(107 days)
No reference devices were used in this submission.
No
The summary describes a system that delivers electrical pulses based on user-selected parameters, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which indicates a therapeutic purpose. It delivers electrical energy pulses to disrupt cells and achieve regulated cell death for tissue treatment.
No
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which describes a treatment rather than a diagnostic function.
No
The device description explicitly lists hardware components (CellFX Console, CellFX Handpiece, 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 a living patient's tissue (in vivo), not on samples of tissue, blood, or other bodily fluids outside the body (in vitro).
- Device Description: The device delivers electrical energy pulses directly to targeted tissue using microneedles. This is a direct treatment method, not a method for analyzing samples.
- Anatomical Site: The anatomical site is "Skin," which is a part of the living body.
- Performance Studies: The performance study described is an "Animal safety and performance study" involving treating living animals.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. The CellFX System is a therapeutic device used to treat tissue directly.
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 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.
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
Animal Study: An animal safety study was conducted 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). 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. 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.
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 logo of the U.S. Food & 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.
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
1
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 (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) 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.
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 24, 2021 |
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
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 | ||
| 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 - 110-190 mJ/mm³ | |
| 2.5 x 2.5 mm - 60-110 mJ/mm³ | ||
| 5.0 x 5.0 mm - 45-85 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 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
6
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.