(72 days)
The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher.
The Reprocessed 2515 NAV Variable Electrophysiology (EP) Catheter is specially designed for electrophysiological mapping of the atria of the heart when used with the CARTO® 3 EP Navigation System and a reference device. The 2515 NAV Variable EP Catheter has platinum electrodes positioned on the distal end that can be used for stimulation and recording. The Nitinol loop design allows for the expansion and contraction of the loop to fit veins ranging from 25mm to 15mm diameter (±15%).
The provided text describes Stryker Sustainability Solutions' Reprocessed 2515 NAV Variable Electrophysiology Catheter. It outlines the device's description, indications for use, and a summary of performance testing.
Here's an analysis of the acceptance criteria and the study as per your request:
Acceptance Criteria and Device Performance (Table)
The document does not explicitly state quantitative "acceptance criteria" for specific performance metrics that a study would prove the device meets. Instead, it outlines categories of testing performed to demonstrate that the reprocessed device performs as originally intended and is substantially equivalent to predicate devices. The "reported device performance" is a general statement of success in these categories.
| Acceptance Criteria Category | Reported Device Performance (General) |
|---|---|
| Biocompatibility | Validation of reprocessing indicated acceptable biocompatibility. |
| Sterilization | Validation of reprocessing indicated effective sterilization. |
| Function | Testing demonstrated appropriate function of its components. Performance testing concluded the reprocessed device performs as originally intended. |
| Packaging | Validation indicated suitable packaging integrity. |
| Overall Equivalence | Stryker Sustainability Solutions concludes the reprocessed device is safe, effective, and substantially equivalent to the predicate devices. |
Study Details
Based on the provided text, the "study" conducted for this device is a series of bench and laboratory tests rather than a clinical trial or a multi-reader, multi-case study.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Each individual 2515 NAV Variable EP Catheter is tested for appropriate function of its components prior to packaging and labeling operations." This suggests that every reprocessed unit is functionally tested, but the sample size for the broader "Biocompatibility Validation," "Sterilization Validation," and "Packaging Validation" studies is not disclosed.
- Data Provenance: Not explicitly stated, but given it's a reprocessed medical device, the testing would likely have occurred in a controlled laboratory environment. It is not indicated whether human subject data (clinical data like country of origin, retrospective/prospective) was used for these tests, as they are bench and lab-based.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The tests described are primarily engineering and laboratory validations (biocompatibility, sterilization, function) against established technical specifications, not human interpretation tasks requiring expert ground truth in the sense of medical diagnosis.
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Adjudication Method for the Test Set:
- Not applicable. This concept typically applies to studies where human readers or algorithms make classifications that need to be compared against a consensus ground truth. The described tests are objective measurements and validations against predefined specifications.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and laboratory testing, not on comparing human reader performance with or without AI assistance.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in a metaphorical sense for a physical device. The "device" in this context is the reprocessed catheter. The performance data is derived from direct testing of the device itself (its physical and functional properties), demonstrating its standalone performance against design specifications, without a human "reading" or "interpreting" its output in a diagnostic context. This is not an "algorithm" in the typical software sense but refers to the device's intrinsic mechanical and material performance.
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Type of Ground Truth Used:
- Technical Specifications and Regulatory Standards: The "ground truth" for the performance evaluations (biocompatibility, sterilization, function, packaging) would be based on established engineering specifications, material science standards, and regulatory requirements applicable to medical devices and reprocessing. For example, sterilization validation would verify that the reprocessed device meets sterility assurance levels (SALs). Functional tests would verify that it operates within the same parameters as the original device.
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Sample Size for the Training Set:
- Not applicable. This device is a reprocessed physical medical instrument, not an AI/ML algorithm whose performance depends on a training dataset.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of this reprocessed physical device.
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K//2292
OCT 2 1 2011
SECTION 5: 510(k) SUMMARY
| Submitter: | Stryker Sustainability Solutions10232 South 51st StreetPhoenix, Arizona 85044 | |
|---|---|---|
| Contact: | Ramona KulikRegulatory Affairs Engineer(480) 763-5300 (o)(480) 763-2952 (f)Ramona.kulik@stryker.com | |
| Date of preparation: | August 9, 2011 | |
| Name of device: | Trade/Proprietary Name: Reprocessed 2515 NAV VariableElectrophysiology CatheterClassification Name: Electrode recording catheter or electroderecording probe | |
| Predicate DeviceK081258 | 510(k) TitleLasso™ 2515 NAV VariableCatheter, D-1290-01 & D-1290-02 | ManufacturerBiosense Webster, Inc. |
| K082023 | Reprocessed ElectrophysiologyCatheters | Ascent HealthcareSolutions |
| K031161 | Lasso™ 2515 Variable CircularMapping Catheter | Biosense Webster, Inc. |
| Device description: | The Reprocessed 2515 NAV Variable Electrophysiology (EP)Catheter is specially designed for electrophysiological mappingof the atria of the heart when used with the CARTO® 3 EPNavigation System and a reference device. The 2515 NAVVariable EP Catheter has platinum electrodes positioned on thedistal end that can be used for stimulation and recording. TheNitinol loop design allows for the expansion and contraction ofthe loop to fit veins ranging from 25mm to 15mm diameter(±15%). | |
| Indications for Use: | The Reprocessed 2515 NAV Variable EP Catheter are indicatedfor multiple electrode electrophysiology mapping of cardiacstructures of the heart, i.e. recording or stimulation only. TheReprocessed 2515 NAV Variable EP Catheter are designed toobtain electrograms in the atrial regions of the heart.The Reprocessed 2515 NAV Variable EP Catheter provideslocation information when used with compatible CARTO® EPNavigation Systems version 1.0 or higher. | |
| Technologicalcharacteristics: | The design, materials, and intended use of Reprocessed 2515NAV Variable EP Catheter is identical to the predicate devices.The mechanism of action of Reprocessed 2515 NAV VariableEP Catheter is identical to the predicate devices in that thesame standard mechanical design, materials, and sizes areutilized. There are no changes to the claims, intended use,clinical applications, patient population, performancespecifications, or method of operation. In addition, StrykerSustainability Solutions' reprocessing of 2515 NAV Variable EPCatheter includes removal of adherent visible soil anddecontamination. Each individual 2515 NAV Variable EPCatheter is tested for appropriate function of its componentsprior to packaging and labeling operations. | |
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of Reprocessed 2515NAV Variable EP Catheter. This included the following tests:Biocompatibility Validation of reprocessing Sterilization Validation Function test(s) Packaging ValidationPerformance testing demonstrates that Reprocessed 2515 NAVVariable Electrophysiology Catheter perform as originally.intended. | |
| Conclusion: | Stryker Sustainability Solutions concludes that the modifieddevices (Reprocessed 2515 NAV Variable ElectrophysiologyCatheter) are safe, effective, and substantially equivalent to the |
Stryker Sustainability Solutions
Reprocessed 2515 NAV Variable EP Catheter Traditional 510(k)
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predicate devices as described herein.
Stryker Sustainability Solutions Reprocessed 2515 NAV Variable EP Catheter Traditional 510(k)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 1 2011
Stryker Sustainability Solutions c/o Ms. Ramona Kulik Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix. AZ 85044
Re: K112292
Trade/Device Name: Reprocessed 2515 NAV Variable Electrophysiology Catheter (See Enclosed List of Models) Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: 74 NLH Dated: August 3, 2011 Received: August 4, 2011
Dear Ms. Kulik:
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. 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.
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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Page 2 - Ms. Ramona Kulik
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
- Brian D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
//2292
Device Name: Reprocessed 2515 NAV Variable Electrophysiology Catheter
Indications For Use: The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Division Sign-Off) Division of Cigh Oil)
Division of Cardiovascular Devices
510(k) Number K112292
Stryker Sustainability Solutions Reprocessed 2515 NAV Variable EP Catheter Traditional 510(k)
Press 49
§ 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).