(127 days)
Not Found
No
The summary describes a catheter with a magnetic sensor for real-time tracking using a separate system (MediGuide™ System). There is no mention of AI or ML in the device description, intended use, or performance studies. The MediGuide™ system is described as an adjunct to fluoroscopy, not as an AI/ML-powered system.
No
The device is described as a catheter used for access and delivery of other devices, contrast medium, and guidewires, acting as a conduit rather than providing direct therapeutic treatment.
No
The device is described as a catheter designed for access, subselection, and delivery of other devices and contrast medium during implantation procedures. It serves as a conduit and facilitates procedures, rather than diagnosing conditions.
No
The device description clearly states it is a physical catheter containing a magnetic sensor, which is a hardware component. The performance studies also detail physical testing of the catheter.
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 used within the body for accessing and navigating the heart's venous system, delivering other devices, and facilitating procedures. This is an in vivo application.
- Device Description: The description reinforces the in vivo nature of the device, detailing its use in surgical implantation procedures and its function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for procedural guidance and delivery.
N/A
Intended Use / Indications for Use
The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. The CPS Aim, MediGuide Enabled slittable inner catheter (subselector/cannulator) contains a magnetic sensor allowing it to be tracked using the MediGuide™ System. The inner catheter facilitates cannulation of the coronary sinus or subselection of branch veins off of the coronary sinus/great cardiac vein during surgical implantation procedures. It may also be used for the delivery of contrast medium and St. Jude Medical™ devices, including guidewires. When used in conjunction with outer guide catheters, the CPS Aim, MediGuide Enabled slittable inner catheter (subselector/cannulator) can function as a dual-catheter assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and 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)
Product verification was performed on the CPS Aim™ MediGuide EnabledTM slittable inner catheter 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 testing with the CPS Aim™ MediGuide Enabled™ slittable inner catheter demonstrated that it met all specified design and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.1250 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
Public Health Service
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 Sr. Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342
Re: K142235
Trade/Device Name: CPS Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Models DS2M051, DS2M052, DS2M053, DS2M054 and DS2M055 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 21, 2014 Received: November 24, 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
1
Page 2 - Mr. Price
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.
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 Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Device Name: Models DS2M051, DS2M052, DS2M053, DS2M054 and DS2M055
Indications for Use: The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated 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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
CPS Direct™ MediGuide Enabled™ Inner Catheter Traditional 510(k) St. Jude Medical
3
Image /page/3/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left side and the text "St. Jude Medical" on the right side. The text is in a serif font and is black in color. 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 Aim™ MediGuide Enabled™ Slittable Inner Guide Catheter Models
DS2M051, DS2M052, DS2M053, DS2M054, and DS2M055 |
| 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 Aim™ SL Slittable Inner Catheter (K090613)
cleared on July 7, 2009 |
| | MediGuide Guided Measurement Catheter (GMC) (K091780) cleared on
October 16, 2009 |
| Device Description: | The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner
catheter (subselector/cannulator) is used to facilitate left heart lead
delivery procedures. The CPS Aim, MediGuide Enabled slittable inner
catheter (subselector/cannulator) contains a magnetic sensor allowing it to
be tracked using the MediGuide™ System. The inner catheter facilitates
cannulation of the coronary sinus or subselection of branch veins off of the
coronary sinus/great cardiac vein during surgical implantation procedures.
It may also be used for the delivery of contrast medium and St. Jude
Medical™ devices, including guidewires. |
| | When used in conjunction with outer guide catheters, the CPS Aim,
MediGuide Enabled slittable inner catheter (subselector/cannulator) can
function as a dual-catheter assembly. |
4
Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid with a tilted square in the center, followed by the text "ST. JUDE MEDICAL" in a sans-serif font. The word "MEDICAL" is followed by the registered trademark symbol.
The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner Intended Use: catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.
Comparison to
- Predicate Devices The St Jude Medical CPS Aim™ MediGuide Enabled™ slittable inner guide catheter and accessories have a similar intended use and the same fundamental scientific technology as the predicate devices. All technological characteristics of CPS Aim™ MediGuide EnabledTM slittable inner catheter and accessories 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 Aim™ MediGuide EnabledTM slittable inner catheter 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 testing with the CPS Aim™ MediGuide Enabled™ slittable inner catheter demonstrated that it met all specified design and performance specifications.
- Conclusion : St Jude Medical considers the CPS Aim™ MediGuide Enabled™ slittable inner catheter and accessories to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in
5
Image /page/5/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left and the words "ST. JUDE MEDICAL" in a serif font on the right. The grid is made up of smaller squares, with one square slightly tilted.
design, technological characteristics, principle of operation, materials and indications for use.