(21 days)
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 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).
The provided documents describe a Special 510(k) submission for the Numeris™ Guided Coagulation System with VisiTrax®, which introduces modifications to a previously cleared device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing to assure that the modifications do not significantly affect safety or efficacy.
Therefore, the study supporting this submission is a performance bench test study, rather than a clinical trial with acceptance criteria for a specific device performance metric in human subjects.
Here's a breakdown of the requested information based on the provided text, with explanations where information is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states: "Performance bench tests were executed to ensure that the Numeris Guided Coagulation System with VisiTrax performed as intended and met design specifications."
However, the specific acceptance criteria (e.g., maximum temperature, impedance range, coagulation depth) and the detailed reported device performance against these criteria are not provided in this summary. Instead, it makes a general statement that the device "met design specifications."
| Acceptance Criteria (Example - Not explicitly stated in document) | Reported Device Performance (Summary statement) |
|---|---|
| (Specific design specifications, e.g., RF energy delivery accuracy, temperature profile, coagulation zone dimensions, electrical safety parameters) | "Performed as intended and met design specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance bench tests," implying a series of tests performed on the modified devices. These tests would involve a certain number of units or test conditions, but the exact sample size is not detailed.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by the manufacturer, nContact Surgical, Inc., in the USA. The study is retrospective in the sense that it's performed on manufactured devices to verify design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not stated. Bench tests generally rely on established engineering standards and design specifications, not expert interpretation of results in the way clinical studies do. The "ground truth" is defined by the device's design specifications and performance standards.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be performed by qualified engineers or technicians.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench testing for substantial equivalence evaluates physical and electrical performance against predefined specifications, which does not typically involve adjudication by experts in the same way clinical image interpretation or diagnosis would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This submission is for a medical device which transmits RF energy, not an AI-assisted diagnostic tool. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the nature of this device.
- Effect size: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Was it done? Not applicable in the context of an AI algorithm. This device is an electrosurgical device; its performance is inherent to its physical and electrical characteristics, rather than an algorithm performing a task. The "standalone performance" is the device's ability to coagulate tissue as designed, which was assessed via bench testing.
7. Type of Ground Truth Used
- Type of Ground Truth: Design specifications and engineering standards. The "ground truth" for these performance bench tests would be the established acceptable ranges and values for various physical and electrical parameters as defined by the device's design and applicable medical device standards.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set." The device is built and tested against design specifications.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there is no training set for this type of device.
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FEB 1 7 2009
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Special 510(k) Summary:
| Application Date: | January 23, 2009 |
|---|---|
| Sponsor: | nContact Surgical, Inc.1001 Aviation Parkway, Suite 400,Morrisville, NC 27560 |
| Establishment RegistrationNumber: | 3006142617 |
| Correspondent: | Jane RicuperoDirector of Regulatory & Quality1001 Aviation Parkway, Suite 400,Morrisville, NC 27560 |
| Contact Numbers: | Phone: 919 655-1355Fax: 919 655-1690E-mail:jricupero@ncontactsurgical.com |
| Device Proprietary Name(s): | Numeris™ Guided CoagulationSystem with VisiTrax®Model numbers: CSK-121; CSK-122;CSK-123; CSK-125 |
| Device Common Name: | Electrosurgical device andaccessories |
| Device Classification: | 21 CFR 878.4400Class II |
| Product Code: | OCL |
| Classification Name: | Electrosurgical cutting andcoagulation device and accessories |
| Predicate Device | 1. nContact Surgical Inc.,nContact Guided Coagulation System(VisiTrax)(CSK) Model numbers: CSK-212;CSK-515 (K071819)2. Numeris Tethered CoagulationSystem with VisiTrax, Modelnumbers: CSK-021, CSK-022, CSK-023, CSK-025 (K082203) |
| Legally marketed unmodifieddevice 510k number | K071819 cleared July 26/07K082203 cleared Dec. 30/08 |
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Section 5 – Summary
Page 5-1 of 5-2
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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
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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
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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
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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 |
|---|---|
| --------------- | --------- |
§ 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.