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.

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 ●

AI/ML Overview

The provided 510(k) premarket submission for the A-Med Systems, Inc. Vascular Cannula (K991541) does not contain acceptance criteria or study details in the requested format for AI/software-as-a-medical-device (SaMD) products.

This submission is for a physical medical device (a vascular cannula) and follows the regulatory pathway for such devices, primarily relying on non-clinical performance testing and substantial equivalence to a predicate device.

Therefore, many of the requested fields are not applicable to this submission. I will address the applicable parts based on the provided text, and explicitly state when a requested piece of information is not available or not relevant to this type of device submission.

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Substantial equivalence to predicate device (Baxter/RMI FEM FLEX II Cannula K891576, K974259)	Achieved; "The performance of this device is substantially equivalent to the predicate device and performs as intended."
Compliance with A-Med Systems, Inc. performance specifications	Achieved; "performance characteristics of this device were tested and compared with A-Med Systems, Inc. performance specifications."
No clinical testing required for intended use	Not applicable; "Clinical testing was not performed on this device."

2. Sample size used for the test set and the data provenance

Not Applicable in the context of SaMD. For this physical device, the "test set" refers to the specific cannulas and materials used in the non-clinical performance tests (e.g., mechanical strength, flow rates, material compatibility). The document does not specify the number of units tested.
Data Provenance: The tests were conducted internally by A-Med Systems, Inc. (implied by "A-Med Systems, Inc. performance specifications"). The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's address. The data is "prospective" in the sense that the tests were performed specifically for this submission, not a retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a physical device like a vascular cannula, "ground truth" in the SaMD sense (e.g., expert consensus on image interpretation) is not established. Performance is measured directly (e.g., flow rates, material properties, mechanical integrity) against specifications validated by engineering and regulatory standards. The expertise involved would be in engineering, material science, and quality assurance, rather than clinical interpretation.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in studies involving subjective assessments (e.g., radiology reads). This is not relevant for the non-clinical performance testing of a physical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a physical medical device, not an AI/software device designed to assist human readers. Therefore, an MRMC study is not relevant or applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the SaMD context is not applicable.

7. The type of ground truth used

Engineering Specifications and Predicate Device Performance: The "ground truth" for this device's performance is established by:
- Comparison to the performance characteristics of the legally marketed predicate device (Baxter/RMI FEM FLEX II Cannula).
- Adherence to internal A-Med Systems, Inc. performance specifications, which would be derived from engineering requirements, material standards, and clinical needs for such a device.
- This is not "expert consensus," "pathology," or "outcomes data" in the typical SaMD sense.

8. The sample size for the training set

Not Applicable. This is a physical device, not a machine learning algorithm. There is no concept of a "training set" for manufacturing and testing a vascular cannula for regulatory submission in this context.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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510(k) Premarket Submission-A-Med Systems, Inc. Vascular Cannula

K991541/

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 AvenueSacramento, California, 95691
Contact Person:	Roberta L. ThompsonVice 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:

. 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 ●

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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.

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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

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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:

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)

Over-The-Counter Use Optional Format 1-

Regulation Number and Section

§ 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).