(88 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is intended to selectively stop or control blood flow, which is a direct therapeutic action on the patient's physiology.
No
The device is intended for "selectively stopping or controlling blood flow in the peripheral vasculature," which describes a therapeutic or interventional function, not a diagnostic one. While it mentions "pressure monitoring capability," this is a feature to aid in its therapeutic function rather than a primary diagnostic purpose.
No
The device description clearly outlines a physical catheter with balloons, a multi-port manifold, and other hardware components. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The CoAxia FloControl™ Catheter is a device designed to be inserted into the peripheral vasculature (blood vessels) to physically control blood flow using balloons. This is an in vivo procedure (performed inside the body).
The description clearly indicates a device used for a therapeutic or interventional procedure within the body, not for analyzing samples outside the 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.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The CoAxia FloControl™ Catheter is a 9F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 9F introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic, heparin 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 8cm. Each balloon can be inflated independently to a diameter from 10mm to 20mm to control blood flow in the selected vessel. 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
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 ISO, EN 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.
K990487, K974175, K991320, K012512
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
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FEB 2 1 2003
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510(k) Summary
Sponsor
| Name & Address: | CoAxia, Inc.
10900 73rd Avenue N. Suite 102
Maple Grove, MN 55369
Telephone: 763-315-8383
FAX: 763-315-3660 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Gregory W. Sachs
Vice President - Clinical, Regulatory and Quality Assurance |
| Date Prepared: | November 21, 2002 |
Name and Classification
| Trade Name: | CoAxia FloControl™ Catheter |
|---|---|
| Common Name: | Peripheral Vascular Occlusion Balloon |
| Predicate Device(s): | Equinox™ Occlusion Balloon System (K990487) |
| Heartport® Endoaortic Clamp™ Catheter (K974175) | |
| MedComp® DUO-COAT Catheter Double Lumen (K991320) | |
| SetPoint® Endovascular Temperature Management System (K012512) |
Device Description
The CoAxia FloControl™ Catheter is a 9F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 9F introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic, heparin 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 8cm. Each balloon can be inflated independently to a diameter from 10mm to 20mm to control blood flow in the selected vessel. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.
Intended Use
The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.
Summary of Studies
The CoAxia FloControl™ Catheter was tested in accordance with ISO, EN 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings, and a human profile facing right within the body of the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
CoAxia, Inc. c/o Mr. Gregory W. Sachs Vice President - Clinical, Regulatory and Quality Assurance 10900 73rd Avenue N., Suite 102 Maple Grove, MN 55369
Re: K023914 Trade Name: CoAxia FloControl™ Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (two) Product Code: MJN Dated: November 22, 2002 Received: November 25, 2002
Dear Mr. Sachs:
· 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.
2
Page 2 -- Mr. Gregory W. Sachs
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 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 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
CoAxia, Inc.
KØ23914
Confidential
Indications for Use
| 510(k) Number: | To be assigned |
|---|---|
| Device Name: | CoAxia FloControl™ Catheter |
| Indications for Use: | The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K23914
ORIC
November 22, 2002