(77 days)
Not Found
No
The summary does not mention AI or ML, and the device description is consistent with a standard electrosurgical device.
Yes.
The device is intended for the removal and destruction of skin lesions and coagulation of tissue, which are therapeutic actions.
No
The device is intended for the removal and destruction of skin lesions and coagulation of tissue, rather than diagnosing conditions.
No
The device description clearly states it is a "handheld battery powered device" and lists hardware components like a handpiece, tips, and a battery charger. This indicates it is a physical medical device, not software-only.
Based on the provided information, the SubNovii device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "removal and destruction of skin lesions and coagulation of tissue." This is a direct treatment applied to the patient's body.
- Device Description: The device generates an electrical arc to the skin. This is an electrosurgical device used for therapeutic purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SubNovii does not perform any such analysis of specimens.
The SubNovii is a therapeutic device used for surgical procedures on the skin.
N/A
Intended Use / Indications for Use
The SubNovii is intended for the removal and destruction of skin lesions and coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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)
Performance Testing:
Test: Electrical
Objective: Compliance with EN 60601-1
Results: Pass
Test: Electrical
Objective: Compliance with EN 60601-1-2
Results: Pass
Test: Thermal Effects on 4 Yucatan mini Pig tissues (liver, kidney, muscle and skin) per FDA Guidance Premarket Notification (510(K)) Submission for Electrosurgical Devices for General Surgery
Objective: The tests were conducted on 4 Yucatan mini Pig tissues (liver, kidney, muscle and skin). Histological evaluation with nitro blue tetrazolium (NBT) demonstrated the tissue damages by the subject device are less than 0.25mm, which is considered superficial and substantially equivalent to the tissue damages by the predicate device.
Results: Equivalent
Results of Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.
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.
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
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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.
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 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 Rd | |
| Melville, NY 11747 | ||
| Contact Person: | Gabe Lubin | |
| Telephone: | 877-662-2783 | |
| Preparation Date: | glubin@cartessaaesthetics.com | |
| May 27, 2020 | ||
| Device Trade Name: | SubNovii Advanced Plasma Technology | |
| Common Name: | Electrosurgical, cutting & coagulation & accessories | |
| Regulation Name: | Electrosurgical cutting and coagulation device and | |
| accessories | ||
| 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 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. | ||
| Intended use of SubNovii: | The SubNovii is used in the removal and destruction of skin | |
| lesions and the coagulation of tissue. | ||
| Performance Testing: | The following performance testing was conducted to prove | |
| compliance with performance requirements and support | ||
| substantial equivalence. | ||
| Test | Objective | Results |
| Electrical | Compliance with EN 60601-1 | Pass |
| Compliance with EN 60601-1-2 | Pass | |
| Thermal Effects on 4 | ||
| Yucatan mini Pig tissues | ||
| (liver, kidney, muscle and | ||
| skin) per FDA Guidance | ||
| Premarket Notification | ||
| (510(K)) Submission for | ||
| Electrosurgical Devices for | ||
| General Surgery | The tests were conducted on 4 | |
| Yucatan mini Pig tissues (liver, | ||
| kidney, muscle and skin). | ||
| Histological evaluation with nitro | ||
| blue tetrazolium (NBT) | ||
| demonstrated the tissue damages | ||
| by the subject device are less than | ||
| 0.25mm, which is considered | ||
| superficial and substantially | ||
| equivalent to the tissue damages | ||
| by 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 | |
|---|---|---|
| SubNovii | ||
| K201738 | Neauvia, Inc. | |
| PLASMA IQ | ||
| K192813 | ||
| Characteristic | ||
| Indications for | ||
| Use | Intended for the removal and | |
| destruction of skin lesions and | ||
| coagulation of tissue. | Intended for the removal and | |
| destruction of skin lesions and | ||
| coagulation of tissue. | ||
| Mode of | ||
| Operation | Plasma | |
| Radiofrequency energy ionizes | ||
| the air creating a Plasma stream | Plasma | |
| Radiofrequency energy ionizes the air | ||
| creating 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 Power | ||
| Output | 5W | 5W |
| System | ||
| Components | System consists of a handpiece | |
| that incorporates the | ||
| electrosurgical generator unit, | ||
| docking station, and an active | ||
| electrode. | System consists of a | |
| handpiece that | ||
| incorporates the | ||
| electrosurgical generator | ||
| unit, docking station, and | ||
| an active electrode. | ||
| Electrical Safety | ||
| Standards | 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.