(65 days)
Not Found
No
The 510(k) summary describes a purely mechanical balloon catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's intended use is for temporary occlusion of large vessels or to expand vascular prostheses, which are interventional procedures rather than therapeutic in nature.
No
The device is described as a temporary occlusion device or used to expand vascular prostheses, which are therapeutic functions. While it uses fluoroscopy for positioning, this is for guidance during a procedure, not for diagnosing a condition.
No
The device description clearly details a physical catheter with lumens, a balloon, radiopaque bands, and specific dimensions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary occlusion of large vessels, or to expand vascular prostheses." This describes a direct intervention within the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a catheter with a balloon designed for physical manipulation within blood vessels. This is consistent with a medical device used for treatment or intervention, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The COOK CODA™ BALLOON CATHETER is a therapeutic/interventional device.
N/A
Intended Use / Indications for Use
The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The COOK CODA™ BALLOON CATHETER is a 2-lumen catheter. The distal lumen extends the length of the catheter for use over a ,035 wire quide. The other lumen communicates with the balloon and is used to expand and deflate it. Radiopaque bands are placed at both the distal and proximal aspects of the balloon to assist with positioning of the device under fluoroscopy. The balloon will be provided in diameters ranging from 30 to 40 mm, and in lengths ranging from 100 to 120 cm. The device is packaged in sterile, sealed double pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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)
The COOK CODA™ BALLOON CATHETER underwent testing to assess biocompatibility, mechanical properties, performance characteristics, and safety, The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
LDOB BALLOON CATHETER (K002286), ILIAC BALLOON CATHETER (K003495)
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.
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
| 510(k) Summary | NOV 1 9 2003 |
|---|---|
| Submitted By: | Theodore Heise, PhD, RAC |
| Director of Regulatory Scientific Affairs | |
| Cook Incorporated | |
| 750 N. Daniels Way | |
| Bloomington, IN 47404 | |
| (812) 339-2235 | |
| September 12, 2003 | |
| Names of Device: |
COOK CODA™ BALLOON CATHETER Trade Name: Common/Usual Name: Balloon catheter Classification Name: Percutaneous catheter
Intended Use:
The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Predicate Devices:
Predicate devices are the LDOB BALLOON CATHETER (K002286) manufactured by Cook Incorporated (vessel occlusion), and the ILIAC BALLOON CATHETER (K003495) manufactured by Guidant Corporation (prosthesis expansion).
Device Description:
The COOK CODA™ BALLOON CATHETER is a 2-lumen catheter. The distal lumen extends the length of the catheter for use over a ,035 wire quide. The other lumen communicates with the balloon and is used to expand and deflate it. Radiopaque bands are placed at both the distal and proximal aspects of the balloon to assist with positioning of the device under fluoroscopy. The balloon will be provided in diameters ranging from 30 to 40 mm, and in lengths ranging from 100 to 120 cm. The device is packaged in sterile, sealed double pouches.
Substantial Equivalence:
The COOK CODA™ BALLOON CATHETER is comparable with respect to technical characteristics and intended use to predicate devices in terms of 510(k) substantial equivalence.
Discussion of Tests and Test Results:
The COOK CODA™ BALLOON CATHETER underwent testing to assess biocompatibility, mechanical properties, performance characteristics, and safety, The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
Conclusions Drawn from Tests:
The COOK CODA™ BALLOON CATHETER met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, black line drawing.
NOV 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Theodore Heise Director of Regulatory Scientific Affairs c/o Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489
Re: K032869 CODA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 12, 2003 Received: September 15, 2003
Dear Dr. Heise:
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.
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.
2
Page 2 – Dr. Theodore Heise
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 yours.
Arlile B. Boam
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known) __ K03 2869
COOK CODA BALLOON CATHETER
Indications for Use:
Device Name:
The COOK CODA BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
ll
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashley B. Boane
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K032869
Image /page/3/Picture/10 description: The image shows the text "Prescription Use" followed by the text "(Per 21 CFR 801.109)". There is a check mark above the line after the word "Use". The text is black and the background is white.