(140 days)
Not Found
No
The device description and performance studies focus on the physical and electrical characteristics of a diagnostic EP catheter, with no mention of AI or ML for data analysis or interpretation.
No
The device is indicated for electrophysiological mapping of cardiac structures (i.e., stimulation and recording only) and is designed for use in the coronary sinus for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for electrophysiological mapping of cardiac structures" and is a "Diagnostic EP Catheter."
No
The device description clearly details a physical catheter with electrodes, a steerable tip, and a rocker lever, indicating it is a hardware device, not software only.
No, 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 device directly into the body to interact with the heart's electrical activity.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The device is used in vivo (within the living body) to directly measure and stimulate electrical signals.
Therefore, based on the provided information, the Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is an invasive medical device used for diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed for use in the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The Reprocessed Webster Coronary Sinus (CS) Diagnostic Electrophysiology (EP) Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115cm. The catheter has a high-torque shaft with a bi-directional deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
Standard features of this catheter include a braided bi-directional deflectable tip section with an array of platinum electrodes that includes a 2mm tip dome. Additionally, two asymmetric curve types are available providing two 180º opposed, single plane curves. The curve types include DF and FJ. A Rocker Lever is used to deflect the tip. The hightorque shaft allows the plane 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, 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 CS Bi-directional Diagnostic EP Catheters. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- o Visual Inspection
- . Dimensional Verification
- Electrical Continuity and Resistance ●
- Simulated Use ●
- Mechanical Characteristics ●
- Auto ID Verification .
- 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.
Not Found
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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May 4, 2021
Innovative Health, LLC Christina Fleming VP, Compliance and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K203655
Trade/Device Name: Reprocessed Webster CS Bi-Directional 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: March 5, 2021 Received: March 8, 2021
Dear Christina Fleming:
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
1
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 (OS) 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 Acting 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
Details of Reprocessed Devices:
The item numbers included in the scope of this submission are as follows:
| Item Number | Description | Sheath
Usable
Length
(cm) | French
Size | Curve | Spacing
(mm) |
|---------------|---------------------------------------------------------------------------------------|------------------------------------|----------------|-------|-----------------|
| BD710DF282RTS | Reprocessed
Webster CS
Bi-Directional
Diagnostic EP
Catheter | 115 | 7F | D-F | 2-8-2 |
| BD710FJ282RTS | Reprocessed
Webster CS
Bi-Directional
Diagnostic EP
Catheter | 115 | 7F | F-J | 2-8-2 |
| BD710DF282CT | Reprocessed
Webster CS
Bi-Directional
Diagnostic EP
Catheter with Auto ID | 115 | 7F | D-F | 2-8-2 |
| BD710FJ282CT | Reprocessed
Webster CS
Bi-Directional
Diagnostic EP
Catheter with Auto ID | 115 | 7F | F-J | 2-8-2 |
Table 10.1: Device Scope
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3
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed Webster CS Bi-directional Diagnostic Electrophysiology (EP) Catheters
Indications for Use (Describe)
The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed for use in 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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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:
Christina Fleming VP. Compliance and Requlatory Affairs Innovative Health, LLC. (480) 525-5972 (office) (888) 965-7706 (fax) tfleming@innovative-health.com
Date prepared:
December 14, 2020
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Webster CS Bi-directional Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K170922 | Reprocessed Webster CS Bi-Directional | |
| Diagnostic Electrophysiology Catheter | Innovative Health, LLC. | |
| K101345 | Webster CS Catheter with EZ Steer | |
| Technology, Webster CS Catheter with | ||
| EZ Steer Technology and Auto ID | Biosense Webster |
Device Description:
The Reprocessed Webster Coronary Sinus (CS) Diagnostic Electrophysiology (EP) Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115cm. The catheter has a high-torque shaft with a bi-directional deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
Standard features of this catheter include a braided bi-directional deflectable tip section with an array of platinum electrodes that includes a 2mm tip dome. Additionally, two asymmetric curve types are available providing two 180º opposed, single plane curves. The curve types include DF and FJ. A Rocker Lever is used to deflect the tip. The hightorque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
5
For Devices with Auto ID Technology:
The catheter is equipped with Electronically Erasable Programmable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize he catheter information.
The catheter interfaces with CARTO EP Navigation Systems equipped with Auto ID Technology via interface cables with the appropriate connectors.
Note: Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.
| Item Number | Description | Sheath
Usable
Length
(cm) | French
Size | Curve | Spacing
(mm) |
|---------------|---------------------------------------------------------------------------------|------------------------------------|----------------|-------|-----------------|
| BD710DF282RTS | Reprocessed Webster CS
Bi-Directional Diagnostic
EP Catheter | 115 | 7F | D-F | 2-8-2 |
| BD710FJ282RTS | Reprocessed Webster CS
Bi-Directional Diagnostic
EP Catheter | 115 | 7F | F-J | 2-8-2 |
| BD710DF282CT | Reprocessed Webster CS
Bi-Directional Diagnostic
EP Catheter with Auto ID | 115 | 7F | D-F | 2-8-2 |
| BD710FJ282CT | Reprocessed Webster CS
Bi-Directional Diagnostic
EP Catheter with Auto ID | 115 | 7F | F-J | 2-8-2 |
The item numbers included in the scope of this submission are as follows:
Table 5.1: Item Numbers
This 510(k) adds two (2) reprocessing cycles to the same device cleared under K170922 and minor changes to the reprocessing and sterilization release method.
Indications for Use:
The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed for use in the coronary sinus.
Technoloqical Characteristics:
The purpose, design, materials, function, and intended use of the Webster CS Bidirectional 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 CS Bi-directional Diagnostic EP Catheters.
6
This included the following:
- Biocompatibility
- Cleaning Validation .
- Sterilization Validation .
- Functional Testing 0
- o Visual Inspection
- . Dimensional Verification
- Electrical Continuity and Resistance ●
- Simulated Use ●
- Mechanical Characteristics ●
- Auto ID Verification .
- Electrical Safety Testing ●
- Dielectric and Current Leakage ●
- Packaging Validation ●
The Reprocessed Webster Coronary Sinus (CS) Bi-directional Diagnostic Electrophysiology (EP) Catheters are reprocessed no more than three (3) times. 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.
Predicate Comparison:
A comparison of the device and reprocessing methods with the predicates are provided in the table below:
| This 510(k) | K170922 | K101345 | |
|---|---|---|---|
| Device: | Identical | Identical | Identical |
| Reprocessing Cycles: | 3 | 1 | 0 |
| Reprocessing Method: | Change to processing | ||
| parameters. Packaging | |||
| configuration and label | |||
| change. Shelf life | |||
| change. | Cleared/validated | ||
| process | N/A | ||
| Sterilization: | Change to release | ||
| method. No change to | |||
| the sterilization method | |||
| or SAL. | Cleared/validated | ||
| process | N/A | ||
| Routine Monitoring: | Change to frequency | ||
| and adjustment of limits. | Cleared process | N/A |
Table 5.2: Predicate Comparison
Conclusion:
Innovative Health concludes that the Reprocessed Webster Coronary Sinus (CS) Bidirectional Diagnostic Electrophysiology (EP) Catheters are substantially equivalent to the predicate devices described herein.