(237 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The performance studies focus on traditional device testing like biocompatibility, sterilization, and electrical integrity.
Yes.
The device is intended for the coagulation of cardiac tissue, which is a therapeutic intervention.
No
The primary intended use of the device is for the coagulation of cardiac tissue, which is a therapeutic function. While it may be used for temporary cardiac signal sensing and recording, this is described as an optional feature and is for sensing/recording signals, not for diagnosing a condition based on those signals itself.
No
The device description explicitly details hardware components including a sterile, single-use, disposable coagulation electrode device, an Electrosurgical Generator, and instrument cables. Performance studies also include testing of physical properties and electrical integrity.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of cardiac tissue" and "temporary cardiac signal sensing and recording during surgery." These are surgical procedures performed directly on the patient's body.
- Device Description: The device is a "coagulation electrode device" that transmits RF energy to tissue. It also has a "temporary sensing electrode feature" for recording cardiac signals. These functions are all related to direct intervention and monitoring within the body.
- Lack of In Vitro Activity: An IVD is designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.
The device is a surgical tool used for therapeutic (coagulation) and monitoring (sensing) purposes in vivo (within the living body).
N/A
Intended Use / Indications for Use
The EPi-SenseTM Guided Coaqulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
The EPi-Sense™ Guided Coagulation System with VisiTrax® may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.
Product codes
OCL
Device Description
The EPi-Sense Guided Coagulation System with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm 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). An optional temporary sensing electrode feature may be used with . an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-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)
Performance bench tests were executed to ensure that the EPi-Sense Guided Coagulation System with VisiTrax (Generation 4 product) performed as intended and met design specifications.
The subject device incorporates design features and specifications equivalent to those specified by the predicate devices. In vitro and in vivo testing was conducted to verify that no safety or effectiveness issues arise when using the subject device to coagulate cardiac tissue or during use for the temporary cardiac signal sensing and recording function.
The following tests were successfully completed to evaluate equivalence.
-
- Biocompatibility testing per ISO 10993 for device and accessory materials.
-
- Sterilization validation per ISO 11137-2, Sterilization of Health Care Products - Radiation - Method VD Max.
-
- Reliability testing such as shipping and accelerated aging of packaged units.
-
- Tensile testing of critical bonds and joints.
-
- Flexion fatique testing.
-
- Electrical integrity testing for the subject device and accessories to pertinent sections of IEC 60601-1-2.
-
- In-vivo pre-clinical testing to demonstrate equivalent performance for coagulating cardiac tissue and temporary cardiac signal sensing.
-
- In-vitro bench testing to demonstrate tissue coagulation feature equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Numeris Guided Coagulation System with VisiTrax, Model numbers: CSK-121, CSK-122, CSK-123, CSK-125, K090202
Reference Device(s)
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
· ·
.
:
nContact Surgical, Inc.
Coagulation System Device Modification
K120857 – EPi-Sense
:
510(k) Summary:
| Application Date: | March 19, 2012 |
|---|---|
| Date Summary Revised: | September 25, 2012 |
| Sponsor: | nContact Surgical, Inc. |
| 1001 Aviation Parkway, Suite 400, | |
| Morrisville, NC 27560 | |
| Establishment Registration | |
| Number: | 3006142617 |
| Correspondent: | Jane Ricupero |
| VP of Regulatory & Quality | |
| 1001 Aviation Parkway, Suite 400, | |
| Morrisville, NC 27560 | |
| Contact Numbers: | Phone: 919 655-1355 |
| Fax: 919 655-1690 | |
| E-mail: jricupero@ncontactinc.com | |
| Device Proprietary Name(s): | EPi-SenseTM Guided Coagulation |
| System with VisiTrax® | |
| Model numbers: CDK-1411; CDK- | |
| 1412; CDK-1413 | |
| 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 | |
| (for coagulation function) | Numeris Guided Coagulation System |
| with VisiTrax, Model numbers: CSK- | |
| 121, CSK-122, CSK-123, CSK-125 | |
| Predicate Device #2 | |
| (for sensing function) | K090202 cleared Feb. 17, 2009 |
| Estech COBRA Adhere XL 2 | |
| K113475 cleared Mar. 20, 2012 |
Section 5 - Summary Sept. 25, 2012 Page 5-1 of 5-3
·
・・
:
.
・
·
1
Device Description:
The EPi-Sense Guided Coagulation System with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm 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). An optional temporary sensing electrode feature may be used with . an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).
Indications for Use:
Indications for Use: The EPi-Sense™ Guided Coaqulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
The EPi-Sense™ Guided Coagulation System with VisiTrax® may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.
Comparison to Predicate Device and Summary of Technological Characteristics:
The nContact EPi-Sense System has the identical intended use and technological characteristics as the predicate nContact Numeris System for the coagulation function. The sensing function is considered equivalent to the stated predicate #2 for temporary cardiac signal sensing and recording when connected to a temporary external recording device.
The nContact Coagulation System combines design features of marketed predicate devices. The design features of the subject device are the same as or fall within ranges specified by the predicate devices. The dimensional parameters, materials, generator specifications, and design specifications are covered within the ranges offered by predicate devices. Shared features include:
- All devices (subject and predicate) rely on transmitting radiofrequency . energy through electrodes to achieve the intended coagulation use.
- Electrode design is identical to predicate #1. ●
- Perfusion feature is identical to predicate #1. .
- Suction feature is identical to predicate #1. .
- RF Generator energy levels, software revision and hardware are . identical to predicate #1.
- . Temporary cardiac signal sensing feature is similar the function in predicate #2.
Section 5 - Summary Sept. 25, 2012 Page 5-2 of 5-3
Page 2 of 3
2
Summary of Nonclinical Testing:
Performance bench tests were executed to ensure that the EPi-Sense Guided Coagulation System with VisiTrax (Generation 4 product) performed as intended and met design specifications.
The subject device incorporates design features and specifications equivalent to those specified by the predicate devices. In vitro and in vivo testing was conducted to verify that no safety or effectiveness issues arise when using the subject device to coagulate cardiac tissue or during use for the temporary cardiac signal sensing and recording function.
The following tests were successfully completed to evaluate equivalence.
-
- Biocompatibility testing per ISO 10993 for device and accessory materials.
-
- Sterilization validation per ISO 11137-2, Sterilization of Health Care Products - Radiation - Method VD Max.
-
- Reliability testing such as shipping and accelerated aging of packaged units.
-
- Tensile testing of critical bonds and joints.
-
- Flexion fatique testing.
-
- Electrical integrity testing for the subject device and accessories to pertinent sections of IEC 60601-1-2.
-
- In-vivo pre-clinical testing to demonstrate equivalent performance for coagulating cardiac tissue and temporary cardiac signal sensing.
-
- In-vitro bench testing to demonstrate tissue coagulation feature equivalence.
Substantial Equivalence Conclusion:
nContact concludes that the material and design modifications for the EPi-Sense Guided Coagulation System with VisiTrax may be considered substantially equivalent or identical to the legally marketed predicate devices 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 have no substantial changes or modifications that significantly affect the safety or efficacy of the devices. The Epi-Sense Guided Coagulation System with VisiTrax is substantially equivalent to the stated predicate devices.
Page 3 of 3
Section 5 - Summary Sept. 25, 2012 Page 5-3 of 5-3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and resemble a caduceus without the snake.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 3 2012
nContact Surgical Inc. c/o Ms. Jane Ricupero 1001 Aviation Parkway, Suite 400 Morrisville, NC 27560
Re: K120857
Trade Name: EPi-sense Guided Coagulation System with VisiTrax 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 25, 2012 Received: September 27, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
4
Page 2 - Ms. Jane 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, 7
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 K120857 - EPi-Sense
Indications for Use
510(k) Number (if known): K120857
Device Name: EPi-Sense™ Guided Coagulation System with VisiTrax®
The EPi-Sense 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 EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K120857 |
|---|---|
| --------------- | --------- |
Page 1 of
Section 4 - Indications for Use Statement Sept. 25/2012 Page 4-1 of 4-1