(30 days)
The EnSite Array Multi-Electrode Diagnostic Catheter, when used with the EnSite System, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters).
The EnSite Array Multi-electrode Diagnostic Catheter (EnSite Array Catheter) is a single use, 9 French, percutaneous catheter. The EnSite Array Catheter is designed for use only with the EnSite System and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes; one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium.
The EnSite Array Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite System connected to the EnSite Array Catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms detected by the EnSite Array Catheters' MEA.
The provided text is a 510(k) Summary for the St. Jude Medical EnSite Array Multi-Electrode Diagnostic Catheter. It describes the device, its intended use, and comparison to a predicate device. However, it explicitly states that no clinical testing was submitted, referenced, or relied upon for the determination of substantial equivalence. The evaluation was based on non-clinical testing to verify device modifications and biocompatibility.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document. The device's substantial equivalence was determined based on non-clinical aspects and comparison to a predicate device (K983456).
Here's a breakdown of what can be extracted, and what is missing based on the prompt's requirements:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document states "An evaluation of the modified EnSite Array Multi-Electrode Diagnostic Catheter was performed to verify the device modifications. It was concluded that the modified EnSite Array Multi-Electrode Diagnostic Catheter design meets the product specification and intended use." However, specific acceptance criteria and performance metrics are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. No clinical test set was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Missing. Not applicable as no clinical test set was used.
4. Adjudication Method for the Test Set:
- Missing. Not applicable as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Missing. No clinical testing, including MRMC studies, was performed or submitted.
6. Standalone (Algorithm only) Performance Study:
- Missing. The device is a physical catheter, not a standalone algorithm. While it works with an "EnSite System" that "utilizes proprietary software algorithms," the data provided focuses on the catheter's equivalence based on non-clinical aspects. No performance study for such algorithms is detailed.
7. Type of Ground Truth Used:
- Missing. Not applicable as no clinical data or ground truth for the device's diagnostic performance was established for this submission. The "ground truth" for the submission was that the device met its product specifications and intended use via non-clinical verification and biocompatibility testing.
8. Sample Size for the Training Set:
- Missing. Not applicable as no machine learning algorithm training set is mentioned for this submission.
9. How the Ground Truth for the Training Set Was Established:
- Missing. Not applicable as no training set is mentioned.
Summary of Non-Clinical Testing (from the provided text):
- Non-Clinical Testing Performed: Evaluation of modified EnSite Array Multi-Electrode Diagnostic Catheter to verify device modifications. Biocompatibility testing in accordance with ISO 10993-1.
- Conclusion: The modified design meets product specification and intended use. Biocompatibility was confirmed.
- Basis for Equivalence: Same intended use and fundamental scientific technology as the predicate device (EnSite Array Multi-Electrode Diagnostic Catheter, K983456). All technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent. Design modifications do not adversely affect safety and effectiveness.
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K 121006
| 510(k) Summary | |
|---|---|
| 510(k) Number | |
| Date Prepared: | April 2, 2012 |
| Submitter Information: | |
| ManufacturerName/Address: | St. Jude Medical - Atrial Fibrillation DivisionOne St. Jude Medical DriveSt. Paul, MN 55117Establishment Registration Number: 2184149 |
| Submitter Name/Address: | St. Jude Medical - Atrial Fibrillation Division14901 DeVeau PlaceMinnetonka, MN 55345Establishment Registration Number: 3005188751 |
| Contact Person: | Nicole MarwickSr. Regulatory Affairs SpecialistTel: 651-756-5162Fax: 952-930-9481nmarwick@sjm.com |
| Device Information: | |
| Trade Name: | EnSite Array Multi-Electrode Diagnostic Catheter |
| Common Name: | Electrode Recording Catheter |
| Classification Name: | Electrode Recording Catheter |
| Classification: | Class II, 21 CFR 870.1220, Product Code DRF |
| Predicate Device(s): | EnSite Array Multi-Electrode Diagnostic Catheter (K983456) |
| Device Description: | The EnSite Array Multi-electrode Diagnostic Catheter (EnSiteArray Catheter) is a single use, 9 French, percutaneous catheter.The EnSite Array Catheter is designed for use only with theEnSite System and for deployment in the right atrium. Theproximal end contains the patient cable electrical connector, aninflation port for the distal balloon/braid multi-electrode array(MEA), luer port compatible with a 0.035" guidewire, and a pushshaft to facilitate expansion and deployment of the MEA. Theshaft is a coaxial design with a polyurethane outer sheath. At thedistal end in addition to the MEA, there are three ring electrodes;one distal and two proximal mounted at specific locations to the |
| 510(k) Summary | |
| MEA. The tip of the catheter is a pigtail shape to minimizetrauma to the endocardium. | |
| The EnSite Array Catheter does not require direct contact withthe endocardium for the detection of intracardiac electrograms.The EnSite System connected to the EnSite Array Catheterutilizes proprietary software algorithms to reconstruct and displayright atrial endocardiograms detected by the EnSite ArrayCatheters' MEA. | |
| Intended Use/Indicationsfor Use: | The EnSite Array Multi-Electrode Diagnostic Catheter, whenused with the EnSite System, is intended to be used in the rightatrium of patients with complex arrhythmias that may be difficultto identify using conventional mapping systems alone (i.e. linearmapping catheters). |
| Comparison to PredicateDevices: | The modified EnSite Array Multi-Electrode Diagnostic Catheterhas the same intended use and fundamental scientific technologyas the predicate device. All technological characteristics of themodified EnSite Array Multi-Electrode Diagnostic Catheter aresubstantially equivalent to the predicate device includingpackaging, biocompatibility, sterilization, and labeling. Throughbiocompatibility testing and material change evaluation it wasdemonstrated that the design modifications do not adverselyaffect the safety and effectiveness. |
| Summary on Non-ClinicalTesting: | An evaluation of the modified EnSite Array Multi-ElectrodeDiagnostic Catheter was performed to verify the devicemodifications. It was concluded that the modified EnSite ArrayMulti-Electrode Diagnostic Catheter design meets the productspecification and intended use. Biocompatibility was confirmedin accordance with ISO 10993-1. |
| Summary of ClinicalTesting: | This section is not applicable for this submission. No clinicaltesting was submitted, referenced or relied upon for adetermination of substantial equivalence. |
| Statement of Equivalence: | The modified St. Jude Medical EnSite Array Multi-ElectrodeDiagnostic Catheter has the same intended use and technologicalcharacteristics as the predicate device. Based on the results of thebiocompatibility testing per ISO 10993-1 St. Jude Medical'smodified EnSite Array Multi-Electrode Diagnostic Catheter hasbeen shown to be substantially equivalent to the predicate. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers. The symbol is rendered in black and white.
Public Health Service
3 2012
MAY
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Nicole Marwick Senior Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345
Re: K121006 Trade/Device Name: EnSite Array Multi-Electrode Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: MTD Dated: April 2, 2012 Received: April 3, 2012
Dear Ms. Marwick:
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. 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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Page 2 - Ms. Nicole Marwick
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zubkerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K121006 510(K) Number (if known):
Device Name: EnSite Array Multi-Electrode Diagnostic Catheter
Indications for Use:
The EnSite Array Multi-Electrode Diagnostic Catheter, when used with the EnSite System, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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signature
(Division Sigh-Off) Division of Cardiovascular Devices 1121 006 510(k) Number__
§ 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).