(45 days)
No
The description focuses on the physical characteristics and function of a guide catheter, with no mention of AI or ML.
No
The device is a guide catheter used to facilitate the insertion and guidance of other catheters for diagnostic or therapeutic purposes, but it does not directly perform a therapeutic action itself.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It may also be used as a diagnostic angiographic catheter."
No
The device description clearly details a physical catheter with a shaft, radiopaque marker, hydrophilic coating, luer hub, and rotating hemostatic valve, indicating it is a hardware 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 the device is for facilitating the insertion and guidance of other catheters into blood vessels and for diagnostic angiography. These are procedures performed in vivo (within the living body).
- Device Description: The description details a catheter designed for physical manipulation within the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on biological samples outside the body to aid in diagnosis. This device is a tool for accessing and visualizing the vascular system inside the body.
N/A
Intended Use / Indications for Use
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Product codes
DQY
Device Description
The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of an occlusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. A rotating hemostatic valve with side-arm adapter is provided with each catheter for flushing, catheter insertion and aspiration. Modified HD Guide Catheter dimensions are indicated on product label. The Modified HD Guide catheter family is being extended to include a 6.3 F size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vascular systems
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 results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions. Specifically, kink resistance, flow rate, coating lubricity, leak resistance, tensile strength and flexibility testing were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Trade Name:Modified HD Guide CatheterCommon Name:Percutaneous CatheterClassification Name:Percutaneous Catheter, 21CFR 870.1250 – Class II | Trade Name: | Modified HD Guide Catheter | Common Name: | Percutaneous Catheter | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------------------|--------------|-----------------------|----------------------|--------------------------------------------------|
| Trade Name: | Modified HD Guide Catheter | | | | | | |
| Common Name: | Percutaneous Catheter | | | | | | |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | | | | | | |
| Submitter | Concentric ® Medical, Inc.
301 E. Evelyn Avenue
Mountain View, CA 94041
Tel 650-938-2100
Fax 650-237-5230
Facility Registration #2954917 | | | | | | |
| | Contact: Kirsten Valley | | | | | | |
| Predicate Device | HD Guide Catheter (K090335) | | | | | | |
| Date | March 23, 2011 | | | | | | |
Device Description
The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of an occlusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. A rotating hemostatic valve with side-arm adapter is provided with each catheter for flushing, catheter insertion and aspiration. Modified HD Guide Catheter dimensions are indicated on product label. The Modified HD Guide catheter family is being extended to include a 6.3 F size.
Intended Use
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
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Technological Characteristics
The Modified HD Guide Catheter has the same technological characteristics as the K080583 and K090335 predicate devices. The device design, materials used, function, physical properties and composition have not been changed.
Testing Summary
The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions. Specifically, kink resistance, flow rate, coating lubricity, leak resistance, tensile strength and flexibility testing were performed.
Summary of Substantial Equivalence
The Modified HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, and patient population. The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Concentric Medical c/o Ms. Kirsten Valley Senior Vice President, Technology and Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041
APR - 4 2011
Re: K110483
Trade/Device Name: Modified HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 23, 2011 Received: March 24, 2011
Dear Ms. Valley:
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.
...
3
Page 2 - Ms. Kirsten Valley
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/ReportalProblem/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,
Dummer D. Viener
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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Statement of Indications for Use
| INDICATIONS FOR USE | |
|---|---|
| 510(k) Number (if known): | This application K110483 |
| Device Name: | Modified HD Guide Catheter |
| Indications for Use: | The Modified HD Guide Catheter is indicated for |
| use in facilitating the insertion and guidance of | |
| an occlusion catheter, infusion catheter or | |
| other appropriate microcatheter into a selected | |
| blood vessel in the peripheral, coronary and | |
| neuro vascular systems. It may also be used as a | |
| diagnostic angiographic catheter. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_X (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)
Duna R. W. Wiem
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KILO:483
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