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

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SUMMARY OF SAFETY AND EFFECTIVENESS

QUEST MYOCARDIAL PROTECTION SYSTEM PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)

General Information I.

A. Generic Name:	Cardioplegia Delivery System
B. Trade Name of Device:	MPS® Perfusion Assisted DirectCoronary Artery Bypass(PADCAB)
C. Applicant's Name and Address:	Quest Medical, Inc.One Allentown PkwyAllen, TX 75002
D. Premarket Notification Number:	Not assigned to date

II. Indication for Use

III. Device Description

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IV. Device Classification: Class II

Quest Myocardial Protection System PADCAB is reviewed by the FDA Cardiovascular (CV) and (HO) General Hospital Classification Panels. The Product Classification Codes and Panel Codes for this device and predicate devices are:

80 DWK Pump, Infusion, Cardiovascular	21 CFR 880.5725
74 DTR Cardiovascular bypass, Heat exchanger	21 CFR 870.4240
74 DRS Transducer, Blood-Pressure, Extravascular	21 CFR 870.285
74 DXS Cardiopulmonary bypass coronary pressuregauge	21 CFR 870.4310
74 DWF Cardiopulmonary bypass vascular catheter,cannula, or tubing	21 CFR 870.4210
74 KRL Cardiopulmonary bypass bubble detector	21 CFR 870.4205

V. Safety and Effectiveness

Substantial Equivalence:

This device has been shown to be substantially equivalent to the Quest MPS Myocardial Protection System #K953838

VI. Other Safety and Effectiveness Data

Materials:	Fluid contact materials are 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 / ISO11135 – 1994 and EN 550 SAL of 10-6
Pyrogenicity:	Non-Pyrogenic per USP Pyrogen Test (LAL)

Functional Test

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.

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Image /page/2/Picture/0 description: The image shows a white letter Q inside of a black square. The letter Q is stylized with a curved tail extending from the bottom right of the circle. The black square provides a high contrast background, making the white letter stand out.

SUMMARY OF SAFETY AND EFFECTIVENESS

V. Safety and Effectiveness

Substantial Equivalence:

The device has been shown to be substantially equivalent to the Sarns' Integrated Cardioplegia Delivery System (ICDS) #K810079, Sams Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 802147and the Stockert-Shiley Dual Pressure Control Module # K862836.

VI. Other Safety and Effectiveness Data:

Materials:	Fluid contact materials of construction comply with ISO-10993 " BiologicalEvaluation of Medical Devices - Part 1 : Evaluation and Testing" for short termdevices.
Sterilization:	Validated METHOD-1 Radiation Sterilization SAL 10-6
Pyrogenicity:	Non-Pyrogenic per USP Pyrogen test (LAL)

Functional Testing

. .

Leak Test Requirements	No leaks at 15 psi.
Pull Test Requirements	No leaks at 5 lbs for small bore and 10 psi forlarge bore tubing.
Luer Connections	Meets ANSI/HIMA MD70.1-1983 for MedicalMaterials Luer Taper Fittings.
Package Integrity	Tyvek/Polystyrene tray and Tyvek/Polymylarpouches passed burst test with in accordancewith ASTM F1140-88.
Shipping and Distribution Testing	Passed Distribution Simulation Test I/NSTAProject 1A, ASTM D-775-80 and D-999-75.
Accelerated Aging	One (1) year with no effects on performancecharacteristics.
Heat Exchanger Corrosion Test	Resists corrosion for periods of up to 72 hours.
Air In-line Detection	Detects 100uL size air bubbles in blood andsaline.
Hemolytic Characteristics	MPS disposable and instrument lower thanpredicate devices.
Level Sensing and Autoventing	Meets performance specifications for ventingand is equivalent to the predicate device forlevel sensing
Pressure Control Delivery	Allows greater control of pressure than doesthe predicate device.
QUEST Medical, Inc.
Pressure Alarm Verification	Operates within predicate device's alarm rangeof 0% to ± 10% of preset value. Allows abilityto set lower pressure limits.
Pressure Sensor Accuracy	Equivalent to predicate device specification of ±5 mmHg.
Pump Performance at Temperature Extremes	MPS has a mean accuracy of 95% of the flowrates (50, 150, 500 ml/minute) delivered at36°C and 5°C.
Use with Crystalloid Filter	Pressure cuffs allow MPS to provide maximumsettable flow rate with the use of a crystalloidfilter.
Arrest Agent/Additive Concentration Delivery	Adjustable from 4-40 mEq/L and delivers within± 10% of desired concentration.
Blood/Crystalloid Ratio Accuracy	Less than 3% of each components requiredproportion.
Delivery Rate Accuracy	Meets AAMI recommended 5% accuracyspecification for infusion pumps.
Pump Output Flow Profile	Depicts a more linear flow rate than thepredicate device at 50, 300, 500 ml/minute.
Environmental Tests	Meets temperature, humidity specificationrequirements and UL External SurfaceTemperature Safety requirements.
Electrical Safety	Meets UL/CSA requirements for electricalsafety.
Temperature Sensor Accuracy	Meets temperature sensor accuracyspecifications of 5% of the reading.
Warm and Cold Temperature Control	Heat and cools cardioplegia solution withinoperating flow rate ranges.

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Image /page/3/Picture/0 description: The image shows a white letter Q inside of a black square. The letter Q is stylized with a curved tail extending from the bottom right of the circle. The black square provides a high contrast background, making the white letter stand out.

QUEST Medical, Inc.

、日本の中古車を行っています。 2007年の1000

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 1 2000

Mr. Malcolm Lewis Regulatory Affairs Specialist Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211

Re: K994274 R994274
Trade Name: Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (PADCAB) Regulatory Class: II (two) Product Codes: DWK, DTR, DXS, KRL, DRS, and DWF Dated: March 21, 2000 Received: March 29, 2000

Dear Mr. Lewis:

We have reviewed your Section 510(k) notification of intent to market we nave reviews your and we have determined the device is che device forcerched arouter for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure, co regarif mariese pay 28, 1976, the enactment date of the Interstate commerce prior or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In acturante with the primay, therefore, market the device, subject to the general controls provisions of the Act. The general controls che general conclude requirements for annual registration, provisions of thes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special It your device it cremarket Approval), it may be subject to such controlor of Craces - Existing major regulations affecting your device additional concerner code of Federal Regulations, Title 21, Parts 800 can be roama intially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such inopocions. Failure to comply with the GMP regulation may result in assumptions: Farials of Othconcerning your device in the Federal Register. Please note: this conse to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page - 2 - Mr. Lewis

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), or for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sum E. Avery
James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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STATEMENT OF INTENDED USE FORM

510(K) #: Not assigned to date

Device Name: Quest MPS® Perfusion Assisted Direct Coronary Artery Bypass (PADCAB)

Indications for Use:

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 cardioplegia solutions to the head during open heart surgery on either an arrested or beating heart

Rita Q. Samper de

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K994274 510(k) Number .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X

Over-The -Counter Use_

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.