(163 days)
No
The description focuses on electro-mechanical pumping, pressure sensors, and valve control, with no mention of AI or ML terms or concepts. The performance studies are functional tests, not related to AI/ML model performance.
Yes
The device delivers whole blood and/or cardioplegia solutions to the heart during open heart surgery. This is a medical intervention aimed at treating a health condition (heart surgery), thus qualifying it as a therapeutic device.
No
Explanation: The device is intended for delivering whole blood and/or cardioplegia solutions to the heart during open heart surgery. While it has "pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process," this diagnostic function is for the internal operation of the pump itself, not for diagnosing a patient's medical condition. Its primary function is therapeutic delivery, not diagnostic assessment of the patient.
No
The device description explicitly details hardware components such as an electro-mechanical pumping device, stepper motors, pressure sensors, pistons, and disposable cassettes. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "deliver[ing] whole blood and / or cardiopleqia 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 pumping and mixing fluids for delivery to the heart. This aligns with a surgical delivery system, not a device for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body during surgery.
N/A
Intended Use / Indications for Use
The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist 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
Product codes
DWK, DTR, DXS, KRL, DRS, DWF
Device Description
The MPS is designed to deliver whole blood or cardioplegia solution. The MPS pumping subsystem coordinates the pumping and mixing of the blood and additives to deliver the desired composition of cardioplegia solution. The pumping subsystem consist of an electro-mechanical pumping device acting on a variety of disposable cassettes to deliver fluid. A set of four pump pistons, each driven by a stepper motor, displace the contents of the mechanically restrained fluid filled cassettes. Pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process. The main blood pump consist of two motor driven pistons and a symmetrically designed pump cassette with two chambers. Each chamber is designed to alternately fill and pump blood. A set of valves operate on channels formed within the cassette to control the flow of fluids into and out of the chamber. As one chamber is filled, the other chamber is delivering solutions. This overlapping and alternating operation of the pumping system provides an essentially constant fluid output
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
perfusionist and physicians; open heart surgery
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 Test: The function test data to support the safety and efficacy of the device has not changed from the predicate device submission. Please refer to paragraph 3 of pages 15 – 16 of TAB 20 of Volume 4 of original submission (#K953838). A copy has been enclosed for your convenience.
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 100uL 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)
K953838, K810079, K923311, K904171, K864619, 802147, K862836
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
QUEST MYOCARDIAL PROTECTION SYSTEM PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
General Information I.
| A. Generic Name: | Cardioplegia Delivery System |
|---|---|
| B. Trade Name of Device: | MPS® Perfusion Assisted Direct |
| Coronary Artery Bypass | |
| (PADCAB) | |
| C. Applicant's Name and Address: | Quest Medical, Inc. |
| One Allentown Pkwy | |
| Allen, TX 75002 | |
| D. Premarket Notification Number: | Not assigned to date |
II. Indication for Use
The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist and physicians to deliver whole blood (from any arterial source) and / or cardiopleqia solutions to the heart during open heart surgery on either an arrested or beating heart
III. Device Description
The MPS is designed to deliver whole blood or cardioplegia solution. The MPS pumping subsystem coordinates the pumping and mixing of the blood and additives to deliver the desired composition of cardioplegia solution. The pumping subsystem consist of an electro-mechanical pumping device acting on a variety of disposable cassettes to deliver fluid. A set of four pump pistons, each driven by a stepper motor, displace the contents of the mechanically restrained fluid filled cassettes. Pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process. The main blood pump consist of two motor driven pistons and a symmetrically designed pump cassette with two chambers. Each chamber is designed to alternately fill and pump blood. A set of valves operate on channels formed within the cassette to control the flow of fluids into and out of the chamber. As one chamber is filled, the other chamber is delivering solutions. This overlapping and alternating operation of the pumping system provides an essentially constant fluid output
1
IV. Device Classification: Class II
Quest Myocardial Protection System PADCAB is 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 | 21 CFR 880.5725 |
|---|---|
| 74 DTR Cardiovascular bypass, Heat exchanger | 21 CFR 870.4240 |
| 74 DRS Transducer, Blood-Pressure, Extravascular | 21 CFR 870.285 |
| 74 DXS Cardiopulmonary bypass coronary pressure | |
| gauge | 21 CFR 870.4310 |
| 74 DWF Cardiopulmonary bypass vascular catheter, | |
| cannula, or tubing | 21 CFR 870.4210 |
| 74 KRL Cardiopulmonary bypass bubble detector | 21 CFR 870.4205 |
V. Safety and Effectiveness
Substantial Equivalence:
This device has been shown to be substantially equivalent to the Quest MPS Myocardial Protection System #K953838
VI. Other Safety and Effectiveness Data
| Materials: | Fluid contact materials are comply with ISO 10993-1
"Biological Evaluation of Medical Devices – Part 1:
Evaluation and Testing" for short term devices. |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization: | Validated Ethylene Oxide Sterilization per AMI / ISO
11135 – 1994 and EN 550 SAL of 10-6 |
| Pyrogenicity: | Non-Pyrogenic per USP Pyrogen Test (LAL) |
Functional Test
The function test data to support the safety and efficacy of the device has not changed from the predicate device submission. Please refer to paragraph 3 of pages 15 – 16 of TAB 20 of Volume 4 of original submission (#K953838). A copy has been enclosed for your convenience.
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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 curved tail extending from the bottom right of the circle. The black square provides a high contrast background, making the white letter stand out.
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.
VI. Other Safety and Effectiveness Data:
| 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
. .
| 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 100uL 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. | |
| QUEST Medical, Inc. | |
| 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. |
3
Image /page/3/Picture/0 description: The image shows a white letter Q inside of a black square. The letter Q is stylized with a curved tail extending from the bottom right of the circle. The black square provides a high contrast background, making the white letter stand out.
QUEST Medical, Inc.
、日本の中古車を行っています。 2007年の1000
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2000
Mr. Malcolm Lewis Regulatory Affairs Specialist Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211
Re: K994274 R994274
Trade Name: Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (PADCAB) Regulatory Class: II (two) Product Codes: DWK, DTR, DXS, KRL, DRS, and DWF Dated: March 21, 2000 Received: March 29, 2000
Dear Mr. Lewis:
We have reviewed your Section 510(k) notification of intent to market we nave reviews your and we have determined the device is che device forcerched arouter for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure, co regarif mariese pay 28, 1976, the enactment date of the Interstate commerce prior or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In acturante with the primay, therefore, market the device, subject to the general controls provisions of the Act. The general controls che general conclude requirements for annual registration, provisions of thes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special It your device it cremarket Approval), it may be subject to such controlor of Craces - Existing major regulations affecting your device additional concerner code of Federal Regulations, Title 21, Parts 800 can be roama intially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such inopocions. Failure to comply with the GMP regulation may result in assumptions: Farials of Othconcerning your device in the Federal Register. Please note: this conse to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page - 2 - Mr. Lewis
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), or for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sum E. Avery
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
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STATEMENT OF INTENDED USE FORM
510(K) #: Not assigned to date
Device Name: Quest MPS® Perfusion Assisted Direct Coronary Artery Bypass (PADCAB)
Indications for Use:
The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist and physicians to deliver whole blood (from any arterial source) and / or cardioplegia solutions to the head during open heart surgery on either an arrested or beating heart
Rita Q. Samper de
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K994274 510(k) Number .
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use _ X
Over-The -Counter Use_