(41 days)
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 either an arrested or beating heart for use up to six hours in duration.
The MPS® 2 Myocardial Protection System 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.
The provided text describes the acceptance criteria and study for the MPS 2 Myocardial Protection System, a medical device used for myocardial perfusion. This device is not an AI-powered diagnostic tool, but rather a physical system with incorporated functions for heat exchange, temperature control, pressure control, flow rate control, automatic priming, and air detection/removal. Therefore, many of the typical questions regarding AI/ML device studies (e.g., ground truth for training set, MRMC studies, effect size of AI assistance) are not applicable.
Here's the information gleaned from the text for this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In-House Testing Acceptance Criteria: The device must pass all in-house testing acceptance criteria. (Specific criteria not detailed, but implied to cover the operational functions like heat exchange, temperature/pressure/flow control, priming, air detection, and three flow modes). | The MPS 2 console passed all in-house testing acceptance criteria. |
| UL/IEC 60601-1: 2003 and EN/IEC 60601-1-2:2001 Standards Conformance: The device must conform to these electrical and electromagnetic compatibility safety standards. | UL certified the MPS 2 console as conforming to IEC 60601-1-2:2002 and UL 60601-1:2003 standards. |
| Equivalence to Predicate Device: The new characteristics of the device should not raise new safety or effectiveness questions, and performance data must demonstrate equivalence to the predicate MPS console (K994274). | The safety and effectiveness questions are the same as for the predicate. Performance data, including in-house performance testing and simulated use testing, demonstrated equivalence. The MPS 2 console is substantially equivalent to the MPS console. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of this physical device (a myocardial protection system), the concept of "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of diagnostic data is not directly applicable. The "test set" constitutes the device prototypes themselves undergoing various performance and safety tests.
- Sample Size for Test Set: Not explicitly stated as a number of "samples" in the traditional sense, but refers to the physical devices (MPS 2 consoles) that underwent testing.
- Data Provenance: The testing was "in-house" and specific "UL Laboratories testing methods" were used. This suggests a controlled laboratory environment rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the evaluation of a physical medical device like the MPS 2 System. "Ground truth" is established by direct measurement and adherence to engineering and safety standards, rather than expert interpretation of diagnostic images or clinical data. The "experts" involved would be engineers, technicians, and potentially regulatory compliance officers.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in diagnostic studies to resolve discordant expert opinions on ground truth. For a physical device, performance is objectively measured against predefined engineering specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. MRMC studies are typically used to assess the impact of AI assistance on human reader performance in diagnostic tasks. This device is a standalone medical system, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, a "standalone" evaluation of the device's technical performance was the primary focus. The device's functions (heat exchange, temperature control, etc.) were tested independently of human operation to ensure they met specifications. The conclusion specifically states: "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." This demonstrates its standalone performance against established benchmarks.
7. The Type of Ground Truth Used
The ground truth for this device's evaluation was based on:
- Engineering Specifications and Performance Standards: The device's internal performance parameters (e.g., temperature accuracy, flow rate stability, pressure control limits) were measured against its design specifications.
- International Safety and Quality Standards: Conformance to UL/IEC 60601-1:2003 and EN/IEC 60601-1-2:2001, which are widely accepted standards for medical electrical equipment.
- Equivalence to Predicate Device: The predicate device serves as a benchmark for established safety and effectiveness.
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI/ML system that undergoes "training" with data. Its design and manufacturing process would involve engineering design, prototyping, and iterative testing, but not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI/ML model. The "ground truth" for the device's underlying design and functionality would stem from biomedical engineering principles, clinical requirements for myocardial protection, and established safety standards.
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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.
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Public Health Service
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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.
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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
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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): 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
§ 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).