(80 days)
Not Found
No
The description focuses solely on the physical construction and intended use of a catheter for delivering materials in the vascular system. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is designed to deliver substances, including therapeutic agents, but it is a delivery device itself, not a therapeutic device that directly performs a therapeutic action.
No
The device is described as an angiographic intravascular catheter designed for delivering embolic materials and radiopaque media, and "Diagnostic, embolic, or therapeutic agents." While it can deliver diagnostic agents, the device itself performs a delivery function and does not analyze or interpret data to diagnose a condition.
No
The device description clearly details a physical catheter with various material components (nylon, Pebax, pellethane, Texin), a lumen, a hub, and a tip straightener. This is a hardware medical device, not software-only.
Based on the provided information, the Gandras catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivering embolic materials and radiopaque media to selected sites in the vascular system." This is an in vivo application, meaning it's used within the living body.
- Device Description: The description details a catheter designed for insertion into the vascular system, which is consistent with an in vivo medical device.
- 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.) outside of the body to provide information for diagnostic purposes.
IVD devices are specifically designed for testing samples in vitro (outside the body) to diagnose diseases or conditions. The Gandras catheter is an interventional device used directly within the patient's vascular system.
N/A
Intended Use / Indications for Use
The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Gandras catheter is an angiographic intravascular catheter that has a working length of approximately 80cm, not including the tip length. The Gandras catheter is offered in three tip lengths-2cm (model 5580), 4cm (model 5581), or 6cm (model 5582). Each catheter assembly has a single lumen that is formed by a segment of nylon that extends distally from the hub, a segment of 40 durometer Pebax that extends distally from the nylon, and pellethane that forms the distal tip. Each catheter also has a Texin outer layer that overlays the nylon and pebax tubing in the mid-shaft. The distal 10-15cm of the catheter is hydrophilically coated to provide a lubricious outer surface. The catheter's radiopacity is provided by 40% bismuth subcarbonate loading in the nylon, 60% tungsten loading in the Pebax, and 65% tungsten loading in the pellethane tubing components.
Each catheter has a press-fit luer hub and strain relief on the proximal end, and a peelable tip straightener. Each Gandras catheter is compatible with ≥5F introducer sheaths and
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
510(k) Summary (As required by 21 CFR 807.92(c))
510(k) Number: K073200
Date Prepared
January 16, 2008
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore Court |
| Minneapolis, MN 55369 |
| Contact Person: | Julie Tapper |
|---|---|
| Senior Regulatory Affairs Associate | |
| Phone 763-656-4300, x228 | |
| Fax 763-656-4250 |
Device Information
| Trade Name: | Gandras™ Intravascular Catheter |
|---|---|
| Common Name: | Diagnostic intravascular catheter |
| Class: | II |
| Classification Name: | Diagnostic intravascular catheter |
| (21 CFR 870.1200, Product Code DQO) |
Predicate Devices
Renegade STC™ 18 Microcatheter (K023681, K020012), manufactured by Boston Scientific Corporation.
AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters (K061733), manufactured by AngioDynamics, Inc.
Device Description
The Gandras catheter is an angiographic intravascular catheter that has a working length of approximately 80cm, not including the tip length. The Gandras catheter is offered in three tip lengths-2cm (model 5580), 4cm (model 5581), or 6cm (model 5582). Each catheter assembly has a single lumen that is formed by a segment of nylon that extends distally from the hub, a segment of 40 durometer Pebax that extends distally from the nylon, and pellethane that forms the distal tip. Each catheter also has a Texin outer layer that overlays the nylon and pebax tubing in the mid-shaft. The distal 10-15cm of the catheter is hydrophilically coated to provide a lubricious outer surface. The catheter's radiopacity is provided by 40% bismuth subcarbonate loading in the nylon, 60% tungsten loading in the Pebax, and 65% tungsten loading in the pellethane tubing components.
FEB - 1 2003
1
Each catheter has a press-fit luer hub and strain relief on the proximal end, and a peelable tip straightener. Each Gandras catheter is compatible with ≥5F introducer sheaths and Trade Name: Gandras 110 Intravascular Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: January 16, 2008 Received: January 17, 2008
Dear Ms. Tapper:
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. Iisting 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Ms. Julie Tapper
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, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical 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 yours,
buna R. V. de Auner
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 Statement
510(k) Number: K073200
Device Name:
Gandras™ Intravascular Catheter
Indications for Use:
The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
Prescription Use -------X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Duma R. Jachner
(Division Sign-Off) Division of Cardrovascular Devices
510(k) Number_K073260