(116 days)
Not Found
No
The description focuses on software-controlled system parameters and monitoring, with no mention of AI or ML capabilities.
Yes
The device is described as delivering whole blood and/or cardioplegia solutions to the heart during surgery, which directly treats the heart by protecting it.
No
The device is described as a system designed to aid in the delivery of cardioplegia solutions during heart surgery, monitoring and controlling the solution's properties, rather than diagnosing a medical condition.
No
The device description explicitly details multiple hardware components including a console, pumps, sensors, and disposables, in addition to the software controller.
Based on the provided information, the Quest Medical MPS 3 Myocardial Protection System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver whole blood and/or cardioplegia solutions to the heart surgery on either an arrested or beating heart." This describes a system used during a surgical procedure to deliver substances to the patient's body.
- Device Description: The description details a system that mixes and delivers fluids (blood, crystalloid, drugs) to the patient. It monitors and controls parameters like flow rate, pressure, and temperature within the delivery system and the patient's body.
- Lack of In Vitro Activity: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The MPS 3 does not perform any analysis or testing of patient specimens in vitro. It is a delivery system used in vivo (within the living body).
Therefore, the MPS 3 Myocardial Protection System is a medical device used in a surgical setting for the delivery of therapeutic substances, not an IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes
DTR, DWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
perfusionists and physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 tests included:
- Sterilization, Shelf-Life, and Packaging Testing
- Cleaning and Disinfection Validation
- Biocompatibility Testing (Cytotoxicity, Sensitization, Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
- Software Verification Tests
- 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
- Human Factors/Usability Test
- Shipping/Transit Tests
- Disposables Performance Test (Leak Test, Tubing Bonding Strength, Tubing Break Force, Tubing Bend Radius, Priming Volume, Simulated Use, Burst Pressure, Activation Force, Retraction Force, Blood Side Leak, Water Side Leak, Port blockage, High Pressure Leak, Efficiency Tests, Pressure Drop, Corrosion Test, Clamp Test)
- Animal Testing
Clinical testing was not performed.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
Device Name
MPS 3 Myocardial Protection System
Indications for Use (Describe)
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.
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)
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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)]
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.
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.