(24 days)
Not Found
No
The summary describes a passive electrosurgical accessory (neutral plate) and does not mention any computational or analytical capabilities, let alone AI/ML. The testing focuses on electrical safety and biocompatibility.
No.
The device's intended use is to provide a safe return path for electrosurgical current, which is an accessory function for an electrosurgical generator rather than a direct therapeutic action on the patient.
No
The device is described as providing a "safe return path for electrosurgical current" for "minor surgical applications," indicating its role in treatment, not diagnosis. There is no mention of it being used for detecting, monitoring, or analyzing any medical conditions.
No
The device description explicitly states it is a flexible plate made of silicone rubber with a cable, indicating it is a physical hardware component, not software. The performance studies also focus on electrical and biocompatibility testing of a physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing a safe return path for electrosurgical current during minor surgical applications. This is a therapeutic/surgical function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description of a flexible plate made of silicone rubber with a cable aligns with a surgical accessory, not a device used for testing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro, or providing diagnostic information.
- Performance Studies: The performance studies focus on electrical safety, thermal effects, and biocompatibility, which are relevant to surgical devices, not IVDs.
Therefore, the Soniquence Reusable Neutral Plate is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Soniquence Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Soniquence Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Soniquence Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of the reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
The Reusable Neutral Plates 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. Testing was conducted for the following standard and resulted in passing results.
- IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-2-2: Cl. 201.8.7.3.101: Thermal effects of HF Leakage Currents
- o IEC 60601-2-2: Cl. 201.8.8.3.103: ACTIVE ACCESSORY HF dielectric strength
- IEC 60601-2-2: Cl. 201.8.8.3.104: ACTIVE ACCESSORY mains frequency O dielectric strength
- IEC 60601-2-2: Cl. 201.15.101.2: NE cord attachment
- IEC 60601-2-2: Cl. 201.15.101.4: NE cord insulation
- o IEC 60601-2-2: Cl. 201.15.101.6: NE contact impedance
The reusable neutral plate has been tested and evaluated against the following biocompatibility requirements. All tests resulted in passing results.
- In-Vitro Cytotoxicity ISO 10993-5:2010 O
- Sensitization ISO 10993-10:2010 O
- Irritation ISO 10993-10:2010 O
Clinical Testing:
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Soniquence Disposable Neutral Plate (K183611)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of human services, while the text is the name of the organization.
February 3, 2022
Soniquence, LLC Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist 2477 Grand Avenue Baldwin, New York 11510
Re: K220071
Trade/Device Name: Soniquence Reusable Neutral Plate Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 6, 2022 Received: January 10, 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/cfpm/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.
1
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 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 mediation-emitting products, including information about labeling regulations, please see Device (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,
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
510(k) Number (if known) K220071
Device Name Soniquence Reusable Neutral Plate
Indications for Use (Describe)
The Soniquence Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Soniquence Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.
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)
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3
Image /page/3/Picture/1 description: The image is a logo with a purple square background and a white border. Inside the square is a stylized white "S" shape. The "S" appears to be made of a ribbon or folded paper, giving it a three-dimensional look. The logo is simple and modern, with a clean design.
Image /page/3/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.
Exhibit 6. 510(k) SUMMARY
(As required by 21 CFR 807.92(a))
Date Prepared
January 31, 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 Sr. Regulatory Affairs Specialist Phone: (516) 634-1370 Email: slucas@soniquence.com
Device Information (807.92(a)(2))
Trade Name: Soniquence Reusable Neutral Plate
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
Predicate Devices (807.92(a)(3))
- Soniquence Disposable Neutral Plate (K183611) .
4
Image /page/4/Picture/0 description: The image shows the text 'K220071' in a bold, sans-serif font. The text is black and stands out against a white background. The characters are evenly spaced and easily readable. The image appears to be a close-up of the text.
Image /page/4/Picture/1 description: The image is a logo with a purple square background and a white border. Inside the square is a stylized white "S" shape that appears to be made of ribbon or fabric. The "S" is three-dimensional, with shading that gives it depth and a sense of movement.
Image /page/4/Picture/2 description: The image shows the word "Soniquence" in a stylized purple font. The "S" is designed as a flowing ribbon shape, adding a unique visual element to the logo. To the right of the word is the registered trademark symbol. The overall design is clean and modern.
Device Description (807.92(a)(4))
The Soniquence Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of the reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.
Intended Use:
The Soniquence Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Soniquence Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.
Substantial Equivalence Comparison (807.92(a)(6))
The Soniquence Reusable Neutral Plate is substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device by Soniquence (K183611).
| Predicate
Information | Soniquence Reusable Neutral Plate
(SUBJECT DEVICE) | Soniquence Disposable Neutral Plate
(K183611)
(PREDICATE DEVICE) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Reusable Neutral Plate provides a
safe return path for electrosurgical
current and is designed for use with
Soniquence Generators for minor
surgical applications. The Reusable
Neutral Plate is provided nonsterile and
intended for use only in nonsterile
environments. | The Neutral Plate/ Grounding Pad is
designed for use with Soniquence RF
Generators and provides a safe return
path for electrosurgical current. |
| Product Code | GEI | GEI |
| Device Classification | Class II | Class II |
| Functions | Connect to Electrosurgical Generator to
provide safe return path. | Connect to Electrosurgical Generator to
provide safe return path. |
| Operating mode | Monopolar | Monopolar |
| Energy Source | RF Energy | RF Energy |
| Cable Length (ft) | 10 feet | 9 feet |
| Patient Contacting
Materials | Silicone | Aluminum |
| Testing standards
used | IEC 60601-2-2 | IEC 60601-2-2 |
5
Image /page/5/Picture/0 description: The image is a logo with a purple square background and a white border. Inside the square is a stylized white ribbon or paper that forms an 'S' shape. The ribbon appears to be folded or curved, giving it a three-dimensional look against the flat purple background.
Image /page/5/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 to the right of the "S". There is a registered trademark symbol to the upper right of the word.
Non-Clinical Testing (807.92(b)(1))
The Reusable Neutral Plates 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. Testing was conducted for the following standard and resulted in passing results.
- IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-2-2: Cl. 201.8.7.3.101: Thermal effects of HF Leakage Currents
- o IEC 60601-2-2: Cl. 201.8.8.3.103: ACTIVE ACCESSORY HF dielectric strength
- IEC 60601-2-2: Cl. 201.8.8.3.104: ACTIVE ACCESSORY mains frequency O dielectric strength
- IEC 60601-2-2: Cl. 201.15.101.2: NE cord attachment
- IEC 60601-2-2: Cl. 201.15.101.4: NE cord insulation
- o IEC 60601-2-2: Cl. 201.15.101.6: NE contact impedance
The reusable neutral plate has been tested and evaluated against the following biocompatibility requirements. All tests resulted in passing results.
- In-Vitro Cytotoxicity ISO 10993-5:2010 O
- Sensitization ISO 10993-10:2010 O
- Irritation ISO 10993-10:2010 O
Technological Characteristics
The devices are substantially equivalent to the predicate device based on a comparison of physical and performance characteristics. They are all intended to be used with electrosurgical generators to provide a safe return path for the electrosurgical current.
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 Neutral Plates do not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above.