(46 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a micro catheter for infusion, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a microcatheter used for delivery of therapeutic agents and diagnostic materials, but it is not itself a therapeutic agent or device.
No
The device is described as being for "the controlled selective infusion of physician-specified therapeutic agents" and "diagnostic materials such as contrast media," and "subselective infusion of physician specified therapeutic agents or contrast media." This indicates its primary function is for delivery, not for diagnosing a condition itself. The "diagnostic materials" are things like contrast media, which are used in conjunction with imaging modalities (like fluoroscopy) to help in diagnosis, but the catheter itself isn't performing the diagnosis.
No
The device description clearly details a physical catheter with a lumen, shaft, luer adapter, radiopaque marker, and coating, indicating it is a hardware medical device.
Based on the provided information, the Marathon™ Flow Directed Micro Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Marathon™ Catheter's Intended Use: The intended use clearly states it is for accessing peripheral and neuro vasculature for the controlled selective infusion of therapeutic and diagnostic materials within the body.
- Device Description: The description details a catheter designed for insertion into the body for delivery of substances.
- Anatomical Site: The specified anatomical site is within the body (peripheral and neuro vasculature).
The Marathon™ Flow Directed Micro Catheter is an invasive medical device used for delivering substances directly into the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Marathon Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Marathon™ Micro Catheters are single-lumen, endhole catheters designed for the subselective infusion of physician specified therapeutic agents or contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. The stylet accompanying the catheter is used to increase the rigidity of the distal section during introduction into the guiding catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro 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)
MTI performed in vitro and in vivo tests to verify and validate product design. Tests included the following: • Biocompatibility • Angiographic visualization • Dimensional verification • Functional performance
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
FEB 1 3 2004
Micro Therapeutics, Inc. Traditional 510(k) Marathon™ Flow Directed Micro Catheter
December 24, 2003
510(k) Summary 4.
| Prepared December 24, 2003 | |||
|---|---|---|---|
| TRADE NAME | Marathon™ Flow Directed Micro Catheter | ||
| GENERIC NAME | Flow Directed Micro Catheter | ||
| CLASSIFICATION | Class II (21 CFR 870.1210) | ||
| SUBMITTED BY | Micro Therapeutics, Inc. | ||
| 2 Goodyear | |||
| Irvine, CA 92618 | CONTACT | Bill Hyatt | |
| Regulatory Affairs | |||
| (949) 837-3700 | |||
| PREDICATE | |||
| DEVICE(S) | UltraFlow™ HPC Flow Directed Micro Catheter (K024118), | ||
| cleared February 3, 2003 | |||
| Echelon™ Over the Wire Micro Catheter (K030688), | |||
| cleared March 28, 2003 | |||
| DEVICE | |||
| DESCRIPTION | The Marathon™ Micro Catheters are single-lumen, endhole catheters designed | ||
| for the subselective infusion of physician specified therapeutic agents or contrast | |||
| media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and | |||
| a highly flexible distal shaft to facilitate the advancement of the catheter in the | |||
| anatomy. The proximal end of the catheter incorporates a standard luer adapter to | |||
| facilitate the attachment of accessories. The catheter has a radiopaque marker at | |||
| the distal end to facilitate fluoroscopic visualization. The outer surfaces of the | |||
| catheter are coated to increase lubricity. The stylet accompanying the catheter is | |||
| used to increase the rigidity of the distal section during introduction into the | |||
| guiding catheter. | |||
| INDICATIONS FOR | |||
| USE | The Marathon Micro Catheter is intended to access peripheral and neuro | ||
| vasculature for the controlled selective infusion of physician-specified therapeutic | |||
| agents such as embolization materials and of diagnostic materials such as contrast | |||
| media. | |||
| TESTING | MTI performed in vitro and in vivo tests to verify and validate product design. | ||
| Tests included the following: | |||
| • Biocompatibility | |||
| • Angiographic visualization | |||
| • Dimensional verification | |||
| • Functional performance | |||
| SUMMARY OF | |||
| SUBSTANTIAL | |||
| EQUIVALENCE | The Marathon Flow Directed Micro Catheter has | ||
| (1) substantially equivalent device and embolic material compatibility to predicate | |||
| devices (UltraFlow and Echelon Micro Catheters) , including DMSO and Onyx® | |||
| compatibility, | |||
| (2) substantially equivalent flow directability and accessibility to the predicate | |||
| UltraFlow HPC Flow Directed Micro Catheter device, | |||
| (3) substantially equivalent materials and construction to the predicate devices | |||
| (distal shaft = Echelon, proximal shaft = UltraFlow), and | |||
| (4) an identical intended use to the predicate device (Echelon). |
1
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 depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Micro Therapeutics, Inc c/o Ms. Marilyn Pourazar 2 Goodyear Irvine, CA 92618
Re: K034036
Marathon™ Flow Directed Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: December 24, 2003 Received: December 29, 2003
Dear Ms. Pourazar:
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 (sec 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.
2
Page 2 – Ms. Marilyn Pourazar
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 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duauch P. Vichenel
Bram D. Zuckerman M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
MT! Marathon™Flow Directed Micro Catheter
Indications For Use:
The Marathon™ Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Prescription Use (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)
Duma R. Vachner
(Division Sign-Off)
Tivision of Cardiovascular Devices
umber K030436