The catheter is intended for use in diagnostic electrophysiologic procedures in adult patients. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Device Description

The ViaCath* and the AcQRate Dx Steerable Catheters are temporary, steerable, multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.

The main components of the ViaCath catheter are the distal catheter tip with electrodes, catheter shaft, handle, and connecting cable with pluq, which is a Redel connector. The ViaCath product family includes the ViaCath and the ViaCath NG models. Multiple electrode configurations are available with various numbers of electrodes, electrode shapes and electrode spacing.

Unless otherwise noted, the term "ViaCath" is used throuqhout to represent either ViaCath or AcQRate Dx Steerable Catheter.

AI/ML Overview

The document provided is a 510(k) summary for a medical device (ViaCath Catheter and AcQRate Dx Steerable Catheter) and a related patient cable (MPK-R). This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data. Therefore, many of the requested items related to AI/algorithm performance and clinical studies are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of medical device clearance are generally based on meeting recognized industry standards and demonstrating that the device performs as intended without raising new questions of safety or effectiveness compared to a predicate device. The "reported device performance" is essentially that the device successfully passed all the specified tests.

Test Performed	Acceptance Criteria/Standard	Reported Device Performance
ViaCath Catheter
Dimensional and Visual Inspection	Requirements of EN ISO 10555-1 met and correspond to defined specifications.	Pass
Functional and Compatibility Testing	Leakage currents below limits given in IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012.	Pass
Electrical and Mechanical Testing	Applicable requirements of EN ISO 10555-1, EN 62366-1, and EN ISO 60601-1 met, ensuring catheter safety.	Pass
Shelf Life	Confirmation of device functional performance and sterile barrier pouch integrity (seal strength per ASTM F88 and bubble per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16.	Pass
Packaging	Sterile barrier package integrity evaluated using transport simulation, preconditioning, seal strength, peel, and bubble testing.	Pass
Biocompatibility	Requirements of ISO 10993 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and 2020 FDA Biocompatibility guidance met.	Pass
Sterilization Validation	Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014 Sterilization of health care products - Ethylene oxide: Requirements of development, validation and routine control of a sterilization process for medical devices.	Pass
MPK-4-R and MPK-10 Patient Cables
Functional testing (after real-time aging)	a) Visual inspection of packaging and product; b) Functional test of product; c) Electrical measurement.	a) Pass, b) Pass, c) Pass
Sterilization Validation	Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014 Sterilization of health care products - Ethylene oxide: Requirements of development, validation and routine control of a sterilization process for medical devices.	Pass
Reprocessing Validation	Cable can be reprocessed up to 50 times.	Pass

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

The document describes nonclinical bench testing. It does not specify the exact sample sizes for each test. For instance, for "Dimensional and Visual Inspection," it likely involved a sample of manufactured catheters, but the number is not provided. Similarly for other tests like "Functional and Compatibility Testing" or "Mechanical Testing."

The data provenance is from bench testing conducted by the manufacturer, BIOTRONIK, Inc. and VascoMed GmbH. This is retrospective in the sense that it's performed on manufactured devices, but it's not data from patient cases.

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

Not applicable. This is a nonclinical bench testing study of a physical device (catheter and cables), not an AI algorithm or a study requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication method for the test set

Not applicable for a nonclinical bench test of a physical device. Adjudication methods are relevant for studies involving human interpretation or subjective assessments.

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

No. This is not an AI-enabled device.

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

No. This is not an AI-enabled device.

7. The type of ground truth used

For the nonclinical tests, the "ground truth" is defined by the established specifications of the device and recognized international standards. For example, for "Dimensional Inspection," the ground truth is the specified dimensions. For "Electrical and Mechanical Testing," the ground truth is compliance with standards like EN ISO 10555-1 and EN ISO 60601-1.

8. The sample size for the training set

Not applicable. This is not an AI-enabled device that requires a training set.

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

Not applicable. This is not an AI-enabled device that requires a training set.

In summary:

This 510(k) submission seeks substantial equivalence for a physical medical device (catheter and cables) based entirely on nonclinical bench testing. It clearly states "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." Therefore, questions pertaining to AI performance, clinical study design, expert ground truth, and training data are not relevant to this specific regulatory review. The device's performance is demonstrated through adherence to design specifications and relevant international standards.

Summary

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October 15, 2021

BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035

Re: K212593

Trade/Device Name: ViaCath Catheter; AcQRate Dx Steerable Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: August 13, 2021 Received: August 16, 2021

Dear Jon Brumbaugh:

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

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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 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 mediation-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,

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular 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) K212593

Device Name ViaCath Catheter AcQRate Dx Steerable Catheter

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

VIACATH CATHETERS

	510(k) NOTIFICATION K212593
Date Prepared:	August 12, 2021
Contact:	Jon BrumbaughVice President, Regulatory Affairs & New Product DevelopmentBIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035 USAPhone (888) 345-0374Fax (800) 913-6993Email: jon.brumbaugh@biotronik.com
Manufacturer:	VascoMed GmbHHertzallee 179589 Binzen, GermanyPhone: +49 (0)7621 16011 0Fax: +49 (0)7621 16011 9191
Trade Name:	ViaCath CatheterAcQRate Dx Steerable Catheter
Generic/Common Name:	Steerable Diagnostic Catheters
Classification Name:	Electrode recording catheter or electrode recording probe
Classification & Panel:	Class II / 21 CFR § 870.1220, Cardiovascular
Product Code:	DRF
Predicate Device:	StableMapr Steerable Intracardiac Electrode Catheter(K183547, cleared in July 30, 2019)

Catheter

Device Description [807.92(a)(4)]

Unless otherwise noted, the term "ViaCath" is used throuqhout to represent either ViaCath or AcQRate Dx Steerable Catheter.

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Indications for Use [807.92(a)(5)]

The indications for use of the catheters are substantially equivalent to that for the predicate.

Comparison of Technological Characteristics with the Predicate Devices [807.92(a)(6)]

The BIOTRONIK ViaCath Catheters are substantially equivalent to the predicate for this submission, the StableMapr Steerable Intracardiac Electrode Catheter (K183547). These products have the same intended purpose, identical indications for use and have comparable safety and technological features.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the ViaCath Catheter performance testing.

Comparison of Characteristics between Proposed and Predicate Devices
Characteristics	Subject DeviceBIOTRONIKViaCath Catheter(K212593)	Predicate DeviceStableMapr™SteerableIntracardiacElectrode Catheter(K183547)	Rationale for SubstantialEquivalence
Indications forUse	The catheter isintended for use indiagnosticelectrophysiologicprocedures in adultpatients. Thesecatheters aredesigned forrecordingintracardiacelectrograms andtemporary pacingassociated withelectrophysiologystudies.	TheStableMapr™SteerableIntracardiacElectrode Cathetersare Intended for usein diagnosticelectrophysiologicprocedures.Designed forrecording intracardiacelectrograms andtemporary pacingassociated withelectrophysiologystudies.	Substantially equivalent.Minor differences in wordingdo not raise differentquestions of safety oreffectiveness.
Electrodematerial	Platinum/iridium	Platinum/iridium	Identical
Comparison of Characteristics between Proposed and Predicate Devices
	Subject Device	Predicate Device
Characteristics	BIOTRONIKViaCath Catheter(K212593)	StableMapr™SteerableIntracardiacElectrode Catheter(K183547)	Rationale for SubstantialEquivalence
Size	Outside diameter: 6F(2mm)Length of tipelectrode: 2mmLength of ringelectrodes: 1mmEffective lengthViaCath NG: 110 cmEffective lengthViaCath: 90 cm	Outside diameter: 7FLength of tipelectrode: 2mmEffective length: 110cm	Substantially equivalent.Minor differences do not raisedifferent questions of safetyor effectiveness.
Poles(Electrodes)	4, 5, 10 or 20 poles	20 poles	Substantially equivalent.Minor differences do not raisedifferent questions of safetyor effectiveness.
Curve Shapes	ViaCath NG: 3 curveshapesViaCath 20: 1 curveshape	Variable curve shapes	Similar design features.Minor differences do not raisedifferent questions of safetyor effectiveness.
Connector type	ViaCath NG: 4 pin,10 pinViaCath: 10 pin	10 pin	Similar design features.Minor differences do not raisedifferent questions of safetyor effectiveness.
ElectrodeSpacing	ViaCath: 2-8-2 mmViaCath NG: 2mm,5mm, 2-6-2mm, 2-8-2mm, 2-10-2mm	2-10-2 mm	Substantially equivalent. Theminor difference in electrodespacing does not raise newissues of safety andeffectiveness.
Single Use	Yes	Yes	Identical
Supplied Sterile	Yes	Yes	Identical

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Performance Data [807.92(b)]

All necessary bench testing was conducted on the ViaCath Catheter to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device.

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Nonclinical Testing Summary [807.92(b)(1)]

The nonclinical bench testing included:

. Design Verification
- Dimensional Inspection o
- Visual Inspection o
- Functional and Compatibility Testing o
- Mechanical Testing O
- Corrosion Testing o
Design Validation ●
- Usability Testing
. Biocompatibility Testing

In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ViaCath Catheters meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the ViaCath Catheters do not introduce new issues of safety or effectiveness when compared to the predicate device.

Test performed	Device	Test method summary	Results
Dimensional and VisualInspection	ViaCath	Testing demonstrate that requirements ofEN ISO 10555-1 have been met andcorrespond to the defined specifications.	pass
Functional andCompatibility Testing	ViaCath	Functional and compatibility testing wasperformed with FDA approved externalgenerators. The results of the leakagecurrents testing revealed an outcome belowthe limits given in the standard IEC 60601-1:2005, COR1:2006, COR2:2007,AMD1:2012.	pass
Electrical andMechanical Testing	ViaCath	Testing demonstrates that applicablerequirements of EN ISO 10555-1, EN62366-1 and En ISO 60601-1 have beenmet to ensure that the catheter is safe.	pass
Shelf life	ViaCath	Confirmation of device functionalperformance and sterile barrier pouchintegrity (seal strength per ASTM F88 andbubble per ASTM F2096) with acceleratedaging and simulated distribution per ASTM4169-16.	pass
Packaging	ViaCath	The methods applied to evaluate the sterilebarrier package integrity included transportsimulation, preconditioning, seal strength,peel and bubble testing.	pass

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Test performed	Device	Test method summary	Results
Biocompatibility	ViaCath	The biocompatibility testing demonstratesthat the requirements of ISO 10993"Biological evaluation of medical devices -Part 1: "Evaluation and testing within a riskmanagement process" and the 2020 FDABiocompatibility guidance 2have been met.	pass
Sterilization Validation	ViaCath	Full Revalidation of Sterilization ProcessPerformance QualificationISO 11135:2014 Sterilization of health careproducts - Ethylene oxide: Requirements ofdevelopment,validation and routine control of asterilization process for medical devices.	pass

Clinical Performance Data [807.92(b)(2)]

No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.

Cable

Device description:

BIOTRONIK's MPK-4-R and MPK-10 patient cables are four or ten channel cables to connect electrophysiological diagnostic catheters distributed by BIOTRONIK (e.g. MultiCath, ViaCath) and Acutus Medical (AcQRate Dx Fixed Curve Catheter, AcQRate Dx Steerable Catheter) with electrophysiological examination units and stimulators.

Intended use:

MPK-4-R and MPK-10-R are used to connect BIOTRONIK and Acutus Medical diagnostic catheters to a cardiac stimulator or a lab monitoring system for intracardiac diagnostics as part of an electrophysiological study. MPK-R and diagnostic catheters may only be used by medical personnel qualified to work with lab monitoring systems. Patient cables may not be physically modified, e.g., be shortened.

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Cables Functional and Safety Testing:

Test performed	Device	Test method summary	Results
Functional testing:visual inspection,dimensionalverification, electricalcontinuity andresistance, mechanicalcharacteristics	MPK	For validation of the product properties afterreal time aging of 25 months following testsare performed:a) Visual inspection of the packaging andproductb) Functional test of the productc) Electrical measurement	a) Passb) Passc) Pass
Sterilization Validation	MPK	Full Revalidation of Sterilization ProcessPerformance Qualification ISO 11135:2014Sterilization of health care products -Ethylene oxide: Requirements ofdevelopment,validation and routine control ofa sterilization process for medical devices.	Pass
Reprocessing Validation	MPK	Testing demonstrates that the cable can bereprocessed up to 50 times.	Pass

Conclusions [807.92(b)(3)]

Based on the performance testing and the technological characteristics, it can be concluded that the ViaCath Catheter meets its established performance for its intended use and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).