PEAK SUCTION COAGULATOR

K103775 · Peak Surgical, Inc. · GEI · May 27, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103775
• Device Name: PEAK SUCTION COAGULATOR
• Applicant: Peak Surgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PEAK Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils or adenoids.

Device Story

PEAK Suction Coagulator is a single-use electrode attachment for the PEAK PlasmaBlade TnA handpiece. Device features active suction lumen, bendable shaft, and finger grip. Operated by surgeon during general and ENT surgical procedures. Activated via coag button on handpiece. Functions as monopolar electrosurgical device; utilizes RF energy at distal end to coagulate tissue while simultaneously aspirating fluids. Provides surgeon with combined coagulation and suction capability in one instrument. Benefits include streamlined surgical workflow and effective hemostasis.

Clinical Evidence

No clinical data. Evidence consists of bench testing and histological studies comparing thermal effects of the subject device to the predicate device. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 11135-1, ISO 10993-1, and ISO 10993-7 standards.

Technological Characteristics

Monopolar electrosurgical device; RF-powered distal end. Features active suction lumen, bendable shaft, and handpiece attachment interface. Single-use; ethylene oxide sterilized (ISO 11135-1). Complies with IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (High Frequency Surgical Equipment). Biocompatibility per ISO 10993-1 and ISO 10993-7.

Indications for Use

Indicated for general and otolaryngology (ENT) surgical procedures requiring tissue coagulation and fluid aspiration. Contraindicated for tonsil and adenoid removal.

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

• Valleylab Suction Coagulator (K091223)
• PEAK PlasmaBlade TnA (K083415)

Submission Summary (Full Text)

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K103775 Pg 1 of 3

## 510(k) Summary: PEAK Suction Coagulator

MAY 2 7 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

## 1. Submitter Name and Address:

PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: [phone] Fax: [phone]

Contact: Lois Nakayama Sr. Manager, Regulatory Affairs

Date prepared: April 29, 2011

### 2. Device Name:

| Trade Name: | PEAK Suction Coagulator |
|----------------------|-------------------------------------------------------------------|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Regulation Number: | 21 CFR § 878.4400 |
| Product Code: | GEI |
| Regulatory Class: | Class II |

## 3. Predicate Devices:

Valleylab Suction Coagulator (K091223) PEAK PlasmaBlade® TnA (K083415)

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#### Device Description: 4.

The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.

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<103775

#### న్. Intended Use:

The PEAK Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils or adenoids.

#### 6. Technological Characteristics

The PEAK Suction Coagulator is similar to the predicate device, the Valleylab Suction Coagulator in output energy, delivery system and blade specifications. They are both monopolar electrosurgical devices coagulate tissue, utilizing RF powered distal ends.

## Non-clinical Performance Data: 7.

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Data demonstrated that the PEAK Suction Coagulator complies with the following standards:

- IEC 60601-1; Medical Electrical Equipment Part 1: General Requirements for . ● Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- . IEC 60601-1-2; Medical Electrical Equipment - Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, 2001, Amendment 1: 2004.
- . IEC 60601-2-2; Medical Electrical Equipment -- Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Fourth Edition, 2006)
- ISO 11135-1; Sterilization of Healthcare Products - Ethylene Oxide - Part1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (First Edition, 2007)
- . ISO 10993-1; Biological evaluation of medical devices - Part I: Guidance on selection of tests (2009)
- . ISO 10993-7; Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (2008)

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Histological studies comparing thermal effects of the device to the predicate device demonstrated that the PEAK Suction Coagulator is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

## 8. Sterilization

The PEAK Suction Coagulator is provided sterile. The device is not intended for reuse or resterilization.

## 9. Conclusion:

By virtue of design, materials function and intended use, the PEAK Suction Coagulator is substantially equivalent to the predicate device. In establishing substantial equivalence to the predicate device, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

PEAK Surgical, Inc. % Ms. Lois Nakayama Senior Manager, Regulatory Affairs 2464 Embarcadero Way Palo Alto, California 94303

MAY 27 2011

Re: K103775

Trade/Device Name: PEAK Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 29, 2011 Received: May 02, 2011

Dear Ms. Nakayama:

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. 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

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Page 2 - Ms. Lois Nakayama

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 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.

Sincerely yours,

Eric S. Keith

for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K103775

Device Name: PEAK Suction Coagulator

Indications for Use:

The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.

Signature

(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103775

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)