(60 days)
Not Found
No
The description focuses on the physical characteristics and electrical signal recording capabilities of the catheter, with no mention of AI or ML for data analysis or interpretation.
No
The device is for diagnostic mapping of cardiac arrhythmias and recording intracardiac signals, not for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." The device description also refers to them as "Diagnostic Mapping Catheters."
No
The device description clearly details physical components such as catheters, electrodes, and connectors, 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 for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This involves directly interacting with the patient's body to record electrical signals and potentially stimulate the heart.
- Device Description: The description details a physical catheter designed to be inserted into the heart. It describes its physical characteristics, materials, and how it's used for recording intracardiac signals and cardiac stimulation.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not process samples; it directly interacts with the patient's internal environment.
The device described is a medical device used for electrophysiology studies, which are invasive procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Product codes
DRF
Device Description
The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient’s heart. They are available in fixed curve and steerable configurations.
The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies.
The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle. Table 5-1 lists the models and characteristics of the catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial and ventricular regions of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Map-iT™ Diagnostic Mapping Catheters were thoroughly tested based on existing standards and test methods. These tests included visual, dimensional, electrical performance - continuity, leakage impedance, dielectric; mechanical performance - tensile, torque, deflection, shaft buckling, radio-detectability, corrosion; biocompatibility (short term
§ 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
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2016
Access Point Technologies Ep, Inc. % Laurie Lewandowski Consultant Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, Minnesota 55123
Re: K160390
Trade/Device Name: Map-it™ Diagnostic Mapping Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: February 10, 2016 Received: February 11, 2016
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mitchell Stein
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160390
Device Name Map-ItTM Diagnostic Mapping Catheters
Indications for Use (Describe)
The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
| 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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Access Point Technologies 12560 Fletcher Lane Suite 300 Rogers, Minnesota 55374 USA Ph: 763-428-0010 Fax: 763-428-0012
==============================================================================================================================================================================
510(K) SUMMARY
Submitter:
Access Point Technologies EP (APT EP) dba APT Sean Carroll, President 12560 Fletcher Lane Suite 300 Rogers, MN 55374 763-428-0010 Telephone: Fax: 763-428-0012 Email: sean.carroll@apt-inc.us
Primary Contact:
| Laurie Lewandowski | |
|---|---|
| Consultant, Honkanen Consulting | |
| 738 Saddle Wood Drive | |
| Eagan, MN 55123 | |
| Telephone: | 612-770-4038 (cell) |
| Fax: | 763-428-0012 |
| Email: | lalew207@gmail.com |
DATE PREPARED:
April 9, 2016
NAME OF MEDICAL DEVICE:
| Proprietary Name: | Map-iT TM Diagnostic Mapping Catheters |
|---|---|
| Common/Usual Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Electrode Recording Catheter |
4
DEVICE CLASSIFICATION:
| Classification Panel: | Cardiovascular |
|---|---|
| Regulatory Class: | II |
| Product Code: | DRF |
| Regulation Number: | 21 CFR 870.1220 |
PREDICATE DEVICES:
| Proprietary Name: | LivewireTM Electrophysiology Catheter |
|---|---|
| Common/Usual Name: | Diagnostic Mapping Catheter |
| Classification Name: | Electrode Recording Catheter |
| 510K Number: | K022380 |
DEVICE DESCRIPTION:
The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient's heart. They are available in fixed curve and steerable configurations.
The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies.
The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle. Table 5-1 lists the models and characteristics of the catheters.
5
INTENDED USE/INDICATION FOR USE:
The APT Map-It ™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
Technologically the Map-iT™ Diagnostic Mapping Catheters are similar to St. Jude Medical Livewire™ Diagnostic Mapping Catheters in terms of indications for use, design, materials, technology and performance. Both families of catheters have shafts comprised of thermoplastic elastomer and platinum-iridium electrodes. Both come in multiple sizes, lengths, preformed curve shapes and configurations, including fixed and steerable, with varying number of electrodes and spacing's that are designed to reach specific areas in the targeted chambers of the heart. The 4/3.3F model functions the same as the predicate devices, with a taper for access. Similarly, the guidewire tip functions identically to a guidewire, providing easier access of the catheter to smaller anatomies.
TESTING PERFORMED
The Map-iT™ Diagnostic Mapping Catheters were thoroughly tested based on existing standards and test methods. These tests included visual, dimensional, electrical performance - continuity, leakage impedance, dielectric; mechanical performance - tensile, torque, deflection, shaft buckling, radio-detectability, corrosion; biocompatibility (short term