(393 days)
Not Found
Not Found
No
The description mentions a "microprocessor based system" for controlling pump speed, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The performance studies focus on hardware validation and EMC testing, not algorithmic performance.
No
The device is a component of an extracorporeal circuit used to initiate and maintain blood flow, which is a supportive function rather than directly providing therapy.
No
The device is a blood pump system described as a component of an extracorporeal circuit to initiate and maintain blood flow, not to diagnose a condition.
No
The device description explicitly states it is a "Blood Pump Console" which is a microprocessor-based system with a power cord and internal battery, indicating it is a hardware device that includes software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "initiate and maintain blood flow for up to six hours" as a component of an extracorporeal circuit. This describes a device that directly interacts with the patient's blood flow outside the body, not a device used to examine specimens in vitro (in a lab setting).
- Device Description: The description details a blood pump system that drives and controls the speed of a disposable centrifugal blood pump. This is consistent with a device used for circulating blood during procedures like dialysis or cardiopulmonary bypass, not for diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other components typically associated with in vitro diagnostic devices.
Therefore, the IsoFlow Blood Pump System is a medical device used for therapeutic or supportive purposes related to blood circulation, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The IsoFlow Blood Pump System is indicated as a component of an extracorporeal circuit to initiate and maintain blood flow for up to six hours.
Product codes
DWA
Device Description
The Blood Pump Console is made up of the console, one power cord, and an Operator's Guide. The console is a microprocessor based system which drives and controls the speed of the disposable centrifugal blood pump in the extracorporeal circuit. Each console operates off of single phase AC power and is capable of a flow rate of up to 8 LPM against a maximum pressure head of 600 mmHG. In addition each console comes with an internal battery which is capable of running the pump for a minimum of 30 minutes when fully charged in the event of a loss of AC power.
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)
To verify that the changes did not adversely impact the performance of the console the affected boards were validated and the system validation was repeated. In addition EMC testing was conducted per EN60601-1-2 to verify the device's resistance to EMC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bard" Lifestream" Blood Pump
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).
0
MAY 1 4 1998
Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000
510(k) SUMMARY FOR THE BARD* ISOFLOW* BLOOD PUMP
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21CFR $807.92.
Submitter Information: I.
| Name: | Bard Vascular Systems Division, C.R. Bard Inc. |
|---|---|
| Address: | 25 Computer Drive, Haverhill, MA 01832 |
| Contact Person: | Sandra L. Perreand |
| Date Summary Prepared: | April 14, 1997 |
II. Device Name:
| Proprietary Name: | Bard • Isoflow • Blood Pump |
|---|---|
| Common or Usual Name: | Blood Pump |
| Classification Name: | Cardiopulmonary Bypass Pump Speed Control |
III. Predicate Device(s):
- Bard" Lifestream" Blood Pump 1)
IV. Device Description:
The Blood Pump Console is made up of the console, one power cord, and an Operator's Guide. The console is a microprocessor based system which drives and controls the speed of the disposable centrifugal blood pump in the extracorporeal circuit. Each console operates off of single phase AC power and is capable of a flow rate of up to 8 LPM against a maximum pressure head of 600 mmHG. In addition each console comes with an internal battery which is capable of running the pump for a minimum of 30 minutes when fully charged in the event of a loss of AC power.
V. Indications for Use:
The IsoFlow Blood Pump System is indicated as a component of an extracorporeal circuit to initiate and maintain blood flow for up to six hours.
1
VI. Technological Characteristics:
The Isoflow" Blood Pump Console (QB2521) is an integral part of our Blood Pump System (OB2520). Each IsoFlow Blood Pump System is made up of four components. They are as follows:
- A. The Blood Pump Console (QB2521) is made up of the console, one power cord, and an Operator's Guide. The console is a microprocessor based system which drives and controls the speed of the disposable centrifugal blood pump in the extracorporeal circuit. Each console operates off of single phase AC power and is capable of a flow rate of up to 8 LPM against a maximum pressure head of 600 mmHG. In addition each console comes with an internal battery which is capable of running the pump for a minimum of 30 minutes when fully charged in the event of a loss of AC power.
- B) The Remote Motor Drive (OB2522) is positionable on an IV pole/mast or on the console using an optional utility post. The drive holds the disposable pump head and drives the blood flow through magnetic coupling between the pump head and the motor drive. The remote motor drive includes the motor drive, an Allen wrench, one motor drive holder assembly, and an IFU.
- C) The Flow Sensor (OB2523) is a reusable, non-patient contacting ultrasonic flow sensor which can detect flows from 0-10 LPM and can detect retrograde flow of ≥ 40 cc/min. This sensor is compatible with 3/8" ID by 3/32" wall tubing. Each flow sensor includes the flow sensor, one tube of petroleum jelly, a plastic storage case, and an IFU.
- D) The Hand Crank (QB2524) provides a manual means of driving the pump head in the event that both AC and battery power are unavailable to the pump. This hand crank provides sufficient power to deliver 7 LPM of blood flow against a 600 mmHg pressure head. Each hand crank includes one hand crank body, one hand crank handle, one hand crank holder, one serial number label, three screws, two Allen wrenches, and an IFU.
VII. Performance testing
To verify that the changes did not adversely impact the performance of the console the affected boards were validated and the system validation was repeated. In addition EMC testing was conducted per EN60601-1-2 to verify the device's resistance to EMC.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.
MAY 1 4 1998
Ms. Sandra L. Perreand Regulatory Affairs Manger Bard Cardiology-Cardiopulmonary Cardiac Assist Products Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832
K971421 Re : Bard® IsoFlow® Centrifugal Blood Pump System Regulatory Class: II (Two) Product Code: DWA February 12, 1998 Dated: Received: February 13, 1998
Dear Ms. Perreand:
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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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. Sandra L. Perreand
This letter will allow you to begin 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its infernet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. CallaMan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known):
Device Name: Bard IsoFlow Blood Pump System
Indications For Use:
The IsoFlow Blood Pump System is indicated as a component of an extracorporeal circuit to initiate and maintain blood flow for up to six hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Scott Souperle
(Division Sign-Off) (Division of Cardiovascular, Respiratory, -and Neurological Devices
510(k) Number K971421
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use
:.
(Optional Format 1-2-96)
.