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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Ion Medical Bipolar Coagulation Pen. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the way a new, innovative device might. Therefore, many of the typical elements of a study proving a device meets acceptance criteria are not present.

Here's an analysis based on the information provided, highlighting what can be inferred and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary does not detail specific quantitative performance metrics or acceptance criteria for the device's function (e.g., coagulation time, temperature efficacy, tissue damage limits). Instead, it relies on demonstrating compliance with safety standards and substantial equivalence to existing devices.

Acceptance Criteria	Reported Device Performance
Not specified in this document. The submission focuses on substantial equivalence and compliance with general safety and biocompatibility standards rather than specific performance metrics for coagulation efficacy against defined criteria.	Not specified in this document. The document states compliance with general electrical safety and biocompatibility, but no quantitative performance data for coagulation is provided.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. As this is a 510(k) for substantial equivalence, the document describes what was tested (electrical safety, biocompatibility) but not the sample sizes for those tests, nor does it refer to a "test set" of clinical data in the typical sense for performance evaluation. The data provenance (country of origin, retrospective/prospective) for any clinical performance is therefore also not applicable/provided.

The testing mentioned relates to:

Device electrical safety: Compliance with ANSI/AAMI HF18 and IEC 60601-2-2.
Biocompatibility: Evaluation and testing in accordance with ISO 10993-1.

These are standard engineering and materials tests, not a clinical study on a patient population.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Given that no clinical "test set" for performance evaluation is described, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done and is not applicable to this 510(k) submission. This type of study is typically used for diagnostic or imaging devices where human interpretation is involved and AI assistance is being evaluated. The Ion Medical Bipolar Coagulation Pen is a surgical instrument.

6. Standalone (Algorithm Only) Performance Study

A standalone algorithm performance study was not done and is not applicable. This device is a physical electrosurgical handpiece, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the claims made in this submission is implicit in the compliance with recognized standards for electrical safety (ANSI/AAMI HF18, IEC 60601-2-2) and biocompatibility (ISO 10993-1). For the core function of coagulation, the ground truth is established by its substantial equivalence to already legally marketed predicate devices (Kirwan Bipolar Pencil Coagulator (K962678) and Mentor Wet-Field Hemostatic Eraser Bipolar Instrument (K911160)). This means the FDA assumes similar safety and effectiveness to the predicates based on similar technology and intended use.

There is no mention of pathology, outcomes data, or expert consensus being used to establish a "ground truth" for the device's performance in the typical sense of a clinical trial.

8. Sample Size for the Training Set

This information is not provided and is not applicable. This device does not involve machine learning or an "algorithm" that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable. As there is no training set mentioned, there is no discussion of how its ground truth would be established.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to legally marketed predicate devices and compliance with relevant safety and biocompatibility standards. It is not a clinical study designed to test specific performance criteria against a predefined acceptance threshold using a clinical dataset.

Summary

{0}------------------------------------------------

K07-2911 P3 1 of

510(k) Summary

Date Prepared:	December 3, 2007
Applicant:	Ion Medical, LLC6900 Philips Highway, Suite #41Jacksonville, FL 32216Phone: (904) 645-7303Fax: (904) 645-5994
Contact Person:	Keith Huron
Proprietary Name:	Ion Medical Bipolar Coagulation Pen
Common Name:	Electrosurgical handpiece
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400, Product Code GEI)

Device Description:

Intended Use:

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.

{1}------------------------------------------------

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 useinstrument intended to coagulate tissue usingradiofrequency electric current during general andophthalmic surgical procedures where wet field conditionsexist.

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)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized human figure with three heads, representing the department's focus on health, well-being, and human services. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

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

{3}------------------------------------------------

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

{4}------------------------------------------------