(77 days)
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No
The summary describes a physical catheter and its intended use for accessing the venous system and delivering devices and fluids. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
No.
Explanation: The device is designed for intracardiac access and as a conduit for delivery of devices and fluids, not for treating a condition or restoring function.
No
The device is described as a conduit for delivering devices and fluids during implantation, not for diagnosing a medical condition.
No
The device description clearly indicates it is a physical catheter designed for intracardiac access and delivery of devices and fluids, 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 for accessing the venous system of the heart and serving as a conduit for delivering other devices and fluids within the body. This is an in vivo application, meaning it's used inside a living organism.
- IVD Definition: In vitro diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. This process happens outside the body (in vitro).
The description of the St. Jude Medical CPS Direct® SL II Slittable Outer Catheters clearly indicates an in vivo use case, not an in vitro one.
N/A
Intended Use / Indications for Use
The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters 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, the outer guide catheters can work with inner catheters as a system.
Product codes
DQY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 9 2011
St. Jude Medical, CRDM c/o Ms. Colleen Canan Regulatory Affairs 15900 Valley View Court Sylmar, CA 91342
Re: K103250
Trade/Device Name: CPS Direct SL II Slittable Outer Catheter Models DS2C007 and DS2C017 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 17, 2010 Received: December 20, 2010
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. 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.
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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); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health`s (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
OBram 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) | K103250 |
|---|---|
| Device Name | CPS Direct SL II Slittable Outer Catheter |
| Indications for Use | The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters 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, the 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 | K103250 |
|---|---|
| --------------- | --------- |
CPS Direct® SL II slittable
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