The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 console and the MPS Delivery Set 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 beart for use up to six hours in duration.

Device Description

The MPS 2 console is a single device for myocardial perfusion that incorporates several different functions: heat exchanger, temperature control, pressure control, flow rate control, automatic priming and air detection / removal, and 3 flow modes - normal, cyclic, low volume.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Quest Medical MPS2 Myocardial Protection System Console, focusing on a labeling modification related to disinfection protocols. The submission asserts substantial equivalence to a predicate device (K041979).

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (Disinfection Efficacy)	Reported Device Performance
Intermediate level of disinfection against Pseudomonas aeruginosa (P. aeruginosa)	6-Log reduction against P. aeruginosa
Intermediate level of disinfection against Mycobacterium chimaera (M. chimaera)	3-Log reduction against M. chimaera
Compatibility of disinfectant and microbial growth inhibitor with water circulation system materials	Disinfectant and microbial growth inhibitor were shown to be compatible with the materials of the water circulation system.
Surface cleaning and disinfection effectiveness	Supported with results from surface cleaning and disinfection testing (specific performance metrics not detailed).
Heat exchanger performance	Supported with results from heat exchanger performance testing (specific performance metrics not detailed, but implies continued function after disinfection).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the disinfection efficacy testing (e.g., number of test articles, number of microbial inoculations). It mentions "bench testing," which implies laboratory-based studies. The provenance information (country of origin, retrospective/prospective) is also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the study is a benchtop disinfection validation, not a clinical study requiring expert interpretation of patient data. The ground truth for microbial reduction (e.g., 6-Log and 3-Log reduction) is established through standardized microbiological testing methods rather than expert consensus on medical images or clinical outcomes.

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

This section is not applicable for a benchtop disinfection validation study. Adjudication methods are relevant for clinical studies where multiple experts interpret data.

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

This section is not applicable. The study described is a benchtop validation of a disinfection protocol for a medical device, not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted.

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

This section is not applicable. The device is a "Myocardial Protection System Console" and the study focuses on validating a disinfection protocol for its water circulation system. There is no mention of an algorithm or AI functionality for standalone performance testing.

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

The ground truth used for the disinfection efficacy testing is microbiological quantification. This involves:

Inoculation: Introducing a known concentration of target microorganisms (P. aeruginosa and M. chimaera) onto surfaces or into test systems.
Disinfection: Applying the validated disinfection protocol.
Recovery and Enumeration: Quantifying the number of surviving microorganisms after disinfection using standard microbiological techniques (e.g., plating and colony counting).
Log Reduction Calculation: Comparing the initial microbial load to the post-disinfection load to determine the log reduction.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not a machine learning or AI device that requires training data. The study is a validation of a disinfection protocol.

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

This section is not applicable for the same reason as point 8.

Summary

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October 1, 2018

Quest Medical, Inc. % Ronald Warren Sr. Director, Regulatory Affairs Experien Group 224 Airport Parkway San Jose, California 95110

Re: K173716

Trade/Device Name: MPS2 Myocardial Protection System Console Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchanger Regulatory Class: Class II Product Code: DTR, DWC Dated: August 22, 2018 Received: August 23, 2018

Dear Ronald Warren:

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 Actinclude 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Fernando Aguel -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173716

Device Name MPS2 Myocardial Protection System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6352 Fax: 469-795-2352

Contact Person:

Ronald S. Warren Vice President, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-505-3926 Fax: 408-400-0865 Email: ron@experiengroup.com

Date Prepared: September 25, 2018

DEVICE INFORMATION [807.92(a)(2)]

Classification: Class II per 21CFR§870.4240

Product Code: DTR

Trade Name: MPS2 Myocardial Protection System Console

Generic/Common Name: Myocardial Perfusion System

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

MPS2 Myocardial Protection System Console (K041979)

DEVICE DESCRIPTION [807.92(a)(4)]

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

The MPS System, MPS console and the MPS delivery set used together, is 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.

The proposed MPS2 will have the same indication for use as the predicate MPS2 system as cleared under K041979.

SUBSTANTIAL EQUIVALENCE

This labeling modification for the MPS2 is being submitted in order to provide end-user instructions related to the disinfection of the MPS2 water circulation system. Due to emerging concerns with sources of patient infection during cardiothoracic surgery and increased efforts to reduce biofilm formation in devices that may contribute to microbial contamination in the clinical setting, many perfusionists and other end-users are now requesting validated disinfection protocols. To address this clinical need, Quest Medical has validated a disinfection procedure, the details of which are to be added to the product labeling. This proposed change to product labeling summarized in this Traditional 510(k) premarket notification does not affect the intended use or the indication for use, and does not alter the fundamental scientific technology of the device. The modified MPS2 shares the same indication for use and the same technological characteristics as the predicate device. Therefore, based on the similarities between the two devices, the modified MPS2 is substantially equivalent to the predicate MPS2 device previously cleared under K041979.

PERFORMANCE DATA [807.92(b)]

All necessary bench testing was conducted on the proposed MPS2 to support a determination of substantial equivalence to the predicate device. The disinfection method added to the product labeling was validated based on relevant guidance from AAMI TIR12. AAMI TIR30. FDA Guidance on Reprocessing Medical Devices, and the FDA Advisory Panel meeting on Circulatory System Devices, which occurred on June 2-3, 2016. The disinfection method meets requirements for an intermediate level of disinfection on Pseudomonas aeruginosa and Mycobacterium chimaera. The disinfection validation demonstrated a 6-Log reduction against the P. aeruginosa and a 3-Log reduction against M. chimaera. The prescribed disinfectant and microbial growth inhibitor were shown to be compatible with the materials of the water circulation system. In addition, this 510(k) notification was supported with results from surface cleaning and disinfection testing and heat exchanger performance testing.

SUMMARY

The proposed MPS2 device 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).