(145 days)
Not Found
No
The summary describes a physical catheter and its use with existing navigation systems. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the physical characteristics and functionality of the catheter itself.
No
This device is for diagnostic purposes, specifically for recording intracardiac signals and cardiac stimulation during electrophysiology studies to map the heart. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies."
No
The device description clearly outlines a physical catheter with a handle, shaft, electrodes, and a control mechanism, indicating it is a hardware device. While it interacts with software systems (EnSite Precision and MediGuide), the core device itself is 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 clearly states that the catheter is used for "recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies" and to "map the atrial regions of the heart." This describes a procedure performed within the body (in vivo) to gather physiological data directly from the heart.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The information provided does not mention any testing of samples outside the body.
- Device Description: The description details a catheter designed to be inserted into the body.
- Anatomical Site: The anatomical site is the "Atrial regions of the heart," which is an internal part of the body.
The device is an in vivo medical device used for diagnostic and mapping purposes within the heart.
N/A
Intended Use / Indications for Use
The Reprocessed Advisor FL Circular Mapping Catheter is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide Technology system to enable real-time positioning and navigation. The MediGuide Technology system is indicated for use as an adjunct to fluoroscopy.
Product codes
NLH
Device Description
The Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled, is a steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented counter-clockwise as viewed from the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial regions of the heart
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 Catheter. 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 .
- . Packaging Validation
Key results: Innovative Health concludes that the Reprocessed Advisor Catheter is as safe and effective as the predicate devices described herein.
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2018
Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 N. Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K181458
Trade/Device Name: Reprocessed Advisor FL, Sensor Enabled, Circular Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 17, 2018 Received: September 18, 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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
Muda Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K181458 - Amanda Babcock
The following device models are included in the scope of this 510(k) submission:
| Description | Item Number | Curve | Length
(cm) | Number of
Electrodes | Spacing
(mm) | Loop
Diameter
(mm) | French
Size |
|-----------------------------------------------------------------|--------------|-------|----------------|-------------------------|-----------------|--------------------------|----------------|
| Advisor FL
Sensor Enabled
Circular
Mapping
Catheter | DAVSEDF10F15 | DF | 115 | 10 | 3-3-3 | 15 | 8 |
| | DAVSEDF10F20 | DF | 115 | 10 | 5-5-5 | 20 | 8 |
3
Indications for Use
510(k) Number (if known) K181458
Device Name
Reprocessed Advisor FL, Sensor Enabled, Circular Mapping Catheter
Indications for Use (Describe)
The Reprocessed Advisor FL Circular Mapping Catheter is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide Technology system to enable real-time positioning and navigation. The MediGuide Technology system is indicated for use as an adjunct to fluoroscopy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 Regulatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
May 31, 2018
Device Information:
| Trade/Proprietary Name: | Reprocessed Advisor FL, Sensor Enabled, Circular Mapping
Catheter |
|-------------------------|----------------------------------------------------------------------|
| Common or Usual Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Electrode Recording Catheter or Electrode Recording Probe |
| Classification: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K160335 | Advisor FL Circular Mapping Catheter | St. Jude Medical |
Device Description:
The Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled, is a steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented counter-clockwise as viewed from the handle.
The item numbers in scope of this submission are as follows:
| Description | Item Number | Curve | Length
(cm) | Number of
Electrodes | Spacing
(mm) | Loop
Diameter
(mm) | French
Size |
|-----------------------------------------------------------------|--------------|-------|----------------|-------------------------|-----------------|--------------------------|----------------|
| Advisor FL
Sensor Enabled
Circular
Mapping
Catheter | DAVSEDF10F15 | DF | 115 | 10 | 3-3-3 | 15 | 8 |
| | DAVSEDF10F20 | DF | 115 | 10 | 5-5-5 | 20 | 8 |
Table 5.1: Device Scope
Innovative Health Reprocessed Catheters
5
Indications for Use:
The Reprocessed Advisor FL Circular Mapping Catheter is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide Technology system to enable real-time positioning and navigation. The MediGuide Technology system is indicated for use as an adjunct to fluoroscopy.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Advisor 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 Catheter. This included the following:
- Biocompatibilitv ●
- . Cleaning Validation
- Sterilization Validation .
- Functional testing ●
- . Visual Inspection
- . Dimensional Verification
- Electrical Continuity and Resistance .
- . Simulated Use
- Mechanical Characteristics 트
- Electrical Safety Testing
- Dielectric and Current Leakage .
- . Packaging Validation
The Reprocessed Advisor 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 Advisor Catheter is as safe and effective as the predicate devices described herein.