(85 days)
Not Found
No
The summary describes a physical guide catheter and its materials. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on bench testing of the physical device's properties.
No
The device description states that the Medtronic Guide Catheters "are designed to provide a pathway through which therapeutic devices are introduced," indicating it is an accessory device, not a therapeutic device itself.
No
The device is a guide catheter designed to provide a pathway for therapeutic devices, not to diagnose medical conditions.
No
The device description clearly outlines physical components like an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band, and a soft distal tip, indicating it is a hardware device. The performance studies also focus on bench and biocompatibility testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" within the coronary or peripheral system. This describes a device used in vivo (within the body) for a procedural purpose, not for analyzing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical construction of a catheter designed for insertion into blood vessels. This aligns with an in vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely procedural and mechanical.
N/A
Intended Use / Indications for Use
The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DOY
Device Description
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or the peripheral system
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)
Bench and biocompatibility testing were conducted in accordance with the recommendations from the relevant FDA guidance to demonstrate that the modified 5F and 8F Launcher Guide Catheters met the acceptance criteria and performed similarly to the predicate devices.
Bench Testing performed was specific to the luer hub due to the new material change. The tests performed included:
-
- Visual Analysis Sink Mark, Flash, Short Shot and Discoloration.
-
- Visual Analysis Luer Taper ISO 594-1 Gauge.
-
- Dimensional Analysis Hub Shaft ID.
-
- Hub/Shaft Tensile.
-
- Leak
-
- Luer Hub Leak and Aspiration Test
-
- Visual Analysis Hub Inside Inspection for Exposed Wires.
Biocompatibility Testing: Cytotoxicity Testing was performed as a screening test for this device modification.
No new safety or effectiveness issues were raised during the testing.
No clinical investigation has been performed for these devices.
- Visual Analysis Hub Inside Inspection for Exposed Wires.
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
| | FEB 1 1 2011
Special 510(k) Summary |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Vascular
35-37A Cherry Hill Drive
Danvers, MA 01923-5186 |
| Contact Person: | Anu Gaur
Regulatory Affairs Specialist
Phone: (978) 739-3080
Fax: (978) 739-7380 |
| Alternate Contact | Fred Boucher
Director of Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 750-8204 |
| Date Prepared: | November 17th, 2010 |
| Trade Name: | Medtronic Vascular 5F Launcher® Guide Catheter
Medtronic Vascular 8F Launcher® Guide Catheter |
| Common Name: | Guiding Catheter |
| Classification
Name: | Catheter, Percutaneous
21CFR 870.1250, Product Code DQY |
| Predicate Devices: | K030779 - 5F Launcher® Guide Catheter.
K023402 - 8F Launcher® Guide Catheter |
| Device
Description: | The Medtronic Launcher Guide Catheter is constructed with an
inner liner, stainless steel braid, outer shaft jacket, sleeve,
marker band and a soft distal tip. The inner lumen of the
Launcher Guide Catheter has a thin lubricious coating. |
| Statement of
Intended Use: | The Medtronic Guide Catheter is designed to provide a pathway
through which therapeutic devices are introduced. The guiding
catheter is intended for used in the coronary or peripheral
vascular system. |
| Summary of
Technological
Characteristics: | The technological characteristics of the subject medical devices
5F and 8F Launcher Guide Catheters are identical to the
predicate devices.
Luer hub: The luer hub allows interfacing of the catheter with
other devices.
Outer jacket: The outer jacket provides the catheter with its
ability to retain its curve, and also provides additional support. |
・
I
1
Wire braided shaft: The wire braided shaft provides the catheter with torque response and crush resistance.
Inner liner: The inner liner provides sufficient lumen lubricity for therapeutic device to pass through.
Distal segments: The distal segments allow a transition of catheter stiffness from the proximal catheter shaft to the soft distal tip.
Soft tip: The soft tip minimizes the potential for vessel trauma when the catheter is advanced in the vasculature system.
Summary of Nonclinical Data:
The bench and biocompatibility testing were conducted in accordance with the recommendations from the relevant FDA guidance to demonstrate that the modified 5F and 8F Launcher Guide Catheters met the acceptance criteria and performed similarly to the predicate devices.
Bench Testing performed was specific to the luer hub due to the new material change. The tests performed included:
-
- Visual Analysis Sink Mark, Flash, Short Shot and Discoloration.
-
- Visual Analysis Luer Taper ISO 594-1 Gauge.
-
- Dimensional Analysis Hub Shaft ID.
-
- Hub/Shaft Tensile.
-
- Leak
-
- Luer Hub Leak and Aspiration Test
-
- Visual Analysis Hub Inside Inspection for Exposed Wires.
Biocompatibility Testing: Cytotoxicity Testing was performed as a screening test for this device modification.
No new safety or effectiveness issues were raised during the testing.
No clinical investigation has been performed for these devices.
Summary of Clinical Data:
Conclusion from Data:
Medtronic Vascular has demonstrated that the modified 5F Launcher and 8F Launcher Guide Catheters are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 4 2011
Medtronic Vascular c/o Anupama Gaur, Ph.D., MBA, MSRA Regulatory Affairs Specialist 35-37 A Cherry Hill Drive Danvers, MA 01923
Re: K103386
Trade/Device Name: Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher® Guide Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: January 11, 2011 Received: January 12, 2011
Dear Dr. Gaur:
This letter corrects our substantially equivalent letter of February 11, 2011.
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.
3
Page 2 - Dr. Anu Gaur
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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 youns.
Bram D. Zuckerman, M.D.
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
510(k) Number: K10386
Device Names: Medtronic Vascular 5F Launcher Guide Catheter and 8F Launcher Guide Catheter.
Indications for Use:
The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)
Sign-Off
on of Cardiovascular Device:
mber K103386
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