MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260

K041979 · Quest Medical, Inc. · DTR · Sep 2, 2004 · Cardiovascular

Device Facts

• Record ID: K041979
• Device Name: MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
• Applicant: Quest Medical, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Sep 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 arrested or beating heart for use up to six hours in duration.

Device Story

MPS 2 Myocardial Protection System is a console-based device for myocardial perfusion; used by perfusionists and physicians in clinical settings. Device integrates heat exchange, temperature control, pressure control, flow rate control, automatic priming, and air detection/removal. Operates in three flow modes: normal, cyclic, and low volume. System delivers whole blood and/or cardioplegia solutions to the heart. Provides automated management of perfusion parameters to support cardiac surgery. Benefits include precise control of cardioplegic delivery and myocardial protection during procedures up to six hours.

Clinical Evidence

Bench testing only. Performance data included in-house simulated use testing and UL certification to IEC 60601-1:2003 and EN/IEC 60601-1-2:2001 standards. No clinical data presented.

Technological Characteristics

Console-based myocardial perfusion system. Features heat exchanger, temperature/pressure/flow control, and automated priming/air detection. Electrical safety/EMI compliance per UL 60601-1:2003 and IEC 60601-1-2:2002. System includes console and delivery set.

Indications for Use

Indicated for perfusionists and physicians to deliver whole blood and/or cardioplegia solutions to an arrested or beating heart during procedures lasting up to six hours.

Regulatory Classification

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.

Predicate Devices

• MPS Myocardial Protection System (K994274)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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