The MultiCath* and the AcQRate Dx Fixed Curve Catheter are pre-shaped multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.

The device consists of a catheter body with a distal curve, an array of platinum/iridium (PtIr) electrodes, and a proximal multipolar connector. Multiple electrode configurations are available with various numbers of electrodes and electrode spacing.

Unless otherwise noted, the term "MultiCath" is used throughout to represent either MultiCath or the AcQRate Dx Fixed Curve Catheter.

AI/ML Overview

The provided text is a 510(k) Summary for the BIOTRONIK MultiCath and AcQRate Dx Fixed Curve Catheter, and related MPK patient cables. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does NOT describe a study that proves the device meets specific acceptance criteria in terms of AI/algorithm performance (e.g., sensitivity, specificity, accuracy). The device in question is an electrophysiological catheter and patient cables for cardiac mapping and recording, which are hardware devices, not AI/algorithm-based diagnostic software.

Therefore, I cannot fulfill your request for information related to AI/algorithm performance, acceptance criteria for such algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The provided text focuses on the following types of performance data for a medical device (hardware):

Nonclinical Bench Testing: This includes design verification (dimensional, visual inspection, functional/compatibility, mechanical, corrosion testing) and design validation (usability testing).
Biocompatibility Testing: To ensure the materials are safe for human contact.
Sterilization, Shelf Life, and Packaging Validations: To ensure the device remains sterile and functional over time.

The acceptance criteria are implicitly that the device passes these various engineering and safety tests and demonstrates substantial equivalence to the predicate device in terms of functionality and safety. The reported device performance is "pass" for all listed tests.

To directly answer your request based only on the provided text, while acknowledging the mismatch with an AI/algorithm context:

1. A table of acceptance criteria and the reported device performance:

Test Performed	Implicit Acceptance Criteria	Reported Device Performance
Dimensional and Visual Inspection	Requirements of EN ISO 10555-1 met and correspond to defined specifications.	Pass
Functional and Compatibility Testing (including leakage currents)	Leakage currents below limits of IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012; proper functionality and compatibility with external generators.	Pass
Electrical and Mechanical Testing	Applicable requirements of EN ISO 10555-1, EN 62366-1, and EN ISO 60601-1 met to ensure safety.	Pass
Shelf Life (functional performance, sterile barrier pouch integrity - seal strength, bubble per ASTM F88, ASTM F2096)	Confirmation of device functional performance and sterile barrier pouch integrity with accelerated aging and simulated distribution (ASTM 4169-16).	Pass
Packaging (integrity, transport simulation, preconditioning, seal strength, peel, bubble testing)	Evaluation of sterile barrier package integrity against transport simulation and relevant tests.	Pass
Biocompatibility	Requirements of ISO 10993 "Biological evaluation of medical devices - Part 1" and 2020 FDA Biocompatibility guidance met.	Pass
Sterilization Validation (Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014)	Requirements of ISO 11135:2014 met for ethylene oxide sterilization.	Pass
Functional testing of MPK (visual inspection, dimensional verification, electrical continuity and resistance, mechanical characteristics after real-time aging)	Product properties validated after 25 months real-time aging; visual inspection, functional test, electrical measurement all pass.	Pass (a, b, c)
Reprocessing Validation (MPK cable)	Cable can be reprocessed up to 50 times.	Pass

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

The document does not specify exact sample sizes (N) for each individual test. It states "All bench testing was conducted on the MultiCath Catheters necessary for Electrophysiological Diagnostics."
Data provenance: Not explicitly stated, but implies internal company testing (BIOTRONIK / VascoMed GmbH in Germany) for the devices. It is non-clinical bench data.

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

Not applicable as this is hardware testing against engineering standards, not a diagnostic algorithm requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable; standard engineering and laboratory testing protocols are followed, where pass/fail is determined by objective measurements against predefined specifications.

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 device is a catheter and cables, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

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

Not applicable. This is a hardware device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For hardware, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, IEC, ASTM) and the manufacturer's own validated design specifications. The performance is objectively measured against these, not against human expert consensus or clinical outcomes data in the context of this 510(k).

8. The sample size for the training set:

Not applicable. This is not an AI/ML algorithm that requires training data.

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

Not applicable.

In summary, the provided document is a 510(k) submission for a physical medical device (catheter and cables), not an AI/ML-based diagnostic software. Therefore, many of the questions regarding AI/ML performance metrics, data sets, and expert involvement are not relevant to this document's content.

Summary

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September 2, 2021

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

Re: K201445

Trade/Device Name: MultiCath, AcQRate Dx Fixed Curve Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 30, 2021 Received: August 2, 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 (Acting) 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) K201445

Device Name MultiCath AcQRate Dx Fixed Curve Catheter

Indications for Use (Describe)

The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.

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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510(k) Summary

MULTICATH CATHETERS FOR ELECTROPHYSIOLOGICAL DIAGNOSTICS

510(K) NOTIFICATION K201445

Date Prepared:	May 28, 2020
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:	MultiCathAcQRate Dx Fixed Curve Catheter
Generic/Common Name:	Catheters for Electrophysiological Diagnostics
Classification Name:	Catheter, Electrode Recording, Or Probe, Electrode Recording
Classification & Panel:	Class II / 21 CFR § 870.1220, Cardiovascular
Product Code:	DRF
Predicate Device:	Cordis Webster fixed curve catheters(K992965, cleared November 26, 1999)

Catheter

Device Description [807.92(a)(4)]

Unless otherwise noted, the term "MultiCath" is used throughout to represent either MultiCath or the AcQRate Dx Fixed Curve Catheter.

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

The indications for use for the MultiCath Catheter and the predicate are the same.

The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.

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

The MultiCath Catheters are substantially equivalent to the predicate devices based on comparisons of the device functionality, technological characteristics, and intended use. The differences in tip curvature offerings are minor and do not raise new issues of safety and effectiveness. The diameter and number of electrodes have been evaluated through bench and biocompatibility testing. Bench testing demonstrated that the subject device is substantially equivalent to the predicate device.

Comparison of Characteristics between Proposed and Predicate Devices
	Subject Device	Predicate Device
Characteristics	BIOTRONIKMultiCath Catheters(K201445)	Cordis WebsterFixed CurveCatheters(K992965)	Rationale for SubstantialEquivalence
Precurved tip	Yes	Yes	Identical
Electrodematerial	Platinum/iridium	Platinum/iridium	Identical
Steerable	No	No	Identical
Tip type	Normal or soft tip	Normal or soft tip	Identical
Poles(Electrodes)	4, 5, or 10 electrodes	10 electrodes	Substantially equivalent. TheMultiCath is available with asfew as 4 electrodes. The modelswith fewer than 10 electrodesdo not introduce new issues ofsafety and effectiveness.
Diameters	6 F, 5 F and 4 Fversions	6 F, 5 F and 4 Fversions	Identical
Curve Type	HIS, Josephson,Damato, Courmand,Josephson special,Multi-purpose	HIS, Josephson,Damato, Courmand,Levine	Substantially equivalent. TheMultiCath is available in 6 tipcurvatures. The minordifferences in tip shapes donot introduce new issues ofsafety and effectiveness.
Insertion length	80, 100, 110 cm	60, 110, 115, 120 cm	Substantially equivalent. TheMultiCath has three differentlengths, which fall within therange of lengths for the clearedpredicate. There is no new worstcase. Any difference in lengthsdoes not introduce new issues ofsafety and effectiveness.

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Comparison of Characteristics between Proposed and Predicate Devices
	Subject Device	Predicate Device
Characteristics	BIOTRONIKMultiCath Catheters(K201445)	Cordis WebsterFixed CurveCatheters(K992965)	Rationale for SubstantialEquivalence
Torque shaft	Yes	Yes	Identical
Tip electrodesize	1.67 mm	1 mm	Substantially equivalent. Theminor difference in tip sizedoes not introduce new issuesof safety and effectiveness.
ElectrodeSpacing	Various electrodespacings available:2-5-2 mm, 2-8-2 mm,2 mm, 5 mm,5-5-5-280 mm	Various electrodespacings available:2-5-2 mm, 2-8-2 mm,and 2-10-2 mm	Substantially equivalent. Theminor difference in electrodespacing does not introducenew issues of safety andeffectiveness.
Single Use	Yes	Yes	Identical
Supplied Sterile	Yes	Yes	Identical
Internal BraidDesign	Yes	Yes	Identical

Performance Data [807.92(b)]

All bench testing was conducted on the MultiCath Catheters necessary for Electrophysiological Diagnostics 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
- o Corrosion Testing
Design Validation .
- Usability Testing
. Biocompatibility Testing

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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 MultiCath Catheters meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the MultiCath 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	MultiCath	Testing demonstrate that requirements ofEN ISO 10555-1 have been met andcorrespond to the defined specifications.	pass
Functional andCompatibility Testing	MultiCath	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	MultiCath	Testing demonstrates that applicablerequirements of EN ISO 10555-1, EN 62366-1and EN ISO 60601-1 have been met to ensurethat the catheter is safe.	pass
Shelf life	MultiCath	Confirmation of device functional performanceand sterile barrier pouch integrity (sealstrength per ASTM F88 and bubble perASTM F2096) with accelerated aging andsimulated distribution per ASTM 4169-16.	pass
Packaging	MultiCath	The methods applied to evaluate the sterilebarrier package integrity included transportsimulation, preconditioning, seal strength,peel and bubble testing.	pass
Biocompatibility	ViaCath	The biocompatibility testing demonstrate thatthe requirements of ISO 10993 "Biologicalevaluation of medical devices -Part 1:"Evaluation and testing within a riskmanagement process" and the 2020 FDABiocompatibility guidance 2have been met.	pass
Sterilization Validation	MultiCath	Full Revalidation of Sterilization ProcessPerformance QualificationISO 11135:2014 Sterilization of health careproducts - Ethylene oxide: Requirements ofdevelopment, validation and routine control ofa sterilization process for medical devices.	pass
Test performed	Device	Test method summary	Results
Functional testing -visual inspection,dimensional verification,electrical continuity 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 controlof a sterilization process for medical devices.	pass
Reprocessing Validation	MPK	Testing demonstrates that the cable can bereprocessed up to 50 times.	pass

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

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

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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, AcQ 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.q., shortened.

Functional and Safety Testing:

Conclusions [807.92(b)(3)]

Based on the performance testing and the technological characteristics, it can be concluded that the MultiCath 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).