(50 days)
No reference devices were used in this submission.
No
The summary describes a system that delivers electrical pulses based on user-selected parameters. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as affecting biological function (cell death) to treat dermatological conditions, which aligns with the definition of a therapeutic device.
No
The device is described as being used for "dermatological procedures requiring ablation and resurfacing of the skin," and it "delivers nanosecond duration electrical pulses that disrupt the function of cells leading to cell death." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly lists hardware components: CellFX Console, CellFX Handpiece, and CellFX Treatment Tips, in addition to the software.
Based on the provided information, the CellFX® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin." This describes a direct treatment applied to the patient's body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The device delivers electrical pulses directly to targeted tissue using microneedles. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The CellFX System's function is to directly treat tissue, not to diagnose conditions based on sample analysis.
N/A
Intended Use / Indications for Use
The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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 treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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." The battery of testing included Pyrogenicity, Material Mediated, Systemic Toxicity, Sensitization, Irritation, Cytotoxicity, and 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.
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. Completed software testing supports the safety and effectiveness of the device. Cybersecurity controls have been implemented.
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-pigs 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.
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. 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.
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.
No reference devices were used in this submission.
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
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
1
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,
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.
3957 Point Eden Way
Hayward, CA 94545
Phone: (510) 906-4649 |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Punam Gollamudi
Director of US Regulatory Affairs
Pulse Biosciences, Inc.
Phone: (415) 305-4404 |
| 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 |
| 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.
4
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 | ||||
| Statement | The CellFX System is intended for | |||
| dermatological procedures requiring | ||||
| ablation and resurfacing of the skin. | The CellFX System 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 | Nano-Pulse Stimulation: ultrafast | |||
| nanosecond electrical pulses to the | ||||
| targeted tissue via treatment tips with | ||||
| an array of microneedles | ||||
| Pulse Frequency | 1-10 Pulses per second | 1-10 Pulses per second | ||
| Pulse | ||||
| 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
Range | 7.5 x 7.5 mm – 40-70 mJ/mm³
10.0 x 10.0 mm– 40-70 mJ/mm³ | 1.5 x 1.5 mm – 110-190 mJ/mm³
2.5 x 2.5 mm – 60-110 mJ/mm³
5.0 x 5.0 mm – 45-85 mJ/mm³ |
|---------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Use of Local
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
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.
6
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.
7
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.