(199 days)
The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.
The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.
The Reprocessed DECANAV™ Catheter is a sterile, single patient use device designed to be used with the CARTO® 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The Reprocessed DECANAV™ Catheter has a single proximal electrode that can be used for unipolar recording signals. The Reprocessed DECANAV™ Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in curve types D and F. Pushing the thumb knob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens. The plane of the curved tip can be rotated during use. The Reprocessed DECANAV™ Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.
The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is a sterile, single patient use device designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. 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 thumb knob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
The provided text describes the 510(k) summary for reprocessed electrophysiology catheters, which are medical devices, not AI/ML-enabled software. Therefore, the questions related to AI/ML device performance, such as sample size for test sets (data provenance), number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, and training set information (sample size, ground truth establishment), are not applicable to this document.
The document discusses acceptance criteria and device performance in the context of demonstrating substantial equivalence for reprocessed medical devices to their predicate devices.
1. A table of acceptance criteria and the reported device performance
The document lists several tests performed to demonstrate appropriate functional characteristics and substantial equivalence to predicate devices. It states that "Performance testing shows the Reprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters perform as originally intended." and "Results demonstrated substantial equivalence to the predicate devices."
Specific acceptance criteria (e.g., numerical thresholds for compliance) are not explicitly detailed in this summary. However, the types of tests conducted serve as the basis for determining if the reprocessed devices meet acceptable performance comparable to the original predicate devices.
| Acceptance Criteria (Implicit by Test Type) | Reported Device Performance |
|---|---|
| Cleaning Validation | Validated |
| Sterilization Verification | Verified |
| Ethylene Oxide Residual Testing | Compliant with ISO 10993-7 |
| Packaging Validation | Compliant with ASTM D4169, ASTM F88, ASTM F2096 |
| Shelf-Life Validation | Validated to ASTM 1980-07 |
| Functional Performance (Bench Testing) | "Perform as originally intended" (through simulated use, visual inspection, and fatigue testing) |
| Joint Bond Strength | "Perform as originally intended" |
| Torsional Resiliency | "Perform as originally intended" |
| Tip Buckle | "Perform as originally intended" |
| Fluid Integrity | "Perform as originally intended" |
| Deflection Cycling | "Perform as originally intended" |
| Flexation Cycling | "Perform as originally intended" |
| Shaft Stiffness | "Perform as originally intended" |
| Electrical Continuity | "Perform as originally intended" |
| Electrical Leakage | "Perform as originally intended" |
| Electrical Connector Cycling | "Perform as originally intended" |
| Cable to Handle Retention Strength | "Perform as originally intended" |
| CARTO® 3 System Compatibility of Duo-Decapolar | "Perform as originally intended" |
| CARTO® 3 System Recognition of DECANAV Electrical Resistance and Isolation | "Perform as originally intended" |
| Coronary Sinus Handling | "Perform as originally intended" |
| Biocompatibility | Compliant with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility |
2. Sample size used for the test set and the data provenance
The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for each test or the total test set.
- Data provenance: Not explicitly stated, but the testing was conducted by Sterilmed, Inc. or its contractors in the context of their reprocessing efforts. This would be considered internal data from the reprocessing process. The data is retrospective in the sense that it evaluates the reprocessed devices after manufacturing, but the tests themselves are prospective studies on those samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a reprocessed electrophysiology catheter. Performance is assessed through engineering and biocompatibility tests against established specifications and comparison to the original (OEM) device, not through expert human review of interpretative data like medical images.
4. Adjudication method for the test set
This question is not applicable, as the performance evaluation relies on objective engineering and biological test results, not expert human interpretation or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This question is not applicable. MRMC studies are typically used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without an AI assist. This document is for a reprocessed medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/ML-enabled device.
7. The type of ground truth used
The "ground truth" for the performance of these reprocessed catheters is established by:
- Engineering specifications and performance characteristics of the original equipment manufacturer (OEM) predicate devices. The reprocessed devices are tested to ensure they meet these specifications.
- Compliance with recognized standards for medical device reprocessing, safety, and performance (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging and shelf-life, and internal functional performance criteria designed to mimic intended use).
- Visual inspection for physical integrity.
Essentially, the ground truth is the performance and safety profile of the new, original predicate device.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML-enabled device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2024
Sterilmed, Inc. Rachel Poltilove Regulatory Affairs 5010 Cheshire Pkwy N, Suite 2 Plymouth, Minnesota 55446
Re: K240826
Trade/Device Name: Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar 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: September 10, 2024 Received: September 11, 2024
Dear Rachel Poltilove:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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 S. Deoras -S
Aneesh Deoras 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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K240826 - Rachel Poltilove
The following devices are included in the scope of this 510(k) premarket notification:
| Device Name | Biosense WebsterModel Numbers | SterilmedModel Numbers | Description |
|---|---|---|---|
| ReprocessedDECANAV™ElectrophysiologyCatheter | R7D282CT | RR7D282CT | D Curve, 7F, 115cm, Electrodes: 11, SP: 2-8-2mm,Tip Length: 2.4mm, Pin Connector: 34 |
| ReprocessedWEBSTER® Duo-DecapolarElectrophysiologyCatheter | R7F282CT | RR7F282CT | F Curve, 7F, 115cm, Electrodes: 11, SP: 2-8-2mm,Tip Length: 2.4mm, Pin Connector: 34 |
| ReprocessedWEBSTER® Duo-DecapolarElectrophysiologyCatheter | D728260RT | RD728260RT | Large Curve 270, 7F, 110 cm, Electrodes: 20, SP: 2-9-3...61...3-9-3mm, Tip Length: 2mm, PinConnector: 10 |
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Indications for Use
510(k) Number (if known) K240826
Device Name
Reprocessed DECANAVTM Electrophysiology Catheter Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.
The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and 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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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date Prepared: | October 11, 2024 | |
|---|---|---|
| Submitter andManufacturer: | Sterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446www.sterilmed.com | |
| ManufacturingFacility Address: | 11400 73rd AvenueNorth Maple Grove, MN 55369 | |
| OfficialCorrespondent: | Dr. Rachel PoltiloveRegulatory ConsultantSterilmed, Inc.Tel: 301-213-7224Email: rpoltilo@its.jnj.com | |
| Trade Name: | Reprocessed DECANAV™ Electrophysiology CatheterReprocessed WEBSTER® Duo-Decapolar ElectrophysiologyCatheter | |
| ClassificationName: | Catheter, Recording, Electrode, Reprocessed | |
| Common Name: | Diagnostic Electrophysiology Catheter | |
| DeviceClassification: | Class II, 21 CFR 870.1220 | |
| Product Code | NLH | |
| Primary PredicateDevice: | Biosense Webster CS RefStar™ (DECANAV) Catheter (K080425) | |
| SecondaryPredicate Devices: | Biosense Webster CS RefStar™ (DECANAV) Catheter (K231312)Biosense Webster Duo-Decapolar Catheter (K101991) | |
| Device Description: | The Reprocessed DECANAV™ Catheter is a sterile, single patientuse device designed to be used with the CARTO® 3 EP NavigationSystem (a magnetic field location technology) to facilitateelectrophysiological mapping of the heart. The catheter has a hightorque shaft with a deflectable tip section containing an array ofplatinum/iridium electrodes that can be used for stimulation andrecording of cardiac electrical signals. The ReprocessedDECANAV™ Catheter has a single proximal electrode that can beused for unipolar recording signals. The Reprocessed DECANAV™Catheter tip deflection is controlled by a proximal hand piece thatfeatures a thumb operated sliding piston and is offered in curve | |
| types D and F. Pushing the thumb knob forward causes thecatheter tip to bend (curve); when the knob is pulled back, the tipstraightens. The plane of the curved tip can be rotated during use.The Reprocessed DECANAV™ Catheter interfaces with standardrecording equipment and CARTO® 3 EP Navigation Systemequipment via interface cables with the appropriate connectors. | ||
| The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is asterile, single patient use device designed to facilitateelectrophysiological mapping of the heart. The catheter has ahigh-torque shaft with a deflectable tip section containing anarray of platinum electrodes that can be used for stimulation andrecording. Tip deflection is controlled at the proximal end by atubular handpiece in which a piston slides. When the piston ispushed forward with the thumb knob, the tip is deflected(curved). When the piston is pulled back, the tip straightens. Thehigh torque shaft allows the plane of the curved tip to be rotatedto facilitate accurate positioning of the catheter tip at the desiredsite. The catheter interfaces with standard recording equipmentvia interface cables with the appropriate connectors. | ||
| RR7D282CT | Reprocessed DECANAV™ Electrophysiology Catheter,D Curve, 7F, 115cm, Electrodes: 11, SP: 2-8-2mm, TipLength: 2.4mm, Pin Connector: 34 | |
| Model Numbers | RR7F282CT | Reprocessed DECANAV™ Electrophysiology Catheter,F Curve, 7F, 115cm, Electrodes: 11, SP: 2-8-2mm, TipLength: 2.4mm, Pin Connector: 34 |
| RD728260RT | Reprocessed WEBSTER® Duo-DecapolarElectrophysiology Catheter, Large Curve 270, 7F, 110cm, Electrodes: 20, SP: 2-9-3613-9-3mm, TipLength: 2mm, Pin Connector: 10 | |
| tip location information.Indications ForUse: | The Reprocessed DECANAV™ Electrophysiology Catheter isindicated for electrophysiological mapping of cardiac structures,i.e., recording and stimulation, including in the Coronary Sinus. Inaddition, the Reprocessed DECANAV™ Catheter is used withcompatible Carto® 3 EP Navigation Systems to provide catheter | |
| and coronary sinus. | The Reprocessed WEBSTER® Duo-Decapolar ElectrophysiologyCatheter is indicated for electrophysiological mapping of cardiacstructures, i.e., stimulation and recording only. In addition, theReprocessed WEBSTER® Duo-Decapolar Catheter is designed tofacilitate electrogram mapping in the atrial region of the heart | |
| TechnologicalCharacteristics: | The design, materials, function, and intended use of theReprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters are the same as that of thepredicate devices. There are no changes to the claims, clinicalapplications, patient population, performance specifications, ormethod of operation. | |
| Functional andSafety Testing: | 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 Reprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters are reprocessed no morethan one (1) time. The catheters are marked and tracked throughthe reprocessing cycle. After the devices have reached themaximum number of reprocessing cycles, the devices are rejectedfrom further reprocessing. It is Sterilmed's policy to restrict itsreprocessing to exclude devices previously reprocessed by otherreprocessors. | |
| Summary ofNon-Clinical TestsConducted: | Specific non-clinical tests performed included: cleaningvalidation, sterilization verification, ethylene oxide residualtesting (ISO 10993-7), packaging validation (ASTM D4169, ASTMF88, ASTM F2096), and shelf-life validation (ASTM 1980-07). Inaddition, validation of functional performance (bench testing)was performed through simulated use, visual inspection, andfatigue testing. Testing performed:• Joint Bond Strength• Torsional Resiliency• Tip Buckle• Fluid Integrity• Deflection Cycling• Flexation Cycling• Shaft Stiffness• Electrical Continuity• Electrical Leakage• Electrical Connector Cycling• Cable to Handle Retention Strength• CARTO® 3 System Compatibility of Duo-Decapolar | |
| CARTO® 3 System Recognition of DECANAV Electrical Resistance and Isolation Coronary Sinus Handling Performance testing shows the Reprocessed DECANAV™ andReprocessed WEBSTER® Duo-Decapolar ElectrophysiologyCatheters perform as originally intended.In addition, the devices were tested for biocompatibility perISO 10993-1 for external communicating device, shortduration contact with circulating blood (<24 hours).Biocompatibility testing included: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity Hemocompatibility including Thrombogenicity, Hemolysis,and Complement Activation | ||
| Conclusion: | Sterilmed conducted performance testing for the ReprocessedDECANAV™ and Reprocessed WEBSTER® Duo-DecapolarElectrophysiology Catheters against the OEM predicate devices,Biosense Webster CS RefStar™ (DECANAV) Catheter (K080425 &K231312) and Biosense Webster Duo-Decapolar Catheter(K101991). Results demonstrated substantial equivalence to thepredicate devices.Based on testing results, the Reprocessed DECANAV™ andReprocessed WEBSTER® Duo-Decapolar ElectrophysiologyCatheters are substantially equivalent to the predicate devices,the Biosense Webster CS RefStar™ (DECANAV™) Catheter and theBiosense Webster Duo-Decapolar Catheter |
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The following devices are included in the scope of this 510(k) submission:
| Device Name | Biosense WebsterModel Numbers | SterilmedModel Numbers | Description |
|---|---|---|---|
| ReprocessedDECANAV™ElectrophysiologyCatheter | R7D282CT | RR7D282CT | D Curve, 7F, 115cm, Electrodes: 11, SP: 2-8-2mm,Tip Length: 2.4mm, Pin Connector: 34 |
| ReprocessedWEBSTER® Duo-DecapolarElectrophysiologyCatheter | R7F282CT | RR7F282CT | F Curve, 7F, 115cm, Electrodes: 11, SP: 2-8-2mm,Tip Length: 2.4mm, Pin Connector: 34 |
| ReprocessedWEBSTER® Duo-DecapolarElectrophysiologyCatheter | D728260RT | RD728260RT | Large Curve 270, 7F, 110 cm, Electrodes: 20, SP: 2-9-3...61...3-9-3mm, Tip Length: 2mm, PinConnector: 10 |
§ 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).