CellFX System

K211444 · Pulse Biosciences, Inc. · GEI · Aug 25, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211444
• Device Name: CellFX System
• Applicant: Pulse Biosciences, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 25, 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. It delivers nanosecond electrical pulses (Nano-Pulse Stimulation) to targeted tissue to induce regulated cell death while sparing non-cellular structures. 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; the operator (physician) applies the microneedle tips directly to the skin. The system provides controlled energy delivery (up to 15 kV, 100-700 ns pulse width) to achieve tissue ablation. This process allows for precise dermatological procedures, potentially benefiting patients by enabling targeted tissue removal with minimal thermal damage.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and an animal study. Bench testing verified electrical safety (IEC 60601-1, 60601-2-2) and EMC compliance. An animal study in two Yucatan pigs evaluated 2-Row treatment tips (1.5mm, 2.5mm, 5.0mm). Results showed successful ablation, degeneration, and necrosis of target sites with intact epidermis and no thermal damage. All performance criteria were met with no adverse events reported.

Technological Characteristics

Platform delivers nanosecond electrical pulses (1 Hz-10 Hz, 300V-15kV, 100-700 ns width). Components: Console, handpiece, sterile stainless steel microneedle treatment tips (EO sterilized). Dimensions: 132cm x 46cm x 53cm; Weight: 54kg. Power: 100-240 VAC, 30W output. Compliance: IEC 60601-1, 60601-1-2, 60601-2-2, 60601-1-6, 62366, 62304. Software: Moderate level of concern.

Indications for Use

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

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 (K203299)

Submission Summary (Full Text)

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August 25, 2021

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

Re: K211444

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: August 9, 2021 Received: August 10, 2021

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

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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 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,

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) K211444

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 24, 2021 |

#### 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

K203299 - 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 energy pulses that disrupt the function of cells leading to regulated 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 treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.

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# 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. The design, materials, and energy source remain the same. 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 (K203299) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | CellFX® System | CellFX® System |
| Prescription Only | Yes | Yes |
| Regulation<br>Number | 878.4400 | 878.4400 |
| Product Code | GEI | GEI |
| Indications for Use | | |
| Indications for Use<br>Statement | The CellFX System is intended<br>for dermatological procedures<br>requiring ablation and resurfacing<br>of the skin. | The CellFX System is intended for<br>dermatological procedures<br>requiring ablation and resurfacing<br>of the skin. |
| Technological Characteristics | | |
| Mechanism of<br>Action | Nano-Pulse Stimulation: ultrafast<br>nanosecond electrical pulses to<br>the targeted tissue via treatment<br>tips with an array of microneedles | Nano-Pulse Stimulation: ultrafast<br>nanosecond electrical pulses to the<br>targeted tissue via treatment tips<br>with an array of microneedles |
| Pulse Frequency | 1 Hz -10 Hz | 1 Hz -10 Hz |
| 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 |
| Energy Density<br>Range | 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 | 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 | Single Handpiece for 2-Row Tips | Single Handpiece for 2-Row Tips |
| 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 | 2-Row | 2-Row |
| Microneedle<br>Configuration | | |
| 1.5 x 1.5 mm | 2 rows of 3 needles per row | 2 rows of 3 needles per row |
| 2.5 x 2.5 mm | 2 rows of 3 or 4 needles per row | 2 rows of 3 needles per row |
| 5.0 x 5.0 mm | 2 rows of 4 or 6 needles per row | 2 rows of 4 needles per row |
| Tip Insertion Depth | 1 mm and 2 mm | 2 mm |

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#### VII. PERFORMANCE DATA

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

#### Biocompatibility Testing

Biocompatibility testing was not required as there were no changes to the device compared to the predicated that would impact biocompatibility.

#### 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

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Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."

### Animal Study

An animal safety study was conducted to validate the safety and performance of the CellFX System.

### Validation Report for CellFX System Using 2-Row Tips in Swine Skin

An animal study was conducted to characterize treatment ablation areas to validate the safety and performance of the CellFX System. The study was conducted on two Yucatan pigs that underwent skin treatments with the subject device including 2-Row CellFX Treatment Tips (1.5mm, 2.5mm, and 5.0mm).

Safety

All CellFX treatments were successfully completed with no adverse events. Pathology results support the safety of the CellFX System with acceptable histological findings and no evidence of thermal damage at CellFX treatment sites.

#### Performance

All test articles met the acceptance criteria for device performance. The treatment ablation areas 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.

#### Conclusion

CellFX treatments in a swine skin animal model 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.

## 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.