(42 days)
No
The document describes a physical medical device (a catheter) and its materials and construction. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device acts as a conduit for delivery of contrast medium and other devices, but does not itself provide a therapeutic effect.
No
The device is described as a "Guiding Catheter" intended to access the coronary venous system and serve as a conduit for delivering contrast medium and devices. This function is interventional, not diagnostic.
No
The device description clearly details physical components like a flexible shaft, luer, soft tip, PTFE liner, PEBAX layers, stainless steel braid, and silicone coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to access the coronary venous system and serves as a conduit for delivering contrast medium and devices into the body. This is an in vivo (within a living organism) application.
- Device Description: The description details a physical catheter designed for insertion into 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 to perform tests outside of the body on samples taken from the body. This device is used inside the body for interventional procedures.
N/A
Intended Use / Indications for Use
The Guidant RAPIDO™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dual-catheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
Product codes
DOY
Device Description
The RAPIDO Cut-Away Guiding Catheter is similar to the approved RAPIDO Guiding Catheter. The Cut-Away Catheter is comprised of a flexible shaft, lucr (hub) and a soft tip. The catheter shaft is comprised of an inner liner of polytetrafluoroethylene (PTFE), an outer layer of radiopaque polyether block amide (PEBAX), with a reinforcing layer of 304V stainless steel braid sandwiched between the two. A blue PEBAX luer (sometimes referred to as a "hub") is attached to the proximal end of the shaft using a cyanoacrylate adhesive. A silicone coating is applied to the exterior of the shaft to improve device lubricity. The distal end of the catheter is formed into a variety of shapes as needed to access differing areas of the anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary venous system
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)
Testing demonstrated that the RAPIDO Cut-Away Guiding Catheters met the acceptance criteria and performed similarly to the predicate device. No new safety or effectiveness issues were raised during the testing program. The RAPIDO Cut-Away Guiding Catheter may be considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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K031505
page 1 of 1
510(K) Summary
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- Device Trade Name RAPIDOTM Cut-Away™ Guiding Catheter
-
- Device Common Name Percutaneous Catheter
3. Device Description
The RAPIDO Cut-Away Guiding Catheter is similar to the approved RAPIDO Guiding Catheter. The Cut-Away Catheter is comprised of a flexible shaft, lucr (hub) and a soft tip. The catheter shaft is comprised of an inner liner of polytetrafluoroethylene (PTFE), an outer layer of radiopaque polyether block amide (PEBAX), with a reinforcing layer of 304V stainless steel braid sandwiched between the two. A blue PEBAX luer (sometimes referred to as a "hub") is attached to the proximal end of the shaft using a cyanoacrylate adhesive. A silicone coating is applied to the exterior of the shaft to improve device lubricity. The distal end of the catheter is formed into a variety of shapes as needed to access differing areas of the anatomy.
4. Intended Use
The Guidant RAPIDO™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dual-catheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
5. Technological Characteristics
Comparisons of the RAPIDO Cut-Away Guiding Catheters and predicate devices show that the technological characteristics such as design and intended use are substantially equivalent to the currently marketed predicate device.
6. Performance Data
Testing demonstrated that the RAPIDO Cut-Away Guiding Catheters met the acceptance criteria and performed similarly to the predicate device . No new safety or effectiveness issues were raised during the testing program. The RAPIDO Cut-Away Guiding Catheter may be considered substantially equivalent to the predicate device.
7. Conclusion
The Guidant RAPIDO Cut-Away Guiding Catheters are substantially equivalent to the currently marketed Guidant RAPIDO Guiding Catheter (K021455, cleared August 02, 2002) with regards to intended use and design.
1
Image /page/1/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2003
Guidant Coporation Cardiac Rhythm Management c/o Mr. Shah M. Hilali Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112
Re: K031505
Trade Name:RAPIDO™ Cut-Away™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: May 14, 2003 Received: May 14, 2003
Dear Mr. Hilali:
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.
2
Page 2 - Mr. Shah M. Hilali
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
V
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) K031505
Manufacturer: GUIDANT Corporation
Device Name: RAPIDO™ Cut-Away™ Guiding Catheter
Indications for Use: The Guidant RAPIDO™ Cut- Away™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dualcatheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
Valentin
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103505
Prescription Use Only