The Medtronic Torqr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catherer is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Device Description

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.

AI/ML Overview

This FDA 510(k) summary (K190132) is for the Medtronic Torqr Intracardiac Electrode Catheter and Soloist Intracardiac Electrode Catheter. It is a submission for modifications to existing devices, specifically concerning labeling, packaging design and materials, and product requirement specifications. There are no changes to the finished diagnostic catheter designs or materials, or their fundamental scientific technology, intended use, or indications for use. Therefore, the device performance information in this document relates to confirming that these modifications do not negatively impact the existing performance and safety of the devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative manner as one might expect for a new AI/software device with specific performance metrics (e.g., sensitivity, specificity thresholds). Instead, it focuses on verifying that the proposed changes (labeling, packaging, product requirements) do not compromise the established safety and effectiveness of the already cleared predicate devices. The "acceptance criteria" are implied to be meeting all applicable proposed product requirements after the changes, and the "device performance" is reported as successful completion of performance testing (bench) demonstrating this.

Acceptance Criterion (Implied)	Reported Device Performance
Product Requirement Testing
Corrosion Resistance	Met (testing successfully completed)
Visual – Foreign Material and Defects	Met (testing successfully completed)
Visual – Butt Joint Inspection	Met (testing successfully completed)
Visual – Band Electrodes	Met (testing successfully completed)
Visual – Tip Assembly	Met (testing successfully completed)
Visual – Lot Number	Met (testing successfully completed)
Catheter Outer Diameter	Met (testing successfully completed)
Electrode Band Spacing	Met (testing successfully completed)
Working Length	Met (testing successfully completed)
Connector to Shaft Pull Test (Torqr)	Met (testing successfully completed)
Band and Tip DC Resistance	Met (testing successfully completed)
Connector Interface Requirements	Met (testing successfully completed)
Packaging Requirement Testing
Packaging Configuration (Torqr)	Met (testing successfully completed)
Traceability	Met (testing successfully completed)
Material Sterilization Compatibility	Met (testing successfully completed)
Packaging Performance	Met (testing successfully completed)
Sterile Barrier Integrity	Met (testing successfully completed)
Seal Strength	Met (testing successfully completed)
Shelf Life Format	Met (testing successfully completed)
Lot Number Identification	Met (testing successfully completed)
Storage and Shipping Conditions	Met (testing successfully completed)
Label Legibility Testing	Met (testing successfully completed)
Label Durability Testing	Met (testing successfully completed)
Bubble Leak Testing	Met (testing successfully completed)

Study Proving Acceptance Criteria is Met:

The study proving the acceptance criteria is met is the performance testing (bench) completed in support of the proposed modifications. The document states: "The results of the design verification testing completed in support of the proposed changes demonstrate that all diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test in the "test set" (i.e., the units exposed to accelerated aging and then tested). It states that tests were performed "on test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years." The provenance of the data is prospective bench testing conducted by the manufacturer, Medtronic, in the United States (Mounds View, Minnesota).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission. The tests are bench tests verifying physical, electrical, and packaging integrity/performance. They do not involve clinical interpretation or human expert "ground truth" establishment in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable. As these are bench tests for physical and performance characteristics, there is no adjudication process involving human observers for discrepancies or ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for modifications to existing physical medical devices (catheters), not an AI or software device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" used for this type of submission is based on engineering and physical performance specifications, material properties, and regulatory standards. For example, the "ground truth" for "corrosion resistance" would be the absence of corrosion after specific exposure, and for "electrical resistance," it would be measurement within a predefined range. These are objective, measurable parameters.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this traditional medical device modification submission. AI models are not being developed or refined here.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. Since there is no training set, there is no ground truth establishment process for a training set.

Summary

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July 30, 2019

Medtronic Matthew Lobeck Sr. Regulatory Affairs Specialist 8200 Coral Sea St NE Mounds View, Minnesota 55112

Re: K190132

Trade/Device Name: Torqr Intracardiac Electrode Catheter, Soloist 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190132

Device Name

Torqr™ Intracardiac Electrode Catheter
Soloist™ Intracardiac Electrode Catheter

Indications for Use (Describe)

The Medtronic Torqr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catherer is 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. TorqrTM Intracardiac Electrode Catheter2. SoloistTM Intracardiac Electrode Catheter
Common Name:Classification Name:Classification & Panel:Product Code:	Diagnostic catheterCatheter, Electrode Recording, Or Probe, ElectrodeRecordingClass II, 21 CFR 870.1220, CardiovascularDRF
Predicate Device:	1. TorqrTM Intracardiac Electrode Catheter (K923915)2. SoloistTM Intracardiac Electrode Catheter (K953185)
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 updatespackaging 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 Torqr catheter is intended for use indiagnostic electrophysiologic procedures. The catheter isdesigned for recording intracardiac electrograms andtemporary pacing associated with electrophysiologystudies.2. The Medtronic Soloist catheter is intended for use indiagnostic electrophysiologic procedures. The catheter isdesigned 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 conditioninformationGeneral symbol updates, formatting and grammaticalchangesInclusion of contraindication and adverse eventinformationVarious additional changes as part of general labelingimprovementsPackaging Changes:Relocation of labeling from shelf carton to productlabelsNew label stocks for product labels and warrantydocument

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Addition of a protective paperboard sleeve insert •
. Addition of a seal label and packaging tape to the shelf carton

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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 Material andDefects	All
Visual - Butt Joint Inspection	All
Visual - Band Electrodes	All
Visual - Tip Assembly	All
Visual - Lot Number	All
Catheter Outer Diameter	All
Electrode Band Spacing	All
Working Length	All
Connector to Shaft Pull Test	Torqr Intracardiac ElectrodeCatheter
Band and Tip DC Resistance	All
Connector InterfaceRequirements	All
Packaging Requirements
Packaging configuration	Torqr Intracardiac ElectrodeCatheter
Traceability	All
Material SterilizationCompatibility	All
Packaging Performance	All
Sterile Barrier Integrity	All
Seal Strength	All
Shelf Life Format	All
Lot Number Identification	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 .

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Same indications for use ●
Same fundamental scientific technology ●
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 all 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 ●
Catheter tensile testing ●
Electrical resistance testing

Packaging Requirement Testing:

Visual inspections ●
. Sterilization pre-conditioning

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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.

Regulation Number and Section

§ 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).