(239 days)
No
The device description and performance studies focus on the physical characteristics and non-clinical performance of a vascular cannula, with no mention of AI or ML capabilities.
No
The device is a vascular cannula used for accessing the circulatory system during extracorporeal circulation, which is a supportive function and not explicitly identified as a therapeutic treatment itself.
No
The device is a cannula intended for accessing the circulatory system for extracorporeal support, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines a physical medical device (cannula) with specific material and structural components, not a software-only product.
Based on the provided information, the A-Med Vascular Cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "accessing the circulatory system during extracorporeal circulation" and "intraoperative access to the arterial or venous system." This describes a device used in vivo (within the body) for a surgical or medical procedure.
- Device Description: The description details a physical cannula designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. The A-Med Vascular Cannula is a tool for accessing the circulatory system, not for analyzing samples from it.
N/A
Intended Use / Indications for Use
The A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system. (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.
Product codes
DWF
Device Description
The A-Med Vascular Cannula is a cannula comprised of a flexible tip, radiopaque stripes, wire reinforced tubing, non-reinforced proximal clamp zone, and a proximal connector. Configurations are available with the following options:
- . Outer diameter: 24 French
- . Effective length: 10, 21 inch
- Number of holes in tip: 8, 16, 32, 44 (dependant on length) ●
- Proximal connector: barb, barb with side luer lock, quick connect ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
circulatory system, arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system. (i.e., femoral vein, right atrium)
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)
Nonclinical Performance:
The performance characteristics of this device were tested and compared with the performance characteristics of the currently marketed predicate device. In addition, performance characteristics of this device were tested and compared with A-Med Systems, Inc. performance specifications.
Clinical Performance:
Clinical testing was not performed on this device.
Conclusions from Nonclinical Tests:
The performance of this device is substantially equivalent to the predicate device and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
510(k) Premarket Submission-A-Med Systems, Inc. Vascular Cannula
PHC 28 1999 510(k) Summary of Safety and Effectiveness
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Application Information:
| Date Prepared: | April 23, 1999 |
|---|---|
| Submitter: | A-Med Systems, Inc. |
| Address: | 2491 Boatman Avenue |
| Sacramento, California, 95691 | |
| Contact Person: | Roberta L. Thompson |
| Vice President, Clinical, Regulatory and Quality | |
| Telephone Number: | (916) 375-7400 (extension 374) |
| Fax Number: | (916) 375-7444 |
Device Information:
| Trade Name: | A-Med Vascular Cannula |
|---|---|
| Common Name: | Vascular cannula |
| Classification Name: | "Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing" |
| (21 CFR 870.4210) |
Predicate Devices:
Claim of Substantial Equivalence of the A-Med Vascular Cannula is made to the Baxter/RMI FEM FLEX II Cannula (K891576, K974259) manufactured by Baxter Healthcare Corporation Baxter Research Medical Inc., 6864 South 300 West, Midvale, UT 84047 USA.
Device Description:
The A-Med Vascular Cannula is a cannula comprised of a flexible tip, radiopaque stripes, wire reinforced tubing, non-reinforced proximal clamp zone, and a proximal connector. Configurations are available with the following options:
- . Outer diameter: 24 French
- . Effective length: 10, 21 inch
- Number of holes in tip: 8, 16, 32, 44 (dependant on length) ●
- Proximal connector: barb, barb with side luer lock, quick connect ●
1
Intended Use:
A-Med Vascular Cannula is intended for use in accessing the circulatory system during extracorporeal circulation.
Technological Characteristics:
This device has technological characteristics identical to the predicate device.
Nonclinical Performance:
The performance characteristics of this device were tested and compared with the performance characteristics of the currently marketed predicate device. In addition, performance characteristics of this device were tested and compared with A-Med Systems, Inc. performance specifications.
Clinical Performance:
Clinical testing was not performed on this device.
Conclusions from Nonclinical Tests:
The performance of this device is substantially equivalent to the predicate device and performs as intended.
2
Image /page/2/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that resemble a person embracing or supporting another person. The logo is presented in black and white.
DEC 2 8 1999
Ms. Roberta L. Thompson Vice President Clinical, Regulatory Affairs and Quality A-Med Systems, Inc. 2491 Boatman Ave West Sacramento, CA 95691
Re: K991541
A-Med Vascular Cannula Modules V24-10-08,V24-10-16 Regulatory Class: II Product Code: DWF Dated: September 23, 1999 Received: September 29, 1999
Dear Ms. Thompson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3
Page 2 - Ms. Roberta L. Thompson
This letter will allow you to continue marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sory, Bose & Campbell
Celia M. Witten, Ph.D., Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K991541
Device Name: A-Med Vascular Cannula, Models V24-10-08, V24-10-16
Indications for Use:
The A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system. (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.
Bule G. Temper Jr.
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices $10(k) Number_k_ 99154
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use U (Per 21 CFR 801.109)
OR
Over-The-Counter Use Optional Format 1-