(127 days)
No
The summary describes a mechanical catheter with a steerable tip and mentions only standard performance testing, with no indication of AI/ML components or data processing.
No
The device is described as a "diagnostic" catheter intended for "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which indicates diagnostic rather than therapeutic use.
Yes
Explanation: The Intended Use/Indications for Use section explicitly states that the device is for "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which falls under the definition of diagnostic purposes. The device name itself also includes "Diagnostic Electrophysiology Catheters."
No
The device description clearly indicates a physical catheter with a polymer shaft and a plunger mechanism, which are hardware components. The performance studies also focus on physical and electrical characteristics of the hardware.
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, not a device used to examine specimens outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter with a flexible shaft and a steerable tip, designed for insertion into the heart. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (in a lab setting).
The device described is an invasive medical device used for electrophysiology procedures.
N/A
Intended Use / Indications for Use
The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology 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 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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Dynamic Tip Steerable Diagnostic EP Catheter. This included the following:
- Biocompatibility
- 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
- Packaging Validation
Key Metrics
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Innovative Health, LLC Rafal Chudzik VP, R&D and Operations 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K161464
Trade/Device Name: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (Models per Table 1 in Enclosure) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: August 26, 2016 Received: August 29, 2016
Dear Rafal Chudzik:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mula Jellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Item Number | Description | Electrodes | Spacing
(mm) | Curve | French
Size | Usable
Length
(cm) |
|-------------|-------------------------------------------------|------------|-----------------|-----------|----------------|--------------------------|
| 200131 | Dynamic Tip Steerable
Diagnostic EP Catheter | 4 | 10 | Large 4.0 | 6 | 110 |
| 200344 | Dynamic Tip Steerable
Diagnostic EP Catheter | 4 | 5 | Large 4.0 | 6 | 110 |
| 6DYNTP002 | Dynamic Tip Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Large 4.0 | 6 | 110 |
| 6DYNTP006 | Dynamic Tip Steerable
Diagnostic EP Catheter | 8 | 2 | Large 4.0 | 6 | 110 |
| 6DYNTP001 | Dynamic Tip Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Large 4.0 | 6 | 110 |
Table 1: Reprocessed Single-Use Devices Included in K161464 Clearance
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Indications for Use
510(k) Number (if known) K161464
Device Name
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology 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:
Rafal Chudzik VP, R&D and Operations (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com
Date prepared:
May 25, 2016
Device Information:
| Trade/Proprietary Name: | Reprocessed Dynamic Tip Steerable Diagnostic |
|---|---|
| Electrophysiology Catheters | |
| Common Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Catheter, Recording, Electrode, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K891908 | Bard Tip Deflecting Electrode Catheter | C.R. Bard, Inc. |
Device Description:
The Reprocessed Dynamic Tip 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 included in the scope of this submission are as follows:
| Description | Item Number | Number of
Electrodes | French
Size | Electrode
Spacing
(mm) | Curve | Length (cm) |
|-------------------------------------------------------|-------------|-------------------------|----------------|------------------------------|-----------|-------------|
| 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 |
Table 5.1: Device Scope
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Indications for Use:
The Reprocessed Dynamic Tip Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Technoloqical Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Dynamic Tip 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 Steerable Diagnostic EP Catheter. This included the following:
- Biocompatibility ●
- 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
- Packaging Validation ●
The Reprocessed Dynamic Tip Steerable Diagnostic EP Catheters are reprocessed no more than one (1) time. Each device is marked and 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 Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.