(102 days)
No
The summary describes a hardware clamping system with sensors and software control, but there is no mention of AI or ML algorithms being used for data analysis, decision-making, or control.
No
The device is described as an accessory to a pump console for extracorporeal circulation of blood, specifically an occluder for blood lines, and its function is to manage blood flow. It is not directly treating a disease or condition.
No
The device is described as a "clamping system for the occlusion of both arterial and venous blood lines" used during cardiopulmonary bypass procedures, and while it supports sensors, its primary function is not to diagnose conditions. The sensors provide additional readings for monitoring, but the device itself does not diagnose.
No
The device description explicitly states it is a "clamping system" and mentions "hardware testing of printed circuit boards," indicating it includes physical hardware components beyond just software.
Based on the provided text, the Quantum Smart Occluder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an accessory for extracorporeal circulation of blood during cardiopulmonary bypass procedures. This is a life support procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on its function as a clamping system for blood lines and its integration with a pump console and workstation. While it has sensor attachments, these sensors are used to monitor parameters within the extracorporeal circuit (flow, pressure, level), not to perform diagnostic tests on blood or other biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures for analyzing biological samples to diagnose a condition or disease.
The device is clearly intended for use in a clinical setting during a medical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Product codes (comma separated list FDA assigned to the subject device)
DTQ
Device Description
The Quantum Smart Occluder is a clamping system for the occlusion of both arterial and venous blood lines. The Quantum Smart Occluder is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The operation of the Quantum Smart Occluder is managed from the Quantum Workstation (K163657).
The Quantum Smart Occluder has the availability for 5 sensor attachments:
- . 2 Flow Sensors
- 2 Pressure Sensors
- 1 Level Sensor .
These sensors are identical with the use of the same sensor PCB boards previously cleared with the Quantum Diagnostic Module (K173591) and Quantum Ventilation Module (K181942). These sensor connections can be used in conjunction with the sensor connections used on the Quantum Diagnostic Module (K173591) or Quantum Ventilation Module (K181942) to provide additional readings. Or used solely on the Quantum Smart Occluder to reduce the amount of cabling that is attached to the Quantum Pump Console (K173834).
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
qualified medical professional who is experienced in the operation of this or similar equipment.
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)
The following non-clinical testing was performed to support the substantial equivalence of the Quantum Smart Occluder to the named predicate devices:
- Electrical safety .
- Electromagnetic compatibility (EMC) .
- . Electrosurgery interference
- Hardware testing of printed circuit boards ●
- Software verification and validation ●
No animal testing was submitted to support the substantial equivalence of the Quantum Smart Occluder to the predicate devices.
No clinical data were submitted to support the substantial equivalence of the Quantum Smart Occluder to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "U.S. Food & Drug Administration".
May 24, 2019
Spectrum Medical Ltd Colleen Powell Director of Regulatory Affairs Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GL2 9QL Gb
Re: K190282
Trade/Device Name: Ouantum Smart Occluder Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: February 8, 2019 Received: February 11, 2019
Dear Colleen Powell:
We have reviewed vour 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
1
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 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@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Nicole Ibrahim 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications forUse
510(k) Number (if known)
Device Name
Quantum Smart Occluder
Indications for Use (Describe)
The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Traditional 510(k) Application February 8, 2019
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Spectrum Medical Ltd Quantum Smart Occluder
SpectrumMedical
Traditional 510(k) Application February 8, 2019 Quantum Smart Occluder 510(k) Summary K190282 Page 1 of 3
I. SUBMITTER
Spectrum Medical Ltd Harrier 4, Meteor Business Park Cheltenham Road East Gloucester GL2 9QL United Kingdom
Phone: +44 (0) 1242 650 120 Fax: +44 (0) 8452 808 127
Contact Person: Colleen Powell, Director of Regulatory Affairs
Date Summary Prepared: February 6, 2019
II. DEVICE
| Proprietary Name: | Quantum Smart Occluder |
|---|---|
| Common Name: | Electronic Tube Clamp |
| Classification Name: | Heart-Lung, Machine, Cardiopulmonary Bypass |
| (21 CFR 870.4220) | |
| Regulatory Class: | II |
| Product Code: | DTQ |
| Panel: | Office of Device Evaluation (ODE) / |
| Division of Cardiovascular Devices (DCD) | |
| Circulatory Support Devices Branch (CSDB) |
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III. PREDICATE DEVICE
The Quantum Smart Occluder is an accessory to the Quantum Pump Console. The predicate devices for this submission are listed below: (Primary) - Sorin/LivaNova Stockert S5 System (K060053);
(Reference) - Quantum Pump Console (K173834).
(Reference) - Quantum Diagnostic Module (K173591)
These predicates will be used to determine substantial equivalence.
IV. DEVICE DESCRIPTION
The Quantum Smart Occluder is a clamping system for the occlusion of both arterial and venous blood lines. The Quantum Smart Occluder is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The operation of the Quantum Smart Occluder is managed from the Quantum Workstation (K163657).
The Quantum Smart Occluder has the availability for 5 sensor attachments:
- . 2 Flow Sensors
- 2 Pressure Sensors
- 1 Level Sensor .
These sensors are identical with the use of the same sensor PCB boards previously cleared with the Quantum Diagnostic Module (K173591) and Quantum Ventilation Module (K181942). These sensor connections can be used in conjunction with the sensor connections used on the Quantum Diagnostic Module (K173591) or Quantum Ventilation Module (K181942) to provide additional readings. Or used solely on the Quantum Smart Occluder to reduce the amount of cabling that is attached to the Quantum Pump Console (K173834).
V. INTENDED USE / INDICATIONS FOR USE
The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Spectrum Medical Ltd.'s Quantum Smart Occluder, Sorin/LivaNova Stockert S5 System (K060053), the Quantum Pump Console (K173834) and the Quantum Diagnostic Module (K173591) have the same intended use/indications for use, clinical setting, target user, target patient population, principle of operation. The Quantum Smart Occluder, Sorin/LivaNova Stockert S5 System and the Quantum Diagnostic Module provide measurements via attached sensors for blood flow, bubble detection, pressure and level. For the Quantum Smart Occluder and Quantum Diagnostic Module, the sensors and sensor PCB boards are identical. The Quantum Smart Occluder, Quantum Diagnostic Module and Quantum Pump Console (K173834) are controlled from the Quantum Workstation.
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 Smart Occluder to the predicate devices. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Smart Occluder to the named predicate devices:
- Electrical safety .
- Electromagnetic compatibility (EMC) .
- . Electrosurgery interference
- Hardware testing of printed circuit boards ●
- Software verification and validation ●
VIII. PERFORMANCE DATA - CLINICAL TESTING
No clinical data were submitted to support the substantial equivalence of the Quantum Smart Occluder to the predicate devices.
IX. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Smart Occluder has been shown to be substantially equivalent to legally marketed predicate devices.