(104 days)
Not Found.
No
The device description and performance studies focus on the mechanical and material properties of a guide catheter, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a guide catheter intended to facilitate the introduction of other interventional/diagnostic devices and inject fluids, not to provide therapy itself.
No
The device is a guide catheter intended to introduce other interventional/diagnostic devices, not to perform a diagnostic function itself.
No
The device description clearly outlines a physical catheter with a hub, tip, lumen, and luer connection, indicating it is a hardware device. The performance studies also focus on physical properties like tensile strength, burst pressure, and flow rate.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids" within the peripheral vasculature. This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a catheter with a lumen for introducing other devices and fluids. This aligns with an interventional or diagnostic tool used in a procedure, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment based on the analysis of biological samples.
- Reagents, calibrators, or controls typically associated with IVD tests.
The device is a tool used in a medical procedure to facilitate the use of other devices or the delivery of fluids. This falls under the category of a medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature for the intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Peripheral Guide Catheter is a family of single use, catheters that are intended to facilitate introduction of interventional/diagnostic devices.
The NexGen Peripheral Guide Catheter features a proximal hub for attaching to ancillary devices such as Rotating Hemostasis Valves and Syringes and a distal, atraumatic tip that is radiopaque.
The catheter has a single lumen that can be used to facilitate introduction of interventional /diagnostic devices and injection of physician specified fluids.
The Guide Catheter comes in two profiles, 4F and 8F and multiple lengths. The 4F profile has a 65cm and 150cm working length and the 8F profile has a 20cm and 90cm working length.
Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Peripheral vasculature
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 following bench testing was conducted to verify the device met design specifications and its intended use:
- Tensile Test .
- Catheter Torque Test .
- Catheter Burst Pressure Test .
- Catheter leak Test
- Catheter Kink Diameter Test ●
- Catheter Pushability Trackability Test
- Catheter Flow Rate Test
All appropriate biocompatibility tests for the guide catheters were successfully completed.
All testing demonstrated that the NexGen Guide Catheter is mogety "and the predicate devices and introduces no new safety and effectiveness issues when used as indicated.
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
SECTION 5 - 510(k) SUMMARY
JAN 1 8 2011
510(k) Number: K102979
Submitted by:
NexGen Medical Systems, Inc. 10471 Double R Blvd, Suite A Reno, NV 89521 US
NexGen Peripheral Guide Catheter
Catheter, Percutaneous (870.1250)
Catheter, Intravascular, Diagnostic (870.1200
Undetermined at this time
Percutaneous Catheter
| Contact Person: | John Kucharczyk, CEO
775.851.7337 (o)
775.849.4162 (f) |
|-----------------|--------------------------------------------------------------|
| Date Prepared: | January 3, 2011 |
Name of the Device:
Proprietary Name:
Common Name:
Classification:
SUMMARY STATEMENT:
Predicate Device: The NexGen Peripheral Guide Catheter is substantially equivalent to the Cordis Vista Brite Tip Guiding Catheter (K972978) and the Terumo Radiofocus Glidecath (K090040).
Device Description:
The Peripheral Guide Catheter is a family of single use, catheters that are intended to facilitate introduction of interventional/diagnostic devices.
The NexGen Peripheral Guide Catheter features a proximal hub for attaching to ancillary devices such as Rotating Hemostasis Valves and Syringes and a distal, atraumatic tip that is radiopaque.
The catheter has a single lumen that can be used to facilitate introduction of interventional /diagnostic devices and injection of physician specified fluids.
The Guide Catheter comes in two profiles, 4F and 8F and multiple lengths. The 4F profile has a 65cm and 150cm working length and the 8F profile has a 20cm and 90cm working length.
Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.
1
Intended Use: The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature for the intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.
Summary of Non-Clinical Testing
Performance Testing:
The following bench testing was conducted to verify the device met design specifications and its intended use:
- Tensile Test .
- Catheter Torque Test .
- Catheter Burst Pressure Test .
- Catheter leak Test �
- Catheter Kink Diameter Test ●
- Catheter Pushability Trackability Test
- Catheter Flow Rate Test
Biocompatibility:
All appropriate biocompatibility tests for the guide catheters were successfully completed.
Summary of Substantial Equivalence:
The NexGen Peripheral Guide Catheters are similar in design, construction, indication for use The Nexton receptarateristics to other commercially available guide catheters. Mechanical, safety and biocompatibility tests were performed to verify the functional safety, structural integrity and material safety. All testing demonstrated that the NexGen Guide Catheter is mogety "and the predicate devices and introduces no new safety and effectiveness issues when used as indicated.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a bird-like design with three curved lines representing wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NexGen Medical Systems, Inc. c/o Mr. Craig Pagan 1050 W. NASA Blvd Suite 136 Melbourne, FL 32901
JAN 1 8 201
Re: K102979
Trade/Device Name: NexGen Peripheral Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: January 3, 2011 Received: January 5, 2011
Dear Mr. Pagan:
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 for ass bated in the 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, de need that have boon require approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelors, mains of the Act include requirements for annual registration, listing of general controls providers of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultieration. Ticaso note: ODFET as : abeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (controls. Existing major regulations affecting your device can be may be subject to additional controls. "Encling may been of the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
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); 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number: K102979
Device Name: NexGen Peripheral Guide Catheter
INDICATIONS:
Intended Use: The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature for the introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.
CONTRAINDICATIONS:
No known contraindications.
Prescription Use _ V (Part 21 CFR 801 Subpart D).
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K022979 |
|---|---|
| --------------- | --------- |
| Page | 1 |
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NexGen Peripheral Guide Catheter - K102979 Response to FDA Questions - 12/9/10