(14 days)
Not Found
No
The document describes a physical medical device (a guiding catheter) and its intended use, design, and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
The device is described as a guiding catheter intended to access the coronary sinus and serve as a conduit for other devices, not to directly treat a condition.
No
The device is a guiding catheter intended to access the coronary sinus and serve as a conduit for the delivery and support of other devices, rather than to diagnose medical conditions.
No
The device description clearly indicates it is a physical catheter with specific dimensions and shapes, which is a hardware medical device, not software.
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 a guiding catheter intended to access the coronary sinus and serve as a conduit for delivering and supporting devices introduced into the venous system. This describes a device used in vivo (within the living body) for a medical procedure.
- Device Description: The description details a physical catheter with specific dimensions and shapes 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 compatibility testing.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The Guidant EASYTRAK Guiding Catheter is intended to access the coronary sinus. The Catheter may serve as a conduit for the delivery and support of devices introduced into the coronary venous system.
Product codes
DQY
Device Description
The BASYTRAK Guiding Catheter is a catheter with a 0.087" inner diameter. The catheter is available in five shapes which include a Coronary Sinus-Multi Purpose Hook (CS-MPH), Coronary Sinus-Hook (CS-H), Coronary Sinus-Multi-Purpose Long (CS-MPL), and Coronary Sinus-Amplatz 6 (CS-A6). The catheter is available in working lengths ranging from 30cm to 47cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus, 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
In vitro bench testing and in vivo performance evaluations demonstrated that the EASYTRAK Guiding Catheter met the acceptance criteria and performed similarly to the predicate device (e.g., TOURGUIDE). An animal study was conducted and the results of the in vivo animal evaluation show that the EASYTRAK Guiding Catheter is acceptable. No new safety or effectiveness issues were raised during the testing program. The EASYTRAK Guiding Catheter may be considered substantially equivalent to the predicate device.
The EASY TRAK Guiding Catheter was evaluated in a clinical investigation. The results demonstrated that the EASYTRAK Guiding Catheter is safe and effective.
Key Metrics
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).
0
KQ21284
510(K) Summary
1. Device Trade Name EASYTRAK® Guiding Catheter
- Device Common Name Guiding Catheter
3. Device Description
The BASYTRAK Guiding Catheter is a catheter with a 0.087" inner diameter. The catheter is available in five shapes which include a Coronary Sinus-Multi Purpose Hook (CS-MPH), Coronary Sinus-Hook (CS-H), Coronary Sinus-Multi-Purpose Long (CS-MPL), and Coronary Sinus-Amplatz 6 (CS-A6). The catheter is available in working lengths ranging from 30cm to 47cm.
4. Intended Use
The Guidant EASYTRAK Guiding Catheter is intended to access the coronary sinus. The Catheter may serve as a conduit for the delivery and support of devices introduced into the coronary venous system.
5. Technological Characteristics
Compansons of the EASYTRAK Guiding Catheter 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
In vitro bench testing and in vivo performance evaluations demonstrated that the EASYTRAK Guiding Catheter met the acceptance criteria and performed similarly to the predicate device (e.g., TOURGUIDE). An animal study was conducted and the results of the in vivo animal evaluation show that the EASYTRAK Guiding Catheter is acceptable. No new safety or effectiveness issues were raised during the testing program. The EASYTRAK Guiding Catheter may be considered substantially equivalent to the predicate device.
The EASY TRAK Guiding Catheter was evaluated in a clinical investigation. The results demonstrated that the EASYTRAK Guiding Catheter is safe and effective.
7. Conclusion
The Guidant EASYTRAK Guiding Catheter is substantially equivalent to the currently marketed Cardima VUEPORT™ Coronary Sinus Balloon Occlusion Guiding Catherer (K973298, cleared June 26, 1998) with regards to intended use, and to the Advanced Cardiovascular Systems (ACS) TOURGUIDE™ Guiding Catheter (K953987, cleared December 7, 1995) with regards to design characteristics and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2002
Ms. Karen S. Alsop Pr. Regulatory Affairs Associate Guidant Corporation 4100 Hamline Avenue N St. Paul, MN 55112
Re: K021282
Trade Name: LV-1 Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold fitting Regulatory Class: Class II (two) Product Code: DTL
Re: K021283
Trade Name: Guidant Balloon Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO
Re: K021284
Trade Name: EASYTRAK® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY
Re: K021285
Trade Name: HI-TORQUE® Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 17, 2002 Received: April 18, 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 enclosures) 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
2
Page 2 - Ms. Karen S. Alsop
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.
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.
Daetilln
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
. KO21284
Device Name: EASYTRAK® Guiding Catheter
Intended Use/Indications for Use:
The Guidant EASYTRAK Guiding Catheter is intended to access the coronary sinus. The catheter serves as a conduit for the delivery and support of devices 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)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K021284 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter
(Optional Format 1-1-96) |
| ------------------------------------------ | ------------------------------------------ | ---------------------------------------------- |
|---|
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |