(30 days)
No
The description mentions "proprietary software algorithms" for reconstructing and displaying electrograms, but there is no mention of AI, ML, or related terms. The focus is on the hardware and basic signal processing.
No
The device is described as a "Diagnostic Catheter" intended for identifying complex arrhythmias, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "The EnSite Array Multi-Electrode Diagnostic Catheter... is intended to be used... in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone." This indicates its purpose is to identify or diagnose these arrhythmias. The "Device Description" also refers to specific components, such as the "multi-electrode array (MEA)" and "three ring electrodes," designed to detect "intracardiac electrograms," which are physiological signals used in diagnosis. Furthermore, the name of the predicate device is "EnSite Array Multi-Electrode Diagnostic Catheter," reinforcing its diagnostic nature.
No
The device description clearly details a physical catheter with multiple hardware components (shaft, balloon, electrodes, ports, etc.). While it mentions proprietary software algorithms used by the EnSite System, the device itself is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in the right atrium of patients" for identifying complex arrhythmias. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a catheter designed for percutaneous insertion into the body and deployment within the right atrium. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are designed for testing these types of samples in vitro (in glass, or in a lab setting).
Therefore, the EnSite Array Multi-Electrode Diagnostic Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / 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).
Product codes
DRF, MTD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium
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
Not Found
Summary of Performance Studies
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. Biocompatibility was confirmed in accordance with ISO 10993-1.
This section is not applicable for this submission. No clinical testing was submitted, referenced or relied upon for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
EnSite Array Multi-Electrode Diagnostic Catheter (K983456)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
.
K 121006
| 510(k) Summary | |
|---|---|
| 510(k) Number | |
| Date Prepared: | April 2, 2012 |
| Submitter Information: | |
| Manufacturer | |
| Name/Address: | St. Jude Medical - Atrial Fibrillation Division |
| One St. Jude Medical Drive | |
| St. Paul, MN 55117 | |
| Establishment Registration Number: 2184149 | |
| Submitter Name/Address: | St. Jude Medical - Atrial Fibrillation Division |
| 14901 DeVeau Place | |
| Minnetonka, MN 55345 | |
| Establishment Registration Number: 3005188751 | |
| Contact Person: | Nicole Marwick |
| Sr. Regulatory Affairs Specialist | |
| Tel: 651-756-5162 | |
| Fax: 952-930-9481 | |
| nmarwick@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 (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 | |
| 510(k) Summary | |
| 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. | |
| Intended Use/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). | |
| Comparison to Predicate | |
| Devices: | The modified EnSite Array Multi-Electrode Diagnostic Catheter |
| has the same intended use and fundamental scientific technology | |
| as the predicate device. All technological characteristics of the | |
| modified EnSite Array Multi-Electrode Diagnostic Catheter are | |
| substantially equivalent to the predicate device including | |
| packaging, biocompatibility, sterilization, and labeling. Through | |
| biocompatibility testing and material change evaluation it was | |
| demonstrated that the design modifications do not adversely | |
| affect the safety and effectiveness. | |
| Summary on Non-Clinical | |
| Testing: | 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. Biocompatibility was confirmed | |
| in accordance with ISO 10993-1. | |
| Summary of Clinical | |
| Testing: | This section is not applicable for this submission. No clinical |
| testing was submitted, referenced or relied upon for a | |
| determination of substantial equivalence. | |
| Statement of Equivalence: | The modified St. Jude Medical EnSite Array Multi-Electrode |
| Diagnostic Catheter has the same intended use and technological | |
| characteristics as the predicate device. Based on the results of the | |
| biocompatibility testing per ISO 10993-1 St. Jude Medical's | |
| modified EnSite Array Multi-Electrode Diagnostic Catheter has | |
| been shown to be substantially equivalent to the predicate. |
: 上一篇:
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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.
3
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
4
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__