(357 days)
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.
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.
The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.
| Acceptance Criteria (Implicitly from substantial equivalence to predicate) | Reported Device Performance |
|---|---|
| Functional Characteristics: | Performance testing demonstrates that the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter performs as originally intended. Specific tests included: 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. |
| Cleaning and Sterilization Validation: | Process validation testing was performed to validate cleaning and sterilization. |
| Ethylene Oxide Residual Testing: (to ISO 10993-7 standard) | Testing performed to ISO 10993-7. |
| Packaging Validation: (to ASTM D4169, ASTM F88, ASTM F2096 standards) | Testing performed to ASTM D4169, ASTM F88, ASTM F2096. |
| Shelf-life Validation: (to ASTM 1980-07 standard) | Testing performed to ASTM 1980-07. |
| Biocompatibility: (per ISO 10993-1 for external communicating device, short duration contact with circulating blood (<24 hours)) | Biocompatibility testing included: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity, Pyrogenicity. |
| Visual Inspection: | Manufacturing process includes visual inspection of all products. |
| Validated Functional Testing: | Manufacturing process includes validated functional testing of all products. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." However, it does not specify the exact sample size used for the test set for any of the non-clinical tests.
Regarding data provenance, the testing was performed by Sterilmed, Inc., the manufacturer and submitter of the 510(k). This indicates the data is prospective in the context of validating the reprocessed device. The country of origin of the data is not explicitly stated but can be inferred to be the United States, given the submission to the FDA and the company's address in Minnesota.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
This type of information is not applicable to this submission. The tests described are non-clinical, primarily bench testing, process validation (cleaning, sterilization, packaging), and material biocompatibility. These tests rely on established scientific methods, standards (e.g., ISO, ASTM), and laboratory protocols rather than human expert interpretation of a diagnostic outcome. Therefore, there is no "ground truth" to be established by experts in the context of image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical and do not involve human interpretation or diagnostic decision-making that would require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a medical device (a reprocessed catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an algorithm or software as a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" is defined by established engineering specifications, performance standards (e.g., ISO, ASTM), and validated scientific methods. For example:
- Functional tests: The ground truth is whether the device meets its design specifications (e.g., electrical resistance within a certain range, correct deflection, proper bond strength).
- Sterilization: The ground truth is the absence of viable microorganisms after the sterilization process, validated through microbiological testing.
- Biocompatibility: The ground truth is the device's interaction with biological systems falling within acceptable safety limits, as defined by ISO 10993 standards and relevant biological endpoints (e.g., no cytotoxicity, no irritation).
8. The Sample Size for the Training Set
There is no training set mentioned or implied in this document. This is a submission for a reprocessed medical device, and the testing described is primarily for validation and verification, not for training a machine learning model.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this question is not applicable.
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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
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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
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| Device Name | BiosenseWebsterModel Numbers | SterilmedModel Numbers | Description |
|---|---|---|---|
| ReprocessedPENTARAY®NAV ecoHigh-DensityMappingCatheter | 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:
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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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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 andManufacturer: | Sterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446www.sterilmed.com | |
| ManufacturingFacility Address: | 11400 73rd AvenueNorth Maple GroveMN 55369 | |
| OfficialCorrespondent: | Jan FlegeauAssociate Director, Regulatory AffairsSterilmed, Inc.Tel: 786-575-5903Email: jflegeau@its.jnj.com | |
| Trade Name: | Reprocessed PENTARAY® NAV eco High-Density MappingCatheter | |
| 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-DensityMapping Catheter is designed to facilitate electrophysiologicalmapping of the heart with the CARTO® 3 EP NavigationSystem. It is designed for deployment in a heart chamberthrough an 8 Fr guiding sheath. This deflectable catheterconsists of multiple 3 Fr spines on the distal tip, each spinehaving multiple platinum electrodes that are used forstimulation and recording. A magnetic location sensorembedded in the deflectable tip transmits location informationto the CARTO® 3 EP Navigation System. The catheter has twoelectrodes on the deflectable tip to provide for visualization ofthe 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. Thiscatheter includes an irrigation lumen for connection to a sourceof 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-DensityMapping Catheter is indicated for multiple electrodeelectrophysiological mapping of cardiac structures in the heart,i.e., recording or stimulation only. This catheter is intended toobtain electrograms in the atrial and ventricular regions of theheart. The Reprocessed PENTARAY® NAV eco High-DensityMapping Catheter provides location information when usedwith compatible CARTO® 3 EP Navigation Systems. Thiscatheter is not compatible with CARTO® 3 EP NavigationSystems prior to Version 3.x. | |
| TechnologicalCharacteristics: | The Reprocessed PENTARAY® NAV eco High-DensityMapping Catheter family is a 7 Fr, multi-electrodeelectrophysiological mapping catheter designed for diagnosticelectrogram mapping and pacing in all chambers (atria andventricles) of the heart.The catheters have five flexible spines, each with four ringelectrodes for a total of 20 electrodes. There are two differentelectrode spacing configurations (4-4-4 or 2-6-2mm) and twodifferent curves (F or D) in order to accommodate differentclinical situations. The tip of the shaft houses a MagneticLocation Sensor that provides magnetic location informationwhen used with the CARTO® 3 EP Navigation System. Inaddition to the 20 spine electrodes, two additional RingElectrodes are located near the tip of the shaft for a total of 22ring electrodes that provide location information via AdvancedCatheter Location (ACL) technology when used with theCARTO® 3 EP Navigation System. | |
| Functional and SafetyTesting: | Representative samples of reprocessed devices were tested todemonstrate appropriate functional characteristics. Processvalidation testing was performed to validate cleaning andsterilization as well as device packaging. In addition, themanufacturing process includes visual and validated functionaltesting of all products produced.The PENTARAY® NAV eco High-Density Mapping Catheter | |
| Summary ofNon-Clinical TestsConducted: | Specific non-clinical tests performed included: cleaningvalidation, sterilization verification, ethylene oxide residualtesting (ISO 10993-7), packaging validation (ASTM D4169,ASTM F88, ASTM F2096), and shelf-life validation (ASTM1980-07). In addition, validation of functional performance(bench testing) was performed through simulated use, visualinspection, 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 ReprocessedPENTARAY® NAV eco High-Density Mapping Catheterperforms as originally intended.In addition, the device was tested for biocompatibilityper ISO 10993-1 for external communicating device,short duration contact with circulating blood (<24 hours).Biocompatibility testing included:Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Hemocompatibility Thrombogenicity Pyrogenicity | |
| Conclusion: | Sterilmed conducted performance testing for the ReprocessedPENTARAY® NAV eco High-Density Mapping Catheteragainst the OEM predicate device, the PENTARAY® NAVeco High-Density Mapping Catheter (K123837). Resultsdemonstrated substantial equivalence to the predicate device.Sterilmed therefore concludes that the ReprocessedPENTARAY® NAV eco High-Density Mapping Catheter issubstantially equivalent to the predicate device, thePENTARAY® NAV eco High-Density Mapping Catheter. |
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§ 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).