(122 days)
Not Found
No
The summary describes a standard electrophysiology catheter for recording and pacing, with no mention of AI/ML capabilities, image processing, or data analysis features typically associated with AI/enabled devices. The performance studies focus on physical and electrical characteristics, not algorithmic performance.
No
The device is described as being for "diagnostic electrophysiologic procedures" and for "recording intracardiac electrograms and temporary pacing associated with electrophysiology studies," which are diagnostic rather than therapeutic uses.
Yes
The "Intended Use / Indications for Use" states that the catheter is "intended for use in diagnostic electrophysiologic procedures" and "designed for recording intracardiac electrograms". Recording electrograms is a diagnostic function.
No
The device description clearly states it is a physical catheter constructed of extruded polymer over stainless steel braid, with a handle for control. The performance studies also include testing of physical characteristics like mechanical properties and electrical safety, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic electrophysiologic procedures" and "recording intracardiac electrograms and temporary pacing associated with electrophysiology studies." This describes a procedure performed on the patient's body (in vivo), not on a sample taken from the patient (in vitro).
- Device Description: The description details a catheter designed for insertion into the heart for recording and stimulation. This is a medical device used directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reprocessed Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Product codes
NLH
Device Description
The Reprocessed Marinr steerable/deflectable tip electrode catheter is a flexible, radiopaque catheter constructed of extruded polymer over stainless steel braid. The catheter is designed for intracardiac recording or stimulation. The Marinr catheter handle controls allow precise tip placement within the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac (within 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:
- 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 (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 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.
November 15, 2018
Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road. Suite 100 Scottsdale, Arizona 85257
Re: K181897
Trade/Device Name: Reprocessed Marinr Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: October 16, 2018 Received: October 17, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Description | Item
Number | Shaft
Size
(French) | Curve
Reach
(mm) and
Curve Type | Number of
Electrodes | Electrode
Spacing
(mm) | Usable
Length
(cm) |
|-------------------------------------|----------------|---------------------------|------------------------------------------|-------------------------|------------------------------|--------------------------|
| Marinr
Diagnostic
EP Catheter | 072302 | 7 | 40-60, MC | 4 | 2-5-2 | 110 |
| | 072402 | 7 | 55-75,
MCXL | 4 | 2-5-2 | 110 |
| | 043302M | 7 | 55, CS | 10 | 2 | 90 |
| | 043325M | 7 | 55, CS | 10 | 2-5-2 | 90 |
| | 043328M | 7 | 55, CS | 10 | 2-8-2 | 90 |
| | 072322M | 7 | 65, SCXXL | 4 | 2-5-2 | 90 |
The item numbers in scope of this submission (K181897) are as follows:
3
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed Marinr Diagnostic Electrophysiology (EP) Catheter
Indications for Use (Describe)
The Reprocessed Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
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:
July 13, 2018
Device Information:
Trade/Proprietary Name: Reprocessed Marinr Diagnostic EP 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 |
|---|---|---|
| K951347 | Marinr Series EP Diagnostic Catheters | Medtronic (CardioRhythm) |
| K931794 | Marinr Series EP Diagnostic Catheters | Medtronic (CardioRhythm) |
Device Description:
The Reprocessed Marinr steerable/deflectable tip electrode catheter is a flexible, radiopaque catheter constructed of extruded polymer over stainless steel braid. The catheter is designed for intracardiac recording or stimulation. The Marinr catheter handle controls allow precise tip placement within the heart.
The item numbers in scope of this submission are as follows:
| Description | Item
Number | Shaft
Size
(French) | Curve
Reach
(mm) and
Curve Type | Number of
Electrodes | Electrode
Spacing
(mm) | Usable
Length
(cm) |
|-------------------------------------|----------------|---------------------------|------------------------------------------|-------------------------|------------------------------|--------------------------|
| Marinr
Diagnostic
EP Catheter | 072302 | 7 | 40-60, MC | 4 | 2-5-2 | 110 |
| | 072402 | 7 | 55-75,
MCXL | 4 | 2-5-2 | 110 |
| | 043302M | 7 | 55, CS | 10 | 2 | 90 |
| | 043325M | 7 | 55, CS | 10 | 2-5-2 | 90 |
| | 043328M | 7 | 55, CS | 10 | 2-8-2 | 90 |
| | 072322M | 7 | 65, SCXXL | 4 | 2-5-2 | 90 |
Table 5.1: Device Scope
Innovative Health Reprocessed Catheters
Page 1 Traditional 510(k) K181897
5
Indications for Use:
The Reprocessed Marinr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Marinr 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 packaqing 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:
- 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 Marinr Catheter is 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 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 Marinr Catheter is as safe and effective as the predicate devices described herein.
Innovative Health Reprocessed Catheters