(357 days)
No
The summary describes a physical mapping catheter and its interaction with a navigation system, but there is no mention of AI or ML being used for data analysis, interpretation, or any other function. The focus is on the device's physical characteristics, location tracking, and performance equivalence to a predicate device.
No.
The device is used for electrophysiological mapping (recording electrograms and providing location information) of cardiac structures, which is a diagnostic procedure, not a therapeutic intervention.
Yes
Explanation: The device is described as a "High-Density Mapping Catheter" indicated for "electrophysiological mapping of cardiac structures" and intended to "obtain electrograms". These functions are inherently diagnostic, as they involve collecting data to understand the electrical activity and structure of the heart, which is crucial for diagnosing various cardiac conditions. While it also mentions "stimulation only," the primary stated purpose emphasizes mapping and obtaining electrograms, which are diagnostic activities.
No
The device description clearly details a physical catheter with electrodes, a magnetic location sensor, and an irrigation lumen, 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 "electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only." This involves interacting directly with the patient's heart to measure electrical activity.
- Device Description: The device is a catheter designed to be inserted into the heart. It has electrodes for recording and stimulation and a sensor for location tracking within the heart.
- 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. This device does not perform tests on samples outside the body.
The device is an invasive medical device used for diagnostic and potentially therapeutic procedures within the heart.
N/A
Intended Use / Indications for Use
The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3 x.
Product codes
NLG
Device Description
The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.
Model Numbers
RD128207: 7Fr, F Curve, 4-4-4 mm spacing, 115 cm
RD128208: 7Fr, F Curve, 2-6-2 mm spacing, 115 cm
RD128210: 7Fr, D Curve, 4-4-4 mm spacing, 115 cm
RD128211: 7Fr, D Curve, 2-6-2 mm spacing, 115 cm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures in the heart (atrial and ventricular regions)
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
Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate cleaning and sterilization as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Specific non-clinical tests performed included: cleaning validation, sterilization verification, ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, and fatigue testing. Testing performed: Electrical Resistance and Isolation Electrical Leakage Leak test Planarity, Curvature and Spine Spacing CCS Calibration Auto ID/EEPROM Reset Verification Connector Cycling Tip Stiffness Tip Side Force Tip Buckle Fluid Integrity Deflection Fatigue Torsional Strength Flexation Fatigue Shaft Rotation Fatigue Shaft and Connector Bond Strength Micro Lumen Inspection Final Rinse and blow out.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilmed conducted performance testing for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter against the OEM predicate device, the PENTARAY® NAV eco High-Density Mapping Catheter (K123837). Results demonstrated substantial equivalence to the predicate device. Performance testing demonstrates that the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter performs as originally intended.
In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 23, 2021
Sterilmed, Inc. Jan Flegeau Associate Director, Regulatory Affairs 5010 Cheshire Parkway N, Suite 2 Plymouth, Minnesota 55446
Re: K201806
Trade/Device Name: Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: NLG Dated: Mav 20, 2021 Received: May 21, 2021
Dear Jan Flegeau:
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
| Device Name | Biosense
Webster
Model Numbers | Sterilmed
Model Numbers | Description |
|----------------------------------------------------------------------------|--------------------------------------|----------------------------|----------------------------------------|
| Reprocessed
PENTARAY®
NAV eco
High-Density
Mapping
Catheter | D128207 | RD128207 | 7Fr, F Curve, 4-4-4 mm spacing, 115 cm |
| | D128208 | RD128208 | 7Fr, F Curve, 2-6-2 mm spacing, 115 cm |
| | D128210 | RD128210 | 7Fr, D Curve, 4-4-4 mm spacing, 115 cm |
| | D128211 | RD128211 | 7Fr, D Curve, 2-6-2 mm spacing, 115 cm |
The following device models are included in the scope of this 510(k) submission:
3
Indications for Use
510(k) Number (if known) K201806
Device Name
Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter
Indications for Use (Describe)
The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3 x.
| 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
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date Prepared: | June 21, 2021 | |
|---|---|---|
| Submitter and | ||
| Manufacturer: | Sterilmed, Inc. | |
| 5010 Cheshire Parkway N, Suite 2 | ||
| Plymouth, MN 55446 | ||
| www.sterilmed.com | ||
| Manufacturing | ||
| Facility Address: | 11400 73rd Avenue | |
| North Maple Grove | ||
| MN 55369 | ||
| Official | ||
| Correspondent: | Jan Flegeau | |
| Associate Director, Regulatory Affairs | ||
| Sterilmed, Inc. | ||
| Tel: 786-575-5903 | ||
| Email: jflegeau@its.jnj.com | ||
| Trade Name: | Reprocessed PENTARAY® NAV eco High-Density Mapping | |
| Catheter | ||
| Regulation Name: | Catheter, Intracardiac Mapping, High-Density, Reprocessed | |
| Common Name: | Deflectable Tip Electrophysiology Catheter-Diagnostic | |
| Device Classification: | II | |
| Product Code | NLG | |
| Predicate Device: | PENTARAY® NAV eco High-Density Mapping Catheter | |
| (Biosense Webster K123837) | ||
| Device Description: | The Reprocessed PENTARAY® NAV eco High-Density | |
| Mapping Catheter is designed to facilitate electrophysiological | ||
| mapping of the heart with the CARTO® 3 EP Navigation | ||
| System. It is designed for deployment in a heart chamber | ||
| through an 8 Fr guiding sheath. This deflectable catheter | ||
| consists of multiple 3 Fr spines on the distal tip, each spine | ||
| having multiple platinum electrodes that are used for | ||
| stimulation and recording. A magnetic location sensor | ||
| embedded in the deflectable tip transmits location information | ||
| to the CARTO® 3 EP Navigation System. The catheter has two | ||
| electrodes on the deflectable tip to provide for visualization of | ||
| the tip when used with the CARTO® 3 EP Navigation System. | ||
| Pushing forward on the catheter thumb knob deflects the tip; | ||
| pulling back on the thumb knob straightens the tip. This | ||
| catheter includes an irrigation lumen for connection to a source | ||
| of continuous drip anticoagulant fluid. | ||
| Model Numbers | RD128207 | 7Fr, F Curve, 4-4-4 mm spacing, 115 cm |
| RD128208 | 7Fr, F Curve, 2-6-2 mm spacing, 115 cm | |
| RD128210 | 7Fr, D Curve, 4-4-4 mm spacing, 115 cm | |
| RD128211 | 7Fr, D Curve, 2-6-2 mm spacing, 115 cm | |
| Indications For Use: | The Reprocessed PENTARAY® NAV eco High-Density | |
| Mapping Catheter is indicated for multiple electrode | ||
| electrophysiological mapping of cardiac structures in the heart, | ||
| i.e., recording or stimulation only. This catheter is intended to | ||
| obtain electrograms in the atrial and ventricular regions of the | ||
| heart. The Reprocessed PENTARAY® NAV eco High-Density | ||
| Mapping Catheter provides location information when used | ||
| with compatible CARTO® 3 EP Navigation Systems. This | ||
| catheter is not compatible with CARTO® 3 EP Navigation | ||
| Systems prior to Version 3.x. | ||
| Technological | ||
| Characteristics: | The Reprocessed PENTARAY® NAV eco High-Density | |
| Mapping Catheter family is a 7 Fr, multi-electrode | ||
| electrophysiological mapping catheter designed for diagnostic | ||
| electrogram mapping and pacing in all chambers (atria and | ||
| ventricles) of the heart. | ||
| The catheters have five flexible spines, each with four ring | ||
| electrodes for a total of 20 electrodes. There are two different | ||
| electrode spacing configurations (4-4-4 or 2-6-2mm) and two | ||
| different curves (F or D) in order to accommodate different | ||
| clinical situations. The tip of the shaft houses a Magnetic | ||
| Location Sensor that provides magnetic location information | ||
| when used with the CARTO® 3 EP Navigation System. In | ||
| addition to the 20 spine electrodes, two additional Ring | ||
| Electrodes are located near the tip of the shaft for a total of 22 | ||
| ring electrodes that provide location information via Advanced | ||
| Catheter Location (ACL) technology when used with the | ||
| CARTO® 3 EP Navigation System. | ||
| Functional and Safety | ||
| Testing: | Representative samples of reprocessed devices were tested to | |
| demonstrate appropriate functional characteristics. Process | ||
| validation testing was performed to validate cleaning and | ||
| sterilization as well as device packaging. In addition, the | ||
| manufacturing process includes visual and validated functional | ||
| testing of all products produced. | ||
| The PENTARAY® NAV eco High-Density Mapping Catheter |
| |
| | | |
| Summary of
Non-Clinical Tests
Conducted: | Specific non-clinical tests performed included: cleaning
validation, sterilization verification, ethylene oxide residual
testing (ISO 10993-7), packaging validation (ASTM D4169,
ASTM F88, ASTM F2096), and shelf-life validation (ASTM
1980-07). In addition, validation of functional performance
(bench testing) was performed through simulated use, visual
inspection, and fatigue testing. Testing performed:
Electrical Resistance and Isolation Electrical Leakage Leak test Planarity, Curvature and Spine Spacing CCS Calibration Auto ID/EEPROM Reset Verification Connector Cycling Tip Stiffness Tip Side Force Tip Buckle Fluid Integrity Deflection Fatigue Torsional Strength Flexation Fatigue Shaft Rotation Fatigue Shaft and Connector Bond Strength Micro Lumen Inspection Final Rinse and blow out Performance testing demonstrates that the Reprocessed
PENTARAY® NAV eco High-Density Mapping Catheter
performs as originally intended.
In addition, the device was tested for biocompatibility
per ISO 10993-1 for external communicating device,
short duration contact with circulating blood (