CellFX System

K222075 · Pulse Biosciences, Inc. · GEI · Sep 2, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222075
• Device Name: CellFX System
• Applicant: Pulse Biosciences, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 2, 2022
• 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. It delivers nanosecond electrical pulses (Nano-Pulse Stimulation) to targeted tissue, causing cell death while sparing non-cellular tissue. The system comprises a console, handpiece, and sterile treatment tips with stainless steel microneedles. The physician selects treatment parameters via a touchscreen interface on the console. The device is used in a clinical setting by a physician. The electrical pulses are applied directly to the skin via the microneedle array. The output is the controlled ablation of targeted dermatological lesions. This process benefits patients by providing a method for skin resurfacing and lesion removal. The system is operated by a clinician who monitors the interface to ensure appropriate energy delivery based on the specific dermatological condition.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (biocompatibility, electrical safety, EMC) and an animal study. The animal study involved 10 Yucatan mini-pigs treated with 3-row tips (7.5 mm and 10.0 mm) across various energy settings. Endpoints included safety (adverse events, pathology, healing) and performance (degeneration/necrosis of target sites). Results showed full, acceptable healing, no adverse events, and successful tissue ablation, confirming the device performs as intended.

Technological Characteristics

Platform delivers nanosecond electrical pulses (100-700 ns width, 300V-15kV amplitude). Uses stainless steel microneedle arrays on sterile, EO-sterilized treatment tips. Console features touchscreen UI. Power: 100-240 VAC, 30W output. Complies with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-1-6, IEC 62366, and IEC 62304. System is a standalone unit.

Indications for Use

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

• CellFX® System (K211444)

Submission Summary (Full Text)

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September 2, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Pulse Biosciences, Inc. Punam Gollamudi Director US Regulatory Affairs 3957 Point Eden Way Hayward. California 94545

## Re: K222075

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: July 13, 2022 Received: July 14, 2022

Dear Punam Gollamudi:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

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)

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: | Punam Gollamudi<br>Director of US Regulatory Affairs<br>Pulse Biosciences, Inc.<br>Phone: [phone] |
| Date Prepared: | August 30, 2022 |

#### II. DEVICE INFORMATION

| 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

K211444 - CellFX® System, Pulse Biosciences, Inc. 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.

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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 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

The subject device has the same technological characteristics as the predicate device. The fundamental scientific technology, energy source, materials, and processes for packaging and sterilization have not been changed from the predicate device. The device design is similar to the predicate. To support a determination of substantial equivalence, Pulse Biosciences performed verification and validation testing demonstrating the subject device performs as intended. Based on the data provided, the additional Treatment Tips do not raise any new or different questions of safety and effectiveness.

| | Subject Device | Predicate Device (K211444) | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Trade Name | CellFX® System | CellFX® System | | |
| Prescription Only | Yes | Yes | | |
| Regulation Number | 878.4400 | 878.4400 | | |
| Product Code | GEI | GEI | | |
| Indications for Use | | | | |
| Indications for Use<br>Statement | The CellFX System is intended for<br>dermatological procedures requiring<br>ablation and resurfacing of the skin. | The CellFX System is intended for<br>dermatological procedures requiring<br>ablation and resurfacing of the skin. | | |
| Technological Characteristics | | | | |
| Mechanism of Action | Nano-Pulse Stimulation: ultrafast<br>nanosecond electrical pulses to the<br>targeted tissue via treatment tips with<br>an array of microneedles | Nano-Pulse Stimulation: ultrafast<br>nanosecond electrical pulses to the<br>targeted tissue via treatment tips with<br>an array of microneedles | | |
| Pulse Frequency | 1-10 Pulses per second | 1-10 Pulses per second | | |
| Pulse<br>Amplitude/Voltage | 300V to 15kV | 300V to 15kV | | |
| Pulse Width | 100 ns - 700 ns | 100 ns - 700 ns | | |
| Power Input | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50/60 Hz, 2A | | |
| Power Output | 30 Watts | 30 Watts | | |

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| Energy Density<br>Range | 7.5 x 7.5 mm – 40-70 mJ/mm³<br>10.0 x 10.0 mm– 40-70 mJ/mm³ | 1.5 x 1.5 mm – 110-190 mJ/mm³<br>2.5 x 2.5 mm – 60-110 mJ/mm³<br>5.0 x 5.0 mm – 45-85 mJ/mm³ |
|---------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Use of Local<br>Anesthesia | Yes | Yes |
| Sterile Tip | EO Sterilization | EO Sterilization |
| Handpiece | Universal Handpiece | Universal Handpiece |
| System Physical Characteristics | | |
| Height | 132 cm | 132 cm |
| Length | 46 cm | 46 cm |
| Width | 53 cm | 53 cm |
| Weight | 54 kg | 54 kg |
| Power Input | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50/60 Hz, 2A |
| Tip Characteristics | | |
| Treatment Tip | 3-Row | 2-Row |
| Microneedle<br>Configuration | | |
| 1.5 x 1.5 mm | N/A | 2 rows of 3 needles per row |
| 2.5 x 2.5 mm | N/A | 2 rows of 3 or 4 needles per row |
| 5.0 x 5.0 mm | N/A | 2 rows of 4 or 6 needles per row |
| 7.5 x 7.5mm | 3 rows of 9 needles per row | N/A |
| 10 x 10mm | 3 rows of 11 needles per row | N/A |
| Tip Insertion Depth | 1 mm and 2 mm | 1 mm and 2 mm |

## VII. PERFORMANCE DATA

The following performance data was referenced or provided in support of the substantial equivalence determination.

#### Biocompatibility Testing

The testing was conducted in accordance with FDA Guidance, issued September 4, 2020: 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:

- · Pyrogenicity, Material Mediated
- · Systemic Toxicity
- · Sensitization
- Irritation
- · Cytotoxicity
- Hemolysis

All biocompatibility tests met their respective acceptance criteria.

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#### 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.

#### Bench Testing

The performance testing for the CellFX System (Console, Handpiece and Tip) verified that the CellFX System performed as intended and met product specifications.

#### 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."

#### Animal Study

## Safety and Performance Evaluation of the CellFX® System Using 3 Row Tips in Swine Skin

An animal safety study was conducted to evaluate the safety and performance of the CellFX System utilizing the 7.5 mm and 10.0 mm Treatment Tips at acute and chronic timepoints. The treatment zones were characterized across a range of energy settings (minimum, default, and maximum). The study was conducted on 10 Yucatan mini-bigs that underwent skin treatments with the subject device including 3-Row CellFX Treatment Tips (7.5 mm and 10.0 mm). Animals were divided into five cohorts of two animals each for the following timepoints: 0, 2, 6, 14, and 30 days.

#### Safety

All CellFX treatments were successfully completed with no acute procedural-related adverse events or procedural complications during the skin treatment or in-life phase of the study. Pathology results support the safety of the CellFX System as there was full and acceptable healing of treated sites, no effect on draining lymph nodes or nontarget organs.

#### Performance

All test articles met the acceptance criteria for device performance. The treatment zones met the acceptance criteria and successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact in the majority of the treatment sites. The device performed as intended.

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#### Conclusion

CellFX treatments in the swine skin using the 3-Row Treatment Tips were shown to be safe and performed as intended. Therefore, this animal study data confirmed that the device performs as intended and does not raise safety concerns.

#### Summary

Based on the animal safety study, the CellFX System was found to have a safety and performance profile that is equivalent to the predicate device and does not raise any different questions of safety or effectiveness.

#### CONCLUSION

The CellFX System has the same indication for use, technological characteristics and principles of operation as its predicate device. 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.