(141 days)
Not Found
No
The summary describes a physical catheter with mechanical steering and electrical sensing capabilities, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The intended use states "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," indicating diagnostic rather than therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the catheters are intended for "intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which are diagnostic activities. Furthermore, "Diagnostic" is part of the device's name: "Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters".
No
The device description and performance studies clearly indicate this is a physical catheter with mechanical and electrical components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias." This describes a device used within the body for diagnostic and therapeutic purposes related to the heart's electrical activity.
- Device Description: The description of a "radiopaque, flexible, insulated catheter with a polymer shaft" and a "plunger mechanism" aligns with an invasive medical device used for procedures inside the body.
- Anatomical Site: The specified anatomical site is "Intracardiac," meaning inside the heart.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform tests on samples outside the body.
This device is an invasive medical device used for electrophysiology procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Product codes
NLH
Device Description
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Dynamic Tip and XT Steerable Diagnostic EP Catheters. This included the following:
-Biocompatibilitv
-Cleaning Validation
-Sterilization Validation
-Functional Testing
-Visual Inspection
-Dimensional Verification
-Electrical Continuity and Resistance
-. Simulated Use
-Mechanical Characteristics
-. Electrical Safety Testing
-. Dielectric and Current Leakage
-Shelf-life Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2021
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K211276
Trade/Device Name: Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: August 13, 2021 Received: August 16, 2021
Dear Amanda Babcock:
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
1
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,
Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| Description | Item
Number | Number of
Electrodes | French
Size | Electrode
Spacing
(mm) | Distal Reach | Usable Length
(cm) |
|----------------------------------------------------------------------|----------------|-------------------------|----------------|------------------------------|--------------|-----------------------|
| Reprocessed
Dynamic Tip
Steerable
Diagnostic EP
Catheter | 200131 | 4 | 6 | 10 | Large 4.0 | 110 |
| | 200344 | 4 | 6 | 5 | Large 4.0 | 110 |
| | 6DYNTP002 | 4 | 6 | 2,5,2 | Large 4.0 | 110 |
| | 6DYNTP006 | 8 | 6 | 2 | Large 4.0 | 110 |
| | 6DYNTP001 | 10 | 6 | 2,5,2 | Large 4.0 | 110 |
| Reprocessed
Dynamic XT
Steerable
Diagnostic EP
Catheters | 201103 | 4 | 6 | 2,5,2 | Large 4.0 | 110 |
| | 201104 | 4 | 6 | 5 | Large 4.0 | 110 |
| | 201110 | 4 | 6 | 10 | Large 4.0 | 110 |
| | 201112 | 4 | 6 | 2 | Large 4.0 | 110 |
| | 201115 | 4 | 6 | 1 | Large 4.0 | 110 |
| | 201109 | 6 | 6 | 10 | Large 4.0 | 110 |
| | 201113 | 6 | 6 | 5 | Large 4.0 | 110 |
| | 201114 | 6 | 6 | 1 | Large 4.0 | 110 |
| | 201105 | 8 | 6 | 2,5,2 | Large 4.0 | 110 |
| | 201106 | 8 | 6 | 2 | Large 4.0 | 110 |
| | 201107 | 8 | 6 | 5 | Large 4.0 | 110 |
| | 201108 | 8 | 6 | 2,10,2 | Large 4.0 | 110 |
| | 201101 | 10 | 6 | 2,5,2 | Large 4.0 | 110 |
| | 201102 | 10 | 6 | 2,6,2 | Large 4.0 | 110 |
| | 6DYNXT009 | 4 | 6 | 2,5,2 | Large 4.0 | 110 |
| | 6DYNXT011 | 4 | 6 | 5 | Large 4.0 | 110 |
| | 6DYNXT002 | 10 | 6 | 5 | Large 4.0 | 110 |
| | 6DYNXT004 | 10 | 6 | 2 | Large 4.0 | 110 |
The item numbers included in the scope of this submission are as follows:
3
Indications for Use
510(k) Number (if known) K211276
Device Name
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology (EP) Catheters
Indications for Use (Describe)
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
| 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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SECTION 5: 510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Amanda Babcock Requlatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
April 26, 2021
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K161464 | Reprocessed Dynamic Tip Steerable | |
| Diagnostic Electrophysiology Catheter | Innovative Health, LLC. | |
| K891908 | Bard Tip Deflecting Electrode Catheter | C.R. Bard, Inc. |
Device Description:
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
The item numbers in scope of this submission are as follows:
| Description | Item
Number | Number of
Electrodes | French
Size | Electrode
Spacing
(mm) | Distal Reach | Usable Length
(cm) |
|----------------------------------------------------------------------|----------------|-------------------------|----------------|------------------------------|--------------|-----------------------|
| Reprocessed
Dynamic Tip
Steerable
Diagnostic EP
Catheter | 200131 | 4 | 6 | 10 | Large 4.0 | 110 |
| | 200344 | 4 | 6 | 5 | Large 4.0 | 110 |
| | 6DYNTP002 | 4 | 6 | 2,5,2 | Large 4.0 | 110 |
| | 6DYNTP006 | 8 | 6 | 2 | Large 4.0 | 110 |
| | 6DYNTP001 | 10 | 6 | 2,5,2 | Large 4.0 | 110 |
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| Reprocessed
Dynamic XT
Steerable
Diagnostic EP
| Catheters | 201103 | 4 | 6 | 2,5,2 | Large 4.0 | 110 |
|---|---|---|---|---|---|---|
| 201104 | 4 | 6 | 5 | Large 4.0 | 110 | |
| 201110 | 4 | 6 | 10 | Large 4.0 | 110 | |
| 201112 | 4 | 6 | 2 | Large 4.0 | 110 | |
| 201115 | 4 | 6 | 1 | Large 4.0 | 110 | |
| 201109 | 6 | 6 | 10 | Large 4.0 | 110 | |
| 201113 | 6 | 6 | 5 | Large 4.0 | 110 | |
| 201114 | 6 | 6 | 1 | Large 4.0 | 110 | |
| 201105 | 8 | 6 | 2,5,2 | Large 4.0 | 110 | |
| 201106 | 8 | 6 | 2 | Large 4.0 | 110 | |
| 201107 | 8 | 6 | 5 | Large 4.0 | 110 | |
| 201108 | 8 | 6 | 2,10,2 | Large 4.0 | 110 | |
| 201101 | 10 | 6 | 2,5,2 | Large 4.0 | 110 | |
| 201102 | 10 | 6 | 2,6,2 | Large 4.0 | 110 | |
| 6DYNXT009 | 4 | 6 | 2,5,2 | Large 4.0 | 110 | |
| 6DYNXT011 | 4 | 6 | 5 | Large 4.0 | 110 | |
| 6DYNXT002 | 10 | 6 | 5 | Large 4.0 | 110 | |
| 6DYNXT004 | 10 | 6 | 2 | Large 4.0 | 110 |
Indications for Use:
The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology (EP) Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Dynamic Tip and XT Steerable Diagnostic EP Catheters. This included the following:
- Biocompatibilitv ●
- Cleaning Validation
- Sterilization Validation ●
- Functional Testing ●
- Visual Inspection .
- Dimensional Verification ●
- Electrical Continuity and Resistance ●
- . Simulated Use
- Mechanical Characteristics ●
- . Electrical Safety Testing
- . Dielectric and Current Leakage
- Shelf-life Validation
The Reprocessed Dynamic Tip and XT Steerable Diagnostic EP Catheters are reprocessed no more than three (3) times. Each device is marked, serialized and
6
tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Dynamic Tip and XT Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.