(72 days)
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.
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I am sorry, but the provided text from K082932 is a 510(k) clearance letter for the CPS Aim SL Slittable Inner Catheter. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device for marketing purposes.
It does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics, sample sizes, expert involvement, or AI-specific evaluations.
Therefore, I cannot provide the requested information based on the input text.
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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.
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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
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement -
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| 510(k)Number(if known) | K082932 |
|---|---|
| Device Name | CPS Aim SL Slittable inner catheter |
| Indicationsfor Use | The St. Jude Medical CPS Aim SL Slittable inner catheter intended useis designed for intracardiac access of the coronary sinus and subselectionof the venous system of the heart, and to serve as a conduit duringimplantation for the delivery of contrast medium and St. Jude Medicaldevices, including guidewires. In addition, the inner catheters can workwith 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
§ 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).