(41 days)
Not Found
No
The summary describes a system with various control functions (temperature, pressure, flow rate, etc.) and flow modes, but there is no mention of AI, ML, or any learning or adaptive capabilities. The testing described is standard performance and safety testing, not related to AI/ML model validation.
Yes
The device is intended to deliver whole blood and/or cardioplegia solutions to the heart, which is a direct medical intervention for therapeutic purposes.
No
The device is described as a system for delivering whole blood and/or cardioplegia solutions to the heart, incorporating functions like heat exchange, temperature control, pressure control, and flow rate control. Its purpose is to perform a therapeutic function (myocardial protection), not to diagnose a condition.
No
The device description explicitly states it 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". This indicates a physical hardware system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver whole blood and/or cardioplegia solutions to either an arrested or beating heart". This describes a device used in vivo (within the body) for therapeutic or procedural purposes, not for examining specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details functions related to controlling and delivering fluids to the heart (heat exchange, temperature/pressure/flow control, priming, air detection). These are all functions of a device used during a medical procedure on a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on delivering fluids directly to the heart during a medical procedure.
N/A
Intended Use / Indications for Use
The Quest Medical MPS® 2 Myocardial Protection System, consisting of the MPS 2 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 myocardium on either an arrested or beating heart for use up to six hours in duration.
Product codes
DTR
Device Description
EVIOL DEGORIE 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
myocardium
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
Inhouse performance testing data, including simulated use testing, and UL testing data for certification to UL/IEC 60601-1: 2003 and EN/IEC 60601-1-2:2001 are available. The MPS 2 console passed all in-house testing acceptance criteria. UL certified the MPS 2 console as conforming to IEC 60601-1-2:2002 and UL 60601-1:2003 standards.
Key Metrics
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION: 1.
| Name: | Quest Medical, Inc |
|---|---|
| Address: | One Allentown Parkway |
| Telephone: | 972-390-9800 x 320 |
| Fax Number: | 972-390-2881 |
| Contact Person: | Jane Ann Martin, RA Mgr. |
| Date Prepared: | August 9, 2004 |
DEVICE INFORMATION: 2.
Proprietary Name: Common/Usual Names: Classification:
MPS® 2 Myocardial Protection System Console Myocardial Perfusion System Class II, 21 CFR 870.4240
- MPS Myocardial Protection System: K994274 PREDICATE DEVICE: 3.
DEVICE DESCRIPTION: 4.
EVIOL DEGORIE 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.
INTENDED USE 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 and physiolans to doirver where anded or beating heart for use up to six hours in duration.
6. TECHNOLOGICAL CHARACTERISTICS: From FDA memo #K86-3 flowchart:
1 - Does new device have the same indication statement? Yes. The MPS 2 has the same intended use as the predicate.
2 – Does the new device have the same technological characteristics? No. The modified device has additional user options.
3 - Could the new characteristics affect safety or effectiveness? Yes.
4 – Do the new characteristics raise new type of safety or effectiveness questions? No. The safety and effectiveness questions are the same as for the predicate
5 - Do accepted scientific methods exist for assessing effects of the new characteristics? Yes. The same in-house test methods were used as in the original 510(K) submission. UL Laboratories testing methods were used for the electrical / EMI evaluations.
6 - Is performance data available to assess effects of new characteristics? Yes. Inhouse performance testing data, including simulated use testing, and UL testing data for certification to UL/IEC 60601-1: 2003 and EN/IEC 60601-1-2:2001 are available.
7 - Does performance data demonstrate equivalence? Yes. The MPS 2 console passed all in-house testing acceptance criteria. UL certified the MPS 2 console as conforming to IEC 60601-1-2:2002 and UL 60601-1:2003 standards.
The MPS 2 console is substantially equivalent to the MPS console. 7. CONCLUSION:
80 MPS is a registered trademark of Quest Medical, Inc.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2004
Quest Medical, Inc. c/o Ms. Jane Ann Martin Regulatory Affairs Manager One Allentown Parkway Allen, TX 75002
Re: K041979
MPS® 2 Myocardial Protection System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchanger Regulatory Class: Class II (two) Product Code: DTR Dated: August 9, 2004 Received: August 10, 2004
Dear Ms. Martin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of 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). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Jane Ann Martin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Touse be actived that Fermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or cars is with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematted 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), please 11 you teber of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Donna E. Kirchner
Image /page/2/Picture/5 description: The image shows a signature next to the text "Br", "Di", and "Di". The signature is a stylized series of curved lines and loops, appearing to be handwritten. The text is aligned vertically to the right of the signature, with each two-letter word on a separate line.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K041979_____________________________________________________________________________________________________________________________________
MPS® 2 Myocardial Protection System_ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Quest Medical MPS® 2 Myocardial Protection System, consisting of the MPS 2 The Quest Medical MPS Delivery Set together, is intended for use by perfusionists and Oblisore and the MF O Doliver whole blood (from any arterial source) and / or cardioplegia solutions to priyalians to ocirer whole blood it on either an arrested or beating heart for use up to six hours in duration
®MPS is a registered trademark of Quest Medical, Inc.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vanne R. Vochner
(Division Sign-Off) Oivision of Cardiovascular Devices
510(k) Number KO41979