(92 days)
Not Found
No
The summary describes a reprocessed electrophysiological catheter used for mapping cardiac structures. It mentions interfacing with a navigation system but does not describe any features or functions related to AI or ML, nor does it mention image processing or data analysis that would typically involve these technologies. The performance studies focus on standard device testing like biocompatibility, electrical safety, and functional testing, not AI/ML performance metrics.
No
The device is used for electrophysiological mapping and recording, which are diagnostic procedures, not therapeutic interventions.
Yes
The device is indicated for "electrophysiological mapping of cardiac structures i.e., recording and stimulation," which are diagnostic activities. It "facilitates electrophysiological mapping of the heart" by recording cardiac electrical signals, which are used to diagnose cardiac conditions.
No
The device description clearly details a physical catheter with electrodes, a deflectable tip, and a hand piece, indicating it is a hardware device, not software-only.
Based on the provided information, the Reprocessed DecNav Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this catheter is used within the body for electrophysiological mapping and stimulation of cardiac structures. It is a medical device used for diagnosis and treatment in vivo, not for testing samples in vitro.
- The device description focuses on the physical characteristics and function of the catheter within the heart. It describes the shaft, electrodes, tip deflection, and interface with navigation and recording systems, all of which are related to its use inside the body.
- The performance studies listed are typical for an invasive medical device. Biocompatibility, cleaning validation, sterilization validation, functional testing, mechanical characteristics, electrical safety testing, and packaging validation are all relevant to the safety and effectiveness of a device used internally. These are not the types of studies typically performed for an IVD.
Therefore, the Reprocessed DecNav Catheter is a medical device used for electrophysiological procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.
The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The Reprocessed DecaNav Catheter has been designed to be used with the Carto 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The catheter has a single proximal electrode that can be used for unipolar recording signals. The catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.
This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.
| Description | REF
Number | Item
Number | French
Size | Curve | Number of
Electrodes | Spacing
(mm) | Insertion
Length
(cm) |
|---|---|---|---|---|---|---|---|
| DecaNav
Diagnostic EP
Catheter | R7D282CT | D-1285-01-S | 7 | D | 10 | 2-8-2 | 115 |
| DecaNav
Diagnostic EP
Catheter | R7F282CT | D-1285-02-S | 7 | F | 10 | 2-8-2 | 115 |
The item numbers in scope of this submission are as follows:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures, heart, 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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 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 DecaNav Diagnostic EP Catheter 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.
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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 19, 2018
Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257
Re: K180710
Trade/Device Name: Reprocessed DecaNav Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 18, 2018 Received: May 21, 2018
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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Description | REF
Number | Item
Number | French
Size | Curve | Number of
Electrodes | Spacing
(mm) | Insertion
Length
(cm) |
|--------------------------------------|---------------|----------------|----------------|-------|-------------------------|-----------------|-----------------------------|
| DecaNav
Diagnostic EP
Catheter | R7D282CT | D-1285-01-S | 7 | D | 10 | 2-8-2 | 115 |
| DecaNav
Diagnostic EP
Catheter | R7F282CT | D-1285-02-S | 7 | F | 10 | 2-8-2 | 115 |
The item numbers in scope of this submission are as follows:
Table 1: Device Scope
3
Indications for Use
510(k) Number (if known)
K180710
Device Name
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.
The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 Principal Requlatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
March 16, 2018
Device Information:
Trade/Proprietary Name: Common or Usual Name: Classification Name: Classification Number: Product Code:
Reprocessed DecaNav Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Electrode Recording Catheter or Electrode Recording Probe Class II, 21 CFR 870.1220 NLH
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K080425 | CS RefStar Catheter | Biosense Webster |
Device Description:
The Reprocessed DecaNav Catheter has been designed to be used with the Carto 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The catheter has a single proximal electrode that can be used for unipolar recording signals. The catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.
This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.
| Description | REF
Number | Item
Number | French
Size | Curve | Number of
Electrodes | Spacing
(mm) | Insertion
Length
(cm) |
|--------------------------------------|---------------|----------------|----------------|-------|-------------------------|-----------------|-----------------------------|
| DecaNav
Diagnostic EP
Catheter | R7D282CT | D-1285-01-S | 7 | D | 10 | 2-8-2 | 115 |
| DecaNav
Diagnostic EP
Catheter | R7F282CT | D-1285-02-S | 7 | F | 10 | 2-8-2 | 115 |
The item numbers in scope of this submission are as follows:
Table 5.1: Device Scope
5
Indications for Use:
The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus,
The catheter provides tip location information when used with the compatible Carto 3 EP Navigation Systems.
Technoloqical Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed DecaNav Diagnostic EP Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Catheter 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 Reprocessed 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 DecaNav Diagnostic EP Catheter 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 DecaNav Diagnostic EP Catheter is as safe and effective as the predicate devices described herein.