(72 days)
Not Found
Not Found
No
The summary describes a physical catheter for accessing the heart's venous system and delivering devices/contrast. There is no mention of software, algorithms, or any terms related to AI/ML.
No.
The device is described as an inner catheter used to provide access and serve as a conduit for delivering other devices and contrast medium during implantation, rather than directly treating a condition.
No
The device is described as a conduit for delivering contrast medium and other medical devices during implantation, indicating a therapeutic or interventional function rather than a diagnostic one.
No
The device description clearly indicates a physical catheter intended for intracardiac access and delivery of devices and contrast medium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the body for accessing and delivering other devices or contrast medium. This is an in vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are typically used for tests performed on samples like blood, urine, or tissue in a laboratory setting. This device is clearly designed for direct interaction with the patient's internal anatomy.
N/A
Intended Use / Indications for Use
The St. Jude Medical CPS Aim SL Slittable inner catheter intended use 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 guidewires. In addition, the inner catheters can work with outer guide catheters as a system.
Product codes
DQY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and subselection of the 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a person embracing another person. The symbol is composed of three curved lines that form the shape of a person's arms and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2008
St. Jude Medical Cardiac Rhythm Management Division C/O Colleen Canan 15900 Valley View Court Sylmar, CA 91342
Re: K082932
Trade/Device Name: CPS Aim SL Slittable Inner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 10, 2008 Received: November 13, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0293. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dma R. bachner
Image /page/1/Picture/5 description: The image contains a handwritten symbol or signature. The symbol appears to be a stylized combination of curved lines and a straight line. It is drawn in black ink on a white background. The symbol is located on the left side of the image.
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 Statement -
›
| 510(k)
Number
| (if known) | K082932 |
|---|---|
| Device Name | CPS Aim SL Slittable inner catheter |
| Indications | |
| for Use | The St. Jude Medical CPS Aim SL Slittable inner catheter intended use |
| 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 guidewires. In addition, the inner catheters can work | |
| with outer guide catheters as a system. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801. 109) | X OR Over-The-Counter Use _______ |
|---|---|
| ------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
(Division Sign-Off)
(Division Sign-Off)
Division of Cardrovascular Devices
510(k) number K0 82932
CPS Aim® SL slittable Inner Catheter Special 510(k) St. Jude Medical