(21 days)
Not Found
No
The summary describes a radiofrequency coagulation system and its components, with no mention of AI or ML technologies. The modifications are limited to additional electrode lengths.
Yes.
The device is intended for the coagulation of cardiac tissue, which is a therapeutic intervention.
No
The device is described as a coagulation system that uses RF energy to treat cardiac tissue, not to diagnose conditions.
No
The device description clearly outlines hardware components including a disposable coagulation electrode device, an Electrosurgical Generator, and an Instrument Cable.
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 is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is a "coagulation electrode device" that transmits RF energy. This is a surgical instrument used for treatment.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to perform a surgical procedure on the body.
N/A
Intended Use / Indications for Use
The Numeris™ Guided Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The modified nContact Coagulation System (Numeris Guided Coaquiation System with VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 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 guided system, however two additional 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 Guided Coagulation 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.
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
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FEB 1 7 2009
And Children Children
Special 510(k) Summary:
| Application Date: | January 23, 2009 |
|---|---|
| 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): | Numeris™ Guided Coagulation |
| System with VisiTrax® | |
| Model numbers: CSK-121; CSK-122; | |
| CSK-123; CSK-125 | |
| 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 Guided Coagulation System | |
| (VisiTrax) | |
| (CSK) Model numbers: CSK-212; | |
| CSK-515 (K071819) |
- Numeris Tethered Coagulation
System with VisiTrax, Model
numbers: CSK-021, CSK-022, CSK-
023, CSK-025 (K082203) |
| Legally marketed unmodified
device 510k number | K071819 cleared July 26/07
K082203 cleared Dec. 30/08 |
ﺍ
Section 5 – Summary
Page 5-1 of 5-2
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・・・・
、
1
Device Description:
The modified nContact Coagulation System (Numeris Guided Coaquiation System with VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 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 guided system, however two additional RF coil electrode lengths have been added to the product offering (1cm and 3cm).
Indications for Use:
The Numeris Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques. The indications for use of this System are the same as the cleared predicate system for the coagulation of cardiac tissue.
Technological Characteristics:
The modified 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 Numeris Guided Coagulation 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 Guided Coagulation System with VisiTrax may be considered substantially equivalent to the legally marketed unmodified nContact Guided Coagulation System (cleared under K071819 on July 26, 2007) and the Numeris Tethered Coagulation System with VisiTrax (cleared under K082203 on Dec. 30, 2008) based on the results of design verification and validation. The indications for use, principle of operation, technology, performance specifications (as re-verified through design controls), labeling and sterilization parameters have no substantial changes or modifications that significantly affect the safety or efficacy of the devices. We believe that the Numeris Guided Coagulation System with VisiTrax is substantially equivalent to the unmodified predicate device. V
Section 5 - Summary Page 5-2 of 5-2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three stylized shapes. The symbol is black and the text is in a simple, sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2009
nContact Surgical, Inc. c/o Jane A. Ricupero Director of Regulatory and Quality 1001 Aviation Parkway, Suite 400 Morrisville, NC 27560
Re: K090202
Trade/Device Name: Numeris Guided Coagulation System with Visitrax Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: January 23, 2009 Received: January 27, 2009
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 accordiance with the provisions of the the fleet . 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
3
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 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 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 Surveillance 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,
) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
nContact Surgical, Inc. Coagulation System Device Modification Special 510k Notification - Gen 3 Guided
Indications for Use
510(k) Number (if known): K090202
Device Name: Numeris™ Guided Coagulation System with VisiTrax®
....
Indications for Use: The Numeris™ Guided Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
| 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Date | 2/17/09 |
| Division of Cardiovascular Devices |
Section 4 - Indications for Use Statement
Page 4-1 of 4-1
| 510(k) Number | K090202 |
|---|---|
| --------------- | --------- |