(104 days)
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.
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.
The provided text describes a 510(k) summary for the NexGen Peripheral Guide Catheter. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility assessments. The document does not include information about acceptance criteria and a study proving a device meets those criteria in the context of clinical performance, specifically for an AI/ML powered device.
Therefore, many of the requested sections about AI/ML specific study design (e.g., sample size for test set, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set size and ground truth establishment) cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists several performance tests conducted to verify the device met design specifications and its intended use. However, it does not explicitly state specific acceptance criteria (e.g., "tensile strength must be > X N") nor the quantitative results ("reported device performance") for each test. It only states that the tests were "successfully completed."
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Sufficient Tensile Strength | Successfully completed Tensile Test |
| Adequate Catheter Torque | Successfully completed Catheter Torque Test |
| Withstand Burst Pressure | Successfully completed Catheter Burst Pressure Test |
| No Leakage | Successfully completed Catheter Leak Test |
| Resistance to Kinking | Successfully completed Catheter Kink Diameter Test |
| Good Pushability & Trackability | Successfully completed Catheter Pushability Trackability Test |
| Sufficient Flow Rate | Successfully completed Catheter Flow Rate Test |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing of a physical medical device, not a study involving a "test set" of data or patient cases for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML study. Ground truth in this context would relate to engineering specifications and measurements, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be the established engineering and materials science standards and specifications against which the device's performance was measured. For example, a predefined burst pressure limit or a specific tensile strength requirement.
8. The sample size for the training set
Not applicable. This is not an AI/ML study.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML study.
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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, CEO775.851.7337 (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.
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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.
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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.
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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
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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 |
|---|---|
| ------ | --- |
of T
NexGen Peripheral Guide Catheter - K102979 Response to FDA Questions - 12/9/10
§ 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).