(189 days)
The AchieveTM ST mapping catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The AchieveTM ST mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
The Achieve ST Mapping diagnostic catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve ST Mapping Catheter is a circular loop with evenly spaced electrodes to map electrical conduction within the atrium. The Achieve ST Mapping Catheter is available in a 25mm pre-shaped distal loop diameter.
This document does not contain the information required to populate all sections of the requested table. The provided text is an FDA 510(k) summary for the Medtronic Achieve™ ST Mapping Catheter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a diagnostic algorithm would.
Specifically, the document does not contain information about:
- Specific acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy targets).
- Any in-vivo or clinical study conducted to assess the performance of the device against such criteria. The "in vivo testing" mentioned is general and not detailed with performance metrics.
- Sample sizes for test or training sets related to a performance study.
- Data provenance, expert involvement, adjudication methods, or MRMC studies.
- Standalone algorithm performance or human-in-the-loop performance.
- How ground truth was established for any performance evaluation.
The "Performance Data" section lists various bench and biocompatibility tests, but these are related to safety and fundamental functionality (e.g., radial loop compliance, electrical continuity, corrosion resistance), not diagnostic accuracy or effectiveness in terms of a clinical outcome that would require the type of acceptance criteria and study details you're requesting.
Therefore, I cannot construct the table as requested using the provided text.
However, I can extract information about the types of performance tests conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance / Outcome |
|---|---|---|
| Mechanical/Physical | Radial Loop Compliance | Performs as designed |
| Distal Stiffness | Performs as designed | |
| Axial Load | Performs as designed | |
| Torque Response | Performs as designed | |
| Turns to Failure | Performs as designed | |
| Kink Resistance | Performs as designed | |
| Joint Strength | Performs as designed | |
| Contrast Media Flow Rate | Performs as designed | |
| Stiffness | Performs as designed | |
| Electrical | Electrical Continuity | Performs as designed |
| Electrical Testing | Performs as designed | |
| Electrical Safety Testing | Safe and effective per ISO 60601-1:2006 | |
| Material/Biocompatibility | Cytotoxicity (ISO 10993-5) | Biocompatible |
| Kligman Sensitization (ISO 10993-10) | Biocompatible | |
| Intracutaneous Injection (ISO 10993-10) | Biocompatible | |
| Systemic Injection, Acute (ISO 10993-11) | Biocompatible | |
| Rabbit Pyrogen, Material Mediated (ISO 10993-11) | Biocompatible | |
| Hemolysis (ASTM F756) | Biocompatible | |
| Prothombin Time Assay (ISO 10993-4) | Biocompatible | |
| Unactivated Partial Thromboplastin Time Assay (ISO 10993-4) | Biocompatible | |
| Complement Activation Assay (ISO 10993-4) | Biocompatible | |
| Thrombogenicity (ISO 10993-4) | Biocompatible | |
| Corrosion Resistance (ISO 10555-1:2009) | Performs as designed | |
| Sterilization | Sterilization | Verified |
Regarding the other information requested, based only on the provided text:
- Sample size used for the test set and the data provenance: Not provided. The document mentions "in vitro bench testing and in vivo testing" but does not detail sample sizes, study design, or data provenance for these tests in a way that aligns with evaluating diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of expert assessment for ground truth is typically for diagnostic/AI performance studies, which are not detailed here. The "Performance Data" section describes engineering and biocompatibility tests.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the provided information.
- 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: Not applicable. This device is a physical catheter, not an AI diagnostic algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the engineering and biocompatibility tests, the "ground truth" would be the established scientific and engineering principles, standards (e.g., ISO, ASTM), and specifications against which the device was tested.
- The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (catheter) focused on demonstrating manufacturing, material, and electrical safety and basic functionality in comparison to a predicate device, rather than a performance study of a diagnostic or AI-enabled system.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic, Inc. Heather Taylor Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View, Minnesota 55112
Re: K153139
Trade/Device Name: Achieve ST Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: April 5, 2016 Received: April 6, 2016
Dear Heather Taylor:
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. Iisting 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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) K153139
Device Name AchieveTM ST Mapping Catheter
Indications for Use (Describe)
The AchieveTM ST mapping catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The AchieveTM ST mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
Type of Use (Select one or both, as applicable)
| ☑ Export and/or Wildlife Trade |
|---|
| ☐ Scientific Purposes |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared: | October 26, 2015 | |
|---|---|---|
| Applicant: | Medtronic Inc.710 Medtronic ParkwayMinneapolis, MN 55432Establishment Registration No.: 3001504994 | |
| Contact Person: | Heather TaylorPrincipal Regulatory Affairs SpecialistMedtronic Inc.Coral Sea StreetMounds View, MN 55112Telephone: 763.526.9066Fax: 763.367.9903Email: heather.m.taylor@medtronic.com | |
| Trade Name: | Achieve™ ST Mapping Catheter | |
| Common Name: | Catheter, electrode recording, or probe, electroderecording | |
| Classification Name: | Electrode Recording Catheter | |
| Classification & Panel: | Class II, 21 CFR 870.1220 | |
| Product Code: | DRF | |
| Predicate Device(s): | Achieve™ Mapping Catheter K102588 | |
| Device Description: | The Achieve ST Mapping diagnostic catheter is an intra-cardiacelectrophysiology recording catheter and can be used for cardiacstimulation during electrophysiology studies. The distal mappingsection of the Achieve ST Mapping Catheter is a circular loop withevenly spaced electrodes to map electrical conduction within theatrium. The Achieve ST Mapping Catheter is available in a 25mmpre-shaped distal loop diameter. | |
| Intended Use of Device: | The intended use of the Achieve ST Mapping Catheter is to record |
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intracardiac signals and provide cardiac stimulation during electrophysiology studies.
The Achieve ST mapping catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve ST mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
The Achieve ST Mapping Catheter uses similar technology, has Comparison of Technological Characteristics similar intended use, functions, materials and method of operation as the following predicated device:
| Achieve STCatheter (SubjectDevice) K153139 | Achieve Catheter(predicate device)K102588 | |
|---|---|---|
| Intended Use | Map intracardiacstructures of theheart | Map intracardiacstructures of the heart |
| Indications forUse | The Achieve ST isindicated formultiple electrodeelectrophysiologicalmapping of cardiacstructures (i.e.,recording andstimulation only).The Achieve STCatheter isdesigned to obtainelectrograms in theatrial regions of theheart. | The Achieve isindicatedfor multiple electrodeelectrophysiologicalmapping of cardiacstructures (i.e.,recording andstimulation only). TheAchieve Catheter isdesigned to obtainelectrograms in theatrial regions of theheart. |
| Catheter BodyTubing | Pebax (distal body)Stainless Steel/polyimide(proximal) | Pebax (distal body)Stainless Steel(proximal) |
| Diameter | 3.3F | 3.3F |
| Effective Length | 146cm | 146cm |
| Number ofElectrodes | 10 | 8 |
| Distal End Shape | Circular Loop | Circular Loop |
| Loop Diameter | 25mm | 15mm and 20mm |
| Loop Material | Nitinol insulated | Nitinol insulated with |
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| with PET (Pebax covered) | PET (Pebax covered) | |
|---|---|---|
| Delivered through a delivery catheter | Yes | Yes |
Performance Data
In vitro bench testing and in vivo testing have been performed on the device materials and finished devices. Performance, sterilization and biocompatibility testing verified that the Achieve ST Mapping Catheter performs as designed and is suitable for its intended use.
Performance testing included the following:
Radial Loop Compliance Distal Stiffness Axial Load Torque Response Turns to Failure Electrical Continuity Device Functionality Kink Resistance Joint Strength Contrast Media Flow Rate Stiffness Electrical Testing and Electrical Safety Testing (ISO 60601-1:2006) Corrosion Resistance (ISO 10555-1:2009)
Biocompatability testing included the following: Cytotoxicity (ISO 10993-5) Kligman Sensitization (ISO 10993-10) Intracutaneous Injection (ISO 10993-10) Systemic Injection, Acute (ISO 10993-11) Rabbit Pyrogen, Material Mediated (ISO 10993-11) Hemolysis (ASTM F756) Prothombin Time Assay (ISO 10993-4) Unactivated Partial Thromboplast in Time Assay (ISO 10993-4) Complement Activation Assay (ISO 10993-4) Thrombogenicity (ISO 10993-4)
The associated Connecting Cable has been tested and is considered safe and effective per applicable parts of BS EN 60601-1 (2006, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance).
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Conclusion
The data presented in this submission demonstrate that the Achieve ST Mapping Catheter is substantially equivalent to the predicate device identified in regards to device design, materials, and 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).