(137 days)
Not Found
No
The 510(k) summary describes a standard guide catheter and does not mention any AI or ML components or functionalities.
No.
The device is used to facilitate the insertion and guidance of other catheters or for diagnostic angiography, not to directly treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It may also be used as a diagnostic angiographic catheter."
No
The device description clearly describes a physical catheter with a lumen, braiding, radiopaque markers, a luer hub, and a hydrophilic coating. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to facilitate the insertion and guidance of other catheters within the vascular system for therapeutic or diagnostic purposes (angiography). This is an in vivo procedure, meaning it's performed within a living organism.
- Device Description: The description details a catheter designed for physical manipulation within blood vessels, including features like braiding for stiffness, a radiopaque marker for visualization during fluoroscopy, and a hydrophilic coating for smooth insertion. These are characteristics of a device used for direct intervention within the body.
- 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 to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a tool for accessing and navigating within the body itself.
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 or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Product codes
DQY
Device Description
The Modified HD Guide Catheter is a single-lumen, braided stiffness catheter with a radiopague marker on the distal end a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopague shaft and distal marker facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary or neuro vascular systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 and is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Concentric HD Guide Catheter, K003880
Reference Device(s)
Not Found
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
080583
Concentric Medical, Inc. Special 510(k): Device Modification Concentric HD Guide Catheter
JUL 1 8 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
| Trade Name | Modified HD Guide Catheter |
|---|---|
| Common Name | Percutaneous Catheter |
| Classification | Percutaneous Catheter, 21CFR 870.1250 – Class |
| Submitter | Concentric® Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-938-2700 | |
| Contact | Laraine Pangelina |
| Director, Regulatory Affairs |
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 or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Predicate Device
Concentric HD Guide Catheter, K003880
Device Description
The Modified HD Guide Catheter is a single-lumen, braided stiffness catheter with a radiopague marker on the distal end a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopague shaft and distal marker facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
Materials
All materials used in the manufacture of the Modified HD Guide Catheter are suitable for the intended use of the device and have been used in numerous previously cleared products.
Testing Summary
The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed and is suitable for its intended use.
Summary of Substantial Equivalence
The Modified HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2008
Concentric Medical Inc c/o Ms. Laraine Pangelina Director, Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA
Re: K080583
Trade Device Name: Modified HD Cuide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 7, 2008 Received: July 15, 2008
Dear Ms. Pangelina:
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 such 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
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Page 2 - Ms. Laraine Pangelina
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, picase vontact CDRH 's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours,
Duna R. bi Aener
A 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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Concentric Medical, Inc. Special 510(k): Device Modification Concentric HD Guide Catheter
INDICATIONS FOR USE
Modified HD Guide Catheter
K080583 510(k) Number (if known): This application
Device Name:
ﺎﻧﻪ ﻣﻦ ﻣﻦ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
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 or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Prescription Use _X (Per 21 CFR 801.109)
AND/OR
. .
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
burma R. Vahmus4
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_k080583
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