(304 days)
No reference devices were used in this submission.
No
The description focuses on the hardware (console, handpiece, tips) and the physical mechanism of action (nanosecond electrical pulses). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The user selects treatment parameters, indicating a lack of automated decision-making based on AI/ML.
Yes
The device is indicated for dermatological procedures requiring ablation and resurfacing of the skin and specifically for the treatment of sebaceous hyperplasia (SH). These are therapeutic actions.
No
Explanation: The device description and intended use clearly state that the CellFX® System is designed for treatment (ablation and resurfacing of the skin, specifically for sebaceous hyperplasia). It delivers electrical pulses to disrupt cells and achieve cell death. There is no mention of diagnosis, detection, or analysis of medical conditions.
No
The device description explicitly states that the CellFX System consists of a Console, Handpiece, Treatment Tips, and Software, indicating it is a system with significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin" and specifically for the "treatment of sebaceous hyperplasia (SH)". This describes a therapeutic procedure performed directly on the patient's skin.
- Device Description: The device delivers electrical pulses to "ablate and resurface tissue areas". This is a physical intervention on the body.
- Mechanism of Action: The device "disrupts the function of cells leading to cell death". This is a direct treatment effect on the tissue.
- Anatomical Site: The device is applied to the "Skin".
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any tests on samples.
The CellFX System is a therapeutic device used for treating a dermatological condition, not for diagnosing or monitoring a condition through analysis of biological samples.
N/A
Intended Use / Indications for Use
The CellFX® System is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Specific Indication: The CellFX System with the CellFX Treatment Tip 2.5mm is indicated for the treatment of sebaceous hyperplasia (SH) in patients with Fitzpatrick skin types I-III.
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 delivers 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
Clinical Study: A prospective, multi-center, randomized, comparison clinical study was conducted to support safety and effectiveness of the CellFX System for the treatment of sebaceous hyperplasia (SH). A total of 59 subjects treated with the 2.5mm Tip were mostly female (79.7%) and white (91.5%). All treatments were performed at a depth of 2mm on subjects with Fitzpatrick skin types I-III. A total of 121 SH lesions were randomized to the CellFX System and 107 to Electrodessication in a split-face study design.
Safety Endpoints: The first primary safety endpoint of lesions showing hyperpigmentation and scarring and assessed by the blinded Investigator at 60 days after the last treatment demonstrated CellFX to be non-inferior to Electrodessication. This safety endpoint found with 19.2% of lesions treated with CellFX and 12.1% of lesions treated with electrodessication having pigmentary changes or scarring. The second co-primary safety endpoint of skin textural changes (crusting, or other skin textural changes) as assessed by the blinded Investigator at 30 days after the last treatment showed rates of 6.8% of lesions treated with CellFX and 10.3% of lesions treated with Electrodessication.
Effectiveness Endpoint: The primary effectiveness endpoint of improvement at 60-days post-last treatment as assessed "live" by the blinded site investigator using the 5-point GAIS (1 = much worse, 2 = worse, 3 = no change, 4 = improved, 5 = much improved, with scores of 4 or 5 classified as responders) showed rates of aesthetic appearance to be improved or much improved for 76.9% of lesions treated with CellFX and 75.5% of lesions treated with electrodessication.
Adverse Events: There were 3 (2.5%, n=120) treatment-related non-serious adverse events (AEs) in 3 subjects with mild swelling at the lesion site treated with the CellFX 2.5mm treatment tip. None of the events required medical intervention and all resolved by the 7-day follow-up visit. One subject was instructed to use ice for swelling.
Summary: Evaluation of primary safety and effectiveness endpoints showed CellFX to be noninferior to Electrodessication. Adverse events associated with the procedure were relatively mild, transient, and not unexpected for this type of procedure, demonstrating that the risks associated with CellFX and procedure are minimal. There were no device-related adverse events and no unanticipated adverse events. The clinical study demonstrated that the CellFX System using the CellFX Treatment Tip 2.5mm was safe and effective for the treatment of sebaceous hyperplasia (SH).
Key Metrics
Safety Endpoint 1 (60 days post-treatment, hyperpigmentation and scarring): CellFX 19.2%, Electrodessication 12.1%
Safety Endpoint 2 (30 days post-treatment, skin textural changes): CellFX 6.8%, Electrodessication 10.3%
Effectiveness Endpoint (60 days post-treatment, GAIS score 4 or 5): CellFX 76.9%, Electrodessication 75.5%
Adverse Events: 3 (2.5%, n=120) treatment-related non-serious adverse events (AEs)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
September 22, 2022
Pulse Biosciences, Inc. Punam Gollamudi Director US Regulatory Affairs 3957 Point Eden Way Hayward. California 94545
Re: K213674
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 25, 2022 Received: August 26, 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
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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213674
Device Name CellFX® System
Indications for Use (Describe)
The CellFX® System is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Specific Indication: The CellFX System with the CellFX Treatment Tip 2.5mm is indicated for the treatment of sebaceous hyperplasia (SH) in patients with Fitzpatrick skin types I-III.
| 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: | September 19, 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 delivers 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 indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Specific Indication: The CellFX System with the CellFX Treatment Tip 2.5mm is indicated for the treatment of sebaceous hyperplasia (SH) in patients with Fitzpatrick skin types I-III.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device has the same technological characteristics as the predicate device. The device design, materials, fundamental scientific technology, materials and processes for packaging and sterilization have not been changed from the predicate device.
| 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 indicated | |
| for dermatological procedures | ||
| requiring ablation and resurfacing | ||
| of the skin. | ||
| Specific Indication: The CellFX | ||
| System with the CellFX Treatment | ||
| Tip 2.5mm is indicated for the | ||
| treatment of sebaceous | ||
| hyperplasia (SH) in patients with | ||
| Fitzpatrick skin types I-III. | The CellFX System is intended for | |
| dermatological procedures | ||
| requiring ablation and resurfacing | ||
| of the skin. | ||
| Subject Device | Predicate Device (K211444) | |
| 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 Hz -10 Hz | 1 Hz -10 Hz |
| 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 |
| Energy Density | ||
| Range | 2.5 x 2.5 mm – 30-60 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 | 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 | ||
| Configuration | ||
| 1.5 x 1.5 mm | ||
| 2.5 x 2.5 mm | ||
| 5.0 x 5.0 mm | N/A | |
| 2 rows of 3 or 4 needles per row | ||
| N/A | 2 rows of 3 needles per row | |
| 2 rows of 3 or 4 needles per row | ||
| 2 rows of 4 or 6 needles per row | ||
| Tip Insertion Depth | 1 mm and 2 mm | 1 mm and 2 mm |
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VII. PERFORMANCE DATA
The following performance data was referenced or 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 predicate.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was not required as there were no changes to the device compared to the predicate.
Bench Testing
Performance testing was not required as there were no changes to the device compared to the predicate.
Software Verification and Validation Testing
Software verification and validation testing was not required as there were no changes to the device compared to the predicate.
Animal Study
Animal testing was not required to support the change to the Indications for Use.
Clinical Study
A prospective, multi-center, randomized, comparison clinical study was conducted to support safety and effectiveness of the CellFX System for the treatment of sebaceous hyperplasia (SH). A total of 59 subjects treated with the 2.5mm Tip were mostly female (79.7%) and white (91.5%). All treatments were performed at a depth of 2mm on subjects with Fitzpatrick skin types I-III. A total of 121 SH lesions were randomized to the CellFX System and 107 to Electrodessication in a split-face study design.
Safety Endpoints
The study was designed to evaluate co-primary safety and effectiveness endpoints. The first primary safety endpoint of lesions showing hyperpigmentation and scarring and assessed by the blinded Investigator at 60 days after the last treatment demonstrated CellFX to be non-inferior to Electrodessication. This safety endpoint found with 19.2% of lesions treated with CellFX and 12.1% of lesions treated with electrodessication having pigmentary changes or scarring. The second co-primary safety endpoint of skin textural changes (crusting, or other skin textural changes) as assessed by the blinded Investigator at 30 days after the last treatment showed rates of 6.8% of lesions treated with CellFX and 10.3% of lesions treated with Electrodessication.
7
Effectiveness Endpoint
The primary effectiveness endpoint of improvement at 60-days post-last treatment as assessed "live" by the blinded site investigator using the 5-point GAIS (1 = much worse, 2 = worse, 3 = no change, 4 = improved, 5 = much improved, with scores of 4 or 5 classified as responders) showed rates of aesthetic appearance to be improved or much improved for 76.9% of lesions treated with CellFX and 75.5% of lesions treated with electrodessication.
Adverse Events
There were 3 (2.5%, n=120) treatment-related non-serious adverse events (AEs) in 3 subjects with mild swelling at the lesion site treated with the CellFX 2.5mm treatment tip. None of the events required medical intervention and all resolved by the 7-day follow-up visit. One subject was instructed to use ice for swelling.
Summary
Evaluation of primary safety and effectiveness endpoints showed CellFX to be noninferior to Electrodessication. Adverse events associated with the procedure were relatively mild, transient, and not unexpected for this type of procedure, demonstrating that the risks associated with CellFX and procedure are minimal. There were no device-related adverse events and no unanticipated adverse events. The clinical study demonstrated that the CellFX System using the CellFX Treatment Tip 2.5mm was safe and effective for the treatment of sebaceous hyperplasia (SH).
CONCLUSION
The CellFX System has the same intended use, technological characteristics and principles of operation and similar indications for use as its predicate device. Clinical studies of the CellFX System have demonstrated the safety and effectiveness profile of the device in the intended population. Thus, the CellFX System is substantially equivalent to the predicate device.