ION MEDICAL BIPOLAR COAGULATION PEN

K072911 · Ion Medical, LLC · GEI · Dec 13, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072911
• Device Name: ION MEDICAL BIPOLAR COAGULATION PEN
• Applicant: Ion Medical, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ion Medical Bipolar Coagulation Pen is a single use instrument intended to coagulate tissue using radiofrequency electric current during general and ophthalmic surgical procedures where wet field conditions exist.

Device Story

Handheld electrosurgical device; delivers low-power radiofrequency (RF) current to target tissue for coagulation. Comprised of ABS plastic handle and stainless steel coaxial probe tip; connects to compatible bipolar RF generators via 2-pin connector. Used by surgeons in clinical settings (general/ophthalmic surgery) to control bleeding in wet field conditions. Single-use instrument. Benefits patient by providing localized hemostasis during surgical procedures.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through bench testing, including electrical safety (ANSI/AAMI HF18, IEC 60601-2-2) and biocompatibility (ISO 10993-1).

Technological Characteristics

ABS plastic handle; stainless steel coaxial probe tip. Bipolar RF energy source. Single-use. Sterile. Complies with ANSI/AAMI HF18 and IEC 60601-2-2 for electrical safety and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for patients undergoing general or ophthalmic surgical procedures requiring tissue coagulation in wet field conditions.

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

• Kirwan Bipolar Pencil Coagulator (K962678)
• Mentor Wet-Field Hemostatic Eraser Bipolar Instrument (K911160)

Submission Summary (Full Text)

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K07-2911 P3 1 of

## 510(k) Summary

| Date Prepared: | December 3, 2007 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Ion Medical, LLC<br>6900 Philips Highway, Suite #41<br>Jacksonville, FL 32216<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Keith Huron |
| Proprietary Name: | Ion Medical Bipolar Coagulation Pen |
| Common Name: | Electrosurgical handpiece |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR 878.4400, Product Code GEI) |

#### Device Description:

The lon Medical Bipolar Coagulation Pen is a handheld electrosurgical device which conducts low power radiofrequency current to target tissue for the purpose of coagulation. The device is comprised of an ABS plastic handle with a stainless steel coaxial probe tip and a 2-pin style connector at the proximal end for connection with compatible bipolar radiofrequency coagulation generators and cables.

#### Intended Use:

The Ion Medical Bipolar Coagulation Pen is a single use instrument intended to coagulate tissue using radiofrequency electric current during general and ophthalmic surgical procedures where wet field conditions exist.

#### Substantial Equivalence:

The Ion Medical Bipolar Coagulation Pen is substantially equivalent in technology and intended use to the currently marketed Kirwan Bipolar Pencil Coagulator (K962678) and Mentor Wet-Field Hemostatic Eraser Bipolar Instrument (K911160) in that the device conducts low power radiofrequency current, supplied by a bipolar coagulation electrosurgical generator, to a coaxial probe tip to perform tissue coagulation to control bleeding.

#### Safety and Effectiveness:

Device electrical safety has been demonstrated through compliance with applicable requirements of ANSI/AAMI HF18 and IEC 60601-2-2 for dielectric integrity. Biocompatibility of all patient contact materials is demonstrated through evaluation and testing in accordance with the requirements of ISO 10993-1. The device is supplied sterile and will comply with a sterility assurance level of 10 . No new issues of safety or effectiveness are a result of this device.

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K07-291i 10

# Indications for Use

| 510(k) Number (if known): | K072911 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Bipolar Coagulation Pen |
| Indications for Use: | The Ion Medical Bipolar Coagulation Pen is a single use<br>instrument intended to coagulate tissue using<br>radiofrequency electric current during general and<br>ophthalmic surgical procedures where wet field conditions<br>exist. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2007

ION Medical, LLC % Mr. Keith Huron President 6900 Phillips Highway Suite #41 Jacksonville, Florida 32216

Re: K072911

Trade/Device Name: Bipolar Coagulation Pen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessores Regulatory Class: II Product Code: GEI Dated: October 2, 2007 Received: October 12, 2007

Dear Mr. Huron:

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. Iisting 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 - Mr. Keith Huron

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 Pretmarket, 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 M. Mulhausen

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): K072911

Device Name:

Bipolar Coagulation Pen

Indications for Use:

The Ion Medical Bipolar Coagulation Pen is a single use instrument intended to coagulate tissue using radiofrequency electric current during general and ophthalmic surgical procedures where wet field conditions exist.

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)

Division of General, Restorative, and Neurological Devices 510(k) Number