(276 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI or ML.
No.
The device is used for temporary occlusion or expansion of vessels/prostheses, which is an interventional procedure, not a therapeutic treatment.
No
The "Intended Use / Indications for Use" states the device is "Intended for temporary occlusion of large vessels, or to expand vascular prostheses," which describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines a physical catheter with lumens and a balloon, indicating it is a hardware device, not software-only.
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 (in vivo) for therapeutic or procedural purposes.
- Device Description: The description details a physical catheter with a balloon designed for mechanical action within blood vessels.
- 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 outside the body to analyze samples and provide diagnostic information. This device is clearly intended for use inside the body for a procedural purpose.
N/A
Intended Use / Indications for Use
Intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Product codes
DQY
Device Description
The Coda Balloon Catheter is a 10.0 French device measuring 120 or 140 cm in usable length. The Coda Balloon Catheter shaft contains two independent lumens. The distal lumen extends the length of the catheter and is used for placement over a 0.035 inch diameter wire guide. The balloon (inflation and deflation) lumen extends from the proximal hub to the inflation ports within the balloon. The maximum inflation diameter is 46 mm, with a corresponding maximum balloon inflation volume of 60 mL. The device will be supplied sterile, intended for one-time use.
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 Coda Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Balloon Minimum Burst Strength and Compliance Testing demonstrates the minimum rated burst volume of the test article, calculated for 99% coverage and 95% confidence, is greater than the 60 mL inflation volume corresponding to a 46 mm balloon diameter. The predetermined acceptance criteria were met.
- Occlusion and Migration Testing demonstrates, at the 95% confidence level and with 90% minimum coverage, the ability to occlude a mock vessel when pressurized without any evidence of liquid leakage or migration. The predetermined acceptance criteria were met.
- Balloon Fatigue Testing shows that balloons are free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation (20 unconstrained/20 constrained). The predetermined acceptance criteria were met.
- Inflation/Deflation Time Testing statistically demonstrates that 90% of the overall population from which test articles were sampled have an inflation and deflation time (independently evaluated) below 30 seconds with a 95% confidence level. The predetermined acceptance criteria were met.
- Simulated Use Simulated use testing in a vascular prosthesis and anatomical model shows both devices are compatible with the recommended sheath and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met.
- Catheter Usable Length Testing verifies usable catheter length to the specified length ± 2 cm. The predetermined acceptance criterion was met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.
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).
0
Special 510(K) Premarket Notification Coda Balloon Catheter Cook Incorporated November 27, 2012
510(k) Summary
Submitted By:
Submitted By:
Elysia Easton Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812-339-2235
Device:
Trade Name: Common/Usual Name: Proposed Classification:
Coda Balloon Catheter Occlusion Balloon Catheter Catheter, Percutaneous (74 DQY)
Indications for Use:
Intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Predicate Devices:
Coda Balloon Catheter cleared under the following 510(k) Premarket Notification:
- K032869, November 19, 2003 .
Device Description:
The Coda Balloon Catheter is a 10.0 French device measuring 120 or 140 cm in usable length. The Coda Balloon Catheter shaft contains two independent lumens. The distal lumen extends the length of the catheter and is used for placement over a 0.035 inch diameter wire guide. The balloon (inflation and deflation) lumen extends from the proximal hub to the inflation ports within the balloon. The maximum inflation diameter is 46 mm, with a corresponding maximum balloon inflation volume of 60 mL. The device will be supplied sterile, intended for one-time use.
Substantial Equivalence:
The identical indications for use and technological characteristics of the Coda Balloon Catheter as compared to the predicate device support a determination of substantial equivalence.
Comparison to Predicate Device:
The Coda Balloon Catheter has been modified from the predicate Coda Balloon Catheter to include a balloon diameter of 46 mm and an additional catheter length of 140 cm. It has been demonstrated that the Coda Balloon Catheter is comparable to the predicate device in terms of design, intended use, materials, fundamental technology, and principle of operation.
K 122917
JUN 2 8 2013
1
Special 510(K) Premarket Notification Coda Balloon Catheter Cook Incorporated November 27, 2012
Test Data:
The Coda Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Balloon Minimum Burst Strength and Compliance Testing demonstrates the 1. minimum rated burst volume of the test article, calculated for 99% coverage and 95% confidence, is greater than the 60 mL inflation volume corresponding to a 46 mm balloon diameter. The predetermined acceptance criteria were met.
- Occlusion and Migration Testing demonstrates, at the 95% confidence level and 2. with 90% minimum coverage, the ability to occlude a mock vessel when pressurized without any evidence of liquid leakage or migration. The predetermined acceptance criteria were met.
- Balloon Fatigue Testing shows that balloons are free from leakage and damage on 3. inflation, withstanding 40 cycles of inflation/deflation (20 unconstrained/20 constrained). The predetermined acceptance criteria were met.
- Inflation/Deflation Time Testing statistically demonstrates that 90% of the overall 4. population from which test articles were sampled have an inflation and deflation time (independently evaluated) below 30 seconds with a 95% confidence level. The predetermined acceptance criteria were met.
- Simulated Use Simulated use testing in a vascular prosthesis and anatomical model న. shows both devices are compatible with the recommended sheath and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met.
- Catheter Usable Length Testing verifies usable catheter length to the specified 6. length ± 2 cm. The predetermined acceptance criterion was met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2013
Cook Incorporated C/O Elysia Easton Regulatory Affair Specialist 750 Daniels Way Bloomington, IN 47404
Re: K122917
Trade/Device Name: Coda® Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: May 30, 2013 Received: May 31, 2013
Dear Ms Easton:
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.
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
3
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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 vours.
Maik Jellon
for
Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation. Center for Devices and Radiological Health
Enclosure
4
Special 510(K) Premarket Notification Coda Balloon Catheter Cook Incorporated September 21, 2012
K122917 510(k) Number (if known):
Device Name: Coda Balloon Catheter
Indications for Use:
Intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 807 Subpart C)
1 .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)