(222 days)
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The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
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The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Medtronic diagnostic catheters are flexible radiopaque catheters constructed of extruded polymer over a stainless-steel braid. The catheters contain platinum-iridium sensing band electrodes and are designed for intracardiac recording or stimulation.
This premarket notification covers changes impacting Medtronic diagnostic catheters, including labeling updates, packaging design and packaging material changes, and product requirement updates.
This document is a 510(k) premarket notification review for a medical device. It does not contain information about studies involving AI or human reader performance. The document describes changes to existing devices (Marinr and StableMapr Steerable Intracardiac Electrode Catheters) and demonstrates substantial equivalence to predicate devices through a series of performance (bench) and packaging tests.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable as this document does not describe a study involving an AI algorithm that produces diagnostic outputs requiring such analyses.
Here's the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists "product requirement changes" and "product requirement testing," implying that the tests performed served as acceptance criteria. However, explicit numerical acceptance criteria values are not provided within this document. Instead, the document states: "The results of the design verification testing completed in support of the proposed changes demonstrate that the diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements."
| Item Tested (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Corrosion resistance | Met all applicable proposed product requirements |
| Visual inspections (Foreign Material and Defects, Butt Joint, Band Electrodes, Tip Assembly, Serial Number) | Met all applicable proposed product requirements |
| Catheter outer diameter | Met all applicable proposed product requirements |
| Electrode Band Spacing | Met all applicable proposed product requirements |
| Working Length | Met all applicable proposed product requirements |
| Actuation force for linearly activated controls | Met all applicable proposed product requirements |
| Tip Springback | Met all applicable proposed product requirements |
| Reverse deflection (StableMapr only) | Met all applicable proposed product requirements |
| Extent & Rate of Tip Deflection | Met all applicable proposed product requirements |
| Proximal curve reach | Met all applicable proposed product requirements |
| Proximal curve planarity | Met all applicable proposed product requirements |
| Lateral deflection control (Marinr only) | Met all applicable proposed product requirements |
| Tip lateral deflection travel (Marinr only) | Met all applicable proposed product requirements |
| Distal tip stiffness | Met all applicable proposed product requirements |
| Proximal shaft flexibility in 37°C | Met all applicable proposed product requirements |
| Tip transition kinking | Met all applicable proposed product requirements |
| Lateral Stability (StableMapr only) | Met all applicable proposed product requirements |
| Shaft Torque-ability | Met all applicable proposed product requirements |
| Joint - Tip Composite (Marinr only) | Met all applicable proposed product requirements |
| Joint- Proximal Shaft to Distal Deflectable Tip Tubing | Met all applicable proposed product requirements |
| Electrode path AC impedance (Marinr only) | Met all applicable proposed product requirements |
| Band Electrode Path DC Resistance | Met all applicable proposed product requirements |
| Simulated use: catheter pushability (StableMapr only) | Met all applicable proposed product requirements |
| Simulated use: catheter shaft repeated torqueing (StableMapr only) | Met all applicable proposed product requirements |
| Handle Control Requirements | Met all applicable proposed product requirements |
| Connector Interface Requirements | Met all applicable proposed product requirements |
| Packaging Configuration | Met all applicable proposed product requirements |
| Traceability | Met all applicable proposed product requirements |
| Material Sterilization Compatibility | Met all applicable proposed product requirements |
| Packaging Performance (Marinr only) | Met all applicable proposed product requirements |
| Sterile Barrier Integrity | Met all applicable proposed product requirements |
| Seal strength | Met all applicable proposed product requirements |
| Specified loading configuration | Met all applicable proposed product requirements |
| Storage and Shipping Conditions | Met all applicable proposed product requirements |
| Sterilization pre-conditioning (Packaging) | Met all applicable proposed product requirements |
| Environmental pre-conditioning (Packaging) | Met all applicable proposed product requirements |
| Label legibility testing (Packaging) | Met all applicable proposed product requirements |
| Label durability testing (Packaging) | Met all applicable proposed product requirements |
| Bubble leak testing (Packaging) | Met all applicable proposed product requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years" for product requirement testing. However, the specific sample sizes for each test are not provided. Data provenance (country of origin, retrospective/prospective) is not applicable as these are bench tests on manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a bench testing study for substantial equivalence of physical medical devices, not a diagnostic study requiring expert ground truth or a human-in-the-loop performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a bench testing study.
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
No such study was done. This document pertains to the physical and packaging characteristics of diagnostic catheters, not an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests would be the established engineering and materials specifications and accepted standards for medical device performance. For packaging, it would be packaging integrity and labeling standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning study.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 30, 2019
Medtronic Matthew Lobeck Sr. Regulatory Affairs Specialist 8200 Coral Sea St NE Mounds View, Minnesota 55112
Re: K183547
Trade/Device Name: Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 3, 2019 Received: July 5, 2019
Dear Matthew Lobeck:
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.
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
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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 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,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183547
Device Name
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Marinr™ Steerable Intracardiac Electrode Catheter
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StableMapr™ Steerable Intracardiac Electrode Catheter
Indications for Use (Describe)
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The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
-
The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
| 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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5.0 510(k) Summary
| Date Summary Prepared: | January 25, 2019 |
|---|---|
| Applicant: | Medtronic8200 Coral Sea StreetMail Stop MVS46Mounds View, MN 55112Establishment Registration No. 3001504994 |
| Official Correspondent: | Matthew LobeckSenior Regulatory Affairs SpecialistMedtronic8200 Coral Sea StreetMounds View, MN 55112Telephone: 763.514.9515Fax: 763.367.9903Email: matthew.lobeck@medtronic.com |
| Device Trade Name: | 1. Marinr™ Steerable Intracardiac Electrode Catheter2. StableMapr™ Steerable Intracardiac Electrode Catheter |
| Common Name: | Diagnostic catheter |
| Classification Name: | Catheter, Electrode Recording, Or Probe, ElectrodeRecording |
| Classification & Panel:Product Code: | Class II, 21 CFR 870.1220, CardiovascularDRF |
| Predicate Device: | 1. Marinr™ Steerable Intracardiac Electrode Catheter (K951347, K931794)2. StableMapr™ Steerable Intracardiac Electrode Catheter (K981642) |
| Device Description: | Medtronic diagnostic catheters are flexible radiopaquecatheters constructed of extruded polymer over a stainless-steel braid. The catheters contain platinum-iridium sensingband electrodes and are designed for intracardiac recordingor stimulation.This premarket notification covers changes impactingMedtronic diagnostic catheters, including labeling updates,packaging design and packaging material changes, andproduct requirement updates. |
| Intended Use: | Medtronic diagnostic catheters are intended for use indiagnostic electrophysiologic procedures. The catheters aredesigned for recording intracardiac electrograms andtemporary pacing associated with electrophysiology studies.The intended use is unchanged with the proposedmodifications and remains the same as that previouslycleared under the respective 510(k)s. |
| Indications for Use: | 1. The Medtronic Marinr catheter is intended for use indiagnostic electrophysiologic procedures. The MedtronicMarinr catheter is designed for recording intracardiacelectrograms and temporary pacing associated withelectrophysiology studies.2. The Medtronic StableMapr catheter is intended for use indiagnostic electrophysiologic procedures. These cathetersare designed for recording intracardiac electrograms andtemporary pacing associated with electrophysiologystudies.The indications for use are unchanged with the proposedmodifications and remains the same as those previouslycleared under the respective 510(k)s. |
| Comparison ofTechnologicalCharacteristics: | The following changes are being implemented as part of thispremarket notification:Labeling Changes:Inclusion of updated storage and transit conditioninformation General symbol updates, formatting and grammaticalchanges Inclusion of contraindication and adverse eventinformation Various additional changes as part of general labelingimprovements Packaging Changes: Increase to shelf carton height Relocation of labeling from shelf carton to productlabels |
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- Change to catheter tray design for securement of . catheter within packaging
- Change to a material of the catheter pouch .
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- . Change to dimensions of the catheter pouch
- . Increase to the page count of the IFU and warranty document
- Addition of a protective literature bag
- . New label stocks for product labels and warranty document
- . Addition of a secondary shelf carton label and end cap seal
Product Requirement Changes:
This premarket notification includes updates to the following Product Requirement Specifications (PRS):
| PRS Attribute | Impacted Products |
|---|---|
| Product Requirements | |
| Biocompatibility | All |
| Corrosion resistance | All |
| Visual - Foreign Materialand Defects | All |
| Visual - Butt JointInspection | All |
| Visual - Band Electrodes | All |
| Visual - Tip Assembly | All |
| Visual - Serial Number | All |
| Catheter outer diameter | All |
| Electrode Band Spacing | All |
| Working Length | All |
| Actuation force for linearlyactivated controls | All |
| Tip Springback | All |
| Reverse deflection | StableMapr SteerableIntracardiac Electrode Catheter |
| Extent & Rate of TipDeflection | All |
| Proximal curve reach | All |
| Proximal curve planarity | All |
| Lateral deflection control | Marinr Steerable IntracardiacElectrode Catheter |
| Tip lateral deflection travel | Marinr Steerable IntracardiacElectrode Catheter |
| Distal tip stiffness | All |
| Proximal shaft flexibility in37°C | All |
| Tip transition kinking | All |
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| Lateral Stability | StableMapr SteerableIntracardiac Electrode Catheter |
|---|---|
| Shaft Torque-ability | All |
| Joint - Tip Composite | Marinr Steerable IntracardiacElectrode Catheter |
| Joint- Proximal Shaft toDistal Deflectable TipTubing | All |
| Electrode path ACimpedance | Marinr Steerable IntracardiacElectrode Catheter |
| Band Electrode Path DCResistance | All |
| Simulated use: catheterpushability | StableMapr SteerableIntracardiac Electrode Catheter |
| Simulated use: cathetershaft repeated torqueing | StableMapr SteerableIntracardiac Electrode Catheter |
| Handle ControlRequirements | All |
| Connector InterfaceRequirements | All |
| Packaging Requirements | |
| Packaging Configuration | All |
| Traceability | All |
| Material SterilizationCompatibility | All |
| Packaging Performance | Marinr Steerable IntracardiacElectrode Catheter |
| Sterile Barrier Integrity | All |
| Seal strength | All |
| Specified loadingconfiguration | All |
| Storage and ShippingConditions | All |
While this premarket notification covers changes to labeling, packaging design and materials, and product requirement specifications, there are no changes to the finished diagnostic catheter designs or materials. The manufacturing processes and inspections related to diagnostic catheter assemblies are also remaining unchanged. Compared to the predicate, the subject device features the:
- Same intended use ●
- Same indications for use .
- Same fundamental scientific technology ●
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- Same finished catheter design and dimensions ●
- . Same user interface
- Same materials of construction ●
- Same manufacturing and sterilization processes ●
The differences between the subject and predicate devices involve labeling, packaging, and product requirements only. The subject device design technology, performance characteristics, materials, shelf life and sterilization process are all unchanged.
The proposed changes do not constitute a change in the fundamental scientific technology for the subject devices and do not raise new or different questions of safety and effectiveness. The subject devices do not provide a new therapy, and the intended use and indications for use remain unchanged and identical to the predicates. The modified subject devices described in this 510(k) submission are substantially equivalent to the predicate devices.
Performance Data: Performance testing (bench) was completed in support of the proposed modifications. The results of the design verification testing completed in support of the proposed changes demonstrate that the diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements.
To support the proposed product requirement changes in this premarket notification, the following tests were performed on test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years:
Product Requirement Testing:
- Corrosion resistance testing
- Visual inspections ●
- Electrode band spacing measurement ●
- Catheter shaft dimensional measurements ●
- Actuation force testing
- Tip springback testing
- Catheter shaft reach, deflection, and planarity testing ●
- Catheter shaft stiffness and flexibility testing ●
- Kink resistance testing
- Catheter shaft lateral stability testing
- Catheter shaft torqueability testing
- Catheter tensile testing ●
- Electrode path impedance and resistance testing ●
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- Simulated use testing for pushability and ● torqueability
Packaging Requirement Testing:
- Visual inspections
- Sterilization pre-conditioning .
- Environmental pre-conditioning
- Label legibility testing ●
- Label durability testing ●
- Bubble leak testing ●
Conclusion:
This premarket notification is limited to labeling, packaging design and materials, and product requirement specifications for Medtronic diagnostic catheters. There are no changes to the intended use, indications for use, performance, or fundamental scientific technology, and the subject devices are considered substantially equivalent to the legally marketed predicate devices.
§ 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).