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.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the RMI Hemoconcentrator Tubing Set, structured to address your specific questions.

Note: The provided text primarily focuses on biocompatibility and basic functional performance testing. It does not contain information related to AI/ML device performance, ground truth establishment, expert consensus, or multi-reader multi-case studies. Therefore, many of your requested points will be marked as "Not Applicable" or "Not Provided in Text."

Acceptance Criteria and Device Performance for RMI Hemoconcentrator Tubing Set

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	Not cytotoxic	The test article is not cytotoxic (MEM Elution Test).
	Not a significant sensitizer	Upon rechallenge, none of the test group or negative control animals exhibited scores higher than 1 (response of 1 is not considered significant sensitization) (Guinea Pig Maximization).
	Meets USP Intracutaneous Test requirements	The test article met the requirements of the USP Intracutaneous Test.
	Meets USP Systemic Injection Test requirements	The test article met the requirements of the USP Systemic Injection Test.
	Hemolysis ≤ Acceptable Limit (Implicitly 0% or very low)	The test article had 0.00% Hemolysis.
Functional / Performance Testing
Flow vs. Pressure (Blood Flow)	Deliver flows exceeding 1000 ml/min with line pressure < 70 mmHg (for blood flows up to 500 ml/min in extracorporeal circuit)	Five (5) product samples tested delivered flows exceeding 1000 ml/min with line pressure under 70 mmHg. (This seems to indicate the tubing can pass 1000 ml/min at <70mmHg line pressure while the device itself is designed for up to 500ml/min, implying sufficient capacity).
Overpressure and Leak	Withstand pressure 10 times greater than standard operating pressure	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	Withstand a 6 times minimum acceptable pull force	Five (5) unit samples tested demonstrated a six (6) times minimum acceptable pull force per Q.O.P. #80138.

Sample sizes used for the test set and the data provenance:
- Biocompatibility Testing: The sample sizes are not explicitly stated as a single number but are implied by tests involving "whole product extract," "tubesheet slices," "test group," and "negative control animals." Specific numbers for animals or extraction replicates are not provided in this summary.
- Functional / Performance Testing:
  - Flow vs. Pressure Test: 5 product samples
  - Overpressure and Leak Testing: 5 unit samples
  - Mechanical Strength Test: 5 unit samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a general safety and effectiveness summary, so it's likely part of internal R&D/testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a medical tubing set, and its performance is evaluated through physical and chemical tests, not through expert interpretation of medical images or data requiring "ground truth" in the AI/ML sense. The "ground truth" in this context refers to the measured physical and chemical properties matching predetermined specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from expert opinions, which is not relevant for the types of tests described here (biocompatibility, flow, pressure, mechanical strength). The results of these physical tests are quantitative measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (tubing set), not an AI/ML diagnostic or assistive tool. MRMC studies are not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Ground truth is established by the specified biological responses (e.g., lack of cytotoxicity, minimal sensitization, meeting USP standards for irritation and systemic toxicity, 0.00% hemolysis) as defined by the referenced standards (FDA MATRIX, ISO 10993, USP).
- For functional/performance testing: Ground truth is established by quantitative measurements against predefined engineering specifications (e.g., flow rate, pressure resistance, pull force).
The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.

Summary

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K961927

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 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.

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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

Regulation Number and Section

§ 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).