The Quest Medical MPS 3 Myocardial Protection System, consisting of the MPS 3 Controller, and the MPS 3 Disposables (MPS 3 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 surgery on either an arrested or beating heart for use up to six hours in duration.

Device Description

The MPS 3 Myocardial Protection System (MPS 3) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The MPS 3 System combines blood from the heartlung 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 MPS 3 System consists of a reusable MPS 3 Console, a reusable MPS 3 Controller, and single use MPS 3 Disposables.

The MPS 3 Console incorporates two Blood/Crystalloid pumps (B/C pumps), a temperature- controllable water circulation system, pressure and temperature monitors, a sensor interface, an arrest agent pump, an additive pump and ultra-sonic air detection sensors. The MPS 3 Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure, temperature, and delivery route of the cardioplegia solution delivered to the patient.

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

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Quest Medical, Inc. MPS 3 Myocardial Protection System. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device, as implied by the structure of the requested output (e.g., ground truth, MRMC study, training sets).

The MPS 3 Myocardial Protection System is a hardware system for delivering cardioplegia solutions during heart surgery, and its 510(k) submission is based on demonstrating substantial equivalence to a predicate device (MPS 2 Myocardial Protection System) through non-clinical bench testing. It is not an AI/algorithm-driven diagnostic or assistive device that would typically involve the types of studies outlined in your request (e.g., assessing sensitivity/specificity based on expert consensus, multi-reader multi-case studies, or standalone algorithm performance).

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document explicitly states:

"Clinical Testing Summary [807.92(b)(2)] Not applicable. Clinical testing was not performed to support this 510(k) submission." This means there was no human clinical trial assessing the device's performance in patients in the manner that would generate the data for the requested metrics (e.g., accuracy against ground truth).
The performance data sections detail bench and nonclinical tests (e.g., sterilization, shelf-life, biocompatibility, electrical safety, system performance, mechanical hemolysis, human factors/usability, disposables performance), which are standard for hardware medical devices but do not involve the types of acceptance criteria you've outlined for an AI/algorithm.

To directly answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:
* N/A. The document does not present quantitative acceptance criteria or reported performance metrics in the format of precision, recall, accuracy, sensitivity, specificity, etc., which are typical for AI/algorithm-driven devices. Instead, it lists various non-clinical tests (e.g., "Sterilization, Shelf-Life, and Packaging Testing", "System Performance Tests", "Mechanical Hemolysis Test," "Leak Test," "Efficiency Test") that would have their own internal acceptance criteria (e.g., sterility must be maintained, pressure must hold, flow rate within tolerance). These specific criteria and their results are not detailed in this summary document. The document simply states "The collective results of the performance testing demonstrate that the MPS 3 Myocardial Protection System (MPS 3) meets the established specifications necessary for consistent performance during its intended use."

2. Sample sized used for the test set and the data provenance:
* N/A. As no clinical or AI-centric performance study was conducted, there are no "test sets" of patient data in the context of an AI/algorithm. The "samples" used would be the physical devices and components subjected to various bench and non-clinical tests (e.g., multiple units for reliability testing, materials for biocompatibility). The document does not specify the number of units/samples for each bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Not relevant for this type of device and its non-clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Not relevant.

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. The device is a hardware system, not an AI assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. The device is a hardware system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* N/A. Not applicable for the bench testing performed. Ground truth for the device's function would be based on engineering specifications and physical measurements (e.g., flow rate accuracy measured against a calibrated standard, pressure measurements).

8. The sample size for the training set:
* N/A. Not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:
* N/A. Not applicable.

In summary, the provided document details the regulatory submission for a physical medical device (Myocardial Protection System) and relies on demonstrating substantial equivalence through non-clinical performance testing. It does not involve an AI component or the types of clinical/AI performance studies that would generate the specific data points requested in your prompt.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 19, 2020

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

Re: K200438

Trade/Device Name: MPS 3 Myocardial Protection System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchanger Regulatory Class: Class II Product Code: DTR, DWC Dated: May 19, 2020 Received: May 20, 2020

Dear Tosan Onosode:

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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting (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 (QS) 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-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K200438

Device Name

MPS 3 Myocardial Protection System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

510(k) Notification K200438

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

Date Prepared: February 21, 2020

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

MPS 3 Myocardial Protection System (MPS 3)

Generic/Common Name:

Cardiopulmonary Bypass Heat Exchanger

Classification:

Class II per 21CFR§870.4240

Product Code:

DTR. DWC

{4}------------------------------------------------

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

Quest Medical, Inc., MPS®2 Myocardial Protection System (K173716).

DEVICE DESCRIPTION [807.92(a)(4)]

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

The Quest Medical MPS 3 Myocardial Protection System, consisting of the MPS 3 Console, the MPS 3 Controller, and the MPS 3 Disposables (MPS 3 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.

{5}------------------------------------------------

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

In demonstrating substantial equivalence of the MPS 3 Myocardial Protection System to the predicate MPS 2 Myocardial Protection System, Quest Medical considered the following aspects:

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

The MPS 3 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 has similar design features, technological characteristics, performance specifications, patient contacting materials and labeling as the predicate device. The differences in the technological characteristics between the MPS 3 and the predicate do not raise different questions of safety or effectiveness. Thus, the MPS 3 Myocardial Protection System (MPS 3) 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 Myocardial Protection System (MPS 3) to support a determination of substantial equivalence to the predicate device.

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

The bench and nonclinical tests included:

Sterilization, Shelf-Life, and Packaging Testing
Cleaning and Disinfection Validation ●
- Cleaning and intermediate level disinfection validation testing was conducted to demonstrate the adequacy of the external surface cleaning and disinfection instructions contained in the MPS 3 Operations Manual.
- A Intermediate level disinfection validation testing was conducted on the water circulation system to demonstrate the effectiveness of the disinfection instructions contained in the MPS 3 Operations Manual.
- Long term (6 months) disinfection validation study was conducted to evaluate A the effectiveness of the disinfection procedures in preventing or mitigating biofilm formation in the water circulation system.
Biocompatibility Testing (Cytotoxicity, Sensitization, Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
Software Verification Tests ●

{6}------------------------------------------------

IEC 60601-1 Electrical Safety Tests
IEC 60601-1-2 Electromagnetic Compatibility Tests ●
System Performance Tests
IEC 62133 Battery Compliance Tests ●
Alarm Verification Tests ●
Altitude Test ●
Reliability Tests
Mechanical Hemolysis Test
o Human Factors/Usability Test
Shipping/Transit Tests ●
Disposables Performance Test 0
- Leak Test
- Tubing Bonding Strength
- Tubing Break Force
- Tubing Bend Radius
- Priming Volume
- Simulated Use
- Burst Pressure
- Activation Force A
- Retraction Force A
- A Blood Side Leak
- Water Side Leak
- A Port blockage
- High Pressure Leak A
- Efficiency Test s
- Pressure Drop
- Corrosion Test
- Clamp Test
- Animal Testing

●

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

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

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

{7}------------------------------------------------

510(k) SUMMARY

CONCLUSIONS [807.92(b)(3)]

The results from the performance testing support the conclusion that the MPS 3 Myocardial Protection System (MPS 3) device is substantially equivalent to the legally marketed predicate device.

SUMMARY

The MPS 3 Myocardial Protection System (MPS 3) 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).