The Quest MPS 3 ND Myocardial Protection System, consisting of the Quest MPS 3 ND Console, the Quest MPS 3 Controller, and the Quest MPS 3 ND Disposables (Quest MPS 3 ND Delivery Set and optional Accessories) together is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart during open-heart surgery on either an arrested or beating heart for use up to six hours in duration.

Device Description

The Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The Quest MPS 3 ND System combines blood from the heart-lung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (arrest or additive agent) for delivery to the patient. The Quest MPS 3 ND System consists of a reusable MPS 3 ND Console, a reusable MPS 3 Controller, and single use MPS 3 ND Disposables.

The Quest MPS 3 ND Console incorporates two Blood/Crystalloid pumps (B/C pumps), pressure and temperature monitors, a sensor interface, an Arrest Agent pump, an Additive pump and ultra-sonic air detection sensors. The Quest MPS 3 ND Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure and delivery route of the cardioplegia solution delivered to the patient. The MPS 3 ND Console also monitors the temperature of the cardioplegia solution which is regulated by an external heater cooler device.

The Quest MPS 3 Controller is a touchscreen user interface utilized by the operator to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters and view/save relevant case information and data.

The Quest MPS 3 ND Disposables includes single use delivery sets (also known as the "MPS 3 ND Delivery Sets"), delivery set accessories and blood bypass tubing. The MPS 3 ND Delivery Sets and accessories consist of a flexible cassette, a heat exchanger with water line, drug cartridges and relevant tubing and connectors used to complete the cardioplegia circuit for use with the Quest MPS 3 ND Console. The blood bypass tubing is used as a backup in the event the Quest MPS 3 ND Console becomes unusable.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the Quest MPS 3 ND Myocardial Protection System. It outlines the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

However, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop study. The device in question is a medical protection system for cardiopulmonary bypass surgery, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and its 510(k) submission.

Here's how to address the request based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document broadly mentions "Performance Specifications" and "Software Verification Tests," "MPS 3 ND System Performance Tests," as well as other bench and nonclinical tests. It concludes that "The collective results of the performance testing demonstrate that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) meets the established specifications necessary for consistent performance during its intended use."

However, specific numerical acceptance criteria and their corresponding achieved performance values are not detailed or tabulated in this summary document. This level of detail would typically be found in the full test reports submitted to the FDA, not in the public 510(k) summary.

Acceptance Criteria Category	Reported Device Performance
Software Verification	Meets established specifications (details not provided)
Electrical Safety (IEC 60601-1)	Compliant (details not provided)
Electromagnetic Compatibility (IEC 60601-1-2)	Compliant (details not provided)
System Performance (MPS 3 ND)	Meets established specifications (details not provided for specific metrics like flow rate accuracy, temperature control, etc.)
Battery Compliance (IEC 62133-2, IEC 62281)	Compliant (details not provided)
Human Factors/Usability	Passed (details not provided)
Package Stability/Transit	Passed (details not provided)
Leak Test	Passed (details not provided)
Tubing Bonding Strength	Passed (details not provided)
Simulated Use	Passed (details not provided)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in the provided document. The tests performed are primarily bench and nonclinical (e.g., software verification, electrical safety, system performance). These are not tests on a "test set" of patient data in the way an AI algorithm is evaluated.
Data Provenance: Not applicable in the context of clinical data for AI. The tests are benchtop, simulated use, and engineering verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth from medical images or patient data. Its performance is evaluated against engineering specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human readers or interpretation of data beyond standard engineering and quality control procedures.

5. 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, a MRMC study was not done. This is not an AI-assisted device. The device's function is to deliver medical solutions during surgery, not to aid human readers in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware and software system for medical fluid delivery, not an AI algorithm evaluated for standalone performance. Its "performance" refers to its ability to accurately pump, heat/cool, and control fluids as designed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of typical AI ground truth. For this device, "ground truth" would equate to established engineering standards, physical laws (e.g., pressure, flow, temperature measurements), and functional requirements for a medical device of its type. For example, a flow rate "ground truth" would be the expected flow rate based on pump settings and calibration, not a medical diagnosis.

8. The sample size for the training set:

Not applicable. This device is not an AI system trained on a dataset. Its software is deterministic and based on specified operating parameters.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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November 20, 2020

Quest Medical, Inc. Tosan Eweka Regulatory Affairs Supervisor One Allentown Parkway Allen, Texas 75002

Re: K201984

Trade/Device Name: MPS 3 ND Myocardial Protection System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary bypass heat exchanger Regulatory Class: Class II Product Code: DTR Dated: October 21, 2020 Received: October 22, 2020

Dear Tosan Eweka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K201984

Device Name

Quest MPS 3 ND Myocardial Protection System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

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510(k) Notification K201984

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 Fax: 972-390-2881

Contact Person:

Tosan Eweka Regulatory Affairs Supervisor Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 972-390-2881 Fax: Email: teweka@questmedical.com

Date Prepared: October 21, 2020

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Quest MPS 3 ND Myocardial Protection System (MPS 3 ND)

Generic/Common Name:

Cardiopulmonary Bypass Heat Exchanger

Classification:

Class II per 21CFR§870.4240

Product Code: DTR

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PREDICATE DEVICE(S) [807.92(a)(3)]

MPS 3 Myocardial Protection System (K200438).

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE [807.92(a)(6)]

In demonstrating substantial equivalence of the Quest MPS 3 ND Myocardial Protection System to the predicate MPS 3 Myocardial Protection System, Quest Medical considered the following aspects:

Intended Use/Indications for Use ●
Anatomical Site ●
Patient Population ●
Principles of Operation ●
Design Features/Technological Characteristics ●
Performance Specifications ●
Materials
Labeling ●

The MPS 3 ND System has the same Indications for Use, principles of operation, duration of use, and is used in the same anatomical site in the same patient population as the predicate device. The MPS 3 ND System has similar design features, technological characteristics, performance specifications, patient contacting materials and labeling as the predicate device. The primary differences in technological characteristics between the predicate device and the subject device are outlined below.

The predicate device console includes a water circulation system while the subject device console does not include a water circulation system. The water circulation system in the predicate device regulates and controls the temperature of cardioplegia solution delivered to the patient. With the predicate device, users can also use an external heater cooler device to achieve temperature control, thereby bypassing the internal water circulation system. With exclusion of a water circulation system in the subject device, the subject device console relies on an external heater cooler device to provide temperature regulated water which heats or cools the cardioplegia solution delivered through the device.
The water tubing in the predicate device is reusable while the water tubing in the subject device is disposable. The subject device delivery set includes disposable water tubing with fittings attached to the water ports of the heat exchanger component of the Delivery Set which is not included in the predicate device Delivery Set. The disposable water tubing attached to the heat exchanger is routed through the rear panel of the console where it can be connected directly to the external heater cooler device. The disposable water tubing in the subject device serves the same function as the water tubing in the predicate device (delivery of temperature controlled water to the heat exchanger).

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510(k) SUMMARY

Results from performance testing conducted on the subject device demonstrates that the differences in technological characteristics between the subject device and the predicate do not raise different questions of safety or effectiveness. Thus, the MPS 3 ND Myocardial Protection System (MPS 3 ND) is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(b)]

All necessary bench, nonclinical, and human factors testing was conducted on the MPS 3 ND Myocardial Protection System (MPS 3 ND) to support a determination of substantial equivalence to the predicate device.

Nonclinical Testing Summary [807.92(b)(1)]

The bench and nonclinical tests included:

Software Verification Tests ●
. IEC 60601-1 Electrical Safety Tests
IEC 60601-1-2 Electromagnetic Compatibility Tests ●
MPS 3 ND System Performance Tests ●
IEC 62133-2 and IEC 62281Battery Compliance Tests ●
Human Factors/Usability Test ●
Package Stability/Transit Tests .
Leak Test ●
Tubing Bonding Strength ●
Simulated Use ●

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Clinical Testing Summary [807.92(b)(2)]

Not applicable. Clinical testing was not performed to support this 510(k) submission.

CONCLUSIONS [807.92(b)(3)]

The collective results of the performance testing demonstrate that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) does not raise different questions of safety or effectiveness for Cardiopulmonary Bypass Surgery when compared to the predicate device. The results from the performance testing support the conclusion that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) is substantially equivalent to the predicate device.

SUMMARY

The Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.4240 Cardiopulmonary bypass heat exchanger.

(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).