(60 days)
Not Found
No
The summary describes a standard RF ablation system with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is described as a "Coagulation System" and is "intended for the coagulation of cardiac tissue," which is a therapeutic intervention.
No
The device is described as a "Coagulation System" intended for the "coagulation of cardiac tissue," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it consists of a sterile, single-use, disposable coagulation electrode device and an Electrosurgical Generator, 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 "coagulation of cardiac tissue using Radiofrequency (RF) energy." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "coagulation electrode device" that transmits RF energy to tissue. This is consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly modify tissue through coagulation.
N/A
Intended Use / Indications for Use
The nContact Coagulation System 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 Coagulation System 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).
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)
The nContact Coagulation System has been compared to the listed predicate devices with respect to intended use, technological characteristics, and principle of operation. Performance testing was completed to validate its intended use. All of the features specified for the subject device are covered by those listed in at least one predicate device.
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
DEC - I 2006
nContact Surgical, Inc.
Coagulation System 510k Submission
Traditional Premarket Notification
| Page | 1 of 12 |
|---|---|
| ------ | --------- |
0 63012 510(k) Summary:
| Application Date: | September 29, 2006 |
|---|---|
| Sponsor: | nContact Surgical, Inc. |
| 2880 Slater Road, Suite 103, | |
| Morrisville, NC 27560 | |
| Correspondent: | Jane Ricupero |
| Director of Regulatory & Quality | |
| 2880 Slater Road, Suite 103, | |
| Morrisville, NC 27560 | |
| Contact Numbers: | Phone: 919 466-9810 x3013 |
| Fax: 919 466-9811 | |
| E-mail: jane@ncontact.us | |
| Device Proprietary Name: | nContact Coagulation System |
| Model number: CSK | |
| 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 | |
| Predicate Device(s): | Electrosurgical Cutting & Coagulation |
| Device | |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Descriptions: | 1. Medtronic, Inc., Cardioblate |
| Radiofrequency Ablation System | |
| (K013392) |
1
Page 2 of (2)
Device Description:
The nContact Coagulation System 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).
63012
Intended Use:
The nContact Coagulation System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy.
Non-clinical Performance:
The nContact Coagulation System has been compared to the listed predicate devices with respect to intended use, technological characteristics, and principle of operation. Performance testing was completed to validate its intended use. All of the features specified for the subject device are covered by those listed in at least one predicate device.
Substantial Equivalence:
The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
nContact Surgical, Inc. c/o Ms. Jane Ricupero 2880 Slater Road, Suite 103 Morrisville, NC 27560
Re: K063012
Trade/Device Name: nContact Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: September 29, 2006 Received: October 2, 2006
Dear Ms. Ricupero:
This letter corrects our substantially equivalent letter of December 1, 2006.
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
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 (16 3012
per (UNKNOWN): 10301α
.
Device Name: nContact Coagulation System
Indications for Use: The nContact Coagulation System is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | 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)
(Division Sign-Off)
Division of General, Restorat
and Neurological Devices
| Section 4 - Indications for Use Statement Page 4-1 of 4-1 | 510(k) Number | K063012 |
|---|---|---|
| ----------------------------------------------------------- | --------------- | --------- |