(70 days)
Not Found
Not Found
No
The provided 510(k) summary describes a mechanical balloon catheter and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the removal of emboli and thrombi, which are direct medical interventions to treat a condition.
No
The device is described as being for "removal of fresh, soft emboli and thrombi and for intraluminal irrigation of fluids," which are interventional or therapeutic actions, not diagnostic.
No
The device description clearly identifies it as a "PTFE Balloon Catheter," which is a physical medical device, not software.
Based on the provided information, the Atrium ClearWay™ PTFE Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of emboli and thrombi and for intraluminal irrigation. This describes a physical intervention within the body, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Atrium ClearWay™ PTFE Balloon Catheter is a therapeutic device used for a physical procedure.
N/A
Intended Use / Indications for Use
The Atrium ClearWay™ PTFE Balloon Catheter is intended for the removal of fresh, soft emboli and thrombi and for intraluminal irrigation of fluids.
Product codes
DXE, KRA
Device Description
Atrium Clearway™ PTFE Balloon Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 8 2002
Mr. Joseph P. De Paolo Director of Regulatory Affairs/Quality Assurance Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051
Re: K020634
Trade Name: Atrium Clearway™ PTFE Balloon Catheter Regulation Number: 21 CFR 870.5150 and 870.1210 Regulation Name: Embolectomy Catheter and Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: DXE and KRA Dated: April 10, 2002 Received: April 17, 2002
Dear Mr. De Paolo:
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.
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Page 2 - Mr. Joseph P. De Paolo
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 erth 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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Da. Teek
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known) K626634
Device Name:
Atrium ClearWay™ PTFE Balloon Catheter
Indications for Use:
The Atrium ClearWay™ PTFE Balloon Catheter is intended for the removal of fresh, soft emboli and thrombi and for intraluminal irrigation of fluids.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use the text is:
Division of Cardiovascular & Respiratory Devices
510(k) Number K000634