(24 days)
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.
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.
Acceptance Criteria and Study for Soniquence Reusable Neutral Plate
This document describes the acceptance criteria and the study performed to demonstrate that the Soniquence Reusable Neutral Plate meets these criteria, as derived from the provided 510(k) summary.
The Soniquence Reusable Neutral Plate is an electrosurgical accessory, not a diagnostic AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device and its regulatory clearance process. The primary method for demonstrating safety and effectiveness for such a device is through non-clinical performance and biocompatibility testing against recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Soniquence Reusable Neutral Plate are based on compliance with an recognized international standard (IEC 60601-2-2) and biocompatibility standards (ISO 10993-5:2010 and ISO 10993-10:2010), demonstrating its safety and performance aspects.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard & Clause) | Reported Device Performance |
|---|---|---|
| Performance (Electrical Safety) | IEC 60601-2-2:2017: | All tests resulted in passing |
| - Cl. 201.8.7.3.101: Thermal effects of HF Leakage Currents (ensure safe leakage current levels) | ||
| - Cl. 201.8.8.3.103: ACTIVE ACCESSORY HF dielectric strength (ensure insulation integrity at high frequency) | ||
| - Cl. 201.8.8.3.104: ACTIVE ACCESSORY mains frequency O dielectric strength (ensure insulation integrity at mains frequency) | ||
| - Cl. 201.15.101.2: NE cord attachment (ensure secure and robust cable connection) | ||
| - Cl. 201.15.101.4: NE cord insulation (ensure adequate insulation of the cable) | ||
| - Cl. 201.15.101.6: NE contact impedance (ensure proper electrical contact with patient/generator) | ||
| Biocompatibility | ISO 10993-5:2010: In-Vitro Cytotoxicity (ensure materials are not toxic to cells) | All tests resulted in passing |
| ISO 10993-10:2010: Sensitization (ensure materials do not cause allergic reactions) | All tests resulted in passing | |
| ISO 10993-10:2010: Irritation (ensure materials do not cause skin irritation) | All tests resulted in passing |
2. Sample Size Used for the Test Set and Data Provenance
For electrosurgical accessories like the Soniquence Reusable Neutral Plate, the "test set" typically refers to the manufactured units or representative samples of the device undergoing non-clinical bench testing. The 510(k) summary does not specify the exact number of devices tested for compliance with IEC 60601-2-2 and ISO 10993 standards. However, industry practice for such testing involves a sufficient number of samples to ensure robust and representative results, often dictated by the specific test protocol requirements within the standards. The data provenance is from non-clinical bench testing rather than human subject data, and thus there is no country of origin or retrospective/prospective distinction in the context of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This category is not applicable as the device is not an AI/ML diagnostic tool. Ground truth for an electrosurgical neutral plate is established through objective physical and electrical measurements and chemical analyses conducted according to international standards for safety and biocompatibility. The "experts" involved would be qualified test engineers and laboratory personnel with expertise in electrosurgical device testing and biocompatibility assessment, following the methodologies prescribed by IEC and ISO standards.
4. Adjudication Method for the Test Set
This category is not applicable as the clearance is based on objective, quantifiable non-clinical and biocompatibility test results, not subjective interpretations by experts that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This category is not applicable. The Soniquence Reusable Neutral Plate is an electrosurgical accessory, not an AI/ML algorithm or a device that assists human readers in medical image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This category is not applicable. The Soniquence Reusable Neutral Plate is a physical electrosurgical accessory, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for the Soniquence Reusable Neutral Plate is objective physical and electrical measurements and chemical analyses as defined by the referenced international standards:
- IEC 60601-2-2:2017 provides the methodologies and acceptance criteria for electrical safety and performance of electrosurgical equipment and accessories.
- ISO 10993-5:2010 (Cytotoxicity) and ISO 10993-10:2010 (Sensitization and Irritation) provide the methodologies and acceptance criteria for evaluating the biocompatibility of medical devices.
8. The Sample Size for the Training Set
This category is not applicable. The device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
This category is not applicable. The device is not an AI/ML algorithm and therefore does not have a "training set."
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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.
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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
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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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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) .
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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).
| PredicateInformation | Soniquence Reusable Neutral Plate(SUBJECT DEVICE) | Soniquence Disposable Neutral Plate(K183611)(PREDICATE DEVICE) |
|---|---|---|
| Intended Use | The Reusable Neutral Plate provides asafe return path for electrosurgicalcurrent and is designed for use withSoniquence Generators for minorsurgical applications. The ReusableNeutral Plate is provided nonsterile andintended for use only in nonsterileenvironments. | The Neutral Plate/ Grounding Pad isdesigned for use with Soniquence RFGenerators and provides a safe returnpath for electrosurgical current. |
| Product Code | GEI | GEI |
| Device Classification | Class II | Class II |
| Functions | Connect to Electrosurgical Generator toprovide safe return path. | Connect to Electrosurgical Generator toprovide safe return path. |
| Operating mode | Monopolar | Monopolar |
| Energy Source | RF Energy | RF Energy |
| Cable Length (ft) | 10 feet | 9 feet |
| Patient ContactingMaterials | Silicone | Aluminum |
| Testing standardsused | IEC 60601-2-2 | IEC 60601-2-2 |
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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.
§ 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.