(101 days)
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.
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.
The provided text does not contain any information about acceptance criteria or a study proving the device meets them.
The document is a 510(k) summary for a medical device (CPS Direct™ MediGuide™ Enabled Outer Guide Catheter and accessories) submitted to the FDA. It focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.
Here's a breakdown of what the document does contain, which highlights the absence of the requested information:
- Submitter and Contact Information: Basic administrative details.
- Date Prepared: Date of the submission.
- Trade Name and Classification: Device identification and regulatory classification.
- Product Code: Specific code for the device type.
- Predicate Device: Identifies the legally marketed devices to which the new device is compared for substantial equivalence.
- Device Description: Physical characteristics and components of the new catheter.
- Intended Use: What the device is designed to do.
- Comparison to Predicate Devices: Explicitly states that the new device has "similar intended use and the same fundamental scientific technology as the predicate devices" and that "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device." However, it does not detail this performance testing or its results.
- Conclusion: Declares substantial equivalence based on design, technology, operation, materials, and indications for use.
- FDA Correspondence: Official letter from the FDA granting 510(k) clearance, affirming substantial equivalence.
- Indications for Use Statement: A formal statement of the device's intended use, marked for prescription use.
Therefore, I cannot provide the requested table and study details because the information is not present in the provided text. This type of detailed performance data and acceptance criteria is typically found in the full 510(k) submission, not usually in the publicly available summary.
{0}------------------------------------------------
K120296 pg 1 of 2
MAY 1 1 2012
Page 15
Section 5- 510(k) Summary
| Submitter : | St Jude Medical, CRMD15900 Valley View CourtSylmar, CA 91324Establishment Registration Number: 2017865 |
|---|---|
| Contact Person : | Colleen CananStaff Regulatory Affairs SpecialistPhone (818) 493 2960Fax (818) 493 3615 |
| Date Prepared : | January 27, 2012 |
| Trade Name : | CPS Direct™ MediGuide™ Enabled Outer Guide Catheter andaccessories |
| Classification : | Class II – 21 CFR 870.1250Catheter Percutaneous |
| Product Code : | DQY |
| Predicate Device : | The subject device is equivalent to the following St Jude Medical andMediGuide DevicesSt Jude Medical CPS Direct™ SL II Slittable Outer Catheter (K092075cleared on August 7, 2009)MediGuide Guided Measurement Catheter (GMC) (K091781 cleared onOctober 16, 2009) |
| Device Description : | The St. Jude Medical CPS Direct MediGuide Enabled slittable outer guidecatheter is made from PEBAX and reinforced with a stainless steel braid.The shaft has progressively decreasing durometers of PEBAX from theproximal to the distal end with a soft, atraumatic distal tip. The distal endis embedded with a sensor coil to enable device tip projection onto theMediGuide system and tungsten stripes for fluoroscopic visibility. Thehub contains an integrated hemostasis valve and the proximal shaft isintegrated into the hub creating a slit channel. The hub contains a sideportwith extension tubing for contrast delivery, aspiration or saline flush usinga 3-way stopcock. In addition, the hub contains a port for the connectorcable. |
{1}------------------------------------------------
K120296 pg 2of2
| Intended Use: | The St Jude Medical CPS Direct MediGuide Enabled slittable outer guidecatheter is designed for intracardiac access of the venous system of theheart and to serve as a conduit during implantation for the delivery ofcontrast medium and St. Jude Medical devices (including implantable leftheart leads and delivery tools), and support of fluids where minimizingblood loss is essential. The CPS Direct MediGuide Enabled slittable outerguide catheter is used with the MediGuide System to enable real-time tippositioning and navigation. The MediGuide system is indicated for use asan adjunct to fluoroscopy. In addition, the CPS Direct MediGuideEnabled slittable outer guide catheters can work with inner catheters as asystem |
|---|---|
| Comparison toPredicate Devices | The St Jude Medical CPS Direct MediGuide Enabled slittable outer guidecatheter (from herein referenced as CPS Direct MediGuide Enabled outercatheter kit) has a similar intended use and the same fundamentalscientific technology as the predicate devices. All technologicalcharacteristics of CPS Direct MediGuide Enabled outer catheter kit aresubstantially equivalent to the predicate devices including packaging,biocompatibility, sterilization, and labeling. Where differences existbetween the subject device and the predicate devices performance testingdemonstrated that these differences do not adversely affect the safety andeffectiveness of the subject device. |
| Conclusion : | St Jude Medical considers the CPS Direct MediGuide Enabled outercatheter kit to be equivalent to the predicate devices listed above. Thisconclusion is based upon the device similarities in design, technologicalcharacteristics, 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
§ 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).