(136 days)
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.
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.
This document is a 510(k) summary for the Magic® Infusion Catheter, indicating its substantial equivalence to a predicate device. It primarily focuses on demonstrating that changes to materials and coating do not affect safety and effectiveness. As such, the information typically found in studies for AI/ML devices or diagnostic tools (like acceptance criteria tables, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable here.
Here's a breakdown of the available information based on your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance:
The document describes several tests performed on the Magic Infusion Catheter, particularly regarding the changes to its materials and coating. It states that these tests demonstrate biocompatibility and material integrity.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility (Hydrophilic Coating) | Non-cytotoxic, non-hemolytic, non-pyrogenic, non-mutagenic, non-sensitizing, non-irritating | 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." |
| Biocompatibility (Polyamid Shaft) | Non-cytotoxic, non-hemolytic, non-pyrogenic, non-allergenic, non-toxic, non-irritating | 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. |
| Material Change (Tip Marker - Platinum) | Material properties are well understood and change is not significant. | 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. |
| Other Physical Tests (General Catheter) | Not explicitly stated, but implied to meet performance similar to predicate. | 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. (Specific performance values or direct comparison to criteria for these are not provided in the summary.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document refers to "Testing" but does not detail the number of units or samples used for each test.
- Data Provenance: Not specified. This is a technical performance study, not a clinical data study, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for medical imaging or diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. This is a physical device testing summary, not a study involving expert readers or ground truth in the context of diagnoses or image interpretation. The "ground truth" here is based on laboratory test results and material properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication method is described as this is not a study assessing diagnostic performance or subjective interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI/ML device or a diagnostic device where MRMC studies would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Test Results and Material Properties. The "ground truth" for the device's performance is derived from standardized laboratory tests for biocompatibility, material strength, flexibility, rupture strength, and flow rate, as well as the known properties of the materials used (e.g., platinum).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
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510(k) Summary
023351
| Submitted by: | Tracy Palmer BernsEXPERTech Associates, Inc.100 Main Street, Suite 120Concord, MA 01742Telephone: 978-371-0066Fax: 978-371-1676E-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 TargetTherapeutics, Inc. The subject device is the same device as thepredicate, made by the same manufacturer. | |
| Description | The subject device is intended to operate for regional infusion ofcontrast materials into selected vessels in the neurovasculature.Magic Infusion Catheters are intended to facilitate access throughdistant, tortuous vasculature. Progressive suppleness ranging froma highly flexible tip to a semi-rigid proximal section allows thecatheter to be advanced by the physician. It is not intended for usein the coronary vasculature. Magic catheters are available in 1.8and 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, regionalinfusion into selected vessels. | |
| TechnologicalCharacteristics | The subject device has the same technological characteristics asthe predicate device. The only changes involve a change to thematerials of the proximal shaft of the catheter and the tip marker,and a change in the catheter's coating. The proximal shaft in thesubject Magic catheters is Polyamid, the tip marker is platinum,and the coating is a hydrophilic coating, Hydrospeed™. Thesechanges do not affect the safety and effectiveness of the device. | |
| Testing | Testing on the Magic catheter including biocompatibility, jointstrength, shaft tensile strength, tip tensile strength, tip flexibility,static rupture strength, dynamic rupture strength, and flow rate |
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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.
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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.
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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
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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)
§ 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).