(163 days)
Not Found
No
The summary describes a physical catheter and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
This device is an infusion catheter, which is used for delivering substances (contrast materials) into the body, not for treating a disease or condition itself.
No
The device is an infusion catheter, intended for delivering contrast materials, not for diagnosing conditions.
No
The device description clearly details a physical catheter with various material and design features, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "regional infusion of contrast materials into selected vessels in the neurovasculature." This is a procedure performed in vivo (within the living body) to visualize blood vessels.
- Device Description: The description details a catheter designed for navigating the vascular system and delivering substances. This is a medical device used for a therapeutic or diagnostic procedure performed directly on a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information about a patient's health. The description and intended use of the MAGIC Infusion Catheter do not involve the analysis of biological specimens outside the body.
Therefore, the MAGIC Infusion Catheter is a medical device used for an in vivo procedure, 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 (comma separated list FDA assigned to the subject device)
KRA
Device Description
The MAGIC Infusion Catheters are microcatheters designed with progressive suppleness and a rigid proximal shaft to allow control and navigability in the vascular system. By their diameter and progressive suppleness features, these catheters are specifically designed for catheterization of small diameter, sinuous distal vessels. The catheter body and its distal tip (ring) are radiopaque to provide visibility under fluoroscopy. The MAGIC Infusion Catheter has an external hydrophilic coating which provides a lubricious surface during use. A PTFE coated mandrel is included inside the MAGIC Infusion Catheter to provide support during product preparation and insertion through the guide catheter. The MAGIC Infusion Catheters and accompanying support mandrels are provided sterile, non-pyrogenic, and intended for single use only.
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
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)
Bench testing was conducted to evaluate the performance of the 1.2F MAGIC Infusion Catheter (subject device). The successful test results establish device integrity suitable for its intended clinical use and support substantial equivalence to the 1.5F MAGIC Infusion Catheter (predicate device).
Tests performed: Dimensional and Physical Attributes, Visual Inspection, Torque Strength Test, Catheter Tensile Test, Corrosion Resistance, Flow Rate, Dynamic Pressure, Static Burst Pressure, Pressure and Hub Test (Fluid Leakage), Simulated Use / Coating Lubricity and Durability, Kink Resistance, Radiopacity, Particulates. All tests passed.
Results for Torque Strength Test, Dynamic Pressure, Static Burst Pressure, Pressure and Hub Test (Fluid Leakage) indicated "Device integrity suitable for intended clinical use" or "Device met maximum labeled infusion pressure".
Results for Simulated Use / Coating Lubricity and Durability, Kink Resistance, Particulates indicated "Results comparable to predicate device".
Radiopacity: Marker band shall be detectable under radiographic techniques. (Per ASTM F640-12) - PASS.
Biocompatibility testing was performed in accordance with ISO 10993-1. The catheter is considered an externally communicating medical device with circulating blood contact for less than 24 hours. Tests performed: Cytotoxicity (MEM Elution Test, Agar Overlay Assay), Sensitization (Guinea Pig Maximization Test), Irritation (Intracutaneous Reactivity), Acute Systemic Toxicity (Systemic Injection Test), Systemic Toxicity (Rabbit Pyrogen Test), Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity: Canine Model, Thrombogenicity: Partial Thromboplastin Time Assay, Thrombogenicity: Platelet/Leukocyte Count Assay). All tests passed.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 29, 2021
Balt USA, LLC Corina Pierson Director of Regulatory Affairs 29 Parker Irvine, California 92618
Re: K202366
Trade/Device Name: MAGIC Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: December 16, 2020 Received: December 21, 2020
Dear Corina Pierson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202366
Device Name MAGIC Infusion Catheter
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
MAGIC INFUSION CATHETER 510(K) SUMMARY
This 510(k) summary for the MAGIC Infusion Catheter is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92.
| DATE PREPARED: | December 11, 2020 | | 1.5F MAGIC Infusion Catheter (K023351)
(Predicate Device) | 1.2F MAGIC Infusion
Catheter
(Subject Device) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| APPLICANT: | Balt USA, LLC
29 Parker
Irvine, CA, 92618 USA | 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. | Same |
| CONTACT PERSON: | Corina Pierson, Director of Regulatory Affairs
corina.pierson@baltgroup.com
+1.949.788.1443 | Catheter Body | PVC, Polyamide, Bismuth Carbonate | Same |
| TRADE NAME: | MAGIC Infusion Catheter | Mandrel | Stainless Steel / Polystyene / Polyamide / PTFE | Same |
| COMMON NAME: | Continuous flush catheter | Hydrophilic
Coating | Polyurethane / Polymer / Alcohol | Polyurethane / Polymer /
Alcohol (minor
modification to polymer +
alcohol %) |
| CLASSIFICATION
NAME: | Catheter, Continuous Flush | Strain Relief | Grilamid | Same |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 870.1210 | Hub | Grilamid | Same |
| PRODUCT CODE: | KRA | Shaft length | 155 cm, 165cm | 155cm, 165cm, 180cm |
| PREDICATE
DEVICE: | MAGIC Infusion Catheter (K023351) | Sizes | 1.5F and 1.8F | 1.2F, 1.5F and 1.8F |
| 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. | Tip Marker Band | Platinum / iridium | Platinum / iridium |
| DEVICE
DESCRIPTION: | The MAGIC Infusion Catheters are microcatheters designed with
progressive suppleness and a rigid proximal shaft to allow control
and navigability in the vascular system. By their diameter and
progressive suppleness features, these catheters are specifically
designed for catheterization of small diameter, sinuous distal
vessels. The catheter body and its distal tip (ring) are radiopaque to
provide visibility under fluoroscopy. The MAGIC Infusion
Catheter has an external hydrophilic coating which provides a
lubricious surface during use. A PTFE coated mandrel is included
inside the MAGIC Infusion Catheter to provide support during
product preparation and insertion through the guide catheter. The
MAGIC Infusion Catheters and accompanying support mandrels | Carton | Multilayered, natural fiber composites | Same |
| Pouch | Tyvek® | Same | | |
| Shelf Life | 5 Years | Same | | |
| Sterilization | Ethylene Oxide (EO) | Same | | |
| Use | Single Use | Same | | |
4
are provided sterile, non-pyrogenic, and intended for single use only.
TECHNOLOGICAL CHARACTERISTICS:
The 1.2F MAGIC Infusion Catheter (subject device) is substantially equivalent to the predicate with respect to similar materials of construction, indications for use (intended use) and technological characteristics. A comparison of the Subject device with the Predicate is summarized in the table below.
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PERFORMANCE DATA [807.92(b)]
Bench testing was conducted to evaluate the performance of the 1.2F MAGIC Infusion Catheter (subject device). The successful test results establish device integrity suitable for its intended clinical use and support substantial equivalence to the 1.5F MAGIC Infusion Catheter (predicate device). See table below for the bench test summary results.
| Bench Test | Acceptance Criteria | Results |
|---|---|---|
| Dimensional and | ||
| Physical Attributes | Shall meet the required dimensional measurements | |
| and physical attributes per established | ||
| specifications. | PASS | |
| Visual Inspection | Shall meet the established acceptance criteria for | |
| surface defects and contamination. | PASS | |
| Torque Strength Test | Catheters shall withstand the established | |
| acceptance criteria for torque strength without | ||
| breaking. | PASS | |
| Device integrity | ||
| suitable for intended | ||
| clinical use | ||
| Catheter Tensile Test | Shall meet ISO 105551-1, Annex B | PASS |
| Corrosion Resistance | Shall meet ISO 105551-1, Annex A | PASS |
| Flow Rate | Reference Data | N/A |
| Dynamic Pressure | Catheters shall withstand the maximum infusion | |
| pressure (as indicated on the product labeling) | ||
| under dynamic conditions. | ||
| (Adopted from ISO 105551-1) | PASS | |
| Device met | ||
| maximum labeled | ||
| infusion pressure | ||
| Static Burst Pressure | Catheters shall withstand the maximum infusion | |
| pressure (as indicated on the product labeling) | ||
| under static conditions. | ||
| (Adopted from ISO 105551-1) | PASS | |
| Device integrity | ||
| suitable for intended | ||
| clinical use | ||
| Pressure and Hub Test | ||
| (Fluid Leakage) | Catheters shall not leak when injected with water | |
| at the maximum infusion pressure (as indicated on | ||
| the product labeling) for a 30 second duration. | PASS | |
| Device integrity | ||
| suitable for intended | ||
| clinical use | ||
| Simulated Use / | ||
| Coating Lubricity and | ||
| Durability | Catheters shall be tracked using a benchtop model | |
| under simulated use conditions per product IFU, | ||
| and meet established acceptance criteria for | ||
| product performance, trackability, coating lubricity | ||
| and durability. | PASS | |
| Results comparable | ||
| to predicate device | ||
| Kink Resistance | Catheter body shall be wrapped around different | |
| pin gauges at various locations and meet the | ||
| expected acceptance criteria for kink resistance. | ||
| No kinks shall be noted during Simulated Use. | PASS | |
| Results comparable | ||
| to predicate device | ||
| Bench Test | Acceptance Criteria | Results |
| Radiopacity | Marker band shall be detectable under | |
| radiographic techniques. | ||
| (Per ASTM F640-12) | PASS | |
| Particulates | Shall meet USP criteria | |
| No particulates shall be noted pre and post | ||
| Simulated Use. | PASS | |
| Results comparable | ||
| to predicate device |
6
Summary of Biocompatibility Testing
The 1.2F MAGIC Infusion Catheter was assessed for biocompatibility in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." The catheter is considered an externally communicating medical device with circulating blood contact for less than 24 hours. See table below for tests performed and results.
| Biocompatibility Test | Test Method | Results |
|---|---|---|
| Cytotoxicity | ||
| – MEM Elution Test | ISO 10993-5 | PASSED |
| Cytotoxicity | ||
| – Agar Overlay Assay | ISO 10993-5 | PASSED |
| Sensitization | ||
| – Guinea Pig Maximization Test | ISO 10993-10 | PASSED |
| Irritation | ||
| – Intracutaneous Reactivity | ISO 10993-10 | PASSED |
| Acute Systemic Toxicity | ||
| – Systemic Injection Test | ISO 10993-11 | PASSED |
| Systemic Toxicity | ||
| – Rabbit Pyrogen Test | ISO 10993-11 | PASSED |
| Hemocompatibility | ||
| – Hemolysis | ISO 10993-4 / | |
| ASTM F756 | PASSED | |
| Hemocompatibility | ||
| – Complement Activation | ISO 10993-4 | PASSED |
| Hemocompatibility | ||
| – Thrombogenicity: Canine Model | ISO 10993-4 | PASSED |
| Hemocompatibility | ||
| – Thrombogenicity: Partial | ||
| Thromboplastin Time Assay | ISO 10993-4 / | |
| ASTM F2382-18 | PASSED |
7
| Biocompatibility Test | Test Method | Results |
|---|---|---|
| Hemocompatibility |
- Thrombogenicity: Platelet/
Leukocyte Count Assay | ISO 10993-4 /
ASTM F2888-19 | PASSED |
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The data presented demonstrates that the technological characteristics of the subject device (1.2F MAGIC Infusion Catheter) are substantially equivalent to the technological characteristics of the previously cleared 1.5F MAGIC Infusion Catheter (K023351). Substantial equivalence is determined based on the following similarities:
- Same intended use/indications for use; ●
- Same principles of operation; ●
- Same fundamental scientific technology; ●
- Incorporates similar basic infusion catheter design; ●
- Incorporates similar materials of construction.
CONCLUSION
Upon review of the performance data, intended use, design, materials of construction, principles of operation and fundamental scientific technologies, the 1.2F MAGIC Infusion Catheter (Subject device) is determined to be substantially equivalent to the 1.5F MAGIC Infusion Catheter (Predicate device) previously cleared under K023351. The information and data provided identify no new safety or effectiveness concerns. BALT USA believes that substantial equivalence has been demonstrated.