(61 days)
Not Found
No
The description focuses on the physical components and the mechanism of action (bipolar RF coagulation) and does not mention any AI/ML terms or functionalities.
Yes
The device is used for the coagulation of blood vessels during surgery, which is a therapeutic intervention.
No
The device is described as a coagulation device used for treatment (coagulation of blood vessels), not for diagnosis. It delivers RF power to tissue.
No
The device description explicitly states it is a bipolar radiofrequency (RF) device consisting of a catheter, wire connections, hub, Y connector, and two ring electrodes, which are all hardware components. It also connects to an RF Generator.
Based on the provided information, the Habib™ VesCoag is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "coagulation of blood vessels during general surgery." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter that uses radiofrequency energy to coagulate tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Habib™ VesCoag is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
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)
Performance testing was undertaken to ensure that the Habib™ VesCoag functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness
| Sponsor: | EMcision, Ltd. |
|---|---|
| Contact Person: | Nagy Habib, MD |
| Chief Executive Officer | |
| Liver Surgery Section, Hammersmith Hospital | |
| Du Cane Road | |
| London, W12 0NN | |
| United Kingdom |
Page 1 of 2
OCT 2 2007
| Summary Prepared: | 2007-08-21 |
|---|---|
| Trade Name: | Habib TM VesCoag |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II per 21 CFR 878.4400 |
| Product Code: | GEI |
VNUS Closure™ System catheter manufactured by VNUS Medical Predicate Devices: Technologies Inc., San Jose, California, USA (K974521)
Intended Use:
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
Description:
The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.
1
Image /page/1/Picture/1 description: The image shows the text "Page 2 of 2". The word "Page" is written in cursive. The numbers are handwritten, and the last number 2 is circled.
Technological Differences:
The Habib™ VesCoag has the same basic technological characteristics as the VNUS Closure™ System. Both devices use bipolar RF energy through a number of electrodes to coagulate vessels from the inside.
Performance Data:
Performance testing was undertaken to ensure that the Habib™ VesCoag functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMcision, Ltd. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 E. Trimble Road San Jose, California 95131
OCT 2 2007
Re: K072126 Trade/Device Name: Habib" VesCoag Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 18, 2007 Received: September 20, 2007
Dear Mr. Christensen:
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. Morten Simon Christensen
forth in the quality systems (OS) 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
David Kramer
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 2 Indications for Use Statement
Indications For Use Statement
510(K) Number (if known)
Not yet Allocated
Device Name
Habib™ VesCoag
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
Prescription Use __ OR Over the Counter Use X
(per 21 CFR 801 109)
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Of (Division of General, Restorative, and Neurological Devices
510(k) Number K07215
Habib™ VesCoag 510(k) Revision 1 2007-08-21 Habib
EMcision, Ltd. Page 2-1