The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Device Description

The PEAK Surgery System consists of the PULSAR Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. 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 Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices 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 handpieces.

AI/ML Overview

The provided text describes a 510(k) submission for the PEAK Surgery System, an electrosurgical device. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria in a quantitative manner as typically expected for imaging or AI-driven diagnostics.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is similar enough in intended use, technological characteristics, and performance to devices already approved for marketing.

Here’s a breakdown of what can be extracted or inferred based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance
Intended Use Equivalence: Device's intended use is substantially equivalent to predicate devices.	The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive, ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures. This is presented as substantially equivalent to predicate devices.
Technological Characteristics Equivalence: Device's technological characteristics are substantially equivalent to predicate devices.	The PEAK Surgery System functions as an electrosurgical instrument using RF energy for cutting and coagulation, similar to predicate devices. Microcontroller-based generator, single-use sterile handpieces with insulated blade electrode, rotating bendable shaft, handle controls, and cable.
Safety and Effectiveness: Demonstrate the device is safe and effective when used as intended, comparable to predicate devices.	"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."
Sterility: Devices provided sterile (where applicable).	The PEAK PlasmaBlade Tissue Dissection Devices are provided sterile and are not intended for reuse or resterilization.

Missing specific quantifiable acceptance criteria. For example, there are no reported thresholds for cutting efficiency, coagulation depth, tissue damage profiles, or specific electrical parameters and their tolerance levels that typically would be defined as acceptance criteria in a detailed engineering or performance report. The provided text only states that tests "met design specifications," without detailing those specifications.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "Preclinical laboratory and performance tests," but does not provide details on the number of tests conducted, the type of samples (e.g., in vitro tissue, animal models), or the quantity of each.
Data Provenance: Not explicitly stated. The tests are described as "Preclinical laboratory and performance tests," implying they were conducted in a lab setting, likely by the manufacturer, PEAK Surgical, Inc. Country of origin for data is not specified, but the company is based in Palo Alto, CA, USA. The study design is not specified as retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

Given that this is a 510(k) for an electrosurgical device (not AI, imaging, or diagnostics), the concept of "ground truth" established by human experts in the context of diagnostic accuracy is not directly applicable. The "ground truth" for electrosurgical devices typically relates to objective physical or physiological measurements (e.g., tissue temperature, cut depth, coagulation size, impedance readings) rather than expert interpretation of images or clinical outcomes in the same way.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable/not mentioned. This concept is usually relevant for studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: Not done, or at least not reported in this summary. MRMC studies are typically for evaluating diagnostic imaging devices or AI algorithms where human readers interpret cases. This device is a surgical tool.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic or interpretative device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This is a physical electrosurgical tool, not an algorithm. Its performance is inherent in its physical operation, not a separate algorithmic component.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated in the context of diagnostic accuracy. For this type of device, ground truth would likely refer to:
- Engineering Specifications: Device output parameters (e.g., power, voltage, current) meeting pre-defined ranges.
- Biophysical Effects: Objective measurements of tissue effects (e.g., measured cut depth, coagulation zone, thermal spread, histological analysis) demonstrating performance within acceptable limits or comparable to predicate devices.
- Functional Performance: Successful operation of mechanical and electrical components (e.g., blade articulation, control responsiveness).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a conventional electrosurgical device, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary for the PEAK Surgery System states that "Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications" and that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." However, it does not provide the specific details regarding the acceptance criteria, the scope of the tests, the sample sizes, or the qualitative/quantitative results of these tests, which are typically contained in more in-depth sections of a 510(k) submission not included here. This summary focuses on establishing substantial equivalence based on overall performance and functional similarity to already marketed devices rather than detailed performance metrics against explicit acceptance criteria.

Summary

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082786

DEC 0 3 2008

510(k) Summary for the PEAK Surgery System

1. Submitter name and address:

PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3020 Fax: 650-331-3293

Contact: Grace Carlson, MD

Date Prepared: September 22, 2008

2. Device Name:

Trade Name:	PEAK Surgery System, consisting of:PULSAR TM Generator andPEAK PlasmaBlade TM Tissue Dissection Devices
Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400)

3. Predicate Devices:

PULSAR Generator and PEAK PlasmaBlade Tissue Dissection Device (K073057) Ellman Surgi-Max Generator (K061174) ELECTROMEDICS FAS-CLEAN electrode (K073616)

4. Device description:

Page 1 of 2

K08278

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K082786

5. Intended Use:

Page 2 of 2

Technological Characteristics: 6.

The PEAK Surgery System 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 Devices are provided sterile. The device is not intended for reuse or resterilization.

9. Conclusions:

By virtue of design, materials, function, and intended use, the PEAK Surgery System 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government authority.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2008

Peak Surgical, Inc. % Grace A. Carlson, MD Consultant, Regulatory and Clinical Affairs 2464 Embarcadero Way Palo Alto, California 94303

Re: K082786

Trade/Device Name: PEAK Surgery System (PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Devices

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 22, 2008

Received: September 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 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. 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

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Page 2 - Grace A. Carlson, MD

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.

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 H. Milliman

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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Indications for Use

510(k) Number (if known): K082 786

Device Name: PEAK Surgery System (PULSARTIA Generator and PEAK PlasmaBlade The Tissue Dissection Devices

Indications for Use:

The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin-incisions and development of skin flaps), Daily Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Nithodyh for mxn

(Division Sign-Off) Division of General, Restorative,

PEAK Surgery, Inc. SIO(k) Notification for PEAK Surgery System Expanded MEHICALOgical Devices September 22, 2008

510(k) Number K082786

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.