(304 days)
No
The description focuses on the mechanical and material properties of a centrifugal pump for cardiopulmonary bypass, with no mention of AI or ML.
No
The device is an extracorporeal pump used in cardiopulmonary bypass procedures, which is a life-support function but not directly a therapeutic treatment in itself. Its purpose is to facilitate a medical procedure, not to treat a disease or condition therapeutically.
No
The device description clearly states it is a centrifugal pump used for extracorporeal circulation in cardiopulmonary bypass procedures, not for diagnosing conditions.
No
The device description clearly describes a physical centrifugal pump with mechanical components (impeller, chambers, seals, bearings) and a surface treatment, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as extracorporeal pumps for use in cardiopulmonary bypass procedures only". This describes a device used outside the body to support a physiological function (circulating blood during surgery), not a device used to examine specimens in vitro to provide diagnostic information.
- Device Description: The description details a mechanical pump that moves blood. It does not describe components or processes related to analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on the device's impact on blood components (hemolysis, platelet depletion, WBCs) and its mechanical integrity (life test, burst test). These are relevant to the device's function in circulating blood, not to its ability to provide diagnostic results from a sample.
- Key Metrics: The key metrics (%PLT depletion, % WBC depletion, hemolysis) are measures of the device's effect on blood, not measures of diagnostic accuracy (like sensitivity, specificity, etc.).
IVD devices are typically used to test specimens (like blood, urine, tissue) in vitro to diagnose diseases, monitor conditions, or screen for health issues. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The 3M™ Sarns™ Centrifugal Pumps with Duraflo® II Treatment are indicated as extracorporeal pumps for use in cardiopulmonary bypass procedures only and for use exclusively with Sams™ centrifugal control systems.
Product codes
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Device Description
The Sarns™ Centrifygal Pump is a centrifugal pump which imparts velocity to blood through action of a rotating impeller. The pump is comprised of two chambers. The pump chamber contains the impeller with vanes, seals components, inlet port and outlet port for connection to tubing. The rear chamber contains bearings used to support and align the magnet rotor. The rear chamber is sealed off from the pump chamber. The rear chamber is isolated from atmosphere via a hermetic seal of the housing components forming this chamber. The Duraflo® II Treatment provides a heparin-based blood path containing up to 400 USP units of heparin. This treatment improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.
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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The following invitro studies were conducted to qualify the 3M™ Sarns™ Centrifugal Pumps with Duraflo@ll Treatment: Hemolysis, Platelet Depletion, White Blood Cells, Heparin Leaching, Heparin Quantitation. Test methods were based on the proposed "Special Control Protocol for Evaluation of Blood Trauma Caused by Extracorporeal Centrifugal Pumps". Functional testing included a 12 hour Life Test (n=16), and a Burst Test (n=16) to test the pump housing, housing welds and mechanical seal under conditions of over pressurization.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test results indicated that there was no statistical difference in %PLT depletion or in average % WBC depletion between the coated and uncoated units. While there was a some change noted in hemolysis between the two groups, these results are in line with results from previous centrifugal pump testing at worst case conditions. The test results were also compared to a study that was conducted in early 1995 on the predicate device (K915363). All Duraflo® II treated pumps passed the Life Test and Burst Test.
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.
3M™ Sarns™ Centrifugal Pump
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
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
510(k) Summary
Name and Address of Contact Person 1.
Scott Beggins Baxter Healthcare Corporation CardioVascular Group Bentley Division P.O. Box 19522 Irvine. California 92713-9522
APR 22 1996
- Name of Device: 3M™ Sarns™ Centrifugal Pump with Duraflo® II Treatment 2.
- Predicate Device: 3M™ Sarns™ Centrifugal Pump 3.
4. Device Description
The Sarns™ Centrifygal Pump is a centrifugal pump which imparts velocity to blood through action of a rotating impeller. The pump is comprised of two chambers. The pump chamber contains the impeller with vanes, seals components, inlet port and outlet port for connection to tubing. The rear chamber contains bearings used to support and align the magnet rotor. The rear chamber is sealed off from the pump chamber. The rear chamber is isolated from atmosphere via a hermetic seal of the housing components forming this chamber. The Duraflo® II Treatment provides a heparin-based blood path containing up to 400 USP units of heparin. This treatment improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.
5. Intended Use
The 3M™ Sarns™ Centrifugal Pumps with Duraflo® II Treatment are indicated as extracorporeal pumps for use in cardiopulmonary bypass procedures only and for use exclusively with Sams™ centrifugal control systems.
a. Technology Comparison 6.
The proposed device and predicate device are essentially identical with the exception of the addition of the Duraflo® II treatment. Components remain the same.
b. Testing Summary
The following invitro studies were conducted to qualify the 3M™ Sarns™ Centrifugal Pumps with Duraflo@ll Treatment:
- Hemolysis .
- Platelet Depletion .
1
- . White Blood Cells
- Heparin Leaching .
- Heparin Quantitation .
Test methods were based on the proposed "Special Control Protocol for Evaluation of Blood Trauma Caused by Extracorporeal Centrifugal Pumps". The test results indicated that there was no statistical difference in %PLT depletion or in average % WBC depletion between the coated and uncoated units. While there was a some change noted in hemolysis between the two groups, these results are in line with results from previous centrifugal pump testing at worst case conditions. The test results were also compared to a study that was conducted in early 1995 on the predicate device (K915363).
Functional testing included a 12 hour Life Test (n=16), and a Burst Test (n=16) to test the pump housing, housing welds and mechanical seal under conditions of over pressurization. All Duraflo® II treated pumps passed these tests.
c. Rational for Substantial Equivalence Determination
The coated and uncoated versions of the 3M™ Sarns™ Centrifugal Pumps are essentially identical, basic materials remain the same with the exception being the addition of the Duraflo® II Treatment with the substantially equivalent. Testing has demonstrated that units with the proposed addition of the Duraflo® II Treatment are substantially equivalent to the predicate (uncoated) device, and that there were no adverse effects on overall pump performance.