(300 days)
Not Found
No
The description focuses on standard medical device functions like temperature, pressure, and flow control, with no mention of AI or ML.
Yes
The device is intended to deliver whole blood and/or cardioplegia solutions to the heart during open-heart surgery, directly participating in the care and treatment of a patient's condition.
No
The device is described as a system for delivering whole blood and/or cardioplegia solutions to the heart during open heart surgery. Its functions include heat exchange, temperature control, pressure control, and flow rate control, all of which are related to therapy delivery, not diagnosis. The performance studies also focus on disinfection and performance testing, not diagnostic accuracy.
No
The device description explicitly states it consists of a "console" and a "Delivery Set," which are physical hardware components with functions like heat exchange, temperature control, and flow control.
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 the heart during open heart surgery. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device description focuses on functions related to controlling and delivering fluids (heat exchange, temperature/pressure/flow control, etc.). These are all related to the delivery of substances to the body, not the analysis of samples taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The device is clearly intended for use during a surgical procedure to protect the heart, which falls under the category of a therapeutic or procedural medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 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 heart during open heart surgery on either an arrested or beating heart for use up to six hours in duration.
Product codes
DTR, DWC
Device Description
The MPS 2 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.
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
Perfusionists 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
The disinfection method added to the product labeling was validated based on relevant guidance from AAMI TIR12, AAMI TIR30, FDA Guidance on Reprocessing Medical Devices, and the FDA Advisory Panel meeting on Circulatory System Devices, which occurred on June 2-3, 2016. The disinfection method meets requirements for an intermediate level of disinfection on Pseudomonas aeruginosa and Mycobacterium chimaera. The disinfection validation demonstrated a 6-Log reduction against the P. aeruginosa and a 3-Log reduction against M. chimaera. The prescribed disinfectant and microbial growth inhibitor were shown to be compatible with the materials of the water circulation system. In addition, this 510(k) notification was supported with results from surface cleaning and disinfection testing and heat exchanger performance testing.
Key Metrics
6-Log reduction against Pseudomonas aeruginosa, 3-Log reduction against Mycobacterium chimaera.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 1, 2018
Quest Medical, Inc. % Ronald Warren Sr. Director, Regulatory Affairs Experien Group 224 Airport Parkway San Jose, California 95110
Re: K173716
Trade/Device Name: MPS2 Myocardial Protection System Console Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchanger Regulatory Class: Class II Product Code: DTR, DWC Dated: August 22, 2018 Received: August 23, 2018
Dear Ronald Warren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Fernando Aguel -S
for 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)
K173716
Device Name MPS2 Myocardial Protection System
Indications for Use (Describe)
The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 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 heart during open heart surgery on either an arrested or beart for use up to six hours in duration.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6352 Fax: 469-795-2352
Contact Person:
Ronald S. Warren Vice President, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-505-3926 Fax: 408-400-0865 Email: ron@experiengroup.com
Date Prepared: September 25, 2018
DEVICE INFORMATION [807.92(a)(2)]
Classification: Class II per 21CFR§870.4240
Product Code: DTR
Trade Name: MPS2 Myocardial Protection System Console
Generic/Common Name: Myocardial Perfusion System
PREDICATE DEVICE(S) [807.92(a)(3)]
MPS2 Myocardial Protection System Console (K041979)
DEVICE DESCRIPTION [807.92(a)(4)]
The MPS 2 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.
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INDICATIONS FOR USE [807.92(a)(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 heart during open heart surgery on either an arrested or beating heart for use up to six hours in duration.
The proposed MPS2 will have the same indication for use as the predicate MPS2 system as cleared under K041979.
SUBSTANTIAL EQUIVALENCE
This labeling modification for the MPS2 is being submitted in order to provide end-user instructions related to the disinfection of the MPS2 water circulation system. Due to emerging concerns with sources of patient infection during cardiothoracic surgery and increased efforts to reduce biofilm formation in devices that may contribute to microbial contamination in the clinical setting, many perfusionists and other end-users are now requesting validated disinfection protocols. To address this clinical need, Quest Medical has validated a disinfection procedure, the details of which are to be added to the product labeling. This proposed change to product labeling summarized in this Traditional 510(k) premarket notification does not affect the intended use or the indication for use, and does not alter the fundamental scientific technology of the device. The modified MPS2 shares the same indication for use and the same technological characteristics as the predicate device. Therefore, based on the similarities between the two devices, the modified MPS2 is substantially equivalent to the predicate MPS2 device previously cleared under K041979.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the proposed MPS2 to support a determination of substantial equivalence to the predicate device. The disinfection method added to the product labeling was validated based on relevant guidance from AAMI TIR12. AAMI TIR30. FDA Guidance on Reprocessing Medical Devices, and the FDA Advisory Panel meeting on Circulatory System Devices, which occurred on June 2-3, 2016. The disinfection method meets requirements for an intermediate level of disinfection on Pseudomonas aeruginosa and Mycobacterium chimaera. The disinfection validation demonstrated a 6-Log reduction against the P. aeruginosa and a 3-Log reduction against M. chimaera. The prescribed disinfectant and microbial growth inhibitor were shown to be compatible with the materials of the water circulation system. In addition, this 510(k) notification was supported with results from surface cleaning and disinfection testing and heat exchanger performance testing.
SUMMARY
The proposed MPS2 device is substantially equivalent to the predicate device.