The SubNovii Advanced Plasma Technology is a handheld battery powered device that, when activated and placed in close proximity to the skin, generates an ionized electrical arc through the tip of an electrode (Tip) to the skin without the device or the electrode touching the skin. The SubNovii Advanced Plasma Technology consists of the SubNovii handpiece, single use disposable tips and a battery charger.

AI/ML Overview

The provided FDA 510(k) summary for the SubNovii Advanced Plasma Technology references acceptance criteria and studies primarily focused on establishing substantial equivalence to a predicate device, rather than defining novel performance criteria for a diagnostic AI device.

Here's a breakdown of the requested information based on the provided text, with clarifications where direct answers are not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate equivalence)	Reported Device Performance (SubNovii)
Electrical Safety	Pass (Compliance with EN 60601-1)
Electromagnetic Compatibility (EMC)	Pass (Compliance with EN 60601-1-2)
Tissue Damage (Superficiality)	Equivalent to predicate device (tissue damages < 0.25mm)
Indications for Use	Same as predicate (removal and destruction of skin lesions and coagulation of tissue)
Mode of Operation	Same as predicate (Plasma; Radiofrequency energy ionizes the air creating a Plasma stream)
Output	Same as predicate (Monopolar)
Power Supply	Same as predicate (110-250 VAC 50/60 Hz)
Frequency	Same as predicate (40kHz)
Max Power Output	Same as predicate (5W)
System Components	Same as predicate (handpiece, docking station, active electrode)
Principle of Operation	Same as predicate
Technical Specifications	Same as predicate

2. Sample Size Used for the Test Set and Data Provenance

The primary "test" to demonstrate substantial equivalence was a thermal effects study on animal tissue, not human clinical data or a test set in the traditional sense for an AI device.

Sample Size for Test Set: The study was conducted on 4 Yucatan mini Pig tissues (liver, kidney, muscle, and skin).
Data Provenance: The study was performed on Yucatan mini Pig tissues; the country of origin is not specified, but it represents pre-clinical, in-vitro/ex-vivo data, not human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the animal tissue study was established through histological evaluation with nitro blue tetrazolium (NBT).
The document does not specify the number or qualifications of experts who performed this histological evaluation. It is implied that qualified personnel performed these evaluations as part of standard practice for such studies.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it would apply to a clinical test set with human observers. The evaluation was a direct histological assessment of tissue damage.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance

No MRMC comparative effectiveness study was done. This submission is for an electrosurgical device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No standalone (algorithm-only) performance was done. This device is a physical electrosurgical tool, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the thermal effects study was histological evaluation of animal tissue to determine the extent of tissue damage.

8. The Sample Size for the Training Set

This submission is not for an AI device, so the concept of a "training set" for an algorithm is not applicable. The device's performance was evaluated through engineering tests and animal tissue studies.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI device, there is no training set or associated ground truth establishment in the context of machine learning.

Summary

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September 10, 2020

Cartessa Aesthetics % Connie Hoy Consultant Hoy and Associates 3916 North Potsdam Ave Souix Falls, South Dakota 57104

Re: K201738

Trade/Device Name: SubNovii Advanced Plasma Technology Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 21, 2020 Received: June 25, 2020

Dear Connie Hoy:

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.

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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 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.

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) 510(K) 201738

Device Name

SubNovii Advanced Plasma Technology

Indications for Use (Describe)

The SubNovii is intended for the removal and destruction of skin lesions and coaqulation of tissue.

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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K201738 510(K) Summary SubNovii Advanced Plasma Technology

This 510(K) Summary of safety and effectiveness for the SubNovii Advanced Plasma Technology is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Cartessa Aesthetics
Address:	175 Broadhollow RdMelville, NY 11747
Contact Person:	Gabe Lubin
Telephone:	877-662-2783
Preparation Date:	glubin@cartessaaesthetics.comMay 27, 2020
Device Trade Name:	SubNovii Advanced Plasma Technology
Common Name:	Electrosurgical, cutting & coagulation & accessories
Regulation Name:	Electrosurgical cutting and coagulation device andaccessories
Regulation Number:	21 CFR 878.4400 (Product Code: GEI)
Legally Marketed Predicate Devices:	Neauvia North America, Inc. Plasma IQ
510(K) number:	K192813
Regulatory Class:	Class II Prescription Use
Description of the SubNovii:	The SubNovii Advanced Plasma Technology is a handheldbattery powered device that, when activated and placed inclose proximity to the skin, generates an ionized electricalarc through the tip of an electrode (Tip) to the skin withoutthe device or the electrode touching the skin. The SubNoviiAdvanced Plasma Technology consists of the SubNoviihandpiece, single use disposable tips and a battery charger.
Intended use of SubNovii:	The SubNovii is used in the removal and destruction of skinlesions and the coagulation of tissue.
Performance Testing:	The following performance testing was conducted to provecompliance with performance requirements and supportsubstantial equivalence.
Test	Objective	Results
Electrical	Compliance with EN 60601-1	Pass
	Compliance with EN 60601-1-2	Pass
Thermal Effects on 4Yucatan mini Pig tissues(liver, kidney, muscle andskin) per FDA GuidancePremarket Notification(510(K)) Submission forElectrosurgical Devices forGeneral Surgery	The tests were conducted on 4Yucatan mini Pig tissues (liver,kidney, muscle and skin).Histological evaluation with nitroblue tetrazolium (NBT)demonstrated the tissue damagesby the subject device are less than0.25mm, which is consideredsuperficial and substantiallyequivalent to the tissue damagesby the predicate device.	Equivalent

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K201738 510(K) Summary SubNovii Advanced Plasma Technology

Results of Clinical Study:

A human clinical study was not required as the device is substantially equivalent to the predicate devices.

Technical Specifications / Indications for Use Comparison:

	510(K) Submission	Predicate
	SubNoviiK201738	Neauvia, Inc.PLASMA IQK192813
Characteristic
Indications forUse	Intended for the removal anddestruction of skin lesions andcoagulation of tissue.	Intended for the removal anddestruction of skin lesions andcoagulation of tissue.
Mode ofOperation	PlasmaRadiofrequency energy ionizesthe air creating a Plasma stream	PlasmaRadiofrequency energy ionizes the aircreating a Plasma stream
Output	Monopolar	Monopolar
Power Supply	110-250 VAC 50/60 Hz	110-250 VAC 50/60 Hz

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K201738 510(K) Summary SubNovii Advanced Plasma Technology

Frequency	40kHz	40kHz
Max PowerOutput	5W	5W
SystemComponents	System consists of a handpiecethat incorporates theelectrosurgical generator unit,docking station, and an activeelectrode.	System consists of ahandpiece thatincorporates theelectrosurgical generatorunit, docking station, andan active electrode.
Electrical SafetyStandards	Complies with IEC60601-1,IEC60601-1-2	Complies with IEC60601-1, IEC60601-1-2,

The Subnovii Advanced Plasma Technology device has the same Conclusion: technology, principle of operation, indications for Use, and technical specifications as the predicate device. Performance test results also demonstrated the subject device can perform the same intended use as safely and effectively as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.