(242 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a navigation catheter, with no mention of AI or ML capabilities.
No
The device is a navigation catheter intended to facilitate the placement of guidewires and other interventional devices within the vasculature, rather than directly treating a disease or condition.
No
The provided text describes a navigation catheter used to access vasculature and facilitate placement of other devices, not to diagnose a medical condition.
No
The device description clearly details a physical catheter with various material components (Pebax, polyimide-PTFE, stainless steel, silicone) and physical characteristics (working length, sizes, lumens, radiopaque marker, positioning marks). This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to access and facilitate placement of other devices within the coronary and/or peripheral vasculature. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples in vitro (outside the body). This device is designed for direct use in vivo within the patient's circulatory system.
N/A
Intended Use / Indications for Use
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices.
Product codes
DQY
Device Description
The M2 Navigation catheter and GuideLiner Navigation catheter (Navigation catheters) are rapidexchange catheters with a working length of 163 cm. The device is available in eight sizes and is compatible with GuideLiner catheters (GuideLiner Navigation catheter models) and 6F, 7F, and 8F guide catheters (M2 Navigation catheter models).
The distal portion of the device is a 25 cm single-lumen catheter that serves as the guidewire lumen. Portions of the outer diameter (OD) of the lumen are cross shaped to allow blood to flow around the catheter while staying centered within a guide catheter or GuideLiner catheter. The device is compatible with 0.014 inch exchange length or 180 cm guidewires. The catheter lumen is constructed with two durometers of Pebax (polyether block amide) resin over a polyimide-PTFE composite liner. The device has one radiopaque marker band located 2 mm from the distal tip. The OD of the lumen has a silicone wipe to enhance deliverability to the target vasculature. The proximal end of the lumen transitions to a 304V stainless steel pushwire that has non-radiopaque positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip. A short Pebax hub/sleeve covers the proximal end of the pushwire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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 device design was qualified through the following tests:
- . Visual inspections for:
- o label legibility, wear, or smudging
- sharp edges, points, irregularities o
- lubricious wipe o
- Dimensional verifications .
- . Positioning mark tape test
- . Simulated anatomy/concomitant device use
- . Kink
- . Bond tensile
- . Torque
A biomaterial assessment concluded that biocompatibility testing was not required based on the similarity of materials and manufacturing processes utilized in the predicate device and other devices manufactured by Vascular Solutions, Inc. Results of the verification testing met the specified acceptance criteria and did not raise new safety or performance questions.
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.
GuideLiner Catheter (K091750 - Vascular Solutions, Inc.)
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
0.1383
MAR 2 0 2012
2 510(k) Summarv
[As required by 21 CFR 807.92]
510(k) Number: KII2000
Date Prepared: July 19, 2011
Submitter's Information / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Matt Nienstedt Regulatory Product Specialist Tel: 763.656.4317 (direct) Fax: 763.656.4253 Email: mnienstedt@vasc.com
Alternate Contact Person Stacy Quellette Senior Regulatory Operations Associate Tel: 763.656.4217 (direct) . Fax: 763.656.4253 Email: souellette@vasc.com
General Information
| Trade Name | M2 Navigation Catheter and GuideLiner Navigation Catheter |
|---|---|
| Common / Usual Name | Percutaneous catheter |
| Classification Name | 21 CFR 870.1250, Percutaneous Catheter |
| Predicate Device | GuideLiner Catheter (K091750 - Vascular Solutions, Inc.) |
Device Description
The M2 Navigation catheter and GuideLiner Navigation catheter (Navigation catheters) are rapidexchange catheters with a working length of 163 cm. The device is available in eight sizes and is compatible with GuideLiner catheters (GuideLiner Navigation catheter models) and 6F, 7F, and 8F guide catheters (M2 Navigation catheter models).
The distal portion of the device is a 25 cm single-lumen catheter that serves as the guidewire lumen. Portions of the outer diameter (OD) of the lumen are cross shaped to allow blood to flow around the catheter while staying centered within a guide catheter or GuideLiner catheter. The device is compatible with 0.014 inch exchange length or 180 cm guidewires. The catheter lumen is constructed with two durometers of Pebax (polyether block amide) resin over a polyimide-PTFE
1
composite liner. The device has one radiopaque marker band located 2 mm from the distal tip. The OD of the lumen has a silicone wipe to enhance deliverability to the target vasculature. The proximal end of the lumen transitions to a 304V stainless steel pushwire that has non-radiopaque positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip. A short Pebax hub/sleeve covers the proximal end of the pushwire.
Intended Use / Indications
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices.
Technological Characteristics
Navigation catheters and predicate GuideLiner devices have the same design components consisting of a proximal hub, push wire, and distal lumen. Minor dimensional differences reflect the additional sizes for compatibility of the Navigation catheters with various guide catheters and GuideLiner catheters. Minor material changes were also implemented to increase the lumen flexibility, provide a longer, distal tip that tapers, and simplify device manufacturing.
Inner diameters (ID) of Navigation catheters differ from the predicate GuideLiner catheter. The smaller IDs of Navigation catheters allow for a tapered tip design. The OD of Navigation catheters are cross shaped while the OD of GuideLiner catheters are round.
Substantial Equivalence and Summarv of Studies
Navigation catheters are substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design was qualified through the following tests:
- . Visual inspections for:
- o label legibility, wear, or smudging
- sharp edges, points, irregularities o
- lubricious wipe o
- Dimensional verifications .
- . Positioning mark tape test
- . Simulated anatomy/concomitant device use
- . Kink
- . Bond tensile
- . Torque
A biomaterial assessment concluded that biocompatibility testing was not required based on the similarity of materials and manufacturing processes utilized in the predicate device and other devices manufactured by Vascular Solutions, Inc. Results of the verification testing met the specified acceptance criteria and did not raise new safety or performance questions.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, framing the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 0 2012
Vascular Solutions, Inc. c/o Mr. Matt Nienstedt Regulatory Product Specialist 6464 Sycamore Court Minneapolis, MN 55369
Re: K112100
Trade/Device Name: M2 Navigation Catheter and GuideLiner Navigation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 1, 2012 Received: February 2, 2012
Dear Mr. Nienstedt:
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.
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 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
3
Page 2 - Mr. Matt Nienstedt
(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/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Hillebert
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
K112100 510(k) Number (if known):
Device Name: M2 Navigation Catheter and GuideLiner Navigation Catheter
Indications for Use:
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cm. A. Hillebem
(Division Sian-Off) Division of Cardiovascular Devices
1112100 510(k) Number