The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.

Device Description

The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpiece.

AI/ML Overview

The provided text describes a 510(k) submission for the PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Device. It states that preclinical laboratory and performance tests were conducted to ensure the device met design specifications and functioned as intended. However, the document does not provide explicit acceptance criteria or a detailed study report with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) or their corresponding values.

Instead, it relies on a statement of "substantial equivalence" to predicate devices. This means the device's safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device (predicate device) that has already been cleared by the FDA.

Therefore, many of the requested details cannot be extracted directly from this document. Below is a summary of what can be inferred or explicitly stated, with clear indications where information is missing.

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functioned as intended (cutting and coagulation of soft tissue).	"Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications." The device is intended for "cutting and coagulation of soft tissue during surgical procedures."
Met design specifications.	"Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications."
Substantial equivalence to predicate devices (safety and effectiveness).	"Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." The FDA concurred with this assessment, stating, "We have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence was established by evaluating "the indications for use, materials incorporated, product specification and energy requirements of those systems." Actual quantitative performance metrics for comparison are not provided in this summary.

Additional Information

Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Preclinical laboratory and performance tests."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This type of test typically refers to a clinical study with expert interpretation of results, which is not detailed here. The tests mentioned are "preclinical laboratory and performance tests," which are likely engineering or bench tests rather than clinical studies requiring expert ground truth for interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies involving multiple expert readers, which is not described.
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. This document describes an electrosurgical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Preclinical laboratory and performance tests" would assess the standalone performance of the device against its design specifications. However, the exact methodology and metrics are not provided. The assessment is focused on the device's physical and electrical function rather than an algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "preclinical laboratory and performance tests" of an electrosurgical device, ground truth would likely refer to objective measurements against established engineering standards, material specifications, and functional requirements (e.g., power output, temperature, tissue cutting/coagulation characteristics observed in lab settings). It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.
The sample size for the training set:
- Not applicable/Not specified. This involves an electrosurgical device, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable/Not specified, as this device does not involve a machine learning training set.

Summary

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Ko73057
a. 1.6 2

JUL 2 2 2008

510(k) Summary for the PULSARTM Generator and PEAK PlasmaBlade™ Tissue Dissection Device

1. Submitter name and address:

PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3022 Fax: 650-331-3293

Contact: Grace Carlson, MD

Date Prepared: October 29, 2007

2. Device Name:

Trade Name:	PULSART™ Generator andPEAK PlasmaBlade™ Tissue Dissection Device
Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400)

3. Predicate Devices:

Medtrex OR Pro 300 Electrosurgical Generator (K981724) Ellman Surgitron 120 IEC (K013255) Valleylab E2515 Electrosurgical Accessory (K791639) Valleylab Coated Electrode (K962044) Utah Medical Ceramic Blade Electrode (K960255)

4. Device description:

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న. Intended Use:

The PULSAR Electrosurgical Generator with the PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.

6. Technological Characteristics

The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is similar to the predicate devices in that they are all electrosurgical instruments used to cut tissue and coagulate soft tissue, utilizing RF powered distal ends.

7. Performance Data

Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.

8. Sterilization

The PEAK PlasmaBlade Tissue Dissection Device is provided sterile. The device is not intended for reuse or resterilization.

9. Conclusions

By virtue of design, materials, function, and intended use, the PULSAR Generator and PEAK PlasmaBlade Tissue Dissection Device is substantially equivalent to FDA-cleared devices currently marketed in the United States. In establishing substantial equivalence to the predicate devices, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of those systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2008

PEAK Surgical, Inc. % Grace A. Carlson, MD 2464 Embarcadero Way Palo Alto, California 94303

Re: K073057

Trade/Device Name: PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2008 Received: June 23, 2008

Dear Dr. Carlson:

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 rectassified 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Grace A. Carlson, MD

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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16073057 P. 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: PULSARIM Generator and PEAK PlasmaBlade 10 Tissue Dissection Device

Indications for Use:

The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

PEAK Surgical, Inc.

October 29, 2007

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, PULSAR Generator and PEAK PlasmaBlade Premailed Nemendogical Devices

510(k) Number

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.