(60 days)
Not Found
No
The 510(k) summary describes a physical diagnostic catheter for electrophysiological mapping and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The document explicitly states the device is a "Diagnostic Catheter" indicated for "electrophysiological mapping". It is used for stimulation and recording of cardiac structures, which is a diagnostic function, not a therapeutic one aimed at treating a condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures." The word "Diagnostic" is also present in the device name.
No
The device description clearly describes a physical catheter with electrodes, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "electrophysiological mapping (stimulation and recording) of cardiac structures". This is a procedure performed within the body to assess electrical activity, not a test performed on a sample taken from the body.
- Device Description: The device is a catheter designed to be inserted into the body. IVD devices typically involve reagents, test strips, or instruments that analyze biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
This device is a medical device used for a diagnostic procedure performed in vivo (within a living organism).
N/A
Intended Use / Indications for Use
The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.
Product codes
DRF
Device Description
The Cosine-10 Diagnostic Catheter is a sterile, single-use, steerable decapolar mapping catheter with a bidirectional deflecting tip intended for electrophysiological mapping of cardiac structures (i.e., stimulation and recording). The catheter contains 10 electrodes spaced in 5 pairs, including a distal dome electrode. Two electrode spacing configurations are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All catheter electrodes may be used for recording or stimulation.
The catheter can be used with a compatible introducer sheath (7.5Fr minimum).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures, including in the coronary sinus
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)
Safety and performance testing applicable to the subject device was completed to ensure it performs as intended per product specifications and requirements/user needs. The following testing has been completed in support of the Cosine-10 Diagnostic Catheter, and all acceptance criteria were met in accordance with appropriate standards: Sterilization validation and adoption Biocompatibility Design verification Packaging validation Design validation Pre-clinical animal testing. No questions of safety or effectiveness are raised as a result of the testing. The subject device is as safe and effective as the predicate device and the subject device is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DECANAV Mapping Catheter (K231312)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2023
Medtronic, Inc. Karine Lortie Sr Principal Regulatory Affairs Specialist 8200 Coreal Sea Street NE, MVS3 Mounds View, Minnesota 55112
Re: K233397
Trade/Device Name: Cosine-10TM Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: October 2, 2023 Received: October 3, 2023
Dear Karine Lortie:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Cosine-10TM Diagnostic Catheter
Indications for Use (Describe)
The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.
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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4
15.0 510(k) Summary
| Date Summary Prepared: | October 02, 2023 |
|---|---|
| Applicant: | Medtronic, Inc. |
| 8200 Coral Sea Street NE | |
| Mounds View, MN U.S.A. 55112 | |
| 1.800.328.2518 | |
| Establishment Registration No. 3001504994 | |
| Official Correspondent: | Karine Lortie |
| Senior Principal Regulatory Affairs Specialist | |
| 514.242.5882 | |
| karine.lortie@medtronic.com | |
| Device Trade Name and | |
| Model: | Cosine-10TM Diagnostic Catheter |
| Common Name: | Electrophysiology Catheter |
| Classification Name: | Electrode Recording Catheter |
| Classification & Panel: | Class II, 21 CFR 870.1220, Cardiovascular |
| Product Code: | DRF |
| Predicate Device: | DECANAV Mapping Catheter (K231312) |
| Device Description: | The Cosine-10 Diagnostic Catheter is a sterile, single-use, |
| steerable decapolar mapping catheter with a bidirectional | |
| deflecting tip intended for electrophysiological mapping of | |
| cardiac structures (i.e., stimulation and recording). The | |
| catheter contains 10 electrodes spaced in 5 pairs, including a | |
| distal dome electrode. Two electrode spacing configurations | |
| are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All | |
| catheter electrodes may be used for recording or stimulation. |
The catheter can be used with a compatible introducer sheath
(7.5Fr minimum). |
| Intended Use: | The Cosine-10 Diagnostic Catheter is intended for
electrophysiological mapping of cardiac structures |
| Indications for Use: | The Cosine-10 Diagnostic Catheter is indicated for
electrophysiological mapping (stimulation and recording) of
cardiac structures, including in the coronary sinus |
| Comparison of
Technological
Characteristics: | There are no significant differences in the fundamental
scientific technology between the predicate and subject
devices for the proposed intended use and indications for
use. The subject and predicate devices have the same or
similar underlying technological characteristics. Both
devices are deflectable decapolar diagnostic catheters that
utilize electrodes along a deflectable shaft section for
intracardiac mapping and stimulation. |
| | The Cosine-10 catheter features the following similarities
with the predicate device: Same intended use Same fundamental scientific technology (deflectable decapolar mapping catheter) Same catheter outer diameter Similar catheter effective length |
| | The differences in technological characteristics involve the
following: Presence of magnetic sensor(s) in the predicate device for compatibility with 3D mapping and navigation system Deflection type (predicate is unidirectional and subject device is bidirectional) Additional electrode spacing pattern configuration available with the subject device |
| | Differences in technological characteristics between the
subject and predicate device do not raise different questions
of safety and effectiveness. The absence of magnetic
sensor(s) in the subject device has no impact on safety and
effectiveness of the device for its proposed intended use and
indications for use (electrophysiological mapping of cardiac
structures, i.e., stimulation and recording). |
| Safety and Performance
Data: | Safety and performance testing applicable to the subject
device was completed to ensure it performs as intended per
product specifications and requirements/user needs. The
following testing has been completed in support of the
Cosine-10 Diagnostic Catheter, and all acceptance criteria
were met in accordance with appropriate standards: Sterilization validation and adoption Biocompatibility Design verification Packaging validation Design validation |
5
K233397
6
K233397
- Pre-clinical animal testing
No questions of safety or effectiveness are raised as a result of the testing. The subject device is as safe and effective as the predicate device and the subject device is considered substantially equivalent to the predicate device.
The subject and predicate devices share the same intended Conclusion: use and have the same or similar underlying technological characteristics. Both devices are deflectable decapolar diagnostic catheters that utilize electrodes along a deflectable shaft section for intracardiac mapping and stimulation. Differences between the subject and predicate devices do not raise different questions of safety and effectiveness and safety and performance testing supports that the subject device is as safe and effective as the predicate. The subject device is considered substantially equivalent to the predicate device.