(67 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of the catheter and balloons, with no mention of AI or ML for control, analysis, or any other function.
Yes
The device is intended for selectively stopping or controlling blood flow, which can be considered a therapeutic intervention to manage blood flow in the peripheral vasculature.
No
The device is described as a catheter intended for controlling blood flow, which is a therapeutic function, not a diagnostic one. It does not mention any capabilities for detecting, characterizing, or monitoring diseases or conditions.
No
The device description clearly details a physical catheter with balloons, lumens, and a manifold, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The CoAxia FloControl™ Catheter is a physical device inserted into the body (specifically the peripheral vasculature and descending aorta) to mechanically control blood flow. It does not analyze any biological samples.
The description clearly indicates a device used in vivo (within the living body) for a therapeutic or interventional purpose, not for diagnostic testing of samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature which includes the descending aorta.
Product codes (comma separated list FDA assigned to the subject device)
MIN
Device Description
The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 7F vascular introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8 cm. Each balloon can be inflated independently to a variable diameter to control blood flow in the selected vessel. When used in the descending aorta, balloon inflation results in diversion of cardiac output to the upper torso and core organs, e.g., cardiac, spinal and cerebral vasculature. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, descending aorta
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 CoAxia FloControl™ Catheter was tested in accordance with relevant ISO and EN standards and FDA's Guidance for Use of Short-term and Long-term Use Intravascular Catheters. Testing included tensile strength, balloon characterization, dimensional verification, accessory compatibility, trackability, coating integrity, pressure monitoring capability, shelf life and biocompatibility. All testing demonstrated acceptable performance in accordance with the device specifications. Clinical testing of the FloControl catheter was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CoAxia FloControlTM Catheter (K023914)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
CoAxia FloControl Catheter K09xxxxx
K090970 page ( ot 2 CONFIDENTIAL SPECIAL 510(k)
JUN 1 2 2009
510(k) Summary
Sponsor
Name & Address:
CoAxia, Inc. 10900 73rd Avenue N. Suite 102 Maple Grove, MN 55369 Office: 763-315-8383 Cell: 612-309-4836 FAX: 763-315-3660
Contact:
Sharon Kvistad Vice President - Regulatory Affairs
Date Prepared:
April 3, 2009
Name and Classification
| Trade Name: | CoAxia FloControlTM Catheter |
|---|---|
| Common Name: | Peripheral Vascular Occlusion Balloon |
| Predicate Device(s): | CoAxia FloControlTM Catheter (K023914) |
Classification Name: Device Classification: Product Code:
Catheter, Intravascular Occluding, Temporary Class II MIN
Intended Use:
The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature which includes the descending aorta.
Device Description
The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 7F vascular introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8 cm. Each balloon can be inflated independently to a variable diameter to control blood flow in the selected vessel. When used in the descending aorta, balloon inflation results in diversion of cardiac output to the upper torso and core organs, e.g., cardiac, spinal and cerebral vasculature. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.
1
CoAxia FloControl Catheter K09xxxxx
K090970 page 2 of 2
CONFIDENTIAL
SPECIAL 510(k)
Summary of Studies
The CoAxia FloControl™ Catheter was tested in accordance with relevant ISO and EN standards and FDA's Guidance for Use of Short-term and Long-term Use Intravascular Catheters. Testing included tensile strength, balloon characterization, dimensional verification, accessory compatibility, trackability, coating integrity, pressure monitoring capability, shelf life and biocompatibility. All testing demonstrated acceptable performance in accordance with the device specifications. Clinical testing of the FloControl catheter was not performed.
Equivalence Statement:
The testing performed demonstrates the CoAxia FloControl Catheter is substantially equivalent to the predicate device in terms of the intended use, design, materials, and performance attributes, and raises no new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2009
CoAxia, Inc. c/o Ms. Sharon D. Kvistad VP Regulatory Affairs 10900 73td Avenue North, Suite 102 Maple Grove, MN 55369
Re: K090970
Trade/Device Name: FloControl Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN Dated: April 3, 2009 Received: April 6, 2009
Dear Ms. Kvistad:
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. Iisting 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 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. Sharon D. Kvistad
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours.
R. Vochner
Image /page/3/Picture/6 description: The image contains a close-up of a handwritten symbol or character. It features a small, closed loop at the bottom, resembling the number '6' or a lowercase 'q'. A curved line extends upwards and to the right from the loop, creating a flowing, calligraphic appearance. The symbol is drawn with a dark, bold line, suggesting it was created with a pen or marker.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
4
CoAxia FloControl Catheter K09xxxxx
CONFIDENTIAL SPECIAL 510(k)
Indications for Use
510(k) Number (if known): KO 90970
Device Name: CoAxia FloControl™ Catheter
The CoAxia FloControl™ Catheter is intended for Indications For Use: use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta.
Prescription Use X (Part 21 CFR 801 Subpa
AND/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)
buna R. James
Page 1 of __
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K090970
. .