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 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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the MAGIC Flow-Dependent Microcatheter (K213435). This document does NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. Instead, it details a comparison between the subject device and predicate/reference devices to establish substantial equivalence.

The "acceptance criteria" and "device performance" mentioned in the document relate to bench testing done to demonstrate the subject device's ability to deliver embolic materials. This is not for software performance but for the physical device's function. No AI/ML component is mentioned in the device description or testing.

Therefore, I cannot provide the requested information for an AI/ML device study.

However, based on the provided document, here is the information related to the physical device's performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

Acceptance Criteria (related to bench testing)	Reported Device Performance
Ability to successfully deliver an array of embolic materials in a tortuous anatomical model.	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The description only states "The subject device was evaluated..."
Data Provenance: The test was non-clinical bench testing, meaning it was conducted in a laboratory setting, not with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. For physical device bench testing, "ground truth" is typically established by engineering specifications and direct physical measurement/observation against those specifications, not by expert consensus in diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable. The testing was a direct performance evaluation against predefined criteria, not an interpretive task requiring adjudication.

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 a physical medical device (microcatheter), not an AI/ML algorithm that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used:

For the bench testing, the "ground truth" would be the successful delivery of embolic materials as defined by engineering and performance specifications in the tortuous anatomical model.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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, LLC29 ParkerIrvine, CA 92618Registration No.: 3014162263
Contact Person:	Ryan KenneySpecialist, Regulatory AffairsTelephone: (949) 788-1443Email: ryan.kenney@baltgroup.com

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:

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:

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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(K202366)Predicate Device	Marathon Flow Directed Micro Catheter(K202318)Reference Device	MAGIC Flow-Dependent Microcatheter(K213435)Subject Device
Indications for Use	The MAGIC Infusion Catheter is intended forregional infusion of contrast materials intoselected vessels in the neurovasculature. TheMAGIC Infusion Catheter may be used forcontrolled, regional infusion into selectedvessels and is not intended for use in thecoronary vasculature.	The Marathon Flow Directed Micro Catheter isintended to access the peripheral and neurovasculature for the controlled selective infusionof physician-specified therapeutic agents suchas embolization materials and of diagnosticmaterials such as contrast media.	The MAGIC Flow-DependentMicrocatheter is intended to access theperipheral and neuro vasculature for thecontrolled selective infusion ofphysician-specified embolizationmaterials and diagnostic materials suchas 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 EmbolicMaterials	The subject device wasevaluated using pre-definedacceptance criteria todemonstrate its ability tosuccessfully deliver an array ofembolic materials in a tortuousanatomical 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.

Regulation Number and Section

§ 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).