(77 days)
No
The summary describes a standard electrophysiology catheter for mapping and recording, with no mention of AI or ML capabilities in its function or data processing.
No.
The device is indicated for electrophysiological mapping, stimulation, and recording only, which are diagnostic functions, not therapeutic.
Yes
Explanation: The "Intended Use" states "electrophysiological mapping of cardiac structures" which involves recording electrical activity to help diagnose heart conditions. The "Device Description" also explicitly refers to it as a "Diagnostic Electrophysiology (EP) Catheter."
No
The device description clearly details a physical catheter with a shaft, deflectable tip, electrodes, and a handpiece for control, 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:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a catheter used for "electrophysiological mapping of cardiac structures, i.e. stimulation and recording only." This involves inserting the catheter directly into the body to interact with the heart's electrical activity.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to directly interact with and measure electrical signals within the heart.
Therefore, the Reprocessed Webster Duo-Decapolar EP Catheter is an invasive medical device used for diagnostic purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Webster Duo-Decapolar EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures, atrial region of the heart, coronary sinus
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 Webster Duo-Decapolar Diaqnostic EP Catheters.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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July 1, 2019
Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K190980
Trade/Device Name: Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (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: June 25, 2019 Received: June 26, 2019
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
1
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 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 medical devices and radiation-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 DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
The item numbers included in the scope of this submission are as follows:
| ltem Number | Description | Sheath
Usable
Length
(cm) | French
Size | Curve | Number of
Electrodes | Spacing
(mm) |
|-------------|--------------------------------------------------------|------------------------------------|----------------|-------|-------------------------|--------------------|
| D728260RT | Webster Duo-
Decapolar
Diagnostic EP
Catheter | 110 | 7F | Large | 20 | 2-8-2-60-
2-8-2 |
3
Indications for Use
510(k) Number (if known) K190980
Device Name
Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter
Indications for Use (Describe)
The Reprocessed Webster Duo-Decapolar EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
| 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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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 Requlatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
April 12, 2019
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH
Predicate Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K101991 | Webster Duo-Decapolar Catheter | Biosense Webster |
Reference Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K171503 | Reprocessed CristaCath Diagnostic EP | |
| Catheter | Innovative Health, LLC. | |
| K170922 | Reprocessed Webster CS Bi-Directional | |
| Diagnostic EP Catheter | Innovative Health, LLC. |
Device Description:
The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
5
| ltem Number | Description | Sheath
Usable
Length
(cm) | French
Size | Curve | Number of
Electrodes | Spacing
(mm) |
|-------------|--------------------------------------------------------|------------------------------------|----------------|-------|-------------------------|--------------------|
| D728260RT | Webster Duo-
Decapolar
Diagnostic EP
Catheter | 110 | 7F | Large | 20 | 2-8-2-60-
2-8-2 |
The item numbers included in the scope of this submission are as follows:
Table 5.1: Item Numbers
Indications for Use:
The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Webster Duo-Decapolar Diagnostic 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 Webster Duo-Decapolar Diaqnostic EP Catheters.
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 Webster Duo-Decapolar Diagnostic Electrophysiology (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 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.
6
Conclusion:
Innovative Health concludes that the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.