(279 days)
Not Found
No
The description focuses on the physical characteristics of the catheter and the use of EEPROM for automatic identification by a navigation system. There is no mention of AI or ML for data analysis, interpretation, or decision-making.
No.
The device's intended use is explicitly stated as "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only," which indicates a diagnostic rather than therapeutic purpose.
Yes.
The device is explicitly named a "CS Diagnostic EP Catheter" and its intended use is for "electrophysiological mapping," which is a diagnostic procedure to identify and localize electrical activity in the heart.
No
The device description clearly describes a physical catheter with electrodes, a steerable tip, and a shaft. While it includes EEPROM for identification, the core device is hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This involves interacting directly with the patient's body (in vivo) to measure electrical activity.
- Device Description: The description details a catheter designed to be inserted into the coronary sinus for mapping. This is a physical device used within the body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside of the body (in vitro) to provide information about a patient's health. This device does not perform such analysis on specimens.
Therefore, the Reprocessed CS Diagnostic EP Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed CS 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
NLH
Device Description
The Reprocessed CS Diagnostic Electrophysiology 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 115 cm. The catheter has a high-torque shaft with a braided deflectable, Bi-Directional tip section containing platinum electrodes that can be used for recording and stimulation. Two curve types, D/F and F/J, for CS placement, are available.
Specific to Reprocessed CS Diagnostic Electrophysiology Catheters with Auto ID Technology: Each catheter is equipped with EEPROM (Electronically Erasable Programmable Read Only Memory), which is used to save unique catheter identification information. CARTO® EP Navigation Systems equipped with Auto ID Technology can access the saved information and automatically recognize the catheter information.
This device has been cleared for three (3) reprocessing cycles.
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
Not Found
Key Metrics
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 24, 2019
Stryker Sustainability Solutions Mia McCorkel Regulatory Affairs Specialist 1810 W. Drake Drive Tempe, Arizona 85283
Re: K181056
Trade/Device Name: Reprocessed CS Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: December 21, 2018 Received: December 26, 2018
Dear Mia McCorkel:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 mediation-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
Mada Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Model Number | Description |
|---|---|
| BD710DF282RTS | Bi-Directional Catheter, 7F, DF Curve, 115 cm useable length, 2 mm tip electrode |
| BD710FJ282RTS | Bi-Directional Catheter, 7F, FJ Curve, 115 cm useable length, 2 mm tip electrode |
| BD710DF282CT | Bi-Directional Catheter with Auto ID Technology, 7F, DF Curve, 115 cm useable length, 2 mm tip electrode |
| BD710FJ282CT | Bi-Directional Catheter with Auto ID Technology, 7F, FJ Curve, 115 cm useable length, 2 mm tip electrode |
The following device models are included in the scope of this 510(k) submission:
3
Indications for Use
510(k) Number (if known) K181056
Device Name
Reprocessed CS Diagnostic Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed CS 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)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Change Being Effected – Addition of Contraindication
510(k) Summary
SUBMITTER:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283
CONTACT:
Mia McCorkel Regulatory Affairs Specialist 480-343-1855 (o) 480-763-5310 (f) mia.mccorkel@stryker.com Date of Preparation: January 24, 2019
NAME OF DEVICE:
| Trade/Proprietary Name: | Reprocessed CS Diagnostic Electrophysiology Catheter |
|---|---|
| Model Numbers: | BD710DF282RTS, BD710DF282CT, BD710FJ282RTS, BD710FJ282CT |
| Common Name: | Electrode recording catheter or electrode recording probe |
| Classification Information: | Cardiovascular, Reprocessed (21 CFR §870.1220, Product Code NLH, |
| Class II) |
5
PREDICATE DEVICES:
| 510(k) Number | 510(k) Title | Original Manufacturer |
|---|---|---|
| K100254 | Reprocessed CS Bi-Directional Diagnostic | |
| Electrophysiology Catheter | Stryker Sustainability | |
| Solutions | ||
| K090898 | Coronary Sinus Deflectable Mapping | |
| Catheters, Webster CS Catheter with EZ | ||
| Steer Technology, Webster CS Catheter with | ||
| EZ Steer Technology and Auto ID | Biosense Webster, Inc. | |
| K101345 | Webster CS Catheter with EZ Steer | |
| Technology, Webster CS Catheter with EZ | ||
| Steer Technology an Auto ID | Biosense Webster, Inc. |
DEVICE DESCRIPTION:
The Reprocessed CS Diagnostic Electrophysiology 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 115 cm. The catheter has a high-torque shaft with a braided deflectable, Bi-Directional tip section containing platinum electrodes that can be used for recording and stimulation. Two curve types, D/F and F/J, for CS placement, are available.
Specific to Reprocessed CS Diagnostic Electrophysiology Catheters with Auto ID Technology: Each catheter is equipped with EEPROM (Electronically Erasable Programmable Read Only Memory), which is used to save unique catheter identification information. CARTO® EP Navigation Systems equipped with Auto ID Technology can access the saved information and automatically recognize the catheter information.
This device has been cleared for three (3) reprocessing cycles.
INTENDED USE:
The Reprocessed CS 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.
6
COMPARISON WITH THE PREDICATE DEVICE:
The only modification made was to the Instructions for Use. The following contraindications were added.
- Use of the catheter is contraindicated in patients with totally obstructed Coronary Sinus.
- The catheter should not be used in patients unable to receive heparin or an acceptable alternative to achieve the adequate anticoagulation.
- . Electrophysiology studies are contraindicated when reversible factors make the findings unrepresentative of the patient's disease state (e.g. electrolyte imbalance).
DEVICE MODEL NUMBERS:
| Original Manufacturer | Model Number | Description |
|---|---|---|
| Biosense Webster | BD710DF282RTS | Reprocessed CS Diagnostic Electrophysiology Catheter, 7F, DF Curve, 115 cm useable length, 2 mm tip electrode |
| Biosense Webster | BD710FJ282RTS | Reprocessed CS Diagnostic Electrophysiology Catheter, 7F, FJ Curve, 115 cm useable length, 2 mm tip electrode |
| Biosense Webster | BD710DF282CT | Reprocessed CS Diagnostic Electrophysiology Catheter with Auto ID Technology, 7F, DF Curve, 115 cm useable length, 2 mm tip electrode |
| Biosense Webster | BD710FJ282CT | Reprocessed CS Diagnostic Electrophysiology Catheter with Auto ID Technology, 7F, FJ Curve, 115 cm useable length, 2 mm tip electrode |
CONCLUSION:
The Reprocessed CS Diagnostic Electrophysiology Catheters are safe, effective, and substantially equivalent to the predicate devices as described herein. The only modification made was to the Instructions for Use as described.