FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist and physicians to deliver whole blood (from any arterial source) and / or cardiopleqia solutions to the heart during open heart surgery on either an arrested or beating heart

Device Description

The MPS is designed to deliver whole blood or cardioplegia solution. The MPS pumping subsystem coordinates the pumping and mixing of the blood and additives to deliver the desired composition of cardioplegia solution. The pumping subsystem consist of an electro-mechanical pumping device acting on a variety of disposable cassettes to deliver fluid. A set of four pump pistons, each driven by a stepper motor, displace the contents of the mechanically restrained fluid filled cassettes. Pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process. The main blood pump consist of two motor driven pistons and a symmetrically designed pump cassette with two chambers. Each chamber is designed to alternately fill and pump blood. A set of valves operate on channels formed within the cassette to control the flow of fluids into and out of the chamber. As one chamber is filled, the other chamber is delivering solutions. This overlapping and alternating operation of the pumping system provides an essentially constant fluid output

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quest Myocardial Protection System Perfusion Assisted Direct Coronary Artery Bypass (PADCAB) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text states: "The function test data to support the safety and efficacy of the device has not changed from the predicate device submission. Please refer to paragraph 3 of pages 15 – 16 of TAB 20 of Volume 4 of original submission (#K953838). A copy has been enclosed for your convenience."

Since the detailed K953838 submission is not fully provided, we cannot determine the exact sample sizes for each specific functional test. The data provenance is not explicitly stated as country of origin, nor is it specified as retrospective or prospective, however, functional testing usually implies lab-based, prospective testing conducted by the manufacturer.

For K994274, the provided text directly lists functional testing results, but does not explicitly state sample sizes for these tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the given text. The studies described are primarily functional and engineering tests, not clinical studies involving expert interpretation of data or images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the studies are functional and engineering tests, an adjudication method like 2+1 or 3+1 typically used for clinical assessments or image interpretation algorithms is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study was not done. The provided document is for a medical device (Cardioplegia Delivery System), not an AI algorithm for diagnostic interpretation that would involve human readers. The document focuses on the functional performance and safety of the device itself, often in comparison to predicate devices, but not on human performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a physical medical system (Cardioplegia Delivery System), not an algorithm.

7. The Type of Ground Truth Used

For the functional tests, the "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, AAMI, ANSI/HIMA, ASTM), and direct measurement against those specifications. For example:

"No leaks at 15 psi" implies the ground truth for leakage is verified by applying 15 psi and observing.
"Detects 100uL size air bubbles" implies the ground truth for air detection is based on the known size of simulated air bubbles.
"Accuracy of 95% of the flow rates" implies that the true flow rate (ground truth) is measured independently.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is a hardware system, not an AI algorithm that typically has a "training set." The development of such a device involves design, prototyping, and iterative functional testing, but not machine learning training sets in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is not an AI algorithm with a training set. The "ground truth" for the device's design and performance during its development would be based on engineering principles, clinical needs, and established medical device standards.

Summary

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).

Test Category	Acceptance Criteria	Reported Device Performance
Material Safety	Fluid contact materials comply with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" for short-term devices.	Fluid contact materials comply with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" for short-term devices.
Sterilization	Validated Ethylene Oxide Sterilization per AMI / ISO 11135 – 1994 and EN 550 SAL of 10-6. (NOTE: K994274 states Radiation Sterilization).	Validated Ethylene Oxide Sterilization per AMI / ISO 11135 – 1994 and EN 550 SAL of 10-6. (K994274 states Validated METHOD-1 Radiation Sterilization SAL 10-6)
Pyrogenicity	Non-Pyrogenic per USP Pyrogen Test (LAL).	Non-Pyrogenic per USP Pyrogen Test (LAL).
Functional Testing	(Details from K994274, as the K953838 reference is not fully provided)
Leak Test Requirements	No leaks at 15 psi.	No leaks at 15 psi.
Pull Test Requirements	No leaks at 5 lbs for small bore and 10 psi for large bore tubing.	No leaks at 5 lbs for small bore and 10 psi for large bore tubing.
Luer Connections	Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.	Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.
Package Integrity	Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test with in accordance with ASTM F1140-88.	Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test with in accordance with ASTM F1140-88.
Shipping and Distribution Testing	Passed Distribution Simulation Test I/NSTA Project 1A, ASTM D-775-80 and D-999-75.	Passed Distribution Simulation Test I/NSTA Project 1A, ASTM D-775-80 and D-999-75.
Accelerated Aging	One (1) year with no effects on performance characteristics.	One (1) year with no effects on performance characteristics.
Heat Exchanger Corrosion Test	Resists corrosion for periods of up to 72 hours.	Resists corrosion for periods of up to 72 hours.
Air In-line Detection	Detects 100uL size air bubbles in blood and saline.	Detects 100uL size air bubbles in blood and saline.
Hemolytic Characteristics	MPS disposable and instrument lower than predicate devices.	MPS disposable and instrument lower than predicate devices.
Level Sensing and Autoventing	Meets performance specifications for venting and is equivalent to the predicate device for level sensing.	Meets performance specifications for venting and is equivalent to the predicate device for level sensing.
Pressure Control Delivery	Allows greater control of pressure than does the predicate device.	Allows greater control of pressure than does the predicate device.
Pressure Alarm Verification	Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits.	Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits.
Pressure Sensor Accuracy	Equivalent to predicate device specification of ± 5 mmHg.	Equivalent to predicate device specification of ± 5 mmHg.
Pump Performance at Temperature Extremes	MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C.	MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C.
Use with Crystalloid Filter	Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter.	Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter.
Arrest Agent/Additive Concentration Delivery	Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration.	Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration.
Blood/Crystalloid Ratio Accuracy	Less than 3% of each components required proportion.	Less than 3% of each components required proportion.
Delivery Rate Accuracy	Meets AAMI recommended 5% accuracy specification for infusion pumps.	Meets AAMI recommended 5% accuracy specification for infusion pumps.
Pump Output Flow Profile	Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute.	Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute.
Environmental Test	Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements.	Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements.
Electrical Safety	Meets UL/CSA requirements for electrical safety.	Meets UL/CSA requirements for electrical safety.
Temperature Sensor Accuracy	Meets temperature sensor accuracy specifications of 5% of the reading.	Meets temperature sensor accuracy specifications of 5% of the reading.
Warm and Cold Temperature Control	Heat and cools cardioplegia solution within operating flow rate ranges.	Heat and cools cardioplegia solution within operating flow rate ranges.