(31 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML algorithms for data analysis, image processing, or decision support.
Yes
The device is described as intended for temporary occlusion of large vessels, which directly addresses a physiological condition (occlusion) in the body. Furthermore, the performance studies include "Occlusion Testing" and "Biocompatibility Testing," which are typical for medical devices that interact with the body for therapeutic purposes.
No
The device is described as an "Occlusion Balloon Catheter" intended for "temporary occlusion of large vessels." Its description focuses on its mechanical features, such as lumens for inflation, infusion of contrast, and placement over wire guides, and its physical properties like balloon diameter and radiopaque markers, all pointing to a therapeutic or interventional function rather than a diagnostic one. The performance studies also focus on mechanical and material integrity rather than diagnostic accuracy.
No
The device description clearly describes a physical catheter with lumens, a balloon, and radiopaque markers, indicating it is a hardware device. The performance studies also focus on physical properties and performance of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary occlusion of large vessels." This is a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with lumens and a balloon designed for insertion into blood vessels.
- Function: The device's function is to physically block a vessel, not to analyze a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.
Product codes
DQY
Device Description
The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large vessels. The "Infusion" lumen is used to infuse contrast material through the catheter. The "Distal .035" lumen extends the length of the catheter and is used for placement over wire guides. The "Balloon" lumen is used to inflate and deflate the balloon.
The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.
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
The proposed Occlusion Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- Burst Pressure Testing
- Bond Strength Testing
- Tensile Testing
- Fatigue Testing
- Sheath Compatibility Testing
- Inflation/Deflation Time
- Occlusion Testing
- Accelerated Aged Testing
- Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use.
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
K101877 page 1 of 2
AUG 0 6 2010
Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010
510(k) SUMMARY
Submitted By:
Lisa Webb, MBA, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404
Device:
Trade Name: Proposed Classification:
Occlusion Balloon Catheter Catheter, Percutaneous DQY (21 CFR §870.1250)
Indications for Use:
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.
Predicate Device:
The Occlusion Balloon Catheter is similar in terms of intended use, method of operation, materials of construction, and technological characteristics to the predicate device which was cleared as the CODA Balloon Catheter (K032869).
Device Description:
_ '
The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large vessels. The "Infusion" lumen is used to infuse contrast material through the catheter. The "Distal .035" lumen extends the length of the catheter and is used for placement over wire guides. The "Balloon" lumen is used to inflate and deflate the balloon.
The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.
Substantial Equivalence:
Cook Incorporated currently markets the predicate CODA Balloon Catheter, which was Cook moorporated Carrences 19, 2003 (K032869). The similar indications for use, enethod of operation, and technological characteristics of the Occlusion Balloon Catheter as compared to the predicate device support a determination of substantial equivalence.
1
K101877 page. 2 of 2
Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010
Test Data:
The proposed Occlusion Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- Burst Pressure Testing
- 트 Bond Strength Testing
- 트 Tensile Testing
- Fatigue Testing 트
- 트 Sheath Compatibility Testing
- Inflation/Deflation Time
- 트 Occlusion Testing
- 프 Accelerated Aged Testing
- 트 Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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, bold line drawing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cook, Inc. c/o Ms. Lisa Webb Regulatory Affairs Manager 750 Daniels Way Bloomington, IN 47402
Re: K101877
Trade/Device Name: Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: July 2, 2010 Received: July 6, 2010
Dear Ms. Webb:
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.
3
Page 2 - Ms. Lisa Webb
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.
R. Valner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010
Indications for Use
510(k) Number (if known):
1/10/877
Device Name: Occlusion Balloon Catheter
Indications for Use for the Occlusion Balloon Catheter:
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.
AUG 0 6 2010
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hummer R.S. humel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K101872