(538 days)
EasyMap MAP catheters are indicated for simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart.
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.
This document is a 510(k) premarket notification for a medical device called the EasyMap MAP Catheter. It outlines the device's characteristics, intended use, and a comparison to a predicate device, as well as a summary of the testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the provided text to answer your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it lists the tests performed and whether the device "Passed Test." The underlying acceptance criteria are implied to be that the device successfully meets the requirements of the applied standards or internal test methods.
| Test | Applied Standard | Reported Device Performance | Implied Acceptance Criteria (based on "Passed Test") |
|---|---|---|---|
| Corrosion Test | ISO 10555 | Passed Test | The device's materials must resist degradation (corrosion) when exposed to conditions simulating the human body, as per ISO 10555. |
| Dimension Tests | Internal Test Method | Passed Test | Device dimensions (e.g., diameter, length, electrode spacing) must conform to design specifications, as outlined in the internal test method. |
| Electrical Tests (Continuity, Short Circuit, Isolation/Leakage, High Voltage 1kV) | EN 60601 | Passed Test | The device must meet electrical safety standards (e.g., no unintended current paths, adequate insulation, withstand specified voltage) as defined by EN 60601. |
| Mechanical Test - Mechanical Strength after moisture storage | ISO 10555 | Passed Test | The device must maintain mechanical integrity and specified strength after exposure to moisture mimicking physiological conditions, as per ISO 10555. |
| Mechanical Test - Steerability | Internal Test Method | Passed Test | The catheter tip must be able to deflect to the specified angle (up to 270 degrees) and maintain its steerability as defined by the internal test method. |
| Mechanical Test - Fixation Push / Pull Control | Internal Test Method | Passed Test | The catheter's pushability and pullability, and the control of these actions, must meet the specified requirements of the internal test method. |
| Compatibility with existing products - Bending | Internal Test Method | Passed Test | The catheter must exhibit appropriate bending characteristics and compatibility when used with existing products/systems, as defined by the internal test method. |
| Compatibility with existing products - Dimensions | Internal Test Method | Passed Test | The catheter's dimensions must ensure compatibility when used with existing products/systems, as defined by the internal test method. |
| Biocompatibility | ISO 10993 | Passed Test | The device must not cause unacceptable adverse biological reactions (e.g., cytotoxicity, irritation, sensitization) when in contact with human tissue, complying with ISO 10993. |
| Shelf Life Test | Internal Test Method | Passed Test | The device must maintain its safety and performance characteristics for its specified shelf life, as demonstrated by the internal test method. |
| Packaging Validation | ISO 11607-1 | Passed Test | The packaging must protect the device, maintain sterility, and withstand handling and storage conditions, as validated according to ISO 11607-1. |
| Sterilization Validation | EN 550; ISO11135 | Passed Test | The sterilization process (EO gas) must consistently achieve the required sterility assurance level (SAL) for the device, as validated according to EN 550 and ISO 11135. |
| X-Ray Test / Visibility | Internal Test Method | Passed Test | The device must be adequately visible under X-ray imaging to facilitate proper placement and monitoring during procedures, as determined by the internal test method. |
| Overall Performance Statement | "Performance Based upon the documentation presented in this 510(k)" | Safe and effective | The device is deemed safe and effective for its intended use, based on the aggregate results of all tests and the comparison to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests listed are primarily bench (laboratory) tests performed on the device itself, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The tests performed are engineering and materials science tests, not diagnostic performance evaluations requiring expert-established ground truth.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. No adjudication method is mentioned as the tests are objective measurements against standards or internal methods, not subjective evaluations requiring expert consensus.
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
There is no mention of an MRMC study or any AI assistance in this document. The device is an electrode recording catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For the engineering and material tests, the "ground truth" used is defined by accepted industry standards (ISO, EN) and the manufacturer's own validated internal test methods and specifications. For instance, for the corrosion test, the ground truth is compliance with ISO 10555. For dimension tests, the ground truth is the engineering drawing specifications.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not a machine learning algorithm.
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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
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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
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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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Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter'sinformation | Jörg ReinhardtMedFact Engineering GmbHHammerstrasse 3D-79540 Löerrach/ Germany | Contact: Melissa WalkerGraematter, Inc.1324 Clarkson Clayton Ctr #332Ballwin, MO 63011Phone: 636-405-7498Date: 04/20/2015 |
|---|---|---|
| Device/classificationname | 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. | ||
| Devicedescription | EasyMap MAP is a single-use disposable quadropolar catheter for recordingmonophasic action potentials and for intracardial pacing. Integrated in thecatheter tip are a Silver-Chloride Electrode (AgCI), a Silver Electrode (Ag)and two orthogonally placed Silver Electrodes (Ag). These electrodes enablemapping of cardiac electrochemical potentials. | |
| The catheter tip can be deflected in a single direction up to 270 degrees. | ||
| Indications foruse | EasyMap MAP catheters are indicated for simultaneously pacing andrecording monophasic Action-Potentials (MAPs) from the endocardial surfaceof the human heart. | |
| Continued on next page |
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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 SteerableCombination CatheterPredicate DeviceK903880 | Proposed New Device:EasyMap MAPCatheter |
|---|---|---|
| Physiologic purpose | Aid physician inmanagement ofarrhythmias | same |
| Intended for use by | Cardiac EP orcardiovascular surgeons | same |
| Primary function | MAP recording andtemporary cardiac pacing | same |
| Insertion method | Percutaneous through alarge vein by Seldingertechnique | same |
| Electrode material | MAP: AG/AgClPacing: Platinum | same |
| No. of electrodes | 4-8 electrodes2 MAP2-6 Pacing | 4 electrodes2 MAP2 Pacing |
| Electrode spacing - | MAP electrodes4.5 mm edge to edge | MAP electrodes4.5 mm edge to edge |
| Image: Diagram of pacing and MAP recording electrodes | Pacing electrodes3.6 mm (center to center),1.6 mm (edge to edge) | Pacing electrodes3.6 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
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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.
§ 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).