(65 days)
Not Found
Not Found
No
The summary describes a physical medical device (catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as being used for temporary occlusion, introduction of devices, or infusion of contrast/drug, which are diagnostic or procedural assistance functions rather than directly treating a disease or condition.
No
The device is described as an "Occlusion Balloon Catheter" intended for temporary occlusion, infusion, or introduction of devices. Its function is interventional or for delivery, not for diagnosing a condition.
No
The device is described as an "Occlusion Balloon Catheter," which is a physical medical device and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for procedures involving the coronary sinus and venous system. This includes temporary occlusion, infusion, and device introduction.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVDs, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information based on the analysis of these samples.
- Reagents, calibrators, or controls used for testing.
The device described is a catheter used for interventional procedures within the cardiovascular system, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.
Product codes
DYG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2008
Oscor, Inc. Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 De Soto Boulevard Palm Harbor, Florida 34683
Re: K081052
Trade/Device Name: Occlusion Balloon Catheter, Model Venos™ Regulation Number: 21 CFR 870.1240 Regulation Name: Catheter, Flow-directed Regulatory Class: Class II Product Code: DYG Dated: April 10, 2008 Received: April 14, 2008
Dear Ms. Doskocil:
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
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Page 2 -- Ms. Mila Doskocil
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 cquivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vo
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Ms. Mila Doskocil
Indications for Use
510(k) Number (if known): K081052
Device Name:
Occlusion Balloon Catheter, Model Venos™M
The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of Cardiovascular Devices
K081052 510(k) Number_