(88 days)
Not Found
Not Found
No
The device description and performance studies focus solely on the physical components and mechanical properties of a tubing set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a tubing set used to connect a hemoconcentrator to other components in an extracorporeal circuit; it does not directly perform a therapeutic function itself.
No
The device is described as a "set of tubing, fittings and connectors" used to interconnect a hemoconcentrator within an extracorporeal circuit. Its function is to facilitate blood flow and ultrafiltrate collection, not to diagnose a medical condition or provide diagnostic information.
No
The device description explicitly states it is a "set of tubing, fittings and connectors," which are physical hardware components. There is no mention of software in the description or performance studies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a set of tubing, fittings, and connectors used to interconnect a hemoconcentrator within an extracorporeal circuit. This is a system for processing blood outside the body, not for performing diagnostic tests on biological samples.
- Device Description: The description reinforces the function of connecting components in an extracorporeal circuit.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the physical properties of the tubing set (flow, pressure, mechanical strength), which are relevant to its function in an extracorporeal circuit, not to diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is purely mechanical and related to blood processing outside the body.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.
The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.
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
Biocompatibility Testing:
- The Cytotoxicity Test (MEM Elution Test) was performed. Under conditions of the test, the test article is not cytotoxic.
- The Sensitization Test (Guinea Pig Maximization) was performed. For SCI and OIL Extraction Tests, upon rechallenge none of the test group or negative control animals exhibited scores higher than 1. A response of 1 is not considered to reflect significant sensitization.
- A USP Intracutaneous (Irritation) Test was conducted. Under conditions of the test, the test article met the requirements of the USP Intracutaneous Test.
- The Acute Systemic Toxicity Test (USP Systemic Injection Test) was conducted. Under conditions of the test, the test article met the requirements of the USP Systemic Injection Test.
- The Haemocompatibility (Hemolysis) Test for blood compatibility was conducted. The test article had 0.00% Hemolysis.
Functional / Performance Testing:
- Flow vs. Pressure Test: The five (5) product samples tested delivered flows exceeding 1000 ml/min with line pressure under 70 mmHg.
- Overpressure and Leak Testing: The five (5) unit samples tested demonstrated the product will withstand a pressure ten (10) times greater than the standard operating pressure observed during flow testing.
- Mechanical Strength Test: The five (5) unit samples tested demonstrated a six (6) times minimum acceptable pull force per Q.O.P. #80138.
Key Metrics
Not Found
Predicate Device(s)
To our knowledge, there are no predicates devices for separately sold hemoconcentrator tubing sets.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
Attachment II.A
SMDA Summary of Safety and Effectiveness Information
In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:
1. Device Classification:
The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.
The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.
Research Medical can find no Code of Federal Regulations (CFR) classification for this type of device. Since the RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to a location in an extracorporeal circuit and either a cardiotomy or venous reservoir, Research Medical believes the RMI Hemoconcentrator Tubing Set is a Class II device that could best be classified under the following CFR classifications:
- . $870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
- . §870.4210 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Predicate Device Identification: 2.
To our knowledge, there are no predicates devices for separately sold hemoconcentrator tubing sets.
Class III Summary: 3.
[Not applicable]
4 . Biocompatibility Assessment
Biocompatibility testing was performed on whole product extract and/or tubesheet slices of the ethylene oxide (EtO) sterilized RMI Hemoconcentrator Tubing Set (test article) in accordance with FDA's May 1, 1995 memo, FDA MATRIX FOR BIOCOMPATABILITY TESTING, which is based on ISO 10993 Standard, Biological Evaluation of Medical Devices. The reports are summarized as follows:
- The Cytotoxicity Test (MEM Elution Test) was performed. Under conditions of the test, the test article is not cytotoxic.
- The Sensitization Test (Guinea Pig Maximization) was performed. For SCI and OIL Extraction Tests, upon rechallenge none of the test group or negative control animals exhibited scores higher than 1. A response of 1 is not considered to reflect significant sensitization.
- . A USP Intracutaneous (Irritation) Test was conducted. Under conditions of the test, the test article met the requirements of the USP Intracutaneous Test.
1
- The Acute Systemic Toxicity Test (USP Systemic Injection Test) was conducted. . Under conditions of the test, the test article met the requirements of the USP Systemic Injection Test.
- The Haemocompatibility (Hemolysis) Test for blood compatibility was conducted. . The test article had 0.00% Hemolysis.
Summary of Functional / Performance Testing: 5.
Flow vs. Pressure Test:
The five (5) product samples tested delivered flows exceeding 1000 ml/min with line pressure under 70 mmHg.
Overpressure and Leak Testing:
The five (5) unit samples tested demonstrated the product will withstand a pressure ten (10) times greater than the standard operating pressure observed during flow testing.
Mechanical Strength Test:
The five (5) unit samples tested demonstrated a six (6) times minimum acceptable pull force per Q.O.P. #80138