(321 days)
The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.
The St. Jude Medical Epicardial Catheter System consists of the ResponseTM 6 French quadripolar electrophysiology catheter and the AgilisTM NxT 40 cm steerable guiding introducer (which includes a dilator, guidewire and steerable sheath). The Agilis NxT Steerable Introducer provides pericardial access for the Response catheter to perform electrophysiology studies of the epicardial surface of the heart.
The provided text is a 510(k) summary for the St. Jude Medical Epicardial Catheter System, seeking clearance for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria for a novel AI/software device.
Consequently, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training set details) is not present in the provided text. This document is a regulatory submission for a physical medical device (catheter system) and not an AI or software as a medical device (SaMD) that would typically undergo the types of studies you are asking about.
Therefore, I cannot fulfill your request for that specific information based on the provided input. The document does not describe a study that proves the device meets specific performance acceptance criteria in the way you've outlined for an AI/software product.
Here's an explanation of why the requested information is absent and what is present:
What the document does provide:
- Device Description: The St. Jude Medical Epicardial Catheter System consists of the Response™ 6 French quadripolar electrophysiology catheter and the Agilis™ NxT 40 cm steerable guiding introducer.
- Intended Use: "The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart."
- Predicate Devices: Response™ Electrophysiology Catheter and Agilis™ NxT Steerable Introducer.
- Comparison to Predicate Devices: The submission claims substantial equivalence based on similar intended use and fundamental scientific technology, including packaging, biocompatibility, sterilization, and labeling. It states that "Where differences exist between the proposed devices and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed devices."
- Regulatory Conclusion: St. Jude Medical considers the Epicardial Catheter System to be equivalent to the predicate devices based on similarities in design, technological characteristics, principles of operation, materials, and indications for use.
Why the requested information for AI/software studies is not available in this document:
- Nature of the Device: The St. Jude Medical Epicardial Catheter System is a physical medical device (catheter and introducer) used for electrophysiology studies. It's not an AI/software device.
- Regulatory Pathway: This is a 510(k) premarket notification, a pathway for demonstrating substantial equivalence to a legally marketed predicate device. This pathway typically focuses on comparing the new device's features, materials, and intended use to existing devices, and ensuring any differences do not raise new questions of safety or effectiveness. It does not generally require the detailed clinical performance studies, statistical analyses, or ground truth establishment that are common for novel AI/SaMD products or devices seeking de novo classification or PMA approval.
- "Performance Testing" vs. "Clinical Study": While the document mentions "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness," this likely refers to engineering, bench, or pre-clinical (e.g., animal model) testing to confirm mechanical properties, biocompatibility, and functionality, not a human clinical study with the kind of metrics you're requesting for an AI algorithm.
In summary, the provided document does not contain the information required to populate your table or answer the specific questions related to AI/software device studies.
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KO81803
MAY 1 3 2009
Section 5 – 510(k) Summary
| Submitter: | St. Jude Medical - Atrial Fibrillation Division14901 DeVeau PlaceMinnetonka, MN 55345Establishment Registration Number: 2182269 |
|---|---|
| Contact Person: | Joshua ClarinRegulatory Affairs SpecialistPhone (651) 756-2855Fax (952) 930-9481 |
| Date Prepared: | June 25, 2008 |
| Trade Name: | St. Jude Medical Epicardial Catheter System |
| Classification: | Class 11 - 21 CFR 870.1220Electrode recording catheter or electrode recording probeClass II - 21 CFR 870.1340Catheter Introducer |
| Product Code: | DRFDYB |
| Predicate Device(s): | The subject device is equivalent to the following St. Jude Medicaldevices:◦ ResponseTM Electrophysiology Catheter◦ AgilisTM NxT Steerable Introducer |
| Device Description: | The St. Jude Medical Epicardial Catheter System consists of theResponseTM 6 French quadripolar electrophysiology catheter and theAgilisTM NxT 40 cm steerable guiding introducer (which includes adilator, guidewire and steerable sheath). The Agilis NxT SteerableIntroducer provides pericardial access for the Response catheter toperform electrophysiology studies of the epicardial surface of the heart. |
| Intended Use: | The St. Jude Medical Epicardial Catheter System is intended forelectrophysiology studies involving the epicardial surface of the heart. |
| Comparison toPredicate Devices | The St. Jude Medical Epicardial Catheter System has a similar intendeduse and the same fundamental scientific technology as the predicatedevices. All technological characteristics of the of the Epicardial CatheterSystem are substantially equivalent to the predicate devices includingpackaging, biocompatibility, sterilization, and labeling. Wheredifferences exist between the proposed devices and the predicate devices,performance testing demonstrated that these differences do not adverselyaffect the safety and effectiveness of the proposed devices. |
| Conclusion: | St. Jude Medical considers the Epicardial Catheter System to beequivalent to the predicate devices listed above. This conclusion is basedupon the devices' similarities in design, technological characteristics,principles of operation, materials, and indications for use. |
PreMarket Notification for the St. Jude Medical Epicardial Catheter System
Page 14 of 68
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an abstract human figure or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
MAY 1 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical c/o Mr. Joshua Clarin Regulatory Affair Specialist One St. Jude Medical Drive St. Paul, MN 55117
Re: K081803
.
Trade/Device Name: Epicardial Catheter System Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: April 17, 2009 Received: April 20, 2009
Dear Mr. Clarin:
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 - Mr. Joshua Clarin
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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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| Indications for Use | |||
|---|---|---|---|
| 510(k) Number (if known): | K081803 | ||
| Device Name: | St Jude Medical Epicardial Catheter System | ||
| Indications for Use: | |||
| The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart. | |||
| AND/OR | Over-The-Counter | ||
| Prescription Use | X | ||
| (Part 21 CFR 801 Subpart D | (21 CFR 801 Subpart | ||
| (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 Cardiovascular Devices | |||
| 510(k) Number | K081803 | ||
ACT 2000 Company Company
1 公路
§ 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).