PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES

K082786 · Peak Surgical, Inc. · GEI · Dec 3, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082786
• Device Name: PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
• Applicant: Peak Surgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Device Story

PEAK Surgery System comprises PULSAR Generator, PEAK PlasmaBlade tissue dissection devices, and optional wireless foot pedal. System delivers monopolar and bipolar RF energy for soft tissue cutting and coagulation. Generator is microcontroller-based with isolated output. PlasmaBlade handpieces feature insulated blade electrode, rotating bendable shaft, and integrated controls. Used in OR by surgeons across various specialties (General, Plastic, ENT, Ortho, etc.). Surgeon operates via handpiece controls or optional footswitch. Device provides precise tissue dissection and hemostasis, potentially reducing thermal damage compared to traditional electrosurgery. Single-use, sterile handpieces ensure patient safety.

Clinical Evidence

Bench testing only. Preclinical laboratory and performance tests were conducted to verify device functionality and adherence to design specifications. No clinical data provided.

Technological Characteristics

Electrosurgical system utilizing RF energy. Components: PULSAR Generator (microcontroller-based, isolated output) and single-use sterile PlasmaBlade handpieces (insulated blade electrode, rotating shaft). Connectivity: Optional wireless foot pedal. Sterilization: Sterile (single-use).

Indications for Use

Indicated for cutting and coagulation of soft tissue in patients undergoing General, Plastic, Reconstructive, ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, and Neurological surgical procedures.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Contact: Grace Carlson, MD

Date Prepared: September 22, 2008

#### 2. Device Name:

| Trade Name: | PEAK Surgery System, consisting of:<br>PULSAR ^TM Generator and<br>PEAK PlasmaBlade ^TM Tissue Dissection Devices |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories (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:

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.

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K08278

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K082786

#### 5. Intended Use:

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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.

#### 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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