For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.

Device Description

The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.

AI/ML Overview

This document describes the premarket notification for the Ablacath™ Mapping Catheter, a Class II medical device. The information provided outlines the device's technical specifications, intended use, and substantial equivalence to a predicate device (FIRMap® Catheter K163709). The document focuses on performance data derived from bench testing, preclinical animal studies, biocompatibility testing, and sterilization validation to demonstrate the device's safety and effectiveness.

Acceptance Criteria and Device Performance:

The document primarily relies on the concept of "substantial equivalence" to a predicate device (FIRMap® Catheter K163709) and the fulfillment of predefined acceptance criteria for various tests. The general statement "All tests met the predefined acceptance criteria" indicates the device performance and acceptance.

Table of Acceptance Criteria and Reported Device Performance:

While a direct quantitative table of acceptance criteria and specific numerical reported device performance for all tests is not explicitly provided in the excerpt, the document states that all tests met their predefined acceptance criteria. The comparison table (page 5-6) implicitly serves as a comparison of characteristics against the predicate, which can be seen as meeting the criteria of "similar technological characteristics."

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Bench Testing	Meet predefined acceptance criteria for: Visual/Dimensional, Mechanical Integrity (flexibility, kink, spline radial strength, etc.), Torque Resistance/Strength, Track Force/Withdrawal Cycling & Force, Radiopacity, Corrosion, Fluid Leak, Mating/Uncoupling Force, Tensile Testing, Continuity/Resistance/Pin Short, Electrical Safety.	"All tests met the predefined acceptance criteria."
Packaging	Meet predefined acceptance criteria for: Distribution, Environmental Conditioning, Aging, Packaging (Visual, Bubble Leak, Seal Strength).	"All tests met the predefined acceptance criteria."
Pre-clinical Studies	Ablacath Mapping Catheter conforms to intended user needs and indications for use, meets acute safety attributes, and is clinically acceptable with performance equivalent to predicate; No User Errors/Close Calls in usability.	"The Ablacath Mapping Catheter met all study endpoints; performance and acute safety requirements and was found to be clinically acceptable by all evaluators with the performance equivalent to the predicate device. No User Errors or Close Calls were observed..."
Biocompatibility	Meet endpoints based on ISO 10993 series for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Materials Mediated Rabbit Pyrogen Test, Hemocompatibility (Hemolysis, C3a and SC5b-9 Complement Activation, In Vivo Thromboresistance).	"All devices met their endpoints."
Sterilization	Meet endpoints based on ANSI/AAMI/ISO 11135-1:2014.	"Testing demonstrated that all endpoints were met."
Electrical Rating	Typical = ±27 V, 25 mA (Predicate)	Maximum = ±30 V, 25 mA (Ablacath) (Note: differences reflect actual testing, deemed not to raise new questions of safety/effectiveness).
Basket Dimensions	50 mm, 60 mm, 70 mm (Predicate)	50 mm, 60 mm (Ablacath)
All Other Device Characteristics	Identical to predicate device where stated (e.g., Catheter Shaft Diameter, Length, Number of Splines, Material, Number of Electrodes, Electrode Material, Electrode Configuration, Dielectric Strength, Sterility, SAL, Biocompatible).	"Identical" or "Yes" as stated in the comparison table.

Study Details:

The provided document describes pre-clinical studies, primarily bench testing and animal studies, rather than a clinical study evaluating human patient outcomes or a comparative effectiveness study involving human readers and AI. Thus, several of the requested points are not applicable or cannot be extracted from this specific 510(k) summary.

Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify exact sample sizes for each type of bench test (e.g., number of catheters tested for tensile strength). It implies that sufficient samples were used to demonstrate adherence to acceptance criteria.
- Preclinical Animal Studies: A "swine model" was used. The specific number of animals is not provided.
- Data Provenance: The preclinical animal studies were conducted in accordance with "CFR 21 Part 58" guidelines, which suggests they were conducted in the US or under US regulatory standards. The document does not specify if these were retrospective or prospective studies, but GLP (Good Laboratory Practice) validation and usability testing are typically prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the preclinical animal studies, "physician end-users" were involved as evaluators. The number of physicians and their specific qualifications (e.g., number of years of experience, sub-specialty) are not specified.
Adjudication Method for the Test Set:
- Not described. For the preclinical animal studies, it states "found to be clinically acceptable by all evaluators," implying consensus rather than formal adjudication by differing opinions. However, the exact adjudication method is not provided.
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 MRMC study described. This clearance is for a mapping catheter, not an AI-assisted diagnostic imaging device. Therefore, a study of human readers' improvement with AI assistance is not relevant to this submission and was not performed.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (catheter) for mapping, not a standalone algorithm.
The Type of Ground Truth Used:
- Bench Testing: Ground truth is defined by engineering specifications, material properties, and physical performance standards (e.g., ASTM, ISO standards).
- Preclinical Animal Studies: "Acute safety attributes" and "performance requirements" were evaluated against predefined endpoints and comparison to the predicate device's expected performance in a simulated clinical environment. The "ground truth" here would be the successful demonstration of functionality and safety in a living system according to expert clinical assessment and observed physiological responses.
The Sample Size for the Training Set:
- Not applicable. As this is a hardware device and not an AI/ML algorithm requiring a training set, this question is not relevant to the information provided.
How the Ground Truth for the Training Set was Established:
- Not applicable. (See point 7).

In summary, the document demonstrates the device's substantial equivalence to a legally marketed predicate through adherence to predefined acceptance criteria in rigorous bench testing and preclinical animal studies. It does not involve AI or human reader studies.

Summary

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March 17, 2023

Ablacon, Inc. % Laurie Lewandowski VP Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, Minnesota 55123

Re: K223666

Trade/Device Name: Ablacath™ Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: MTD Dated: February 16, 2023 Received: February 16, 2023

Dear Laurie Lewandowski:

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.

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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 and Part 809); 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 (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.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223666

Device Name Ablacath™ Mapping Catheter

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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510(k) SUMMARY - K223666

1. SUBMITTER INFORMATION

Submitter: Ablacon, Inc Frank Rodrigues 4800 Wadsworth Blvd. Ste. 310 Wheat Ridge, CO 80033 USA Email: fr@ablacon.com

Primary Contact: Laurie Lewandowski Consultant, Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123 Telephone: 612-770-4038 (cell) Email: laurie.lewandowski@ablacon.com

DATE PREPARED: December 07, 2022

2. DEVICE INFORMATION

Proprietary Name: Regulation Number: Regulation Name: Common/Usual Name: Regulatory Class: Product Code:

Ablacath™ Mapping Catheter 21 CFR 870.1220

Electrode Recording Catheter or Electrode Recording Probe Catheter, Intracardiac Mapping, High-Density Array Class II MTD

3. PREDICATE DEVICE INFORMATION

Proprietary Name:	FIRMap® Catheter
Regulation Number:	21 CFR 870.1220
Regulation Name:	Electrode Recording Catheter or Electrode Recording Probe
Common/Usual Name:	Catheter, Intracardiac Mapping, High-Density Array
Regulatory Class:	Class II
Product Code:	MTD
510K Number:	K163709

4. DEVICE DESCRIPTION

The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver

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externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system.

The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.

. AB-0003-50 is the 50 mm basket size
AB-0003-60 is the 60 mm basket size ●

5. INDICATION FOR USE

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacon Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Ablacath Mapping Catheters have similar technological characteristics as the predicate, Abbott FIRMap Catheter, cleared under K163709. The subject and predicate device both are used for intracardiac electrophysiology mapping and pacing.

A comparison of the Ablacath Mapping Catheter and the FIRMap Catheter is in the following table.

Attribute / DeviceCharacteristics	Proposed DeviceAblacath™ Mapping Catheter	FIRMap® CatheterK163709Predicate
Intended Use	Intracardiac electrophysiologymapping and pacing	Identical
Indications for use	For use in cardiacelectrophysiology procedures toassist in the diagnosis ofarrhythmias that may be difficultto identify using conventionalmapping systems alone (i.e., linearmapping catheters). The AblacathAblacath™ Mapping Catheter mayalso be used for delivery ofexternally generated pacingstimuli.	For use in cardiac electrophysiologyprocedures to assist in the diagnosisof arrhythmias that may be difficult toidentify using conventional mappingsystems alone (i.e., linear mappingcatheters). The FIRMap Catheter mayalso be used for delivery of externallygenerated pacing stimuli.
Users	Electrophysiologists	Identical
Device Components	Basket	Identical

Ablacon Inc., Ablacath™ Mapping Catheter K223666

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Attribute / DeviceCharacteristics	Proposed DeviceAblacath™ Mapping Catheter	FIRMap® CatheterK163709Predicate
	ShaftHandleIntroducer Tool
Basket Dimensions	50 mm60 mm	50 mm60 mm70 mm
Catheter ShaftDiameter	2.8 mm	Identical
Length	$128\pm 1$ cm	Identical
Effective Length	113 cm	Identical
Recommended GuideSheath Size	8.5F	Identical
Number of Splines	8 (expanding)	Identical
Strut Material	Nitinol	Identical
Spine Tube Material	Pebax	Identical
Catheter Tubing	Pebax	Identical
Number of Electrodes	64	Identical
Electrode Material	Gold Plated Copper	Identical
ElectrodeConfiguration	Unipolar or Bipolar	Identical
Electrical Rating	Maximum = ±30 V, 25 mA	Typical = ±27 V, 25 mA
Dielectric Strength	500 VDC	500 VDC
Sterility	EO sterilized	Identical
SAL	1x10-6	Identical
Biocompatible	Yes	Identical

The Ablacath Mapping Catheter has the same intended use and indications for use as the predicate. The technological characteristics are similar to the predicate. The difference electrical rating reflects the actual testing performed on the subject device. The Ablacath Mapping Catheter is substantially equivalent to the predicate device.

7. PERFORMANCE DATA

Bench Testing

All testing was performed pre and post aging (per ASTM F1980:2016), except for radiopacity and electrical safety testing, that were performed at T=0.

. Visual / Dimensional

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Mechanical Integrity-flexibility, kink, spline radial strength, basket vertical compression Flexibility
Torque Resistance / Strength ●
Track Force/Withdrawal Cycling and Withdrawal Force ●
Radiopacity per ASTM F640 ●
Corrosion per ISO 10555-1
Fluid Leak
Mating / Uncoupling Force
. Tensile Testing per ISO 10555-1
Continuity / resistance / pin short, spline orientation, and connector alignment ●
Electrical Safety Testing per ISO 60601-1 ●

Packaging

Distribution per ASTM D4169:2016 ●
Environmental Conditioning per ISTA 3A:2011
Aging per ASTM F1980:2016
Packaging per ISO 11607-1:2006
- Visual per ASTM F1886-16/F1886M-16 o
- Bubble Leak per ASTM F2096-11:2019 o
- Seal Strength per ASTM F88/F88M-15 O

All tests met the predefined acceptance criteria. The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.

Summary of Pre-clinical Studies

Preclinical animal studies were performed to confirm validation and usability requirements using a swine model under simulated use conditions. The studies complied with the guidelines for nonclinical laboratory studies as described in CFR 21 Part 58.

. GLP Validation Testing
The purpose of the study was to ensure that Ablacath Mapping Catheter conformed to the intended user needs and indication for use through the evaluation of each performance requirement and met acute safety attributes as evaluated by physician end-users. The Ablacath Mapping Catheter met all study endpoints; performance and acute safety requirements and was found to be clinically acceptable by all evaluators with the performance equivalent to the predicate device.
. GLP Usability Testing
The purpose of the study was to obtain performance data through observation of the end-users under simulated end-use environment. No User Errors or Close Calls were observed in any of the physician end-users in the conduct of the usability validation study.

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Biocompatibility

Biocompatibility testing was performed in accordance with:

. ISO 10993-1:2018 for a limited (<24 hour), externally communicating, circulating blood contacting device
Chemical Characterization per ISO 10993-18:2020 ●
Cytotoxicity: MEM Extraction Cytotoxicity Assay per ISO 10993-5:2009
Sensitization: Guinea Pig Maximization Test per ISO 10993-10:2010 ●
Irritation: Intracutaneous Reactivity Test. per ISO10993-10:2010 ●
. Toxicity: Acute Systemic Toxicity per ISO 10993-11:2017
Toxicity: Materials Medicated Rabbit Pyrogen Test ISO 10993-11:2017
. Hemocompatibility: Hemolysis Direct and Indirect per ISO 10993-4: 2017
. Hemocompatibility: C3a and SC5b-9 Complement Activation ISO 10993-4: 2017
. Hemocompatibility: In Vivo Thromboresistance ISO 10993-4: 2017

All devices met their endpoints.

Sterilization:

Sterilization (ethylene oxide) and packaging of the Ablacath Mapping Catheter were validated using the following standards:

ANSI/AAMI/ISO 11135-1:2014 Sterilization of health-care products -. ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices
Testing demonstrated that all endpoints were met.

8. CONCLUSION

The Ablacath Mapping Catheter is substantially equivalent in terms of the intended use, indications for use, technological characteristic, performance testing and comparison to the cited predicate, and does not present any new questions of safety and effectiveness.

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).