(188 days)
Not Found
No
The description mentions a "microcomputer-based control console" and "demand responsive" flow, but these features are described in terms of automatic responses to physical parameters (resistance, fluid return) and do not explicitly indicate the use of AI or ML algorithms for learning or complex pattern recognition. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
Yes
The device is indicated for pumping blood through an extracorporeal bypass circuit for circulatory support, which is a therapeutic intervention.
No
The device description indicates it is a pump for moving blood, and the intended use states it is for pumping blood through an extracorporeal bypass circuit. This describes a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical blood pump with mechanical components (impeller, drive cable, magnetic coupling) and mentions separate hardware components (motor, ultrasonic flow sensor, control console). This is not a software-only device.
Based on the provided information, the A-Med Large Centrifugal Blood Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- A-Med Large Centrifugal Blood Pump Function: The description clearly states that this device is a pump used to circulate blood through the extracorporeal bypass circuit during surgical procedures like cardiopulmonary bypass. It is directly interacting with blood outside the body to support circulation, not to analyze or test it for diagnostic purposes.
- Intended Use: The intended use is for "pumping blood through the extracorporeal bypass circuit" and "extracorporeal circulatory support." This is a therapeutic and supportive function, not a diagnostic one.
Therefore, the A-Med Large Centrifugal Blood Pump falls under the category of a medical device used for circulatory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The A-Med Large Centrifugal Blood Pump is indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
Product codes
KFM
Device Description
The A-Med Large 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.
A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K020529 p.113. "
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
AUG 2 6 2002
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)
A-Med Systems, Inc 2491 Boatman Avenue West Sacramento, CA 95691-3817 (916) 375-7400 ext. 5316 Contact person: Cynthia G. Royster Date prepared: 13 February 2002
21 CFR §807.92 a (2)
| Trade name: | A-Med Large Centrifugal Blood Pump |
|---|---|
| ------------- | ------------------------------------ |
| Common name: | Centrifugal Pump |
|---|---|
| Classification name: | "Non-roller type Cardiopulmonary Bypass Blood |
| Pumps"870.4360 |
21 CFR §807.92 a (3)
Identification of predicate(s): Substantial equivalence for the A-Med Large Centrifugal Blood Pump is based on its similarities to the predicate devices, A-Med Miniature Centrifugal Blood Pump System (K992592) and Medtronic Bio-Medicus Centrifugal Blood Pump (K973011). The line extension A-Med Large Centrifugal Blood Pump is substantially equivalent to the predicates in intended use, material, design, performance and physical characteristics. The line extension included a larger motor to the existing larger housing to enable it to produce more pressure.
21 CFR §807.92 a (4)
Device Description-parts and function/concept: The A-Med Large 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
1
K020529 p.2-13
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.
A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
21 CFR 8807.92 a (5)
Intended use and relationship to predicate(s): The A-Med Large Centrifugal Blood Pump is indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
CFR 8807.92 a (6)
Technological characteristics and relationship to predicate(s): The A-Med Large Centrifugal Blood Pump is identical in design, material, intended use and technological characteristics to the predicate devices. The difference is size and pressure only.
21 CFR §807.92 b
This substantial equivalence is based on similarities to the predicate devices in terms of intended uses and technological characteristics.
21 CFR §807.92 c
In accordance with the specifications of this subsection, this summary (two pages) is its own section, and has been clearly identified as such.
2
K020529 p 3 /3
Literature (cited)
-
- Driessen JJ. Dhaese H. Fransen G. Verrelst P. Rondelez L. Gevaert L. van Becelaere M, Schelstraete E. "Pulsatile Compared with Nonpulsatile Perfusion Using a Centrifugal pump for Cardiopulmonary Bypass during Coronary Artery Bypass Grafting. Effect on Systemic Haemodynamics. Oxygenation, and Inflammatory Response Parameters", Perfusion 10 No. 1: 3-12 1995.
-
- Glauber M, Szefner J, Senni M, Gamba A, Mamprin F, Fiocchi R, Somachini M, Ferrazzi P. "Reduction of Haemorrhagic Complications during Mechanically Assisted Circulation with the Use of a Multi-System Anticoagulation Protocol", Artificial Organs Vol. 18 No. 10: 649-55 Oct. 1995.
-
- Noon GP, Lafuente JA, Irwin S. " Acute and Temporary Ventricular Support with Bio-Medicus Centrifugal Pump", Ann Thorac Surg. Vol 68 2: 650-4.68 Aug 1999.
-
- Ricardo Grossi Dantas, Eduardo Tavares Costa. "Ultrasonic Pulsed Doppler Blood Flowmeter for Use in Extracorporeal Circulation," Artificial Organs Vol. 24 No.3: 198-201 March 2000.
-
- Takami Y, Makinoushi K, Nakazawa T, Benkowski R, Glueck J, Ohara Y, Nose Y . "Hemolytic characteristics of a Pivot Bearing Supported Gyro Centrifugal Pump (C1E3) Simulating Various Clinical Applications", Artif Organs Vol. 20 No.9: 1042-9 Sept. 1996.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
AUG 26 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A-Med Systems, Inc. Ms. Cynthia G. Royster Director, Regulatory Affairs 2491 Boatman Avenue West Sacramento, CA 95691-3817
Re: K020529
Trade/Device Name: A-Med Large Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump. Regulatory Class: Class III Product Code: KFM Dated: June 3, 2002 Received: June 21, 2002
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
4
Page 2 - Ms. Cynthia G. Royster
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Elia Mallis
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication Statement
Page
510(k) Number (if known): N/A K 020529
Device Name: A-Med Large Centrifugal Blood Pump
Indications for Use
The A-Med Large Centrifugal Blood Pump is indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
(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-
Elias Mollis
Sign-Off
Fratory Device
imber.
10(; .
CONFIDENTIAL
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