(96 days)
No
The summary describes a standard diagnostic EP catheter and its reprocessing, with no mention of AI/ML capabilities or related performance studies.
No
The device is described as a "Diagnostic EP Catheter" used for "intracardiac stimulation (pacing) and/or recording of electrical potentials" in electrophysiology studies, which are diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "The Reprocessed Polaris X Steerable Diagnostic EP Catheter" and is intended for "intracardiac stimulation (pacing) and/or recording of electrical potentials," which are diagnostic activities in electrophysiology studies.
No
The device description and performance studies clearly indicate this is a physical catheter with mechanical and electrical components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials." This describes a device used within the body for direct electrical interaction, not a device used to examine specimens outside the body.
- Device Description: The description focuses on the physical characteristics and function of the catheter for electrical signals within the heart.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information 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's function is entirely focused on direct electrical interaction within the heart.
N/A
Intended Use / Indications for Use
The Reprocessed Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Product codes
NLH
Device Description
The Reprocessed Polaris X Steerable Diagnostic EP Catheters are designed for use in intracardiac pacing and recording only. The catheters have been designed to carry electrical signals for the purpose of endocardial stimulation (pacing) or recording. The catheter is a uni-directional steerable catheter. The curve is actuated by means of a patented thumb-slide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracardiac
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 Polaris X Steerable 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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 10, 2016
Innovative Health, LLC. Rafal Chudzik Director of Engineering 1435 North Hayden Road. Suite 100 Scottsdale, Arizona 85257
Re: K160303
Trade/Device Name: Reprocessed Polaris X Steerable 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: April 8, 2016 Received: April 11, 2016
Dear Rafal Chudzik:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 3 - Rafal Chudzik
| Description | Item Number | Number of Electrodes | Electrode Spacing | French Size | Curve Type | Catheter Length |
|---|---|---|---|---|---|---|
| Polaris X | ||||||
| Steerable | ||||||
| Diagnostic EP | ||||||
| Catheter | 7000D | 10 | 2.5 mm | 6 F | 270° Standard | |
| Curve | 105 cm | |||||
| 7001D | 10 | 5 mm | 6 F | 270° Standard | ||
| Curve | 105 cm | |||||
| 7003D | 10 | 2.5/5/2.5 mm | 6 F | 270° Standard | ||
| Curve | 105 cm | |||||
| 7004D | 10 | 2/8/2 mm | 6 F | 270° Standard | ||
| Curve | 105 cm | |||||
| 7005D | 10 | 2/10/2 mm | 6 F | 270° Standard | ||
| Curve | 105 cm |
The item numbers included in the scope of K160303 are as follows:
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Indications for Use
510(k) Number (if known) K160303
Device Name
Reprocessed Polaris X Steerable Diagnostic Electrophysiology (EP) Catheter
Indications for Use (Describe)
The Reprocessed Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
| 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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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:
Rafal Chudzik Director of Engineering (602) 326-7716 (cell) (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com
Date prepared:
February 3, 2016
Device Information:
| Trade/Proprietary Name: | Reprocessed Polaris X Steerable Diagnostic
Electrophysiology Catheters |
|-------------------------|---------------------------------------------------------------------------|
| Common Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Catheter, Recording, Electrode, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K003452 | Polaris X Catheters | EP Technologies, Inc. |
| K924163 | Explorer/360-Polaris-L.E./Jackman | |
| /Coron Sinus Electrophysiology | Boston Scientific, Corp. |
Reference Device:
| 510(k) Number | 510(k) Title | Reprocessor |
|---|---|---|
| K052414 | Reprocessed Electrophysiology Catheter | Alliance Medical Corp. |
Device Description:
The Reprocessed Polaris X Steerable Diagnostic EP Catheters are designed for use in intracardiac pacing and recording only. The catheters have been designed to carry electrical signals for the purpose of endocardial stimulation (pacing) or recording. The catheter is a uni-directional steerable catheter. The curve is actuated by means of a patented thumb-slide.
5
Indications for Use:
The Reprocessed Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Polaris X Steerable Diagnostic Electrophysiology (EP) Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices 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 Polaris X Steerable 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 Polaris X Steerable Diagnostic EP Catheters are reprocessed no more than one (1) time. Each device is marked 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 Polaris X Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.