(100 days)
Not Found
No
The summary describes a physical mapping catheter and its function in detecting electrical signals. There is no mention of software analysis using AI/ML, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a mapping catheter used to assist in the diagnosis of arrhythmias and detect electrical potentials, which are diagnostic functions. While it can deliver pacing stimuli, this is explicitly stated to be for generating those stimuli for mapping purposes rather than for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to assist in the diagnosis of arrhythmias".
No
The device description explicitly details a physical catheter with electrodes and an expandable basket, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the diagnosis of arrhythmias" by detecting electrical potentials from the endocardial surfaces of the heart. This is a direct measurement of physiological signals within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a catheter designed to be inserted into the heart to detect electrical signals. This is an invasive medical device used for in-vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological state, disease, or condition. This device operates within the body to gather information directly.
N/A
Intended Use / Indications 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 Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.
Product codes
MTD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocardial surfaces of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrophysiologists
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
Not Found
Summary of Performance Studies
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. Tests included Visual / Dimensional, 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 tests included 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, Bubble Leak per ASTM F2096-11:2019, Seal Strength per ASTM F88/F88M-15). All tests met the predefined acceptance criteria.
Pre-clinical Studies: Acute safety attribute and performance validation using a swine model under simulated use conditions. Studies complied with guidelines for nonclinical laboratory studies as described in CFR 21 Part 58.
GLP Validation Testing: Purpose was to ensure Ablacath Mapping Catheter conformed to intended user needs and indications for use through evaluation of performance requirements and acute safety attributes 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 performance equivalent to the predicate device.
GLP Usability Testing: Purpose was to obtain performance data through observation of end-users under simulated end-use environment. No User Errors or Close Calls were observed in any of the physician end-users.
Biocompatibility: Testing performed in accordance with ISO 10993-1:2018 for a limited (
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K223666
Device Name Ablacath™ Mapping Catheter
Indications for Use (Describe)
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.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the Ablacon logo. The logo consists of an orange, geometric shape resembling a stylized heart or a folded paper, followed by the word "ablacon" in lowercase, sans-serif font. The text is in a dark gray or black color, providing a contrast against the white background.
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
4
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 / Device
Characteristics | Proposed Device
Ablacath™ Mapping Catheter | FIRMap® Catheter
K163709
Predicate |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intracardiac electrophysiology
mapping and pacing | Identical |
| Indications 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 Ablacath
Ablacath™ Mapping Catheter may
also be used for delivery of
externally generated pacing
stimuli. | 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 FIRMap Catheter may
also be used for delivery of externally
generated pacing stimuli. |
| Users | Electrophysiologists | Identical |
| Device Components | Basket | Identical |
Ablacon Inc., Ablacath™ Mapping Catheter K223666
5
| Attribute / Device
Characteristics | Proposed Device
Ablacath™ Mapping Catheter | FIRMap® Catheter
K163709
Predicate |
|---------------------------------------|-----------------------------------------------|------------------------------------------|
| | Shaft
Handle
Introducer Tool | |
| Basket Dimensions | 50 mm
60 mm | 50 mm
60 mm
70 mm |
| Catheter Shaft
Diameter | 2.8 mm | Identical |
| Length | $128\pm 1$ cm | Identical |
| Effective Length | 113 cm | Identical |
| Recommended Guide
Sheath 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 |
| Electrode
Configuration | 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
6
- 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.
7
Biocompatibility
Biocompatibility testing was performed in accordance with:
- . ISO 10993-1:2018 for a limited (