The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

Device Description

The A-Med Heparin Coated Miniature Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "A-Med Heparin Coated Miniature Centrifugal Pump System." It describes the device, its intended use, and its similarities to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to the addition of a heparin coating. It does not include specific performance metrics, acceptance criteria, or their corresponding test results for the heparin-coated device.

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

This information is not present in the provided text. No specific test sets or study data are detailed.

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

This information is not present in the provided text. Since no specific test set or study is described, there's no mention of experts establishing ground truth.

4. Adjudication method for the test set

This information is not present in the provided text.

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

A MRMC study is not applicable to this device. This device is a centrifugal blood pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This information is not applicable to this device. This is a medical device (centrifugal pump), not an algorithm.

7. The type of ground truth used

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text.

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

This information is not present in the provided text.

Summary of available information from the document:

Device: A-Med Heparin Coated Miniature Centrifugal Pump System
Predicate Device: A-Med Miniature Centrifugal Blood Pump System (K992592)
Key Change: Addition of a photoactivated hydrogel surface modification (heparin coating).
Basis for Equivalence: Similarities to the predicate device in intended use, material, design, performance, and physical characteristics. The heparin coating is the only change and is stated not to impact the currently cleared indication.
Intended Use: Extracorporeal circulatory support systems (up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc.). For use only with the A-Med Blood Pump Controller.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence through a comparison of the modified device (with heparin coating) to an existing predicate device. It explicitly states that the modification (heparin coating) is the only change to the existing device and that it does not impact the currently cleared indication. This type of submission typically relies on showing that the new modification does not negatively alter the fundamental safety and effectiveness demonstrated by the predicate device, often without presenting new, extensive clinical or performance studies with detailed acceptance criteria in the summary itself. The detailed performance data, acceptance criteria, and specific study results that would typically answer your questions are not included in this high-level regulatory summary.

Summary

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NOV 0 9 2001

510(k) SUMMARY OF SAFET EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

21 CFR §807.92 a (1)

Submitter:
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A-Med Systems, Inc 2491 Boatman Avenue West Sacramento, CA 95691-3817 (916) 375-7400 ext. 5316 Contact person: Cynthia G. Royster Date prepared: 11 October 2001

21 CFR §807.92 a (2)

Trade name:	A-Med Heparin Coated Miniature CentrifugalPump System
Common name:	Centrifugal Pump

Common name:	Centrifugal Pump
Classification name:	"Non-roller type Cardiopulmonary Bypass Blood
Pumps"870.4360

21 CFR 8807.92 a (3)

Identification of predicate(s): Substantial equivalence for the A-Med Heparin Coated Miniature Centrifugal Pump is based on its similarities to the predicate devices, A-Med Miniature Centrifugal Blood Pump System (K992592). The modified A-Med Heparin Coated Centrifugal Blood Pump is substantially equivalent to the uncoated A-Med Miniature Centrifugal Blood Pump System in intended use, material, design, performance and physical characteristics. The modification adding heparin coating is the only change to the existing device.

21 CFR $807.92 a (4)

Device Description-parts and function/concept: The A-Med Heparin Coated Miniature Centrifugal Blood Pump is a sterile, disposable, non-pulsatile,

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non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump.

The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device.

A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.

21 CFR §807.92 a (5)

Intended use and relationship to predicate(s): The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller. The addition of the heparin coating does not impact the currently cleared indication for the existing device.

CFR §807.92 a (6)

Technological characteristics and relationship to predicate(s): The A-Med Heparin Coated Miniature Centrifugal Pump is identical in design, material, intended use and technological characteristics to the uncoated predicate device. The difference between the two devices is the heparin coating only.

21 CFR 8807.92 b

This substantial equivalence is based on similarities to the predicate device in terms of intended uses and technological characteristics.

21 CFR 8807.92 c

In accordance with the specifications of this subsection, this summary (two pages) is its own section, and has been clearly identified as such.

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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is easy to read.

NOV 0 9 2001

Ms. Cynthia G. Royster Director, Regulatory Affairs A-Med Systems, Inc. 2491 Boatman Avenye West Sacramento, CA 95691-3817

Re: K013393

Trade Name: A-Med Heparin Coated Minature Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: II Product Code: KFM Dated: October 11, 2001 Received: October 15, 2001

Dear Ms. Royster:

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.

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

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Page 2 - Ms. Cynthia G. Royster

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) I ins letter will anow you to begin mailering of substantial equivalence of your device to a legally prematication: The PDF misms of casion 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 IT you desire specific arrice for your avitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1500. The of Compliance at (301) 594-4639. Also, please note the your device, pitted, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entined, "Mischanges of esponsibilities under the Act may be obtained from the Outer general information on your respectional 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,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication Statement

K013393

NOV 0 9 2001

of Page

510(k) Number (if known): N/A

Device Name: A-Med Heparin Coated Miniature Centrifugal Blood Pump

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

Optional Format 1-

W. Jobe

Division for Cardiovascular & Respiratory Devices
510(k) Number K01393

CONFIDENTIAL

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.