(25 days)
The St. Jude Medical CPS Direct PL Peelable Outer Guide Catheter intended use 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. In addition, CPS Direct PL Peelable Outer Guide Catheters can work with inner catheters as a system.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for the CPS Direct™ PL Peelable Outer Guide Catheter.
The document is an FDA 510(k) clearance letter, which primarily focuses on classifying the device and confirming its substantial equivalence to a predicate device. It defines the "Indications for Use" but does not delve into detailed performance studies or statistical outcomes typically associated with acceptance criteria validation.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2006
St. Jude Medical c/o Ms. Adele Shoustal Regulatory Affairs Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342
Re: K061710
Trade Name: CPS Direct™ PL Peelable Outer Guide Catheter Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: DQY Dated: June 15, 2006 Received: June 19, 2006
Dear Ms. Shoustal:
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. Adele Shoustal
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Bhemmermonfr
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
.
:
| 510(k) Number (if known) | |
|---|---|
| Device Name | CPS Direct PL Peelable Guide Outer Catheter |
| Indications for Use | The St. Jude Medical CPS Direct PL Peelable Outer Guide Catheter intended use 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. In addition, CPS Direct PL Peelable Outer Guide Catheters can work with inner 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 of Cardiovascular Devices
| 510(k) Number | K04/710 |
|---|---|
| --------------- | --------- |
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CPS Direct™ PL Peelable Outer Guide Catheter Special 510(k) St. Jude Medical
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§ 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).