MICROSURGICAL BIPOLAR HANDPIECE

K024304 · Neomedix Corp. · GEI · Feb 25, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024304
• Device Name: MICROSURGICAL BIPOLAR HANDPIECE
• Applicant: Neomedix Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.

Device Story

Sterile, single-use electrosurgical handpiece; features bipolar probe with integrated irrigation and aspiration channels. Operates by delivering low-power radio frequency (RF) current to soft tissue via probe tip; includes protective foot to shield underlying tissue. Connects to standard bipolar electrosurgical generators via luer fittings and bipolar cables. Used by surgeons in general and ophthalmic procedures; facilitates tissue cutting and coagulation in wet field environments. Irrigation/aspiration channels manage fluid at surgical site. Device provides mechanical and electrical interface; clinical decision-making remains with surgeon based on visual feedback during procedure.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Electrical safety verified per IEC 60601-1 (leakage current) and ANSI/AAMI HF-18 (dielectric voltage). Physical testing conducted for connector integrity, tip bend resistance, and fluidic flow capability. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical probe; ABS plastic body with stainless steel probe tip. Polyimide insulation. Coaxial electrode design with protective foot. Integrated irrigation/aspiration channels with luer fittings. Compatible with standard bipolar electrosurgical generators. Sterile, single-use. Biocompatibility per ISO 10993-1; electrical safety per IEC 60601-1 and ANSI/AAMI HF-18.

Indications for Use

Indicated for soft tissue cutting and coagulation in general and ophthalmic surgery where low impedance or wet field conditions exist. No specific age or gender restrictions; no known contraindications.

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

• Medtronic Bipolar probes (K010487)
• Kirwan Bipolar probes (K962678)
• Xomed Bipolar probes (K993655)
• Oratec Bipolar probes (K991218)
• Mentor Bipolar probes (K971538)
• Storz Bipolar Cautery Probe (K952151)
• Ethicon Bipolar Device (K003587)
• Wolf Multifunction Instrument (K002000)

Submission Summary (Full Text)

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K024304

FEB 2 5 2003

# SECTION 2 - 510 (k) SUMMARY

# SUMMARY OF SAFETY AND EFFECTIVENESS

Date Prepared: November 25, 2002

Manufacturer and Submitter

NeoMedix Corporation 27452 Calle Arroyo San Juan Capistrano, California 92675 Phone: [phone] Fax: [phone]

#### Contact Person

Dr. Soheila Mirhashemi

### Common, Classification and Proprietary Names

- Electrosurgical electrode Common Name:
- Classification names: Electrosurgical cutting and coagulation device and accessories (21 CFR section 878.4400) and Radio frequency cautery device (21 CFR section 886.4100)
- Microsurgical Bipolar Handpiece Proprietary Name:

#### Predicate Devices

The NeoMedix MicroSurgical Bipolar Handpiece is similar in indications, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument (K002000).

#### Indications for Use

The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.

#### Device Description

The Handpiece is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical grade tubing with standard luer fittings. The Handpiece is ABS plastic and incorporates a stainless steel probe designed to operate in the bipolar mode when connected to any compatible bipolar electrosurgical generator capable of low energy output control. The irrigation and aspiration sets provide for connection of the handpiece to irrigation and aspiration devices.

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## Technological Characteristics Comparison

The probe is similar in design to currently marketed bipolar probes (Mentor, Kirwan, Storz) in that the application of radio frequency current is bipolar in nature and occurs at the probe tip. The basic coaxial electrode design has been modified to include a protective foot to shield underlying tissue from current flow. This modification does not affect the safety or effectiveness of the device. A polyimide electrode insulation material provides the electrical isolation between the active and return bipolar electrodes. The irrigation and aspiration capabilities are similar to those in the Richard Wolf Multifunction Instrument. The bipolar electrical connector pins are compatible with standard bipolar cables that connect to an electrosurgical radio frequency generator, such as those used for the Storz, Mentor, Kirwan probes. The construction materials used have an established history of safe use in similar medical devices.

### Performance and Safety

The biological safety of the device has been demonstrated through biocompatibility studies of all patient contact materials in accordance with the standards outlined in ISO 10993-1. Electrical safety has been demonstrated by compliance to applicable requirements defined in IEC 60601-1 for leakage current and ANSI/AAMI HF-18 for handpiece dielectric voltage. Physical testing was performed to assure connector integrity, tip bend resistance and fluidic flow capability. The device is supplied sterile and sterility will conform to a Sterility Assurance Level (SAL) of 10 °. The supplied Instructions for Use provide the user with the applicable warnings and cautions during use. There are no known contraindications. There are no new safety or effectiveness issues related to this device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head and torso.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2003

Underwriters Laboratories, Inc. Robert M. Boonstra Senior Staff Engineer 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K024304

Trade/Device Name: MicroSurgical Bipolar Handpiece Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: Class II Product Code: GEI; HQR Dated: February 7, 2003 Received: February 11, 2003

Dear Mr. Boonstra:

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

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Page 2 – Mr. Robert M. Boonstra

(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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark N Milkerson

Celia M. Witten, Ph.D., M.D. 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 STATEMENT

510(k) Number (if known):

K024304

Device Name:

MicroSurgical Bipolar Handpiece

The NeoMedix MicroSurgical Bipolar Handpiece is to be used Indications for use: in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | <div style="display:inline-block;">✓</div> |
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| OR Over-the-counter: | |

for
Mark N Melleman

(Division Sign-Off)
Division of General. Restorative

| 510(k) Number | K024304 |
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