device Name
Soniquence Reusable 3 Button Fingerswitch Wand
Indications for Use (Describe)
The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for 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/1 description: The image is a logo featuring a stylized letter 'S' in white, set against a square background with rounded corners. The background is a shade of purple. The 'S' appears to be formed from a ribbon or piece of paper that is folded or curved to create the shape, with subtle shading to give it a three-dimensional appearance.
Image /page/3/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized "S" that resembles a ribbon or wave. The rest of the word "oniquence" is written in a simple, sans-serif font, with a registered trademark symbol to the right of the word.
Exhibit 2. 510(k) SUMMARY
(As required by 21 CFR 807.92(a))
Date Prepared
August 30, 2022
Submitter's Information (807.92(a)(1))
Company Name and Address:
Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 Phone: (516) 634-1370 www.soniquence.com
Establishment Registration #: 3014982808
Contact Information:
Ms. Suzanne Lucas Soniquence, LLC Sr. Requlatory Affairs Specialist Phone: (516) 634-1370 Email: slucas@soniquence.com
Device Information (807.92(a)(2))
Trade Name: Soniquence Reusable 3 Button Fingerswitch Wand
Common/Usual Name: Electrosurgical, Cutting & Coagulation Device & Accessories
Classification Name and Regulation: Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR 878.4400
Classification Panel: General and Plastic Surgery
Device Class/Product Code
FDA Classification: Class 2 FDA Product Code: GEI
Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com
5
4
Image /page/4/Picture/0 description: The image shows the text 'K212222' in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, with the 'K' standing out as the only letter among a series of numbers.
Image /page/4/Picture/1 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized letter 'S' that appears to be made of a ribbon or paper strip. The 'S' shape has a flowing, curved design, giving it a dynamic and elegant appearance against the solid purple backdrop.
Image /page/4/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized "S" that looks like a ribbon. The rest of the word "oniquence" is written in a simple, sans-serif font. There is a registered trademark symbol to the right of the word.
Predicate Devices (807.92(a)(3))
- Soniquence Disposable 3 Button Fingerswitch Handpiece (K183611) .
Device Description (807.92(a)(4))
The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Soniquence SmoothWave RF Generator. It is connected to a High Frequency Generator via the male end, and the female end termination connects to the Monopolar Electrode. This device will be provided non-sterile and is intended to be used with Soniquence Monopolar Electrodes.
The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows:
- a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates.
- b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
- c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.
Intended Use:
The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures.
5
Image /page/5/Picture/1 description: The image is a logo featuring a stylized white "S" shape against a purple square background with rounded corners. The "S" appears to be made of a ribbon or folded paper, giving it a three-dimensional effect. The overall design is simple and modern, with a focus on the letter "S" as the central element.
Image /page/5/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized ribbon-like shape on the left side, followed by the word "oniquence" in a sans-serif font. A registered trademark symbol is present to the right of the word.
Substantial Equivalence Comparison (807.92(a)(6))
The Soniquence Reusable 3 Button Fingerswitch Wand is substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device.
| Characteristic | Soniquence Reusable 3 Button
Fingerswitch Wand
(SUBJECT DEVICE) | Soniquence 3 Button Fingerswitch Wand
(K183611)
PREDICATE |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Soniquence Reusable 3 Button
Fingerswitch Wand is designed to be
used with a Soniquence RF Generator
and Soniquence monopolar electrodes for
resection, dissection, incision, and
hemostasis in soft tissue surqical
procedures. | The Soniquence 3 Button Fingerswitch Wand is
designed to be used with a Soniquence RF
Generator and Soniquence monopolar electrodes
for resection, dissection, incision, and hemostasis
in soft tissue surgical procedures. |
| Regulation number | 21 CFR 878.440 | 21 CFR 878.440 |
| Product Code | GEI | GEI |
| OTC or
Prescription | RX Only | RX Only |
| Device
Classification | Class II | Class II |
| General description
of procedures | Soft tissue surgical procedures | Soft tissue surgical procedures |
| Modes of operation | Monopolar Cut, Blend, and Hemo | Monopolar Cut, Blend, and Hemo |
| Operating
mechanism | Button Switch | Button Switch |
| Energy Type | Radio Frequency | Radio Frequency |
| Electrode Tip
configurations | Ball, Loop, Wire, Needle, Spatula, Diamond | Ball, Loop, Wire, Needle, Spatula, Diamond |
| Shaft working
length | 20mm - 180mm | 20mm - 180mm |
| Activation Method | Hand control | Hand control |
| Materials | ABS, TPE | ABS, TPE |
6
Image /page/6/Picture/0 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized letter "S" that appears to be made of a ribbon or folded paper. The "S" shape is flowing and elegant, with a gradient effect that gives it a three-dimensional appearance.
Image /page/6/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized "S" that looks like a ribbon. The rest of the word "oniquence" is in a sans-serif font. There is a registered trademark symbol to the right of the word.
Non-Clinical Testing (807.92(b)(1))
The Soniquence Reusable 3 Button Fingerswitch Wand will be manufactured in accordance with the design control requirements of 21 CFR 820.30. Appropriate non-clinical verification and validation activities were planned and conducted to address identified risks and ensure the safety and effectiveness of the device.
Electrical Safety -The following tests were successfully performed:
-
IEC 60601-1: 3ª edition, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surgical accessories
Biocompatibility:
The device was subjected to the following biocompatibility tests which passed all tests.
-
Intracutaneous Reactivity Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization
- Skin Sensitization Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part A 10: Tests for irritation and skin sensitization
-
In Vitro Cytotoxicity, ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
Sterilization Validation: The device has undergone sterilization reprocessing with passing results according to the requirements of:
- ISO 14937:2009 Sterilization of health care products General requirements for A characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
- AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by A health care facilities: A quide for device manufacturers
- A ASTM E1766-15 - Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
7
Image /page/7/Picture/0 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized letter "S" that appears to be made of a ribbon or folded paper. The "S" shape has a gradient effect, giving it a three-dimensional appearance. The overall design is simple and modern.
Image /page/7/Picture/2 description: The image shows the word "Soniquence" in a stylized purple font. The "S" in "Soniquence" is designed to look like a ribbon or wave, adding a dynamic and fluid element to the logo. The rest of the letters are in a clean, sans-serif font, providing a modern and professional look. There is a registered trademark symbol to the right of the word.
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 subject device, Soniquence Reusable 3 Button Fingerswitch Wands does not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above.