(29 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.
Yes
The device is intended for "temporary occlusion of large vessels" or to "expand vascular prostheses," which are direct interventions aimed at treating a patient's condition.
No
Explanation: The device is intended for temporary occlusion of large vessels or to expand vascular prostheses, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly details a physical balloon catheter with lumens, a balloon, and a wire guide, 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 the "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 designed for use inside the body for a procedural purpose.
N/A
Intended Use / Indications for Use
The Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.
Product codes
DOY
Device Description
The Coda LP Balloon Catheters are over-the-wire catheters that are available with an inflated balloon diameter of 32 millimeters and a balloon volume of 30 cc. The catheters are 9.0 French and are available in lengths of 100 or 120 centimeters. The Coda LP Balloon Catheter shaft contains two independent lumens within a single extrusion. 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 two inflation media exit ports within the balloon. The catheters are supplied sterile and are intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large 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 following tests were performed to demonstrate that the Coda LP Balloon Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- . Balloon Burst Testing - Testing showed that the balloons burst above the maximum rated volume, with all failures being non-fragmentary. The acceptance criteria were met.
- . Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. The acceptance criteria were met.
- . Simulated Use Testing - Testing showed that the catheters were capable of being inserted into and retracted from an appropriately sized sheath without experiencing excessive resistance. Testing showed that this device was able to expand an endovascular graft by inflating the balloon. The acceptance criteria were met.
- Fatigue Testing – Testing showed that the balloons were free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation. The acceptance criterion was met.
- . Occlusion and Migration Testing – Testing showed that this device was able to occlude fluid flow without migrating. The acceptance criteria were met.
- . Tensile Strength Testing – Testing showed that under proper clinical use of the device, the peak load values were in accordance with the acceptance criteria.
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like figure with three heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2015
Cook Incorporated Chad Schulenburg Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47404
Re: K150970
Trade/Device Name: Coda LP Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 10, 2015 Received: April 13, 2015
Dear Chad Schulenburg:
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 device
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150970
Device Name Coda® LP Balloon Catheter
Indications for Use (Describe)
The Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background.
510(k) SUMMARY
Submitted By: Chad Schulenburg, MA Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 Phone: (812) 335-3575 x104073 Fax: (812) 332-0281 Date Prepared: May 12, 2015
Device:
| Trade Name: | Coda® LP Balloon Catheter |
|---|---|
| Common Name: | Occlusion Balloon Catheter |
| Classification Name: | Catheter, Percutaneous |
| DOY (21 CFR §870.1250) |
Indications for Use:
The Coda® Low Profile Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.
Predicate Devices:
The device subject of this submission is substantially equivalent to the predicate devices, cleared for market under 510(k) numbers K032869 on November 19, 2003 and K122917 on June 28, 2013.
Comparison to Predicate Devices:
It has been demonstrated that the Coda LP Balloon Catheters are comparable to the predicate devices. The Coda LP Balloon Catheters are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate devices. The device changes consist of a balloon with a smaller diameter and volume, and a smaller catheter French size. The Coda LP Balloon Catheters are also used through a smaller introducer sheath. The safety and effectiveness of the modifications are supported by testing.
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The logo is simple and clean, and the red and white color scheme is eye-catching.
Device Description:
The Coda LP Balloon Catheters are over-the-wire catheters that are available with an inflated balloon diameter of 32 millimeters and a balloon volume of 30 cc. The catheters are 9.0 French and are available in lengths of 100 or 120 centimeters. The Coda LP Balloon Catheter shaft contains two independent lumens within a single extrusion. 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 two inflation media exit ports within the balloon. The catheters are supplied sterile and are intended for one-time use.
Test Data:
The following tests were performed to demonstrate that the Coda LP Balloon Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- . Balloon Burst Testing - Testing showed that the balloons burst above the maximum rated volume, with all failures being non-fragmentary. The acceptance criteria were met.
- . Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. The acceptance criteria were met.
- . Simulated Use Testing - Testing showed that the catheters were capable of being inserted into and retracted from an appropriately sized sheath without experiencing excessive resistance. Testing showed that this device was able to expand an endovascular graft by inflating the balloon. The acceptance criteria were met.
- Fatigue Testing – Testing showed that the balloons were free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation. The acceptance criterion was met.
- . Occlusion and Migration Testing – Testing showed that this device was able to occlude fluid flow without migrating. The acceptance criteria were met.
- . Tensile Strength Testing – Testing showed that under proper clinical use of the device, the peak load values were in accordance with the acceptance criteria.
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The logo is simple and clean, and the red and white colors are eye-catching.
cook incorporated 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Conclusion:
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices.