(183 days)
Not Found
No
The summary describes a standard diagnostic electrophysiology catheter and mentions only bench testing for physical and electrical properties, with no indication of AI/ML processing of electrograms or other data.
No.
The catheters are explicitly stated to be for "diagnostic electrophysiologic procedures," specifically "recording intracardiac electrograms and temporary pacing," which are diagnostic rather than therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are "intended for use in diagnostic electrophysiologic procedures." Additionally, the "Device Description" section refers to them as "Medtronic diagnostic catheters."
No
The device description explicitly states it is a physical catheter constructed of extruded polymer over a stainless-steel braid with platinum-iridium sensing band electrodes. The performance studies also focus on physical characteristics and packaging, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the catheters are for "diagnostic electrophysiologic procedures" and are designed for "recording intracardiac electrograms and temporary pacing." This involves interacting directly with the patient's body to measure electrical activity within the heart.
- Device Description: The description details a flexible catheter with electrodes designed for "intracardiac recording or stimulation." This further reinforces its use within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for testing these types of samples in a laboratory or similar setting.
The device is an invasive medical device used for diagnostic purposes within the patient's body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- 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.
Product codes (comma separated list FDA assigned to the subject device)
DRF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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
- Environmental pre-conditioning
- Label legibility testing
- Label durability testing
- Bubble leak testing
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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
1
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
2
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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
5.0 510(k) Summary
Date Summary Prepared: January 25, 2019
| Applicant: | Medtronic
8200 Coral Sea Street
Mail Stop MVS46
Mounds View, MN 55112
Establishment Registration No. 3001504994 |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Matthew Lobeck
Senior Regulatory Affairs Specialist
Medtronic
8200 Coral Sea Street
Mounds View, MN 55112
Telephone: 763.514.9515
Fax: 763.367.9903
Email: matthew.lobeck@medtronic.com |
| Device Trade Name: | 1. TorqrTM Intracardiac Electrode Catheter
2. SoloistTM Intracardiac Electrode Catheter |
| Common Name:
Classification Name:
Classification & Panel:
Product Code: | Diagnostic catheter
Catheter, Electrode Recording, Or Probe, Electrode
Recording
Class II, 21 CFR 870.1220, Cardiovascular
DRF |
| Predicate Device: | 1. TorqrTM Intracardiac Electrode Catheter (K923915)
2. SoloistTM Intracardiac Electrode Catheter (K953185) |
| 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. |
| Intended Use: | Medtronic diagnostic catheters are intended for use in
diagnostic electrophysiologic procedures. The catheters are
designed for recording intracardiac electrograms and
temporary pacing associated with electrophysiology studies.
The intended use is unchanged with the proposed
modifications and remains the same as that previously
cleared under the respective 510(k)s. |
| Indications for Use: | 1. 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 catheter is
designed for recording intracardiac electrograms and
temporary pacing associated with electrophysiology
studies.
The indications for use are unchanged with the proposed
modifications and remains the same as those previously
cleared under the respective 510(k)s. |
| Comparison of
Technological
Characteristics: | The following changes are being implemented as part of this
premarket notification:
Labeling Changes:
Inclusion of updated storage and transit condition
informationGeneral symbol updates, formatting and grammatical
changesInclusion of contraindication and adverse event
informationVarious additional changes as part of general labeling
improvements
Packaging Changes:
Relocation of labeling from shelf carton to product
labelsNew label stocks for product labels and warranty
document |
4
- Addition of a protective paperboard sleeve insert •
- . Addition of a seal label and packaging tape to the shelf carton
5
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 and | |
| Defects | 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 Electrode |
| Catheter | |
| Band and Tip DC Resistance | All |
| Connector Interface | |
| Requirements | All |
| Packaging Requirements | |
| Packaging configuration | Torqr Intracardiac Electrode |
| Catheter | |
| Traceability | All |
| Material Sterilization | |
| Compatibility | All |
| Packaging Performance | All |
| Sterile Barrier Integrity | All |
| Seal Strength | All |
| Shelf Life Format | All |
| Lot Number Identification | All |
| Storage and Shipping | |
| Conditions | 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 .
6
- 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
7
- 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.