(136 days)
No
The summary describes a physical catheter device and its mechanical properties and biocompatibility, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is used for regional infusion of contrast materials to selected vessels, which is a diagnostic or procedural aid, not a treatment for a disease or condition.
No
Explanation: The device is described as an "Infusion Catheter" intended for regional infusion of contrast materials. Its purpose is to deliver substances, not to diagnose conditions or process diagnostic images.
No
The device description clearly describes a physical catheter, a hardware component, intended for regional infusion. The performance studies also focus on physical properties and biocompatibility of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Magic Infusion Catheter is a medical device used for the delivery of contrast materials directly into blood vessels within the neurovasculature. It is an invasive device used in vivo (within the living body).
- Intended Use: The intended use clearly states "regional infusion of contrast materials into selected vessels in the neurovasculature." This is a therapeutic or diagnostic procedure performed directly on the patient, not a test performed on a sample outside the body.
Therefore, the Magic Infusion Catheter falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Magic Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The Magic Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Product codes
KRA
Device Description
The subject device is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. Magic catheters are available in 1.8 and 1.5Fr and 165 and 155 cm in length and are available with an "olive" tip configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Testing on the Magic catheter including biocompatibility, joint strength, shaft tensile strength, tip tensile strength, tip flexibility, static rupture strength, dynamic rupture strength, and flow rate. Testing demonstrated that the Magic catheter with the hydrophilic coating was non cytotoxic, non hemolytic, non pyrogenic, non mutagenic, non sensitizing and non irritating attesting to the catheter with the new coating's biocompatibility. Change of the material in the catheter's tip marker is not a significant change as the properties of the new material (platinum) is well understood. Testing on the catheter including the Polyamid section of the shaft demonstrated that the catheter was non cytotoxic, non hemolytic, non pyrogenic, non allergenic, non toxic, and non irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
non cytotoxic, non hemolytic, non pyrogenic, non mutagenic, non sensitizing, non irritating, non allergenic, non toxic.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
023351
| Submitted by: | Tracy Palmer Berns
EXPERTech Associates, Inc.
100 Main Street, Suite 120
Concord, MA 01742
Telephone: 978-371-0066
Fax: 978-371-1676
E-mail: tberns@fdahelp.com | FEB 2 0 2003 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date of summary | October 3, 2002 | |
| Device Trade Name | Magic® Infusion Catheter | |
| Common Name | Continuous Flush Catheter | |
| Classification Name | Catheter, Continuous Flush (21 CFR § 870.1210) | |
| Predicate Device | Magic Infusion Catheter (K923368) submitted by Target
Therapeutics, Inc. The subject device is the same device as the
predicate, made by the same manufacturer. | |
| Description | The subject device is intended to operate for regional infusion of
contrast materials into selected vessels in the neurovasculature.
Magic Infusion Catheters are intended to facilitate access through
distant, tortuous vasculature. Progressive suppleness ranging from
a highly flexible tip to a semi-rigid proximal section allows the
catheter to be advanced by the physician. It is not intended for use
in the coronary vasculature. Magic catheters are available in 1.8
and 1.5Fr and 165 and 155 cm in length and are available with an
"olive" tip configuration. | |
| Intended Use | Magic Infusion Catheters are intended for controlled, regional
infusion into selected vessels. | |
| Technological
Characteristics | The subject device has the same technological characteristics as
the predicate device. The only changes involve a change to the
materials of the proximal shaft of the catheter and the tip marker,
and a change in the catheter's coating. The proximal shaft in the
subject Magic catheters is Polyamid, the tip marker is platinum,
and the coating is a hydrophilic coating, Hydrospeed™. These
changes do not affect the safety and effectiveness of the device. | |
| Testing | Testing on the Magic catheter including biocompatibility, joint
strength, shaft tensile strength, tip tensile strength, tip flexibility,
static rupture strength, dynamic rupture strength, and flow rate | |
1
equivalence relative to the safety and effectiveness of the device. No changes have been made to the design or intended use of the product since the clearance of K923368. Testing demonstrated that the Magic catheter with the hydrophilic coating was non cytotoxic, non hemolytic, non pyrogenic, non mutagenic, non sensitizing and non irritating attesting to the catheter with the new coating's biocompatibility. Change of the material in the catheter's tip marker is not a significant change as the properties of the new material (platinum) is well understood. Testing on the catheter including the Polyamid section of the shaft demonstrated that the catheter was non cytotoxic, non hemolytic, non pyrogenic, non allergenic, non toxic, and non irritating.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three profiles facing right, stacked on top of each other, with flowing lines beneath them.
FEB 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Interventional Technologies c/o Ms. Tracy Palmer Berns Senior Consultant Expertech Associates, Inc. 100 Main Street, Suite 120 Concord, Massachusetts 01742
Re: K023351
Trade Name: Magic® Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: December 18, 2002 Received: December 19, 2002
Dear Ms. Berns:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.
3
Page 2 - Ms. Tracy Palmer Berns
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) 594-4659. 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,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Magic® Infusion Catheter
Indications For Use:
The Magic Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The Magic Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K02335/
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)