MAGIC Flow-Dependent Microcatheter

K213435 · Balt USA, LLC · KRA · Jul 19, 2022 · Cardiovascular

Device Facts

• Record ID: K213435
• Device Name: MAGIC Flow-Dependent Microcatheter
• Applicant: Balt USA, LLC
• Product Code: KRA · Cardiovascular
• Decision Date: Jul 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAGIC Flow-Dependent Microcatheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified embolization materials and diagnostic materials such as contrast media.

Device Story

Flow-dependent microcatheter designed for navigation through small, sinuous distal vessels. Features progressive suppleness and rigid proximal shaft for control. Radiopaque body and distal tip allow fluoroscopic visualization. External hydrophilic coating provides lubricity. Includes support mandrel for preparation and insertion through guide catheter. Used by physicians in clinical settings to deliver embolization or diagnostic agents. Output is the selective delivery of these materials to target vasculature, facilitating therapeutic or diagnostic procedures. Benefits include improved access to complex distal anatomy.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated via compatibility testing with embolic materials in a tortuous anatomical model; results passed pre-defined acceptance criteria.

Technological Characteristics

Materials: PVC, Polyamide, Bismuth Carbonate, Stainless Steel, Polystyrene, PTFE, Platinum/Iridium marker bands. Hydrophilic coating: Polyurethane/Polymer/Alcohol. Features: Progressive suppleness, radiopaque body/tip, support mandrel. Sterilization: Ethylene Oxide. Single-use. No software or electronic components.

Indications for Use

Indicated for accessing peripheral and neuro vasculature for controlled selective infusion of physician-specified embolization and diagnostic materials (e.g., contrast media).

Regulatory Classification

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.

Predicate Devices

• MAGIC Infusion Catheter (K202366)

Reference Devices

• Marathon Flow Directed Micro Catheter (K202318)

Submission Summary (Full Text)

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July 19, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Balt USA, LLC Ryan Kenney Specialist, Regulatory Affairs 29 Parker Irvine, California 92618

Re: K213435

Trade/Device Name: MAGIC Flow-Dependent Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, QJP Dated: June 16, 2022 Received: June 17, 2022

Dear Ryan Kenney:

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

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradvan, 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

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# Indications for Use

510(k) Number (if known) K213435

Device Name MAGIC Flow-Dependent Microcatheter

#### Indications for Use (Describe)

The MAGIC Flow-Dependent Microcatheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified embolization materials and diagnostic materials such as contrast media.

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> |
|---------------|------------------------------------------------------------|
| <div></div> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows a logo with a green circular design on the left and the word "balt" in a stylized font on the right. Below the logo, the text "510(k) Summary: K213435" is displayed. The text indicates that the image is related to a 510(k) summary document with the reference number K213435.

| Applicant: | Balt USA, LLC<br>29 Parker<br>Irvine, CA 92618<br>Registration No.: 3014162263 |
|-----------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ryan Kenney<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Email: [e-mail] |

| Date Summary Prepared: | July 19, 2022 |
|------------------------|---------------------------------------|
| Trade Name: | MAGIC Flow-Dependent Microcatheter |
| Common Name: | Catheter, Continuous Flush |
| Review Panel: | Cardiovascular, Neurology |
| Product Code: | KRA, QJP |
| Regulation Number: | 21 CFR 870.1210, 21 CFR 870.1250 |
| Regulation Name: | Continuous Flush Catheter |
| Device Classification: | Class II |
| Predicate Device: | MAGIC Infusion Catheter |
| | 510(k)#: K202366 |
| Reference Device: | Marathon Flow Directed Micro Catheter |
| | 510(k)#: K202318 |

### Device Description:

The MAGIC Flow-Dependent Microcatheter is 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 Flow-Dependent Microcatheter has an external hydrophilic coating which provides a lubricious surface during use.

A coated mandrel is included inside the MAGIC Flow-Dependent Microcatheter to provide support during product preparation and insertion through the guide catheter.

The MAGIC Flow-Dependent Microcatheter and accompanying support mandrel are provided sterile, nonpyrogenic, and intended for single use only.

### Indications for Use:

The MAGIC Flow-Dependent Microcatheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified embolization materials and diagnostic materials such as contrast media.

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Image /page/4/Picture/0 description: The image shows the Cobalt logo with the text "510(k) Summary: K213435" below it. The logo is a green circle with white circles inside of it, and the word "Cobalt" is written in green letters to the right of the circle. The text "510(k) Summary: K213435" is written in black letters.

# Device Comparison:

| | MAGIC Infusion Catheter<br>(K202366)<br>Predicate Device | Marathon Flow Directed Micro Catheter<br>(K202318)<br>Reference Device | MAGIC Flow-Dependent Microcatheter<br>(K213435)<br>Subject Device |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MAGIC Infusion Catheter is intended for<br>regional infusion of contrast materials into<br>selected vessels in the neurovasculature. The<br>MAGIC Infusion Catheter may be used for<br>controlled, regional infusion into selected<br>vessels and is not intended for use in the<br>coronary vasculature. | The Marathon Flow Directed Micro Catheter is<br>intended to access the peripheral and neuro<br>vasculature for the controlled selective infusion<br>of physician-specified therapeutic agents such<br>as embolization materials and of diagnostic<br>materials such as contrast media. | The MAGIC Flow-Dependent<br>Microcatheter is intended to access the<br>peripheral and neuro vasculature for the<br>controlled selective infusion of<br>physician-specified embolization<br>materials and diagnostic materials such<br>as contrast media. |
| Product Code | KRA | KRA, QJP | KRA, QJP |
| Dimensions | | | |
| Distal Outer Diameter | 1.2 F, 1.5 F, 1.8 F | 1.3 F | Same as K202366 |
| Shaft Length | 155 cm, 160 cm, 165 cm, 180 cm | 165 cm | Same as K202366 |
| Materials | | | |
| Catheter Body | PVC/Polyamide/Bismuth Carbonate | Grilamid/Pebax/Stainless-Steel/Adhesive/PTFE | Same as K202366 |
| Hub | Grilamid | Polypropylene | Same as K202366 |
| Hydrophilic Coating | Polyurethane/Polymer/Alcohol | Hyaluronic Acid/Acrylic Resin Binder | Same as K202366 |
| Mandrel | Stainless Steel/Polystyrene/Polyamide/PTFE | N/A | Same as K202366 |
| Marker Band | Platinum/Iridium | Platinum-Iridium Alloy | Same as K202366 |
| Strain Relief | Grilamid | Elvax/Dynaflex | Same as K202366 |
| Packaging Materials | | | |
| Carton | Multi-Layered Natural Fiber Composites | Natural, PTFE Tubing | Same as K202366 |
| Pouch | Tyvek® | High-Density Polyethylene | Same as K202366 |
| Stability | | | |
| Shelf Life | 5 Years | 1 Year | Same as K202366 |
| Sterilization | | | |
| Method | Ethylene Oxide | Ethylene Oxide | Same as K202366 |

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Image /page/5/Picture/0 description: The image shows the Cobalt logo, which is a green and white design. The logo is followed by the text "510(k) Summary: K213435". The text indicates that the image is related to a 510(k) summary, which is a type of premarket submission to the FDA for medical devices. The number K213435 is the reference number for the summary.

### Biocompatibility:

There are no differences with respect to the materials or technological characteristics of the subject device in comparison to the predicate device. Therefore, no new biocompatibility testing was conducted.

### Performance Data - Bench:

There are no differences with respect to the materials or technological characteristics of the subject device in comparison to the predicate device. To support the modification to the Indications for Use statement the following non-clinical bench testing was conducted for the subject device:

| Test | Test Method Summary | Results |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Compatibility with Embolic<br>Materials | The subject device was<br>evaluated using pre-defined<br>acceptance criteria to<br>demonstrate its ability to<br>successfully deliver an array of<br>embolic materials in a tortuous<br>anatomical model. | Pass |

# Performance Data - Animal:

Balt USA, LLC did not conduct non-clinical animal testing because the subject device is identical to the predicate device with respect to technological characteristics and the modified Indications for Use statement does not raise new questions of safety and effectiveness and is supported through the successful completion of non-clinical bench testing using well-established scientific methods.

# Performance Data - Clinical:

Balt USA, LLC did not conduct a clinical trial because the subject device is identical to the predicate device with respect to technological characteristics and the modified Indications for Use statement does not raise new questions of safety and effectiveness and is supported through the successful completion of nonclinical bench testing using well-established scientific methods.

# Conclusion:

The intended use and technological characteristics of the subject device are the same or similar to that of the predicate and reference devices. The successful completion of non-clinical bench testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate device.