(94 days)
Not Found
No
The summary describes a radiofrequency coagulation system with a disposable electrode and electrosurgical generator. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the physical components and energy delivery for tissue coagulation.
Yes
The device is intended for "coagulation of soft tissue," which is a medical procedure aimed at treating or affecting a biological function.
No
The device is intended for the coagulation of soft tissue using radiofrequency energy, which is a therapeutic function, not a diagnostic one.
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 "coagulation of soft 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 patient to diagnose a condition.
- Device Description: The description details a system for delivering RF energy to tissue, including an electrode device and an electrosurgical generator. This aligns with a surgical or therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. 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 soft tissue using radiofrequency (RF) energy.
Product codes
GEI
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 soft 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
soft 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)
K031247, K992972, K971532, K981981
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
11062539 510(k) Summary:
| Application Date: | August 25, 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 | |
| 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 Bipolar |
| Radiofrequency Ablation System | |
| (K031247) |
- Arthrocare, Corporation
Electrosurgery System (K992972) - Arthrocare, Corporation
Electrosurgery System (K971532) - Boston Scientific, Electrosurgical
System (K981981) |
1
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 soft 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).
Intended Use:
The nContact Coagulation System is intended for the coagulation of soft 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
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, facing left. The eagle is composed of three thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2006
nContact Surgical, Inc. % Ms. Jane Ricupero Director, Regulatory and Ouality 2880 Slater Road, Suite 103 Morrisville, North Carolina 27560
Re: K062539
Trade/Device Name: nContact Coaguation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 22, 2006 Received: November 24, 2006
Dear Ms. Ricupero:
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, 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 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 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.
3
Page 2 - Ms. Jane Ricupero
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,
Mark N. Mellon
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): _1062539
Device Name: nContact Coagulation System
Indications for Use: The nContact Coagulation System is intended for the coagulation of soft 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, Restorative, |
| and Neurological Devices |
| Section 4 - Indications for Use Statement
| Page 4-1 of 4-1 |
|---|
| -------------------------------------------------------------- |
| 510(k) Number | L0625235 |
|---|---|
| --------------- | ---------- |