(62 days)
Not Found
No
The document describes a standard electrosurgical device for coagulation and does not mention any AI or ML components or functionalities.
Yes
This device is intended to coagulate tissue during surgical procedures, which constitutes a therapeutic action. It is used to achieve hemostasis (stop bleeding) by coagulating tissue.
No
The device is an electrosurgical tool for tissue coagulation during general and ophthalmic surgical procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a handheld electrosurgical device comprised of an ABS plastic handle, a stainless steel coaxial probe tip, and a connector, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "coagulate tissue using radiofrequency electric current during general and ophthalmic surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a handheld electrosurgical device that delivers electrical current to tissue. This aligns with a surgical tool, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the Ion Medical Bipolar Coagulation Pen is a surgical instrument used for tissue coagulation during procedures, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
The Ion 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
K07-2911 P3 1 of
510(k) Summary
| Date Prepared: | December 3, 2007 |
|---|---|
| Applicant: | Ion Medical, LLC |
| 6900 Philips Highway, Suite #41 | |
| Jacksonville, FL 32216 | |
| Phone: (904) 645-7303 | |
| Fax: (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:
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.
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 use |
| instrument intended to coagulate tissue using | |
| radiofrequency electric current during general and | |
| ophthalmic surgical procedures where wet field conditions | |
| 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)
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
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