CellFX System

K203299 · Pulse Biosciences, Inc. · GEI · Feb 2, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203299
• Device Name: CellFX System
• Applicant: Pulse Biosciences, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Device Story

CellFX System is a platform technology for dermatological ablation and resurfacing. Device consists of console, handpiece, and sterile treatment tips with stainless steel microneedles. Operates via Nano-Pulse Stimulation (NPS); delivers series of timed, nanosecond duration electrical pulses (100-700 ns) at amplitudes up to 15 kV. Pulses disrupt cellular function leading to cell death while sparing non-cellular tissue. Used in clinical settings by healthcare providers. User selects treatment parameters via console touchscreen. Output is targeted electrical energy applied to skin. Benefits include precise tissue ablation/resurfacing for dermatologic conditions.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (biocompatibility per ISO 10993-1, electrical safety/EMC per IEC 60601 series) and a GLP animal safety study. Animal study used 15 Yucatan pigs comparing CellFX to predicate across 5 cohorts (0-30 days). Results showed successful degeneration/necrosis of target tissue with intact epidermis, no procedure-related complications, and equivalent safety/performance profiles.

Technological Characteristics

Console-based system delivering nanosecond electrical pulses (100-700 ns, 300V-15kV). Treatment tips feature stainless steel microneedles. Power input 100-240 VAC. Compliance with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-1-6, IEC 62366, and IEC 62304. Biocompatibility per ISO 10993-1. Software level of concern: moderate.

Indications for Use

Indicated for dermatological procedures requiring ablation and resurfacing of the skin in patients requiring such dermatological treatment.

Regulatory Classification

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.

Predicate Devices

• Fractora (K102461)

Submission Summary (Full Text)

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February 2, 2021

Pulse Biosciences, Inc. William Knape VP Regulatory, Clinical, & Quality Affairs 3957 Point Eden Way Hayward. California 94545

Re: K203299

Trade/Device Name: CellFX® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 6, 2020 Received: November 9, 2020

Dear William Knape:

We have reviewed vour 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/cdrb/ofdocs/cfpmp/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

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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 (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 ([e-mail]) or phone [phone] 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) K203299

Device Name CellFX® System

Indications for Use (Describe)

The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

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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### 510(K) SUMMARY

# 510(k) Summary

#### I. Submitter

| Applicant: | Pulse Biosciences, Inc.<br>3957 Point Eden Way<br>Hayward, CA 94545<br>Phone: [phone] |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William A. Knape<br>VP Regulatory, Clinical, & Quality Affairs<br>Pulse Biosciences, Inc.<br>Phone: [phone] |
| Date Prepared: | February 2, 2021 |

#### DEVICE INFORMATION II.

| Trade Name: | CellFX® System |
|-----------------------|-------------------------------------------------------------------|
| Regulation Number | 21 CFR § 878.4400 |
| Regulation Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Regulation Class: | Class II |
| Product Code: | GEI |
| Classification Panel: | General and Plastic Surgery |

#### III. PREDICATE DEVICE

K102461 - Fractora by Invasix Ltd. No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The Pulse Biosciences® CellFX® System is a proprietary platform technology. The CellFX System consists of the CellFX Console, CellFX Handpiece, CellFX Treatment Tips, and CellFX Software. The CellFX System delivers nanosecond duration electrical pulses that disrupt the function of cells leading to cell death, while sparing non-cellular tissue. The CellFX System delivers a series of timed, nanosecond electrical pulses (referred to as a "Cycle") to ablate and resurface tissue areas in dermatologic conditions.

The CellFX Console is capable of delivering short electric pulses at amplitudes up to 15 kV and pulse widths up to 700 ns. The electrical energy pulses are applied directly to targeted tissue using sterile Treatment Tips with stainless steel microneedles. The

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treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.

## V. INDICATIONS FOR USE STATEMENT

The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

To support a determination of substantial equivalence, Pulse Biosciences performed verification and validation testing demonstrating the subject device performs as intended; thus, even though the CellFX System has different technological characteristics than the predicate device, the differences do not raise new or different questions of safety and effectiveness.

| | Subject Device | Predicate Device (K102461) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | CellFX® System | Fractora |
| Prescription Only | Yes | Yes |
| Regulation Number | 878.4400 | 878.4400 |
| Product Code | GEI | GEI |
| Indications for Use | Indications for Use | |
| Indications for Use Statement | The CellFX System is intended for dermatological procedures requiring ablation and resurfacing of the skin. | Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin. |
| Technological Characteristics | | |
| Mechanism of Action | Nano-Pulse Stimulation: ultrafast nanosecond electrical pulses to the targeted tissue via treatment tips with an array of microneedles | Non-homogeneous (fractional) pulsed RF energy delivered to skin via an array of multi-electrode pins resulting in heating of skin directly below the electrodes |
| Pulse Frequency | 1-10 Pulses per second | Up to 2 Pulses per second |
| Pulse Amplitude/Voltage | 300V to 15kV | ~300 Volts |
| Pulse Width | 100 ns – 700 ns | Not Applicable |
| Power Input | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50-60 Hz, 1.4 A |
| Power Output | 30 Watts | 75 Watts |
| Energy Range | Minimum: 0.5 Joules @ 0.06 Watts<br>Maximum: 4.3 Joules @ 0.6 Watts | Minimum: 0.2 Joules @ 75 Watts<br>Maximum: 3.7 Joules @ 75 Watts |
| Integrated Skin Temperature Sensor | Not Included | Included |
| Use of Local Anesthesia | Yes | Yes |
| Treatment Tip | Yes | Yes |
| Handpiece | Yes | Yes |

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CELLFX® SYSTEM 510(k) Premarket Notification

| System Physical Characteristics | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Height | 132 cm | 100 cm |
| Length | 46 cm | 36 cm |
| Width | 53 cm | 36 cm |
| Weight | 54 kg | 15 kg |
| Power Input | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50-60 Hz, 1.4 A |
| Tip Characteristics | | |
| Microneedle<br>Configuration | 1.5x1.5mm: 2 rows of 3 pins per row<br>2.5x2.5mm: 2 rows of 3 pins per row<br>5.0x5.0mm: 2 rows of 4 pins per row | 24 pin tip: 6 rows of 4 pins per row<br>60 pin tip: 10 rows of 6 pins per row |

#### PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility Testing

The testing was conducted in accordance with FDA Guidance, issued June 16, 2016: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." All biocompatibility tests met their respective acceptance criteria.

The battery of testing included the following:

- Material-Mediated Pyrogenicity ●
- Systemic Toxicity ●
- Sensitization ●
- Irritation ●
- Cytotoxicity
- . Hemolysis

All biocompatibility tests met their respective acceptance criteria.

#### Electrical safety and electromagnetic compatibility (EMC)

The CellFX System complies with IEC 60601-1, IEC 60601-1-2, 60601-2-2. IEC 60601-1-6, IEC 62366, and IEC 62304. All test conditions were performed as outlined within the IEC standards. All electrical safety and EMC tests passed

#### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure of the device could directly result in minor injury to the patient or operator. Completed software testing supports the safety and effectiveness of the device.

Cybersecurity controls have been implemented to mitigate the risk of malware being introduced into the CellFX System as recommended by FDA's Draft Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."

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# Animal Study

A GLP animal safety study was conducted to validate the safety and performance of the CellFX System. The study was conducted on 15 Yucatan pigs that underwent skin treatments with either the CellFX System (test) or the predicate device (control). Animals were divided into 5 cohorts of 3 animals each for the following timepoints: 0, 2, 6, 14, and 30-days.

Safety

- All animals survived to their termination date with no procedure related . complications. Based on the results of intra-procedural treatments, gross evaluation, histopathological analysis, clinical pathology, and in-life physical examinations the CellFX treatments are considered to be safe.
## Performance

- All test articles met the acceptance criteria for device performance. The treatment . zones met the acceptance criteria. The CellFX treatment sites successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact. The device is expected to perform as intended.
## Summary

Based on the GLP animal safety study, the CellFX System was found to have a safety and performance profile that is equivalent to the predicate device.

## CONCLUSION

The CellFX® System has the same intended use as the predicate. The differences in technological characteristics between the CellFX System and predicate device do not raise any different questions of safety and effectiveness. The non-clinical performance testing and in vivo animal data provided in this submission demonstrate and support that the CellFX System is as safe and as effective as the predicate device. Therefore, the CellFX System is substantially equivalent to the predicate device.