(538 days)
Not Found
No
The summary describes a physical catheter with electrodes for recording and pacing, with no mention of AI/ML, image processing, or data analysis beyond basic signal recording.
No
The device is indicated for pacing and recording monophasic action potentials, which are diagnostic or monitoring functions, not therapeutic.
Yes
The EasyMap MAP catheter records Monophasic Action Potentials (MAPs) and maps cardiac electrochemical potentials to assess the heart's electrical activity, which is a diagnostic function.
No
The device description explicitly states it is a "single-use disposable quadropolar catheter" with integrated electrodes, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EasyMap MAP catheter is used to directly interact with the endocardial surface of the human heart. It records electrical signals (Monophasic Action Potentials) and can also be used for pacing. This is an in vivo procedure, meaning it is performed within the living body.
- Intended Use: The intended use clearly states "simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart." This is a direct interaction with the heart tissue, not a test performed on a sample taken from the body.
Therefore, the EasyMap MAP catheter falls under the category of a medical device used for diagnosis and treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EasyMap MAP catheters are indicated for simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
EasyMap MAP is a single-use disposable quadropolar catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the catheter tip are a Silver-Chloride Electrode (AgCl), a Silver Electrode (Ag) and two orthogonally placed Silver Electrodes (Ag). These electrodes enable mapping of cardiac electrochemical potentials. The catheter tip can be deflected in a single direction up to 270 degrees.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiac EP or cardiovascular surgeons
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)
Performance Based upon the documentation presented in this 510(k) it has been data demonstrated that the EasyMap MAP Catheter is safe and effective for its intended use.
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.
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
MedFact Engineering GmbH % Melissa Walker President & Cto Graematter, Inc 1324 Clarkson Clayton Ctr. #332 Ballwin, Missouri 63011
Re: K151139
Trade/Device Name: EasyMap MAP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: September 11, 2016 Received: September 13, 2016
Dear Melissa Walker:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours.
Mude Jellman
for
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) K151139
Device Name EasyMap MAP Catheter
Indications for Use (Describe)
EasyMap MAP catheters are indicated for simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart.
| 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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3
Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Jörg Reinhardt
MedFact Engineering GmbH
Hammerstrasse 3
D-79540 Löerrach/ Germany | Contact: Melissa Walker
Graematter, Inc.
1324 Clarkson Clayton Ctr #332
Ballwin, MO 63011
Phone: 636-405-7498
Date: 04/20/2015 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | Classification information for the EasyMap MAP Catheter follows:
• 21 CFR 870.1220
• Product Code DRF
• Classification/Common name: Electrode recording catheter or electrode recording probe | |
| | The marketed device(s) to which substantial equivalence is claimed:
• Franz Steerable Combination Catheter 510(k)
• K903880 cleared October 12, 1990. | |
| Device
description | EasyMap MAP is a single-use disposable quadropolar catheter for recording
monophasic action potentials and for intracardial pacing. Integrated in the
catheter tip are a Silver-Chloride Electrode (AgCI), a Silver Electrode (Ag)
and two orthogonally placed Silver Electrodes (Ag). These electrodes enable
mapping of cardiac electrochemical potentials. | |
| | The catheter tip can be deflected in a single direction up to 270 degrees. | |
| Indications for
use | EasyMap MAP catheters are indicated for simultaneously pacing and
recording monophasic Action-Potentials (MAPs) from the endocardial surface
of the human heart. | |
| | Continued on next page | |
4
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
Comparison matrix of basic key characteristics
The table below lists the main characteristics of the proposed EasyMap MAP Catheter compared to the Predicate Franz MAP Catheter. The Franz MAP Catheter was chosen as the predicate device because the intended use is identical to the EasyMap MAP Catheter in that both are designed to detect and record electrical potentials from the endocardial surfaces of the heart and to deliver externally generated pacing stimuli.
| Device Characteristic | Franz Steerable
Combination Catheter
Predicate Device
K903880 | Proposed New Device:
EasyMap MAP
Catheter |
|-------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Physiologic purpose | Aid physician in
management of
arrhythmias | same |
| Intended for use by | Cardiac EP or
cardiovascular surgeons | same |
| Primary function | MAP recording and
temporary cardiac pacing | same |
| Insertion method | Percutaneous through a
large vein by Seldinger
technique | same |
| Electrode material | MAP: AG/AgCl
Pacing: Platinum | same |
| No. of electrodes | 4-8 electrodes
2 MAP
2-6 Pacing | 4 electrodes
2 MAP
2 Pacing |
| Electrode spacing - | MAP electrodes
4.5 mm edge to edge | MAP electrodes
4.5 mm edge to edge |
| Image: Diagram of pacing and MAP recording electrodes | Pacing electrodes
3.6 mm (center to center),
1.6 mm (edge to edge) | Pacing electrodes
3.6 mm (center to center)
1.6 mm (edge to edge) |
| Sterile | Yes | same |
| Method of sterilization | EO gas | same |
| Single use | Yes | same |
| Catheter body material | Pebax | Pebax |
| Catheter diameter | 5, 6, 7 F | 7F |
| catheter length | 80-150 cm | 110 cm |
| Tip deflection angle/
range | 270° in two directions | Unidirectional up to 270° |
Continued on next page
5
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
Test summary The table below lists the applied standards and test results for the EasyMap MAP Catheter.
| Test | Applied Standard | Result |
|---|---|---|
| Corrosion Test | ISO 10555 | Passed Test |
| Dimension Tests | Internal Test Method | Passed Test |
| Electrical Tests |
- Continuity
- Short Circuit
- Isolation/Leakage Test
- High Voltage Test (1 kV) | EN 60601 | Passed Test |
| Mechanical Test - Mechanical Strength after moisture storage | ISO 10555 | Passed Test |
| - Steerability | Internal Test Method | |
| - Fixation Push / Pull Control | Internal Test Method | |
| Compatibility with existing products - Bending
- Dimensions | Internal Test Method | Passed Test |
| Biocompatibility | ISO 10993 | Passed Test |
| Shelf Life Test | Internal Test Method | Passed Test |
| Packaging Validation | ISO 11607-1 | Passed Test |
| Sterilization Validation | EN 550; ISO11135 | Passed Test |
| X-Ray Test / Visibility | Internal Test Method | Passed Test |
Note: Tests are to be performed on sterilized products after storage and moisture (0.9% NaCl water bath 37 °C, 24 h) Thermal Shock Test and bending performance test.
Performance Based upon the documentation presented in this 510(k) it has been data demonstrated that the EasyMap MAP Catheter is safe and effective for its intended use.