(147 days)
No
The document describes a radiofrequency coagulation system and explicitly states that mentions of AI, DNN, or ML were "Not Found".
Yes
The device is intended for the coagulation of cardiac tissue to treat a medical condition (cardiac tissue issues) using radiofrequency energy, which is a therapeutic intervention.
No
The device is intended for the coagulation of cardiac tissue, which is a therapeutic function, not a diagnostic one. It uses RF energy to coagulate tissue, rather than to gather information 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 "coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device is a "coagulation electrode device" that transmits RF energy to tissue. This is a surgical tool used for treatment, not 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 samples, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device is clearly a surgical instrument used for a therapeutic purpose during surgery.
N/A
Intended Use / Indications for Use
The Numeris™ Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The modified nContact system, "Numeris Tethered Coagulation System with VisiTrax", consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, 3cm, & 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, however two addition RF coil electrode lengths have been added to the product offering (1cm and 3cm).
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 Numeris Tethered Coaqulation System with 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.
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
Kortzo3
nContact Surgical, Inc. Coagulation System Device Modification Special 510k Notification - Gen 3 tethered
DEC 3 0 2008
| Special 510(k) Summary: | |
|---|---|
| Application Date: | August 1, 2008 |
| Sponsor: | nContact Surgical, Inc. |
| 1001 Aviation Parkway, Suite 400, | |
| 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: 919 655-1355 |
| Fax: 919 655-1690 | |
| E-mail: | |
| jricupero@ncontactsurgical.com | |
| Device Proprietary Name(s): | NumerisTM Tethered Coagulation |
| System with VisiTrax® | |
| Model numbers: CSK-021; CSK-022; | |
| CSK-023; CSK-025 | |
| Device Common Name: | Electrosurgical device and |
| accessories | |
| Device Classification: | 21 CFR 878.4400 |
| Class II | |
| Product Code: | OCL |
| Classification Name: | Electrosurgical cutting and |
| coagulation device and accessories | |
| 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 |
K071819 cleared July 26/07 (will be
used for packaging comparison only) |
1
Device Description:
The modified nContact system, "Numeris Tethered Coagulation System with VisiTrax", consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, 3cm, & 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, however two addition RF coil electrode lengths have been added to the product offering (1cm and 3cm).
Indications for Use:
The Numeris Tethered Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during openchest cardiac surgery.
The indications for use of this System are the same as the cleared predicate system.
Technological Characteristics:
The Numeris Tethered Coagulation System with VisiTrax 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 Numeris Tethered Coaqulation System with VisiTrax performed as intended and met design specifications.
Substantial Equivalence Conclusion:
This special 510(k) proposes that the material and design modifications for the Numeris Tethered Coagulation System with 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.
Section 5 – Summary Page 5-2 of 5-3
2
We believe that the Numeris Tethered Coagulation System with VisiTrax is substantially equivalent to the unmodified predicate device.
Section 5 – Summary Page 5-3 of 5-3
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three parallel lines forming its body and a flowing ribbon-like tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2008
nContact Surgical, Inc. c/o Jane A. Ricupero Director of Regulatory and Quality 1001 Aviation Parkway, Suite 400 Morrisville, NC 27560
Re: K082203
Trade/Device Name: Numeris Coagulation System with Visitrax (Gen 3 with Tether) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: December 4, 2008 Received: December 5, 2008
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 includications for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbandi, noand 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, TDA move 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 not the Act
4
Page 2 - Ms. Jane A. Ricupero
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 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 markcted 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) 276-0120. 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 Biometrics' (OSB's) Division of Postmarket Survcillance 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.
M. L. Villeneuve
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
nContact Surgical, Inc. Coagulation System Device Modification Special 510k Notification - Gen 3 tethered
Indications for Use
510(k) Number (if known): K082203
Device Name: Numeris™ Tethered Coagulation System with VisiTrax®
Indications for Use: The Numeris™ Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.
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)
M. S. Kelleher
Section 4 - Indications for Use Statement Page 4-1 of 4-1
ﻤﺠﺮ .
510(k) Number K082203