(75 days)
K# Unknown
DLP I.M.A. Cannula, Code #31001, K# Unknown.
No
The device description and performance studies focus on the physical properties and flow rate of a cannula, with no mention of AI or ML.
No.
The device is a cannula used to facilitate fluid flow, which is an instrument, not a therapeutic agent or device intended to treat a medical condition.
No
The device is described as a cannula used for the internal mammary artery, and its performance study focuses on flow rates. There is no information to suggest it is used for diagnosing medical conditions.
No
The device description explicitly states it is composed of physical materials (chrome-plated brass and stainless steel tubing), 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:
- No mention of in vitro testing: The description focuses on a physical cannula used for accessing the internal mammary artery. There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Anatomical site: The device is intended for use within the body (internal mammary artery), which is characteristic of an in vivo device, not an in vitro one.
- Performance study: The performance study compares flow rates, which is a physical characteristic of the device's function in a simulated or real-world application, not a diagnostic performance metric.
IVD devices are typically used to test samples like blood, urine, tissue, etc., outside of the body. This device is clearly designed for direct use within the patient's circulatory system.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal mammary artery
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
A comparative performance test of the RMI Internal Mammary Artery Cannula, IMA-001. to the DLP I.M.A. Cannula, I.M.A. 31001, was completed. The purpose of the test was to compare the relative flow rates of the cannulae. Under conditions of the test the data shows that the flowrate of the RMI Internal Mammary Artery Cannula, IMA-001, is approximately 25% greater than the DLP I.M.A. Cannula, I.M.A. 31001.
Key Metrics
Not Found
Predicate Device(s)
DLP I.M.A. Cannula, Code #31001, K# Unknown.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).
0
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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:
- Predicate Device Identification: A claim of substantial equivalence of the RMI l. Internal Mammary Artery Cannula is made to the:
- DLP I.M.A. Cannula, Code #31001, K# Unknown. .
This device was marketed prior to May 28, 1976 or has received FDA clearance to market since that date.
Class III Summary: 2.
[Not applicable]
3. Statement of Biocompatibility:
The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip. These materials are standard materials used in medical needle devices marketed prior to May 28, 1976, and since that date. Biocompatibility of these materials is well established and testing is not repeated for this product.
Comparative Information: 4 .
- Summary of Functionality/Performance Comparison of the RMI Internal Mammary Artery Cannula to the DLP I.M.A. Cannula:
Test Results
A comparative performance test of the RMI Internal Mammary Artery Cannula, IMA-001. to the DLP I.M.A. Cannula, I.M.A. 31001, was completed. The purpose of the test was to compare the relative flow rates of the cannulae. Under conditions of the test the data shows that the flowrate of the RMI Internal Mammary Artery Cannula, IMA-001, is approximately 25% greater than the DLP I.M.A. Cannula, I.M.A. 31001. Since the flowrate through a cannula indicated for flushing the internal mammary artery with a vasodilator is only an issue if the pressure needed to create the desired flow is too high, it may be concluded that in terms of flow rates, the RMI Internal Mammary Artery Cannula, IMA-001, is substantially equivalent to the DLP I.M.A. Cannula, I.M.A. 31001.
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Comparison_of_Specifications
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| Characteristic | RMI Internal
Mammary Cannula | DLP I.M.A.
Cannula |
|-----------------|---------------------------------|--------------------------|
| Model | RMI IMA-001 | DLP I.M.A. 31001 |
| Female Luer Hub | Chrome-Plated Brass | Plastic |
| Tubing | 26 gauge Stainless Steel | 26 gauge Stainless Steel |
| Tip | 1mm Smooth Bulb Tip | 1mm Smooth Bulb Tip |
| Sterilization | EtO | Unknown |
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