(53 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.
No.
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which is a structural or cosmetic modification, not a therapeutic treatment of a disease.
No
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin by delivering electrical pulses to disrupt cells. It does not mention any diagnostic capabilities or functions.
No
The device description explicitly lists hardware components: CellFX Console, CellFX Handpiece, and CellFX Treatment Tips. The software is part of a larger system that includes physical hardware for delivering electrical pulses.
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, not a test performed on a sample taken from the body.
- Device Description: The device delivers electrical pulses directly to tissue using microneedles. This is a therapeutic action, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting biomarkers, or providing diagnostic information based on laboratory 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 on the body.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
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: A GLP animal study was conducted to validate the safety and performance of the CellFX System.
Study type: Safety and Performance Evaluation of the CellFX® System Using High Energy Settings in Swine Skin. An animal study was conducted following GLP practices to characterize treatment zones across a range of higher energy settings to evaluate the safety and performance of the CellFX System.
Sample size: 15 Yucatan mini-pigs.
Key results: All CellFX treatments were successfully completed with no acute procedural adverse events. Pathology results support the safety of the CellFX System as there was acceptable healing of treated sites, no effect on draining lymph nodes or nontarget organs. 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. CellFX treatments in the swine skin using higher energy levels for the 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.
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
August 1, 2022
Pulse Biosciences, Inc. Punam Gollamudi Director US Regulatory Affairs 3957 Point Eden Way Hayward, California 94545
Re: K221671
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: June 8, 2022 Received: June 9, 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
1
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 (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: | June 8, 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
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 higher energy densities 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 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 | 1.5 x 1.5 mm - 300-575 mJ/mm3 | |
| 2.5 x 2.5 mm - 175-345 mJ/mm3 | 1.5 x 1.5 mm - 110-190 mJ/mm3 | |
| 2.5 x 2.5 mm - 60-110 mJ/mm3 |
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| 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 | 2-Row | 2-Row |
| Microneedle | ||
| 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 4 needles per row | 2 rows of 3 or 4 needles per row |
| 5.0 x 5.0 mm | 2 rows of 6 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 |
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
6
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
A GLP animal study was conducted to validate the safety and performance of the CellFX System.
Safety and Performance Evaluation of the CellFX® System Using High Energy Settings in Swine Skin
An animal study was conducted following GLP practices to characterize treatment zones across a range of higher energy settings to evaluate the safety and performance of the CellFX System. The study was conducted on 15 Yucatan mini-pigs that underwent skin treatments with the subject device including 2-Row CellFX Treatment Tips (1.5mm, 2.5mm, and 5.0mm).
Safetv
All CellFX treatments were successfully completed with no acute procedural adverse events. Pathology results support the safety of the CellFX System as there was 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 higher energy levels for the 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.
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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.