(203 days)
No
The description focuses on microprocessor-based control of physical parameters (mixing, pumping, pressure, temperature) and does not mention any AI/ML capabilities. The "Mentions AI, DNN, or ML" field is also "Not Found".
Yes.
The device is used for "delivery of cardioplegic solutions to the heart during open heart surgery," which directly treats a physiological condition (heart during surgery).
No
The device is described as delivering cardioplegic solutions, monitoring and controlling mixing, pumping, pressure, and heating/cooling of these solutions. It also performs functional tests related to delivery and performance. There is no mention of it diagnosing a condition or disease.
No
The device description explicitly mentions hardware components such as a control unit, disposable cassette sets, heat exchanger, additive cassettes, extension sets, microprocessor-based system, pumps, and a water circulation system. It is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "delivery of cardioplegic solutions to the heart during open heart surgery." This is a therapeutic and surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system for mixing, pumping, and controlling the temperature of solutions delivered directly to the heart. This aligns with a surgical delivery system, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Quest MPS is a medical device used for surgical delivery, not an IVD.
N/A
Intended Use / Indications for Use
The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery
Product codes
DWK, DTR, DXS, KRL, DRS, DWF
Device Description
The Quest MPS device consists of a microprocessor based system for monitoring and controlling the mixing, pumping, pressure, and the heating and cooling of cardioplegia solutions. Sterile disposables are part of the system as well as pumping cassettes, and a heat exchanger with an integral bubble trap. The MPS includes a primary pump where blood crystalloid solutions are mixed at defined ratios, and two secondary pumps for the addition of an arresting agent and other physician-defined additives. The device also contains a water circulation system for supplying warm or cold water to the heat exchanger to achieve user-defined cardioplegia temperatures.
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
Not Found
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
Functional Testing:
Leak Test Requirements: No leaks at 15 psi.
Pull Test Requirements: 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.
Package Integrity: 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.
Accelerated Aging: One (1) year with no effects on performance characteristics.
Heat Exchanger Corrosion Test: Resists corrosion for periods of up to 72 hours.
Air In-line Detection: Detects 100 microliter size air bubbles in blood and saline.
Hemolytic Characteristics: 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
Pressure Control Delivery: 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.
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 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
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 required proportion
Delivery Rate Accuracy: 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.
Environmental Tests: Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements.
Electrical Safety: Meets UL/CSA requirements for electrical safety
Temperature Sensor Accuracy: 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.
Key Metrics
Not Found
Predicate Device(s)
K810079, K923311, K904171, K864619, 802147, K862836
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 a white letter Q inside of a black square. The letter Q is stylized with a tail that extends from the bottom right of the circle. The black square provides a stark contrast to the white letter, making it stand out.
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K953838", followed by the number "14". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with distinct shapes for each number.
SUMMARY OF SAFETY AND EFFECTIVENESS
QUEST MYOCARDIAL PROTECTION SYSTEM
1. General Information
| A. Generic Name: | Cardioplegia Delivery System |
|---|---|
| B. Trade Name of Device: | Quest Myocardial Protection System |
| C. Applicant's Name and Address: | Quest Medical, Inc. |
| One Allentown Parkway | |
| Allen, Texas. | |
| D. Pre-market Notification Number: | Not assigned to date |
11. Indications For Use
The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery
111. Device Description
The Quest MPS device consists of a microprocessor based system for monitoring and controlling the mixing, pumping, pressure, and the heating and cooling of cardioplegia solutions. Sterile disposables are part of the system as well as pumping cassettes, and a heat exchanger with an integral bubble trap. The MPS includes a primary pump where blood crystalloid solutions are mixed at defined ratios, and two secondary pumps for the addition of an arresting agent and other physician-defined additives. The device also contains a water circulation system for supplying warm or cold water to the heat exchanger to achieve user-defined cardioplegia temperatures.
IV. Device Classification: Class II.
Classification:
Myocardial Management System™ (MPS) with Heat Exchanger are 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 74 DTR Cardiopulmonary Bypass, Heat Exchanger 74 DXS Gauge, Pressure, Coronary Cardiopulmonary Bypass 74 KRL Cardiopulmonary, Bypass Bubble Detector 74 DRS Transducer, Blood-Pressure, Extravascular 74 DWF Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing
Image /page/0/Picture/14 description: The image shows the text "QUEST Medical, Inc." The word "QUEST" is in a bold, sans-serif font, while the rest of the text is in a lighter, more delicate font. The text appears to be a company name or logo.
1
Image /page/1/Picture/0 description: The image shows a white letter Q on a black square background. The Q is stylized with a curved tail extending from the bottom right of the circle. The letter is bold and easily visible against the contrasting background.
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.
Other Safety and Effectiveness Data: VI.
| Materials: | Fluid contact materials of construction comply with ISO-10993 " Biological |
|---|---|
| Evaluation of Medical Devices - Part 1 : Evaluation and Testing" for short term | |
| devices. | |
| Sterilization: | Validated METHOD-1 Radiation Sterilization SAL 10-6 |
| Pyrogenicity: | Non-Pyrogenic per USP Pyrogen test (LAL) |
Functional Testing
QUEST Medical, Inc
사용 기능 : 100 :
| Leak Test Requirements | No leaks at 15 psi. |
|---|---|
| Pull Test Requirements | 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. | |
| Package Integrity | 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. | |
| Accelerated Aging | One (1) year with no effects on performance |
| characteristics. | |
| Heat Exchanger Corrosion Test | Resists corrosion for periods of up to 72 hours. |
| Air In-line Detection | Detects 100μL size air bubbles in blood and |
| saline. | |
| Hemolytic Characteristics | 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 | |
| Pressure Control Delivery | 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. | |
| 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 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 | |
| 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 required |
| proportion | |
| Delivery Rate Accuracy | 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. | |
| Environmental Tests | Meets temperature, humidity specification |
| requirements and UL External Surface | |
| Temperature Safety requirements. | |
| Electrical Safety | Meets UL/CSA requirements for electrical |
| safety | |
| Temperature Sensor Accuracy | 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. |
.
Image /page/1/Picture/9 description: The image shows a handwritten signature or symbol. The writing appears to be in black ink on a white background. The characters are connected and stylized, making it difficult to discern specific letters or numbers.
2
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 tail that extends from the lower right side of the circle. The black square provides a stark contrast to the white letter, making it stand out.
Image /page/2/Picture/2 description: The image contains a close-up of a handwritten signature or symbol in black ink against a white background. The signature appears to be stylized, with curved lines and possibly a loop or flourish. The overall impression is that of a quick, fluid stroke, suggesting a signature or initial.
QUEST Medical, Inc.