(109 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on energy-based ablation technology without mentioning AI/ML components.
Yes
The device is intended for "ablation of soft tissue," which is a procedure performed to treat or modify biological tissue. The description states it "ultimately leading to regulated cell death (e.g., apoptosis)," indicating a direct biological effect aimed at addressing a medical condition.
No
The device is intended for the ablation (destruction) of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the system includes hardware components such as a console, electrode, adapter, and footswitch, in addition to software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "ablation of soft tissue in percutaneous and intraoperative surgical procedures." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an energy-based system that delivers electrical pulses to tissue via electrodes. This is a physical intervention on the tissue, not a method for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (inside the body) for a therapeutic purpose (ablation).
N/A
Intended Use / Indications for Use
The CellFX Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures.
The CellFX Percutaneous Electrode System (Percutaneous Electrode) is not intended for use in cardiac procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The CellFX® Percutaneous Electrode System includes the CellFX Console, CellFX Percutaneous Electrode and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of highamplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
percutaneous and intraoperative surgical procedures.
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." All biocompatibility tests met their respective acceptance criteria. The biocompatibility test results successfully demonstrate biocompatibility of the CellFX Percutaneous Electrode.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
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 bench testing was conducted to ensure that the CellFX Percutaneous Electrode System performs as intended per its specifications.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and enhanced documentation was provided as recommended by FDA's Guidance, "Content of Premarket Submissions for Device Software Functions." issued on June 14, 2023. The intended use of this device is for general surgical procedures and in accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued on March 9, 2020, an enhanced documentation level of software testing was included in this 510(k) that supports the safety and effectiveness of the device. Cybersecurity controls have been implemented to mitigate the risk of malware being introduced into the CellFX Percutaneous Electrode System as recommended by FDA's Guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on September 27, 2023.
Pre-Clinical Animal Safety and Performance Studies:
Two in vivo animal studies were conducted to support the safety and performance of the CellFX Percutaneous Electrode System. Based on the in vivo animal safety studies, the data provided in this submission demonstrates and supports that the CellFX Percutaneous Electrode System is safe and effective for ablation of soft tissue and is substantially equivalent to the predicate device.
Human Safety Study:
A prospective single-arm clinical study of ten (10) subjects was completed to demonstrate safety and effectiveness of the CellFX Percutaneous Electrode System. Two to four ablation zones were completed in benign thyroid nodules under ultrasound guidance and subjects were followed at 30 and 90 days post-treatment. Subjects showed an average of 95% reduction in ablation zones by 30 days. No serious adverse events were observed. Overall, the findings of this study provided strong evidence of the safety and effectiveness of the system in a surgical application in soft tissue.
Summary:
The performance testing in pre-clinical and clinical safety studies was conducted to ensure that the CellFX Percutaneous Electrode System performs as intended per its specifications. CellFX Percutaneous Electrode System treatments are deemed nonthermal and did not result in any safety concerns during its intended use. Therefore, the performance testing verified that the device performs as intended and that the tested energy settings and treatment profile in soft tissue does not raise any different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Human Safety Study: average of 95% reduction in ablation zones by 30 days. No serious adverse events were observed.
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.
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
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March 8. 2024
Pulse Biosciences, Inc. Uyen Mai Director, Regulatory Affairs, Quality Assurance, and Quality Control 3957 Point Eden Way Hayward. California 94545
Re: K233705
Trade/Device Name: CellFX Percutaneous Electrode System (SYS3000) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 2, 2024 Received: February 5, 2024
Dear Uyen Mai:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.03.08 12:47:48 -05'00'
Mark Trumbore, 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
2
Indications for Use
510(k) Number (if known) K233705
Device Name
CellFX Percutaneous Electrode System (SYS3000)
Indications for Use (Describe)
The CellFX Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures.
The CellFX Percutaneous Electrode System (Percutaneous Electrode) is not intended for use in cardiac procedures.
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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3
510(k) Summary
I. Submitter
| Applicant: | Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward, CA 94545
Phone: (833) 257-3393 |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Uyen Mai, MS
Director, Regulatory Affairs, QA and QC
Pulse Biosciences, Inc.
Phone: (510) 906-4691 |
| Date Prepared: | November 16, 2023 |
DEVICE INFORMATION II.
CellFX® Percutaneous Electrode System Trade Name:
| 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
K190052 - Surgnova Healthcare Technologies (Zhejiang) Co., Ltd, Radio Frequency Ablation System
Reference Devices K052796 - Valleylab Cool-tip RF Ablation System and K203299 – CellFX System
IV. DEVICE DESCRIPTION
The CellFX® Percutaneous Electrode System includes the CellFX Console, CellFX Percutaneous Electrode and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of highamplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.
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V. INDICATIONS FOR USE STATEMENT
The CellFX® Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures. It is not intended for use in cardiac procedures.
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; therefore, even though the CellFX Percutaneous Electrode System has different technological characteristics than the predicate device, based on the data provided, the CellFX Percutaneous Electrode System does not raise any new or different questions of safety and effectiveness.
| | Subject Device | Predicate
Device
(K190052) | Ref Device
(K052796) | Ref Device
(K203299) | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------|
| Trade Name | CellFX® Percutaneous
Electrode System | Dolphi RF
R150E
Ablation
System | Valleylab Cool-
tip RF Ablation
System | CellFX
System | |
| Prescription Only | Yes | Yes | Yes | Yes | |
| Regulation | 878.4400 | 878.4400 | 878.4400 | 878.4400 | |
| Product Code | GEI | GEI | GEI | GEI | |
| | | Indications for Use | | | |
| Indications for
Use Statement | Intended for ablation of
soft tissue in
percutaneous and
intraoperative surgical
procedures. It is not
intended for use in
cardiac procedures. | Intended for
coagulation and
ablation of soft
tissue. It is not
intended for
use in cardiac
procedures. | Intended for the
use in
percutaneous,
laparoscopic, and
intraoperative
coagulation and
ablation of tissue. | Intended for
ablation and
resurfacing
of the skin. | |
| | | Technological Characteristics | | | |
| Components | RF Generator, Active
Electrode, Adapter,
Footswitch | Radio
Frequency
Generator,
Radio
Frequency
Electrode Kits,
Temperature
Probe, and Foot
Switch | RF Generator,
peristaltic pump,
electrodes,
inflow/outflow
tubing, and return
pads | RF
Generator,
Handpiece,
Treatment
tips | |
| Mechanism of
Action | Nanosecond Pulse
Field Ablation
(nsPFA): ultrafast
nanosecond electrical | Radiofrequenc
y current for
ablation of soft
target tissue | Radiofrequency
current for
ablation of soft
target tissue | Same as
Subject
Device | |
| | Subject Device | Predicate
Device
(K190052) | Ref Device
(K052796) | Ref Device
(K203299) | K233705 |
| | pulses to the targeted
tissue | | | | |
| Output Frequency | 1-10 Pulses per second | 470kHz | 480kHz±10% | Same as
Subject
Device | |
| Pulse
Amplitude/Voltage | 800V to 15kV | Up to 200 watts
@50 ohm | Up to 200 watts
@50 ohm | Same as
Subject
Device | |
| Pulse Width | 100 ns – 500 ns | N/A | N/A | Same as
Subject
Device | |
| Power Input | 100-240 VAC, 50/60 Hz,
2A | 100-240 VAC,
50/60 Hz | 100-240 VAC,
50/60 Hz | Same as
Subject
Device | |
| Max Power
Output | 15 Watts
(when pulsing at 15kV pulse voltage with
500 ns pulse width and 10 Hz pulse
frequency into a 75 Ohm load) | Up to 200
Watts@50
ohms | 0-200 watts max
output @ 50 ohm
load | Same as
Subject
Device | |
| | | Active Electrodes | | | |
| Energy Output | Bipolar RF | Monopolar RF | Monopolar RF | Same as
Subject
Device | |
| Electrode Length
(mm) | 95 | 70, 150, 200,
250 | 100, 144, 150,
200, 250 | Same as
Subject
Device | |
| Exposure Length
(mm) | 14 | 5, 7, 10, 15, 20,
30, 40 | 7, 10, 20, 30 | Same as
Subject
Device | |
| Outer Diameter
(mm) | 2.4 | 1.2, 1.47 | 1.2 | Same as
Subject
Device | |
| Tip Type | Trocar | Trocar | Trocar | Microneedle
Array | |
| Material | Stainless Steel 304 | Stainless Steel
304 | Stainless Steel
304 | Same as
Subject
Device | |
| Disposable/Singe -
Use Device | Single-Use | Single-Use | Single-Use | Same as
Subject
Device | |
| | Subject Device | Predicate
Device
(K190052) | Ref Device
(K052796) | Ref Device
(K203299) | |
| Biocompatibility | Patient-contacting
materials are
biocompatible | Patient-
contacting
materials are
biocompatible | Patient-
contacting
materials are
biocompatible | Same as
Subject
Device | |
| Sterility | EO Sterilization | EO
Sterilization | EO sterilization | Same as
Subject
Device | |
| System Physical Characteristics | | | | | |
| Voltage Supply | 100-240 VAC, 50/60
Hz, 2A | 100-240 VAC, 50/60 Hz, 2A | 100-240 VAC, 50/60 Hz, 2A | Same as
Subject
Device | |
5
6
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, for each of the following tests:
- · Pyrogenicity, Material Mediated
- · Systemic Toxicity
- · Sensitization
- Irritation
- · Cytotoxicity
- · Hemolysis
The biocompatibility test results successfully demonstrate biocompatibility of the CellFX Percutaneous Electrode.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
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 bench testing was conducted to ensure that the CellFX Percutaneous Electrode System performs as intended per its specifications.
Software Verification and Validation Testing
7
Software verification and validation testing were conducted and enhanced documentation was provided as recommended by FDA's Guidance, "Content of Premarket Submissions for Device Software Functions." issued on June 14, 2023. The intended use of this device is for general surgical procedures and in accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued on March 9, 2020, an enhanced documentation level of software testing was included in this 510(k) that supports the safety and effectiveness of the device.
Cybersecurity controls have been implemented to mitigate the risk of malware being introduced into the CellFX Percutaneous Electrode System as recommended by FDA's Guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on September 27, 2023
Pre-Clinical Animal Safety and Performance Studies
In accordance with FDA's Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," two in vivo animal studies were conducted to support the safety and performance of the CellFX Percutaneous Electrode System. Based on the in vivo animal safety studies, the data provided in this submission demonstrates and supports that the CellFX Percutaneous Electrode System is safe and effective for ablation of soft tissue and is substantially equivalent to the predicate device.
Human Safety Study
A prospective single-arm clinical study of ten (10) subjects was completed to demonstrate safety and effectiveness of the CellFX Percutaneous Electrode System. Two to four ablation zones were completed in benign thyroid nodules under ultrasound guidance and subjects were followed at 30 and 90 days post-treatment. Subjects showed an average of 95% reduction in ablation zones by 30 days. No serious adverse events were observed. Overall, the findings of this study provided strong evidence of the safety and effectiveness of the system in a surgical application in soft tissue.
Summary
The performance testing in pre-clinical and clinical safety studies was conducted to ensure that the CellFX Percutaneous Electrode System performs as intended per its specifications. CellFX Percutaneous Electrode System treatments are deemed nonthermal and did not result in any safety concerns during its intended use. Therefore, the performance testing verified that the device performs as intended and that the tested energy settings and treatment profile in soft tissue does not raise any different questions of safety or effectiveness.
VIII. CONCLUSION
The CellFX® Percutaneous Electrode System has the same indication for use, technological characteristics and principles of operation as the predicate device. The non-clinical performance testing, in vivo animal data, and clinical performance study data provided in this submission demonstrate and support that the CellFX Percutaneous Electrode System performs as intended and is as safe and as effective as the predicate device. Therefore, the CellFX Percutaneous Electrode System is substantially equivalent to the predicate device.