(193 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on speed control and hardware/software integration without mentioning adaptive or learning algorithms.
Yes
The "Intended Use" section states that the device is "intended for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speedcontrolled pumping through the extracorporeal circuit". This describes a medical intervention to support a patient's physiological function, specifically relating to cardiopulmonary bypass, which is a therapeutic process.
No
The device is described as a "speed control device" for pumping blood through an extracorporeal circuit during cardiopulmonary bypass. Its function is to manage blood flow, not to diagnose a condition or disease.
No
The device description explicitly states it is a "speed control device" and mentions "Hardware testing" in the performance studies, indicating it includes physical components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "speedcontrolled pumping through the extracorporeal circuit for typical durations of six hours or less" during cardiopulmonary bypass. This describes a device used on a patient to manage blood flow, not a device used to test samples from a patient to diagnose a condition.
- Device Description: The description reinforces its function as a pump control device for circulating blood in an extracorporeal circuit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, 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 the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely mechanical and related to managing blood flow during surgery.
N/A
Intended Use / Indications for Use
The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speed-controlled pumping through the extracorporeal circuit for typical durations of six hours or less.
Product codes
DWA
Device Description
The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping arterial blood through the cardiopulmonary bypass circuit. The Quantum Centrifugal Drive is available in two models - High Pressure and Low Pressure.
The Quantum Centrifugal Drive is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The Quantum Centrifugal Drive is magnetically coupled exclusively with Quantum Pureflow Centrifugal Blood Pumps, designed and manufactured by Qura s.r.l. The operation of the Quantum Centrifugal Drive is managed from the Quantum Workstation (K163657).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No animal testing was submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Centrifugal Drive to the legally marketed predicate:
- Electrical safety .
- Electromagnetic compatibility (EMC) ●
- Electrosurgery interference ●
- Hardware testing ●
- Software verification and validation ●
No clinical data were submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2020
Spectrum Medical Ltd Colleen Powell Director of Regulatory Affairs Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester. GL2 9OL Gb
Re: K192838
Trade/Device Name: Quantum Centrifugal Drive Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA Dated: April 8, 2020 Received: April 9, 2020
Dear Colleen Powell:
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 Act include 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 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
1
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Quantum ஒருநீடுள்ளும் புர்நீச HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known) K192838
Device Name Quantum Centrifugal Drive
Indications for Use (Describe)
The Quantum Centrifygal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speed-controlled pumping through the extracorporeal circuit for typical durations of six hours or less.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. SUBMITTER
| Name: | Spectrum Medical Ltd |
|---|---|
| Address: | Harrier 4, Meteor Business Park |
| Cheltenham Road East | |
| Gloucester GL2 9QL | |
| United Kingdom | |
| Contact Person: | Colleen Powell, Director of Regulatory Affairs |
| Phone: | +44 (0) 1242 650 120 |
| Fax: | +44 (0) 8452 808 127 |
| Date Summary Prepared: | October 2, 2019 |
II. DEVICE
| Proprietary Name: | Quantum Centrifugal Drive |
|---|---|
| Common Name: | Cardiopulmonary bypass pump speed control |
| Classification Name: | Control, Pump Speed, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWA |
| Panel: | Office of Health Technology 2 (OHT2 Cardiovascular Devices) / |
| Division of Health Technology 2B (Circulatory Support, Structural | |
| and Vascular Devices) |
III. PREDICATE DEVICE
The predicate device for this submission is the Sorin/LivaNova Stöckert Centrifugal Pump (K011838).
IV. DEVICE DESCRIPTION
The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping arterial blood through the cardiopulmonary bypass circuit. The Quantum Centrifugal Drive is available in two models - High Pressure and Low Pressure.
The Quantum Centrifugal Drive is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The Quantum Centrifugal Drive is magnetically coupled exclusively with Quantum Pureflow Centrifugal Blood Pumps, designed and manufactured by Qura s.r.l. The operation of the Quantum Centrifugal Drive is managed from the Quantum Workstation (K163657).
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V. INTENDED USE / INDICATIONS FOR USE
The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speedcontrolled pumping through the extracorporeal circuit for typical durations of six hours or less.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Spectrum Medical Ltd.'s Quantum Centrifugal Drive and Sorin/LivaNova's Stöckert Centrifugal Pump have the same intended use, indications for use, clinical setting, target patient population, and principle of operation. Both devices magnetically couple to a disposable centrifugal pump head.
However, the Quantum Centrifugal Drive has two different models and can generate a higher number of revolutions per minute (RPM) compared to the predicate device. The Quantum Centrifugal Drive can also be controlled from the touchscreen interface on the Quantum Workstation or by using rotating knobs on the Quantum Pump Control Module. While both devices contain safety features to protect against low RPMs, this protection is automatically controlled by software on the Quantum Centrifugal Drive.
These differences in technological characteristics do not raise new issues of safety or effectiveness.
VII. PERFORMANCE DATA - NON-CLINICAL TESTING
No animal testing was submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Centrifugal Drive to the legally marketed predicate:
- Electrical safety .
- Electromagnetic compatibility (EMC) ●
- Electrosurgery interference ●
- Hardware testing ●
- Software verification and validation ●
VIII. PERFORMANCE DATA - CLINICAL TESTING
No clinical data were submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump.
IX. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Centrifugal Drive has been shown to be substantially equivalent to a leqally marketed predicate device.
CONFIDENTIAL