(88 days)
Not Found
No
The summary describes a physical guiding catheter and its intended use, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a guiding catheter used to access the coronary venous system and deliver contrast medium and other devices, rather than directly treating a disease or condition. It serves as a tool for a procedure, not a therapeutic agent itself.
No
This device is described as a guiding catheter intended to access the coronary venous system and serve as a conduit for delivery of contrast medium and other devices. Its purpose is to facilitate access and delivery, not to diagnose a condition.
No
The device description clearly describes a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to access the coronary venous system and deliver other devices and contrast medium. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a physical catheter with specific sizes and lengths, designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Guidant Guiding Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Guidant 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
DQY
Device Description
The RAPIDO Guiding Catheters are available in two French sizes (6F and 8F). The 6F RAPIDO Guiding Catheter has a standard working length of 69 cm. The 8F RAPIDO Guiding Catheter has as standard working length of 47 cm.
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 6F/8F RAPIDO Guiding Catheters met the acceptance criteria and performed similarly to the predicate device (EASYTRAK Guiding Catheter). No new safety or effectiveness issues were raised during the testing program. The 6F/8F RAPIDO 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Koa14ss
510(K) Summary
1. Device Trade Name
6F RAPIDO™ Guiding Catheter 8F RAPIDO™ Guiding Catheter
2. Device Common Name
Percutaneous Catheter
3. Device Description
The RAPIDO Guiding Catheters are available in two French sizes (6F and 8F). The 6F RAPIDO Guiding Catheter has a standard working length of 69 cm. The 8F RAPIDO Guiding Catheter has as standard working length of 47 cm.
4. Intended Use
The Guidant 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 6F/8F RAPIDO Guiding Catheters and predicate devices show that the technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
6. Performance Data
Testing demonstrated that the 6F/8F RAPIDO Guiding Catheters met the acceptance criteria and performed similarly to the predicate device (EASYTRAK Guiding Catheter). No new safety or effectiveness issues were raised during the testing program. The 6F/8F RAPIDO Guiding Catheter may be considered substantially equivalent to the predicate device.
7. Conclusion
The Guidant 6F/8F RAPIDO Guiding Catheters are substantially equivalent to the currently marketed EASYTRAK Guiding Catheter (K021284, May 2, 2002) with regards to intended use and design.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2002
Guidant Corporation c/o Ms. Karen S. Alsop Principal Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K021455
Trade Name: RAPIDO™ Guiding Catheters, 6F and 8F Regulation Number: 21 CFR.870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 3, 2002 Received: May 6, 2002
Dear Ms. Alsop:
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 - Ms. Karen S. Alsop
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
N. Dale Till
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
Applicant: Guidant Corporation 4100 Hamline Avenue North St. Paul, MN 55112
510(k) Number (if known): To be assigned by FDA
Device Names: RAPIDO™ Guiding Catheter, 6F and 8F
Intended Use/Indications for Use:
The Guidant 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter _ (Optional Format 1-1-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021455