PK Spatula

K142289 · Gyrus Acmi, Inc. · GEI · Dec 31, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142289
• Device Name: PK Spatula
• Applicant: Gyrus Acmi, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

Device Story

Bipolar electrosurgical instrument; used for resection and coagulation of soft tissue and blood vessels. Input: electrical energy from Olympus ESG-400 Generator. Operation: physician-controlled via handle buttons or foot pedal; electrode tip orientation adjustable via nosecone. Output: thermal energy for cutting/coagulation. Used in laparoscopic and general surgical procedures; operated by physicians. Benefits: allows tissue management without removing eyes from surgical site; enables precise soft tissue resection/coagulation.

Clinical Evidence

Bench testing only. Performance testing included dimensional measurements, cutting/coagulation equivalency, mechanical force testing, design feature testing (rotation/button activation), shelf life, sterilization validation, and biocompatibility testing.

Technological Characteristics

Bipolar electrosurgical instrument. Materials: fluoropolymer sheath, electrode tip, insulation. Standards: ISO 10993-1/5/7/10, ANSI/AAMI/ISO 11607-1, ANSI/AAMI/ISO 11135-1, ISO 14971, ISO 15223-1, IEC 60601-1, IEC 60601-2-2. Energy: bipolar electrosurgical. Form factor: 5mm diameter shaft for cannula/laparoscope channel. Sterilization: ethylene oxide.

Indications for Use

Indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. Patient population includes those undergoing laparoscopic or general surgery.

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

• Gyrus PlasmaCision Laparoscopic Spatula (K041633)

Submission Summary (Full Text)

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

December 31, 2014

Gyrus ACMI, Incorporated Mr. Neil Kelly MBA, RAC Senior Regulatory Affairs Specialist 6655 Wedgwood Road Maple Grove, Minnesota 55311

Re: K142289

Trade/Device Name: PK Spatula Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2014 Received: December 5, 2014

Dear Mr. Kelly:

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) TBD K142289

Device Name PK Spatula

Indications for Use (Describe)

The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc.

# Olympus PK Spatula

# General Information

| Manufacturer: | Gyrus ACMI, Inc.<br>6655 Wedgwood Road<br>Maple Grove, MN 55311<br>Phone: [phone] |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 2183680 |
| 510(k) Submitter: | Gyrus ACMI, Inc.<br>136 Turnpike Rd.<br>Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Neil Kelly<br>Regulatory Affairs Specialist<br>508-804-2690<br>[e-mail] |
| Date Prepared: | August 15, 2014 |
| <b>Device Description</b> | |
| Classification Name:<br>Regulation Number<br>Product Code<br>Regulatory Class<br>Review Panel | Electrosurgical cutting and coagulation<br>device and accessories<br>21 CFR 878.4400<br>GEI<br>Class II<br>General and Plastic Surgery |
| Trade Name: | PK Spatula |
| Generic/Common Name: | Spatula Electrode |

#### Predicate Devices

Gyrus PlasmaCision Laparoscopic Spatula K041633

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# Comparison to Predicate Devices:

The PK Spatula has been compared to our own legally marketed Gyrus PlasmaCision Laparoscopic Spatula (K041633) with respect to intended use and technological characteristics. The comparison and testing results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.

# Product Description

The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is to be used only with the ESG-400 electrosurgical generator. The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.

# Technological Characteristics

The PK Spatula uses bipolar energy in order to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. The PK Spatula is activated using buttons located on the device handle. This allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. Historically foot pedals have been used for such devices and are also available for the proposed device. A nosecone located at the distal end of the handle and at the proximal end of the device shaft allows the physician to alter the orientation of the electrode tip without altering the orientation of the handle.

# Material

The predicate and proposed devices share many common materials. The two patient contact material differences are the sheath, which is now flouropolymer rather than Polyimide tubing, and a new ink was added on the device shaft as well. Biocompatibility testing has been carried out with passing results. As for the electrode tip and insulation all materials remain the same as the predicate.

# Intended Uses

The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

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# Compliance to Voluntary Standards

The design of the proposed device complies with the following standards:

ISO 10993-1, 2009 ISO 10993-5, 2009 ISO 10993-7 2008 ISO 10993-10, 2010 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007 ISO 15223-1; 2012 IEC 60601-1: 2005 IEC 60601-2-2: 2009

# Summary of Sterilization and Shelf Life Discussion

The Olympus PK Spatula is delivered in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf life of three(3) years.

#### Summary of Performance Testing

The following performance tests were conducted:

- Dimensional Measurements ●
- Cutting and Coagulation equivalency to predicate
- Expected forces on devices ●
- Design feature testing (rotation and button activation)
- Shelf Life
- Sterilization ●
- Biocompatibility ●

#### Substantial Equivalence

The proposed PK Spatula has the same intended use, design, and scientific technology as the Predicate PlasmaCision Laparoscopic Spatula (K041633). Both devices are of the same design, intended for the same patient population, have the identical indications for use, and use the same scientific technology. In addition there were no new issues of safety or effectiveness found with the proposed device.

#### Conclusion:

In summary, the PK Spatula is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.