(170 days)
No
The description focuses on the physical characteristics and functionality of a mapping catheter, with no mention of AI or ML for data analysis or interpretation. The "sensor in the catheter tip" is for spatial tracking, not for AI/ML processing of physiological signals.
No.
The device is used for electrophysiological mapping (recording or stimulating only) of cardiac structures, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is indicated for "electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart," which is a diagnostic function to identify and map electrical activity in the heart. The device description also mentions a "sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System," further indicating its role in data collection for diagnosis.
No
The device description clearly details a physical catheter with electrodes, a handle, cable, connector, and a sensor, indicating it is a hardware device, 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 is "electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart." This describes a procedure performed on the patient's body to gather electrical signals from the heart.
- Device Description: The description details a catheter designed to be inserted into the body to interact directly with cardiac tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside of the body (in vitro), such as blood, urine, or tissue samples. The device is used for direct measurement within the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. This device is used for direct physiological measurement within the body.
N/A
Intended Use / Indications for Use
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Product codes
NLG
Device Description
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures 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 the Reprocessed IntellaMap Orion High Resolution Mapping Catheter. This included the following:
- Biocompatibilitv ●
- Cleaning Validation ●
- Sterilization Validation
- Functional testing
- Visual Inspection .
- . Dimensional Verification
- . Dynamic Continuity
- Simulated Use .
- . Leak/Occlusion
- Inner lumen occlusion ■
- . Mechanical Characteristics
- Electrical Safety Testing
- Dielectric and Current .
- Leakage
- Dielectric and Current .
- Packaging Validation ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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November 18, 2021
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Re: K211662
Trade/Device Name: Reprocessed IntellaMap Orion High Resolution Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLG Dated: October 19, 2021 Received: October 20, 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 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
1
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 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,
Aneesh Deoras 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 in the scope of this submission is as follows:
| Item Number | Description | Usable
Length
(cm) | French
Size | Curve | Electrodes |
|-------------|------------------------------------------------------------------------|--------------------------|----------------|-----------------------|------------|
| M004RC64S0 | Reprocessed
IntellaMap Orion
High Resolution
Mapping Catheter | 115 | 8.5F | 180,
Bidirectional | 64 |
3
Indications for Use
510(k) Number (if known) K211662
Device Name
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Indications for Use (Describe)
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
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
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:
May 28, 2021
Device Information:
| Trade/Proprietary Name: | Reprocessed IntellaMap Orion High Resolution Mapping Catheter |
|---|---|
| Catheter | |
| Common or Usual Name: | Diagnostic Electrophysiology Mapping Catheter |
| Classification Name: | Electrode Recording Catheter or Electrode Recording Probe |
| Probe | |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLG |
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K192360 | IntellaMap Orion High Resolution Mapping | |
| Catheter | Boston Scientific | |
| Corporation |
Reference Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K200212 | Reprocessed Advisor HD Grid Mapping | |
| Catheter, Sensor Enabled | Innovative Health, LLC. |
Device Description:
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.
The item number in scope of this submission is as follows:
5
| Item Number | Description | Usable Length (cm) | French Size | Curve | Electrodes |
|---|---|---|---|---|---|
| M004RC64S0 | Reprocessed | ||||
| IntellaMap Orion | |||||
| High Resolution | |||||
| Mapping Catheter | 115 | 8.5F | 180, | ||
| Bidirectional | 64 |
Table 5.1: Device Scope
Indications for Use:
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed IntellaMap Orion High Resolution Mapping Catheter 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 of the device and lumen. Each device (including the lumen) 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 IntellaMap Orion High Resolution Mapping Catheter. This included the following:
- Biocompatibilitv ●
- Cleaning Validation ●
- Sterilization Validation
- Functional testing
- Visual Inspection .
- . Dimensional Verification
- . Dynamic Continuity
- Simulated Use .
- . Leak/Occlusion
- Inner lumen occlusion ■
- . Mechanical Characteristics
- Electrical Safety Testing
- Dielectric and Current .
- Leakage
- Dielectric and Current .
- Packaging Validation ●
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter 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 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 IntellaMap Orion High Resolution Mapping Catheter is substantially equivalent to the predicate devices described herein.