(101 days)
Not Found
No
The description focuses on the physical components of the catheter and its integration with the MediGuide system for real-time tip positioning and navigation, which is described as an adjunct to fluoroscopy. There is no mention of AI or ML in the device description, intended use, or performance study summaries. The MediGuide system itself is not described in enough detail to determine if it uses AI/ML, but the focus here is on the catheter.
No
The device is described as an access and conduit tool for delivering other devices and fluids, rather than directly treating a condition.
No
The device is a guide catheter designed for intracardiac access, delivery of medical devices and fluids, and tip positioning/navigation with the MediGuide system. It facilitates procedures rather than diagnosing conditions.
No
The device description clearly details a physical catheter made of PEBAX and stainless steel, with embedded sensor coils and tungsten stripes. This is a hardware device, 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 Direct™, Mediguide™ Enabled slittable outer guide catheter is a medical device used within the body (intracardiac access) to facilitate procedures like lead implantation and contrast delivery. It is a tool for intervention and visualization, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly describes its function as a conduit and support during procedures, not for diagnostic testing of biological samples.
- Device Description: The description focuses on the physical components and materials of the catheter, not on any reagents or processes for analyzing biological samples.
Therefore, this device falls under the category of an invasive medical device used for interventional procedures, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The St. Jude Medical™ CPS Direct™, Mediguide™ Enabled slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, Mediguide Enabled slittable outer guide catheter are used with the Mediguide™ System to enable realtime tip positioning and navigation. The Mediguide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, Mediguide™ Enabled slittable outer guide catheters can work with inner catheters as a system.
Product codes
DQY, DOY
Device Description
The St. Jude Medical CPS Direct MediGuide Enabled slittable outer guide catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX from the proximal to the distal end with a soft, atraumatic distal tip. The distal end is embedded with a sensor coil to enable device tip projection onto the MediGuide system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and the proximal shaft is integrated into the hub creating a slit channel. The hub contains a sideport with extension tubing for contrast delivery, aspiration or saline flush using a 3-way stopcock. In addition, the hub contains a port for the connector cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system of the heart
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)
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.
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
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K120296 pg 1 of 2
MAY 1 1 2012
Page 15
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 Direct™ MediGuide™ Enabled Outer Guide Catheter and
accessories |
| Classification : | Class II – 21 CFR 870.1250
Catheter Percutaneous |
| Product Code : | DQY |
| Predicate Device : | The subject device is equivalent to the following St Jude Medical and
MediGuide Devices
St Jude Medical CPS Direct™ SL II Slittable Outer Catheter (K092075
cleared on August 7, 2009)
MediGuide Guided Measurement Catheter (GMC) (K091781 cleared on
October 16, 2009) |
| Device Description : | The St. Jude Medical CPS Direct MediGuide Enabled slittable outer guide
catheter is made from PEBAX and reinforced with a stainless steel braid.
The shaft has progressively decreasing durometers of PEBAX from the
proximal to the distal end with a soft, atraumatic distal tip. The distal end
is embedded with a sensor coil to enable device tip projection onto the
MediGuide system and tungsten stripes for fluoroscopic visibility. The
hub contains an integrated hemostasis valve and the proximal shaft is
integrated into the hub creating a slit channel. The hub contains a sideport
with extension tubing for contrast delivery, aspiration or saline flush using
a 3-way stopcock. In addition, the hub contains a port for the connector
cable. |
1
K120296 pg 2of2
| Intended Use: | The St Jude Medical CPS Direct MediGuide Enabled slittable outer guide
catheter is designed for intracardiac access of the venous system of the
heart and to serve as a conduit during implantation for the delivery of
contrast medium and St. Jude Medical devices (including implantable left
heart leads and delivery tools), and support of fluids where minimizing
blood loss is essential. The CPS Direct MediGuide Enabled slittable outer
guide catheter is used with the MediGuide System to enable real-time tip
positioning and navigation. The MediGuide system is indicated for use as
an adjunct to fluoroscopy. In addition, the CPS Direct MediGuide
Enabled slittable outer guide catheters can work with inner catheters as a
system |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Devices | The St Jude Medical CPS Direct MediGuide Enabled slittable outer guide
catheter (from herein referenced as CPS Direct MediGuide Enabled outer
catheter kit) has a similar intended use and the same fundamental
scientific technology as the predicate devices. All technological
characteristics of CPS Direct MediGuide Enabled outer catheter 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 Direct MediGuide Enabled outer
catheter kit to be equivalent to the predicate devices listed above. This
conclusion is based upon the device similarities in design, technological
characteristics, principle of operation, materials and indications for use. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Colleen Canan 15900 Valley View Court Sylmar, CA 91342
MAY 1 1 2012
Re: K120296
Trade/Device Name: CPS Direct MediGuide Enabled Outer Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: May 7, 2012 Received: May 9, 2012
Dear Ms. Canan:
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. 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/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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K120296 pg bf1
Page 14
Indications for Use
Device Name:
CPS Direct™ Mediguide Enabled™ Slittable Outer Guide Catheter Models DS2M021, DS2M022, DS2M023
Indications for Use: The St. Jude Medical™ CPS Direct™, Mediguide™ Enabled slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, Mediguide Enabled slittable outer guide catheter are used with the Mediguide™ System to enable realtime tip positioning and navigation. The Mediguide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, Mediguide™ Enabled slittable outer guide catheters can work with inner catheters as a system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
$\underset{\text{(Part 21 CFR 801 Subpart D)}}{\text{X}}$
AND/OR
Over-The-Counter Use __
(21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120 296