(85 days)
Not Found
No
The summary describes a device that delivers electrical pulses for skin ablation and resurfacing. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation. The user selects treatment parameters.
Yes
The device is described as "ablating and resurfacing of the skin," and the performance study shows it "successfully achieved degeneration and necrosis of active treatment sites," indicating it directly treats or modifies a physiological condition (skin issues).
No
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which are treatment procedures, not diagnostic ones. It delivers electrical pulses to disrupt cells, a therapeutic action.
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 IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin." This describes a procedure performed directly on the patient's body (in vivo), not 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 or surgical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
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 analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Product codes
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
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
- Biocompatibility Testing: Testing 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: Material-Mediated Pyrogenicity, Systemic Toxicity, Sensitization, Irritation, Cytotoxicity, and Hemolysis.
- 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. Completed software testing supports the safety and effectiveness of the device. Cybersecurity controls have been implemented.
- Animal Study: GLP animal safety study conducted on 15 Yucatan pigs. 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, and the treatments were considered safe based on intra-procedural treatments, gross evaluation, histopathological analysis, clinical pathology, and in-life physical examinations.
- Performance: All test articles met the acceptance criteria for device performance. The treatment zones met the acceptance criteria, successfully achieving degeneration and necrosis of active treatment sites while the epidermis remained intact.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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
1
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 (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) 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.
3957 Point Eden Way
Hayward, CA 94545
Phone: (510) 906-4649 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William A. Knape
VP Regulatory, Clinical, & Quality Affairs
Pulse Biosciences, Inc.
Phone: (919) 757-2033 |
| 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 |
| 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
4
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 | |
| Maximum: 4.3 Joules @ 0.6 Watts | Minimum: 0.2 Joules @ 75 Watts | |
| 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 | ||
| Configuration | 1.5x1.5mm: 2 rows of 3 pins per row | |
| 2.5x2.5mm: 2 rows of 3 pins per row | ||
| 5.0x5.0mm: 2 rows of 4 pins per row | 24 pin tip: 6 rows of 4 pins per row | |
| 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.