K Number

Device Name

ViaCath, AcQRate Dx Steerable Catheter

Manufacturer

Biotronick, Inc.

Date Cleared

2021-10-15

(60 days)

Product Code

DRF

Regulation Number

870.1220

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K183547

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical catheter for recording electrical signals and pacing, with no mention of software analysis or algorithms, let alone AI/ML.

Therapeutic

No
The device is described as being for "diagnostic electrophysiologic procedures" and for "recording intracardiac electrograms and temporary pacing associated with electrophysiology studies," which are diagnostic rather than therapeutic actions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states: "The catheter is intended for use in diagnostic electrophysiologic procedures in adult patients." and "These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies." The "Device Description" also mentions "sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device." These statements clearly indicate its use for diagnostic purposes.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like a catheter tip with electrodes, a shaft, a handle, and a connecting cable, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the catheter is for "diagnostic electrophysiologic procedures in adult patients" and is designed for "recording intracardiac electrograms and temporary pacing associated with electrophysiology studies." This describes a procedure performed within the body (in vivo) to gather electrical signals from the heart.
Device Description: The description reinforces this by stating it's a "temporary, steerable, multipolar catheter for sensing of intracardiac signals and diagnostic pacing." Again, this points to an in-body application.
IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).

This device is used inside the body to directly interact with and measure electrical activity of the heart, which is not the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DRF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracardiac

Indicated Patient Age Range

adult patients

Intended User / Care Setting

medical personnel qualified to work with lab monitoring systems.

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

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical bench testing was conducted on the ViaCath Catheter. This included:

Design Verification (Dimensional Inspection, Visual Inspection, Functional and Compatibility Testing, Mechanical Testing, Corrosion Testing)
Design Validation (Usability Testing)
Biocompatibility Testing

In addition, sterilization, shelf life and packaging validations were performed. The results collectively demonstrate that the chosen materials, manufacturing processes, and design meet established specifications for consistent performance during intended use and do not introduce new issues of safety or effectiveness compared to the predicate device.

Specific tests and their results:

Dimensional and Visual Inspection: Passed, met EN ISO 10555-1 requirements.
Functional and Compatibility Testing: Passed, performed with FDA approved external generators, leakage currents below limits of IEC 60601-1.
Electrical and Mechanical Testing: Passed, met applicable requirements of EN ISO 10555-1, EN 62366-1, and EN ISO 60601-1.
Shelf life: Passed, confirmed functional performance and sterile barrier integrity with accelerated aging and simulated distribution.
Packaging: Passed, evaluated sterile barrier package integrity through transport simulation, preconditioning, seal strength, peel, and bubble testing.
Biocompatibility: Passed, met ISO 10993 and 2020 FDA Biocompatibility guidance.
Sterilization Validation: Passed, full revalidation of sterilization process performance qualification ISO 11135:2014.

For the cables (MPK-4-R and MPK-10 patient cables):

Functional testing (visual inspection, dimensional verification, electrical continuity and resistance, mechanical characteristics) after 25 months of real-time aging: Passed.
Sterilization Validation (Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014): Passed.
Reprocessing Validation: Passed, demonstrated the cable can be reprocessed up to 50 times.

No clinical performance data was submitted or relied upon.

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.

StableMapr Steerable Intracardiac Electrode Catheter (K183547)

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

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).

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

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

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 Brumbaugh
Vice President, Regulatory Affairs & New Product Development
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035 USA
Phone (888) 345-0374
Fax (800) 913-6993
Email: jon.brumbaugh@biotronik.com
Manufacturer:	VascoMed GmbH
Hertzallee 1
79589 Binzen, Germany
Phone: +49 (0)7621 16011 0
Fax: +49 (0)7621 16011 9191
Trade Name:	ViaCath Catheter
AcQRate 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.

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 Device
BIOTRONIK
ViaCath Catheter
(K212593)	Predicate Device
StableMapr™
Steerable
Intracardiac
Electrode Catheter
(K183547)	Rationale for Substantial
Equivalence
Indications for
Use	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.	The
StableMapr™Steerable
Intracardiac
Electrode Catheters
are Intended for use
in diagnostic
electrophysiologic
procedures.
Designed for
recording intracardiac
electrograms and
temporary pacing
associated with
electrophysiology
studies.	Substantially equivalent.
Minor differences in wording
do not raise different
questions of safety or
effectiveness.
Electrode
material	Platinum/iridium	Platinum/iridium	Identical
Comparison of Characteristics between Proposed and Predicate Devices
	Subject Device	Predicate Device
Characteristics	BIOTRONIK
ViaCath Catheter
(K212593)	StableMapr™
Steerable
Intracardiac
Electrode Catheter
(K183547)	Rationale for Substantial
Equivalence
Size	Outside diameter: 6F
(2mm)
Length of tip
electrode: 2mm
Length of ring
electrodes: 1mm
Effective length
ViaCath NG: 110 cm
Effective length
ViaCath: 90 cm	Outside diameter: 7F
Length of tip
electrode: 2mm
Effective length: 110
cm	Substantially equivalent.
Minor differences do not raise
different questions of safety
or effectiveness.
Poles
(Electrodes)	4, 5, 10 or 20 poles	20 poles	Substantially equivalent.
Minor differences do not raise
different questions of safety
or effectiveness.
Curve Shapes	ViaCath NG: 3 curve
shapes
ViaCath 20: 1 curve
shape	Variable curve shapes	Similar design features.
Minor differences do not raise
different questions of safety
or effectiveness.
Connector type	ViaCath NG: 4 pin,
10 pin
ViaCath: 10 pin	10 pin	Similar design features.
Minor differences do not raise
different questions of safety
or effectiveness.
Electrode
Spacing	ViaCath: 2-8-2 mm
ViaCath NG: 2mm,
5mm, 2-6-2mm, 2-
8-2mm, 2-10-2mm	2-10-2 mm	Substantially equivalent. The
minor difference in electrode
spacing does not raise new
issues of safety and
effectiveness.
Single Use	Yes	Yes	Identical
Supplied Sterile	Yes	Yes	Identical

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.

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
Dimensional and Visual
Inspection	ViaCath	Testing demonstrate that requirements of
EN ISO 10555-1 have been met and
correspond to the defined specifications.	pass
Functional and
Compatibility Testing	ViaCath	Functional and compatibility testing was
performed with FDA approved external
generators. The results of the leakage
currents testing revealed an outcome below
the limits given in the standard IEC 60601-
1:2005, COR1:2006, COR2:2007,
AMD1:2012.	pass
Electrical and
Mechanical Testing	ViaCath	Testing demonstrates that applicable
requirements of EN ISO 10555-1, EN
62366-1 and En ISO 60601-1 have been
met to ensure that the catheter is safe.	pass
Shelf life	ViaCath	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	ViaCath	The methods applied to evaluate the sterile
barrier package integrity included transport
simulation, preconditioning, seal strength,
peel and bubble testing.	pass

Test performed	Device	Test method summary
Biocompatibility	ViaCath	The biocompatibility testing demonstrates
that the requirements of ISO 10993
"Biological evaluation of medical devices -
Part 1: "Evaluation and testing within a risk
management process" and the 2020 FDA
Biocompatibility guidance 2have been met.	pass
Sterilization Validation	ViaCath	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

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:

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.

Cables Functional and Safety Testing:

Test performed	Device	Test method summary
Functional testing:
visual inspection,
dimensional
verification, electrical
continuity and
resistance, mechanical
characteristics	MPK	For validation of the product properties after
real time aging of 25 months following tests
are performed:
a) Visual inspection of the packaging and
product
b) Functional test of the product
c) Electrical measurement	a) Pass
b) Pass
c) Pass
Sterilization Validation	MPK	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	MPK	Testing demonstrates that the cable can be
reprocessed 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.