(23 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on RF energy delivery and mechanical features, not computational analysis.
Yes
The device is described as being "intended for the coagulation of cardiac tissue," which implies it is used for treatment or correction of a medical condition.
No
The device is described as a coagulation system intended for the treatment (coagulation) of cardiac tissue using RF energy, not for diagnosis.
No
The device description explicitly states it consists of a sterile, single-use, disposable coagulation electrode device, an Electrosurgical Generator, and an Instrument Cable, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of cardiac tissue using Radiofrequency (RF) energy." This describes a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is a "coagulation electrode device" that transmits RF energy to "coagulate cardiac tissue." This is a surgical tool used for treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the nContact Guided Coagulation System (VisiTrax™) is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The nContact Coagulation System (VisiTrax™) is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OCL
Device Description
The nContact Guided Coagulation System (VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
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 bench tests were executed to ensure that the nContact Guided Coagulation System (VisiTrax) performed as intended and met design specifications.
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
nContact Surgical, Inc. Coagulation System Device Modification
Special 510k Notification
KO71819
JUL 26 2007
Special 510(k) Summary:
| Special 510(k) Summary: | |
|---|---|
| Page 1 of 2 | |
| Application Date: | July 2, 2007 |
| Sponsor: | nContact Surgical, Inc. |
| new address: | |
| 1001 Aviation Parkway, Suite 400, | |
| Morrisville, NC 27560 | |
| formerly at: | |
| 2880 Slater Road, Suite 103, | |
| Morrisville, NC 27560 | |
| Establishment Registration | |
| Number: | 3006142617 |
| Correspondent: | Jane Ricupero |
| Director of Regulatory & Quality | |
| 1001 Aviation Parkway, Suite 400, | |
| Morrisville, NC 27560 | |
| Contact Numbers: | Phone: 919 466-9810 x3013 |
| Fax: 919 466-9811 | |
| E-mail: jane@ncontact.us | |
| Device Proprietary Name: | nContact Guided Coagulation System |
| or VisiTrax TM Guided Coagulation | |
| System | |
| Model numbers: CSK-212; CSK-515 | |
| Device Common Name: | Electrosurgical device and |
| accessories | |
| Device Classification: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Classification Name: | Electrosurgical cutting and |
| coagulation device and accessories | |
| Accessory Classification: Cannula | 21 CFR 878.4800 (Manual surgical |
| instrument for general use) | |
| Accessory Product Code: Cannula | GEA (Class I exempt) |
| Predicate Device | 1. nContact Surgical Inc., |
| nContact Coagulation System | |
| (CSK) Model numbers: CSK-100; | |
| CSK-200; CSK-500 | |
| Legally marketed unmodified | |
| device 510k number | K063012 cleared Dec. 1/06 |
Section 5 – Summary
Page 5-1 of 5-2
1
page 2 of (2)
Device Description:
The nContact Guided Coagulation System (VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate system.
Indications for Use:
The nContact Guided Coagulation System (VisiTrax) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy. The indications for use of this System are the same as the cleared predicate system.
Technological Characteristics:
The modified nContact Coagulation Device has minor material changes and minor design modifications with the main technological characteristics of transmitting RF energy from an electrosurgical generator connected by an instrument cable to a coagulation electrode remaining identical to the predicate device.
Performance Data:
Performance bench tests were executed to ensure that the nContact Guided Coagulation System (VisiTrax) performed as intended and met design specifications.
Substantial Equivalence Conclusion:
This special 510(k) proposes that the material and design modifications for the nContact Guided Coagulation System (VisiTrax) may be considered substantially equivalent to the legally marketed unmodified nContact Coagulation System (previously cleared under K063012 on Dec. 1, 2006) based on the results of design verification and validation. The indications for use, principle of operation, technology, performance specifications (as reverified through design controls), labeling and sterilization parameters are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
We believe that the nContact Guided Coagulation System (VisiTrax) is substantially equivalent to the unmodified predicate device.
Section 5 - Summary Page 5-2 of 5-2
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
nContact Surgical, Inc. c/o Ms. Jane Ricupero Director, Regulatory and Quality 1001 Aviation Parkway, Sutie 400 Morrisville, NC 27560
Re: K071819
Trade/Device Name: Contact Guided Coagulation System (VisiTrax™) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL Dated: July 2, 2007 Received: July 3, 2007
Dear Ms. Ricupero:
This letter corrects our substantially equivalent letter of July 26, 2007.
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 (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 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.
3
Page 2 - Ms. Jane Ricupero
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 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 continue 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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
elgmee
$\theta$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): __ K_OZI 81 9
Device Name: nContact Guided Coagulation System (VisiTrax™)
Indications for Use: The nContact Coagulation System (VisiTrax™) is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.
Mark M. Milken
(Division Sign.Off (Division of General, Restorative, and Neurological Devices
09/8/9 510(k) Number_
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Section 4 - Indications for Use Statement Page 4-1 of 4-1