(98 days)
Not Found
No
The summary describes a guidewire with a magnetic sensor for real-time positioning and navigation using a separate system (MediGuide). There is no mention of AI, ML, or any related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms. The technology described is based on magnetic sensing and visualization, not AI/ML analysis.
No.
The guidewire is intended for navigation and positioning, facilitating procedures, but does not directly treat a disease or condition itself. It is explicitly described as an "adjunct to fluoroscopy" and functions as part of a system for visualization, not therapy.
No
The device is a guidewire used for navigation and real-time tip positioning within the vasculature, facilitating procedures like lead implantation. It is a tool for therapy delivery, not for diagnosing a medical condition.
No
The device description explicitly states it is a "guidewire" and contains a "magnetic sensor," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The St. Jude Medical CPS Excel™ MediGuide Enabled™ Guidewire is a medical device used within the body (in vivo) for navigation and positioning during procedures in the coronary and peripheral vasculature. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes its function in facilitating procedures within the vasculature, not for diagnostic testing of bodily samples.
Therefore, this device falls under the category of an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The St. Jude Medical TM CPS Excel TM MediGuide Enabled TM guidewire is intended for use with the MediGuide system to enable real-time tip positioning and navigation within the coronary and peripheral vasculature. The MediGuide system is intended for use as an adjunct to fluoroscopy.
The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy.
Product codes
DQX
Device Description
The St. Jude Medical CPS Excel TM , MediGuide Enabled TM guidewire is a MediGuide enabled guidewire with a hydrophilic coating. The CPS Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing it to be visualized using the MediGuide system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
长120298
中小2 Pago 15
MAY - 8 2012
Section 5- 510(k) Summary
| Submitter : | St Jude Medical, CRMD
15900 Valley View Court
Sylmar, CA 91324
Establishment Registration Number: 2017865 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Colleen Canan
Staff Regulatory Affairs Specialist
Phone (818) 493 2960
Fax (818) 493 3615 |
| Date Prepared : | January 27, 2012 |
| Trade Name : | CPS Excel TM MediGuide Enabled TM Guidewire and accessories |
| Classification : | Class II-21 CFR 870.1330
Catheter, Guidewire |
| Product Code : | DQX |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical and
MediGuide Devices |
| | St Jude Medical CPS Courier TM Guidewire (K073082) cleared on January
9, 2008 |
| | MediGuide Guided Measurement Catheter (GMC) (K091781) cleared on
October 16, 2009 |
| Device Description : | The St. Jude Medical CPS Excel TM , MediGuide Enabled TM guidewire is a
MediGuide enabled guidewire with a hydrophilic coating. The CPS
Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing
it to be visualized using the MediGuide system |
| Intended Use: | The St. Jude Medical TM CPS Excel TM MediGuide Enabled TM guidewire is
intended for use with the MediGuide system to enable real-time tip
positioning and navigation within the coronary and peripheral vasculature.
The MediGuide system is intended for use as an adjunct to fluoroscopy |
| Comparison to
Predicate Devices | The St Jude Medical CPS Excel MediGuide Enabled guidewire has a
similar intended use and the same fundamental scientific technology as the |
1
predicate devices. All technological characteristics of CPS Excel MediGuide Enabled guidewire kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where differences exist between the subject device and the predicate devices performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device.
Conclusion : St Jude Medical considers the CPS Excel MediGuide Enabled guidewire kit to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in design, technological characteristics, principles of operation, materials and indications for use.
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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 features a stylized eagle with three stripes forming its body and tail. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 13 2012
St. Jude Medical c/o Ms. Colleen Canan Staff Regulatory Submission Specialist 15900 Valley View Court Sylmar, CA 91342
K120298 CPS Excel™ MediGuide Enabled™ Guidewire and accessories Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: 74 DQX Dated (Date on orig SE ltr): April 6, 2012 Received (Date on orig SE Itr): April 10, 2012
Dear Ms. Canan:
Re:
This letter corrects our substantially equivalent letter of May 8, 2012.
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 (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. Colleen Canan
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/CDRH0ffices/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/ReportalProblem/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. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
CPS Excel™ MediGuide Enabled™ Guidewire Device Name: Models DS2M027, DS2M028, DS2M029
Indications for Use:
The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Part 21 CFR 801 Subpart D) | |
|---|---|
| ------------------------------------------------- | -- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K120298 |