(276 days)
Not Found
No
The description focuses on mechanical and basic electronic control ("microcomputer-based control console") of a centrifugal pump. There is no mention of AI, ML, or any advanced algorithms for data analysis or decision-making beyond basic "demand responsive" flow control based on resistance and fluid return.
Yes
The device is indicated for use in "extracorporeal circulatory support systems" for procedures like "valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants," which are all medical treatments or interventions, thus making it a therapeutic device.
No
Explanation: The device is a blood pump system for extracorporeal circulatory support, which is a therapeutic function, not a diagnostic one. It pumps blood to support circulation during medical procedures.
No
The device description clearly details multiple hardware components including a pump, motor, flow sensor, and control console. While the control console is microcomputer-based, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "extracorporeal circulatory support systems" during surgical procedures. This involves circulating blood outside the body to support the patient's circulation, not for analyzing samples of blood or other bodily fluids to diagnose or monitor a medical condition.
- Device Description: The description details a mechanical pump system designed to move blood. It describes components like a rotor, bearings, seals, and a control console. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes or biomarkers
The device is a medical device used for therapeutic support during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The A-Med 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 Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
Product codes (comma separated list FDA assigned to the subject device)
KFM, DTQ
Device Description
The A-MED Miniature Centrifugal Pump is a sterile, disposable, non-roller pump which utilizes a rotor to impart energy to the blood through centrifugal forces. The flow of the miniature pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the miniature pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the miniature pump.
The A-MED Miniature Centrifugal Pump System includes a motor, ultrasonic flow sensor and a microcomputer-based control console which are available separately. The Miniature pump consists of inner and outer housings containing a rotor which imparts energy to the pumping fluid through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. The shaft of the rotor is constrained by two sets of bearings that allow it to rotate freely. A lip seal is used just behind the rotor to seal fluid from entering into the bearing area.
A sheath cable assembly connects the pump to the drive motor. The pump end of the cable has a square drive shaft that is bonded and crimped to the cable. This drive shaft fits into a square opening in the end of the rotor. The other end of the cable is connected to a magnet rotor housed in a plastic shell. This end is assembled onto the motor-stator for operation. By assembling the magnet rotor into the end of the cable-sheath assembly, hermitic sealing of the pumping chamber is obtained.
A priming port (valve) is provided on the housing to clear the pump of air before starting circulation. The port is designed to open when a syringe is inserted and seals when the syringe is removed.
The pump is designed to be placed in the sterile field and operated from the A-Med remote motor and microcomputer based blood pump controller, located outside the sterile field. The A-Med Centrifugal Pump System also includes an ultrasonic flow meter, manufactured by Transonics, Inc.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K852807, K973011, K901584, K950739
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
§ 870.4360 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
Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2001 JUL 2
2 2007
2 2001
2 2001
Cynthia G. Royster Director, Regulatory and Clinical Affairs A-Med Systems, Inc. 2491 Boatman Avenue West Sacramento, CA 95691
Re: K992592
Device Name: A-Med System's Miniature Centrifugal Blood Pump System Regulatory Class: III Product Code: KFM and DTQ Dated: April 26, 2000 Received: April 30, 2001
Dear Ms. Royster:
This letter corrects our substantially equivalent letter of May 4, 2000 regarding the product code. Our letter identified the product code as KFM, however it should have also included DTQ as indicated above.
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 (OS) 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 Register. Please note: this response to
1
Page 2 - Cynthia G. Royster
sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
L
へ James E. Dillard III Director -Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number (if known): _K992592
Device Name:_A-Med Miniature Centrifugal Pump System
Indications for Use:
3
The A-Med 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., 1988)
valuloplasty, circulatory support during surgery of the years and valvals as a sport of crecitis ap to six not requiring artificial oxygenation (e.g.,
valvuloplasty, circulatory support during surger of the vena cava or aorta, liver transpl The A-Med Ministry auppert during surgery of the veha cava or aorta, liver transplants, ecc)
The A-Med Miniature Centrifugal Blood Pump is indicated for use only with the A-Pump Controller.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bore L. Xayperich
Sign-Off
Cardiovascular, Rospirarou nogical Dr
310(k) Number K992593
3
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: | February 14, 2000 |
|---|---|
| Submitter: | A-Med Systems, Inc. |
| Address: | 2491 Boatman Avenue |
| West 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 Miniature Centrifugal Pump System |
|---|---|
| Common Name: | A-Med Miniature Centrifugal Pump System |
Classification Name: "Non-roller type Cardiopulmonary Bypass Blood Pumps" (21 CFR -870.4360) "Blood Pump Speed Controllers" (21 CRF - 87.4380)
Predicate Devices:
Claim of Substantial Equivalence of the A-Med Miniature Centrifugal Pump System is made to:
Centrifugal Blood Pump
Medtronic Bio-Medicus BP-50 Centrifugal Pump (K852807) Medtronic Bio-Medicus BPX-80 Bio-Pump (K973011)
Blood Pump Speed Controller
Medtronic Bio-Medicus Bio-Console Model 540 (K901584) Sarns 7800 Centrifugal Pump Control Module (K950739)
4
Device Description:
The A-MED Miniature Centrifugal Pump is a sterile, disposable, non-roller pump which utilizes a rotor to impart energy to the blood through centrifugal forces. The flow of the miniature pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the miniature pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the miniature pump.
The A-MED Miniature Centrifugal Pump System includes a motor, ultrasonic flow sensor and a microcomputer-based control console which are available separately. The Miniature pump consists of inner and outer housings containing a rotor which imparts energy to the pumping fluid through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. The shaft of the rotor is constrained by two sets of bearings that allow it to rotate freely. A lip seal is used just behind the rotor to seal fluid from entering into the bearing area.
A sheath cable assembly connects the pump to the drive motor. The pump end of the cable has a square drive shaft that is bonded and crimped to the cable. This drive shaft fits into a square opening in the end of the rotor. The other end of the cable is connected to a magnet rotor housed in a plastic shell. This end is assembled onto the motor-stator for operation. By assembling the magnet rotor into the end of the cable-sheath assembly, hermitic sealing of the pumping chamber is obtained.
A priming port (valve) is provided on the housing to clear the pump of air before starting circulation. The port is designed to open when a syringe is inserted and seals when the syringe is removed.
The pump is designed to be placed in the sterile field and operated from the A-Med remote motor and microcomputer based blood pump controller, located outside the sterile field. The A-Med Centrifugal Pump System also includes an ultrasonic flow meter, manufactured by Transonics, Inc.
Intended Use:
The A-Med 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 Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
Technological Characteristics:
This device has technological characteristics similar to the predicate devices.