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.

AI/ML Overview

The provided document is a 510(k) summary for the CellFX System. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the level of detail requested in the prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document focuses on demonstrating substantial equivalence to a predicate device (K203299 - CellFX® System) by confirming that the technological characteristics, mechanism of action, and indications for use are the same, and that performance testing validates these similarities.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a study was conducted and that "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."

However, the specific, quantitative acceptance criteria are not detailed in the document. Therefore, a table cannot be fully constructed as requested.

Acceptance Criteria	Reported Device Performance
Not specified in document (e.g., specific percentage of ablation, specific lesion size reduction, specific histological outcomes)	"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."
No adverse events	"All CellFX treatments were successfully completed with no adverse events."
Acceptable histological findings, no evidence of thermal damage at treatment sites	"Pathology results support the safety of the CellFX System with acceptable histological findings and no evidence of thermal damage at CellFX treatment sites."

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Two Yucatan pigs.
Data Provenance: Animal study (swine skin model), conducted to characterize treatment ablation areas. The country of origin is not specified but is implied to be part of the studies supporting a U.S. FDA submission. The study is prospective in nature as it involved applying the device and then observing the results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish the ground truth for the animal study. It mentions "Pathology results," which implies evaluation by pathologists, but no details are given.

4. Adjudication method for the test set

The document does not describe any adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not conducted or reported in this document.
This device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or interpretive device that typically involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to the CellFX System as described. It is a physical medical device (an electrosurgical system) and does not primarily involve an "algorithm only" performance separate from its direct application. The software component mentioned is for control and safety, not for standalone diagnostic or interpretive tasks. The "performance" assessment focuses on the device's physical effects on tissue.

7. The type of ground truth used

The ground truth for the animal study appears to be histological findings from pathology, as the document states, "Pathology results support the safety of the CellFX System with acceptable histological findings and no evidence of thermal damage at CellFX treatment sites."

8. The sample size for the training set

The document does not mention a "training set" in the context of an algorithm or AI. The performance data is based on an animal study and bench testing, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/algorithm is mentioned.

Summary

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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

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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 WayHayward, CA 94545Phone: (510) 906-4649
Contact Person:	Punam GollamudiDirector of US Regulatory AffairsPulse 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 andAccessories
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

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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
RegulationNumber	878.4400	878.4400
Product Code	GEI	GEI
Indications for Use
Indications for UseStatement	The CellFX System is intendedfor dermatological proceduresrequiring ablation and resurfacingof the skin.	The CellFX System is intended fordermatological proceduresrequiring ablation and resurfacingof the skin.
Technological Characteristics
Mechanism ofAction	Nano-Pulse Stimulation: ultrafastnanosecond electrical pulses tothe targeted tissue via treatmenttips with an array of microneedles	Nano-Pulse Stimulation: ultrafastnanosecond electrical pulses to thetargeted tissue via treatment tipswith an array of microneedles
Pulse Frequency	1 Hz -10 Hz	1 Hz -10 Hz
PulseAmplitude/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 DensityRange	1.5 x 1.5 mm - 110-190 mJ/mm³2.5 x 2.5 mm - 60-110 mJ/mm³5.0 x 5.0 mm - 45-85 mJ/mm³	1.5 x 1.5 mm - 110-190 mJ/mm³2.5 x 2.5 mm - 60-110 mJ/mm³5.0 x 5.0 mm - 45-85 mJ/mm³
Use of LocalAnesthesia	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
MicroneedleConfiguration
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

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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.

Regulation Number and Section

§ 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.