(219 days)
No
The summary describes a physical medical device (catheter) for electrophysiological mapping and does not mention any software or algorithms that would suggest the use of AI/ML. The performance studies focus on physical and electrical characteristics, not algorithmic performance.
No
The device is described as an electrophysiological mapping catheter intended for recording or stimulation to obtain electrograms, which are diagnostic purposes for understanding cardiac activity, not for treating a condition.
Yes
Explanation: The device is indicated for "electrophysiological mapping of cardiac structures" and is intended to "obtain electrograms," which are methods of recording and analyzing electrical activity to diagnose cardiac conditions.
No
The device description explicitly details a physical catheter with a handle, shaft, electrodes, and control mechanism, indicating it is a hardware device, not software-only. The performance studies also focus on physical and electrical characteristics of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only." This involves directly interacting with the patient's body to record electrical signals.
- Device Description: The description details a catheter designed for insertion into the heart.
- Anatomical Site: The anatomical site is "cardiac structures in the heart."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device does not process or analyze biological specimens outside the body.
This device is a medical device used for diagnostic and potentially therapeutic procedures performed in vivo (within the body).
N/A
Intended Use / Indications for Use
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Product codes
NLG
Device Description
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated, 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 catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac structures in the heart, i.e., recording or stimulation only; atrial and ventricular 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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. This included the following:
- Biocompatibility ●
- Cleaning Validation .
- Sterilization Validation
- Functional testing
- . Visual Inspection
- . Dimensional Verification
- Electrical Continuity .
- . Simulated Use
- Mechanical Characteristics ■
- Electrical Safety Testing .
- Dielectric and Current Leakage .
- . Packaging Validation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 3, 2020
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K200212
Trade/Device Name: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLG Dated: July 31, 2020 Received: August 3, 2020
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 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
1
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 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.
Mark Fellman Assistant Director 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
The item number included in the scope of this submission is as follows:
| Item Number | Description | Usable
Length
(cm) | French
Size | Curve | Spacing
(mm) | Electrodes | System
Compatibility |
|-------------|-----------------------------------------------------------------------|--------------------------|----------------|-------|-----------------|------------|--------------------------------------------------------------------------------|
| D-AVHD-DF16 | Reprocessed
Advisor HD Grid
Mapping Catheter,
Sensor Enabled | 110 | 8F | DF | 3 | 16 | EnSite
Velocity and
EnSite
Precision
Cardiac
Mapping
Systems |
3
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Indications for Use (Describe)
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
| 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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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 Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
August 21, 2020
Device Information:
| Trade/Proprietary Name: | Reprocessed Advisor High Density (HD) Grid Mapping |
|---|---|
| Catheter, Sensor Enabled | |
| Common or Usual Name: | Diagnostic Electrophysiology Mapping Catheter |
| Classification Name: | Electrode Recording Catheter or Electrode Recording |
| Probe | |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLG |
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K172393 | Advisor HD Grid Mapping Catheter, Sensor | |
| Enabled | St. Jude Medical |
Reference Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K181458 | Reprocessed Advisor FL, Sensor Enabled, | |
| Circular Mapping Catheter | Innovative Health, LLC. | |
| K190785 | Reprocessed PentaRay Nav eco High- | |
| Density Mapping Catheter | Innovative Health, LLC. |
Device Description:
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated, 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 catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.
5
The item number in scope of this submission is as follows:
| ltem Number | Description | Usable
Length
(cm) | French
Size | Curve | Spacing
(mm) | Electrodes | System Compatibility |
|-------------|-----------------------------------------------------------------------|--------------------------|----------------|-------|-----------------|------------|-----------------------------------------------------------------------|
| D-AVHD-DF16 | Reprocessed
Advisor HD Grid
Mapping Catheter,
Sensor Enabled | 110 | 8F | DF | 3 | 16 | EnSite Velocity and
EnSite Precision
Cardiac Mapping
Systems |
Table 1: Device Scope
Indications for Use:
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Advisor HD Grid Mapping Catheter (Sensor Enabled) are identical to the predicate device. 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 the Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. This included the following:
- Biocompatibility ●
- Cleaning Validation .
- Sterilization Validation
- Functional testing
- . Visual Inspection
- . Dimensional Verification
- Electrical Continuity .
- . Simulated Use
- Mechanical Characteristics ■
- Electrical Safety Testing .
- Dielectric and Current Leakage .
- . Packaging Validation
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cvcles, the device is reiected 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 HD Grid Mapping Catheter, Sensor Enabled, is as safe and effective as the predicate devices described herein.