(25 days)
None
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 marked as "Not Found".
Yes
This device is a blood pump system indicated for use in extracorporeal circulatory support, which directly treats or supports a physiological function.
No
The device is a blood pump system used for extracorporeal circulatory support, not for diagnosing medical conditions. Its function is to facilitate blood flow, not to analyze or provide diagnostic information.
No
The device description clearly details a physical blood pump with mechanical components (impeller, drive cable, magnetic coupling) and a proposed surface coating. It also mentions a separate motor, ultrasonic flow sensor, and control console, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "extracorporeal circulatory support systems." This means it's used to circulate blood outside the body during surgical procedures. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a blood pump that physically moves blood. It doesn't mention any components or processes related to analyzing blood or other biological samples to diagnose a condition.
- Lack of IVD Indicators: There are no mentions of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to support circulation, which is a direct intervention on the body, not an analysis of a sample from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
KFM
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.
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)
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
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: |
|---|
| ------------ |
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 Centrifugal
Pump 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,
1
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.
2
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
3
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
4
Indication Statement
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
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.
(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