(127 days)
Not Found
No
The summary describes a physical guide catheter and a navigation system (MediGuide) that uses sensor coils and tungsten stripes for real-time positioning and navigation, adjunct to fluoroscopy. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a guide catheter designed to provide access and serve as a conduit for other devices and fluids, not to directly treat a medical condition itself.
No
Explanation: This device is a guide catheter used to deliver other devices and fluids, not to diagnose a medical condition. Its function is to provide access and support during procedures, not to identify diseases or conditions.
No
The device description clearly details physical components made of PEBAX, stainless steel, and tungsten, and describes mechanical and electrical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device designed for intracardiac access and serving as a conduit for delivering devices and fluids within the heart. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details the physical components of a catheter designed for insertion into the body.
- Anatomical Site: The anatomical site is the intracardiac venous system, which is inside the body.
- Performance Studies: The performance studies focus on the mechanical, functional, and biocompatibility properties of the catheter, which are relevant to its use within the body.
IVD devices are designed to be used in vitro, meaning outside of the body, to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
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 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.
Product codes
DQY
Device Description
The St. Jude Medical CPS DirectTM, MediGuide EnabledTM outer catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX form 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 MediGuideTM system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and a molded 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
Product verification was performed on the CPS Direct™ MediGuide Enabled™ outer catheter kit to confirm that it meets the design requirements and applicable industry standards. Testing included evaluations of (1) package integrity, (2) seal strength, (3) saline and aspiration leak testing, (4) visual inspection, (5) dimensional testing, (6) kink testing, (7) compatibility testing, (8) electrical integrity, (9) tensile testing, (10) rotation capacity, (11) torque testing, (12) slit force, (13) flex testing, (14) radiopacity testing, (15) polarity, and (16) static accuracy. This evaluation of the mechanical, functional, and biocompatibility properties of the CPS Direct™ MediGuide Enabled™ outer catheter kit demonstrated that it met all specified design and performance specifications.
Key Metrics
Not Found
Predicate Device(s)
St Jude Medical CPS DirectTM, MediGuide EnabledTM Slittable Outer Guide Catheter (K120296)
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, possibly representing hair or movement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
St. Jude Medical Zachary Price Senior Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342
Re: K142239
Trade/Device Name: CPS Direct™ Mediguide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 19, 2014 Received: November 20, 2014
Dear Mr. Price,
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.
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
1
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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Melissa A. Torres -S
For
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Device Name: Models DS2M041, DS2M042, DS2M043, DS2M044
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 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
CPS Direct™ MediGuide Enabled™ Outer Catheter Traditional 510(k) St. Jude Medical
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Image /page/3/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left, with one square rotated. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font. The text is black and the logo is simple and professional.
510(k) Summary
| Submitter: | St Jude Medical, CRMD
15900 Valley View Court
Sylmar, CA 91324
Establishment Registration Number: 2017865 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zachary Price
Senior Regulatory Affairs Specialist
Phone (818) 493 2903
Fax (818) 493 3615 |
| Date Prepared: | August 12, 2014 |
| Trade Name: | CPS DirectTM MediGuide EnabledTM Slittable Outer Guide Catheter
Models DS2M041, DS2M042, DS2M043, and DS2M044 |
| 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
MediGuideTM Devices |
| | St Jude Medical CPS DirectTM, MediGuide EnabledTM Slittable Outer
Guide Catheter (K120296 cleared on May 11, 2012) |
| Device Description: | The St. Jude Medical CPS DirectTM, MediGuide EnabledTM outer catheter
is made from PEBAX and reinforced with a stainless steel braid. The
shaft has progressively decreasing durometers of PEBAX form 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
MediGuideTM system and tungsten stripes for fluoroscopic visibility. The
hub contains an integrated hemostasis valve and a molded 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. |
| Intended Use: | The St Jude Medical CPS DirectTM MediGuide EnabledTM 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 |
4
Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left, with one square tilted. To the right of the grid is the text "ST. JUDE MEDICAL" in a sans-serif font. The word "MEDICAL" has a trademark symbol next to it.
blood loss is essential. The CPS Direct™ MediGuide Enabled™ slittable outer guide catheter is 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
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.
Performance Testing
(non-clinical): Product verification was performed on the CPS Direct™ MediGuide Enabled™ outer catheter kit to confirm that it meets the design requirements and applicable industry standards. Testing included evaluations of (1) package integrity, (2) seal strength, (3) saline and aspiration leak testing, (4) visual inspection, (5) dimensional testing, (6) kink testing, (7) compatibility testing, (8) electrical integrity, (9) tensile testing, (10) rotation capacity, (11) torque testing, (12) slit force, (13) flex testing, (14) radiopacity testing, (15) polarity, and (16) static accuracy. This evaluation of the mechanical, functional, and biocompatibility properties of the CPS Direct™ MediGuide Enabled™ outer catheter kit demonstrated that it met all specified design and performance specifications.
- St Jude Medical considers the CPS Direct™ MediGuide Enabled™ outer Conclusion: catheter kit to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in design, technological characteristics, and principle of operation, materials and indications for use.