(60 days)
No
The document describes a gas control unit with regulated oxygen outputs and flow measurements. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on electrical safety, EMC, hardware, and software verification/validation, not on algorithmic performance metrics typical of AI/ML devices.
No
The device provides controlled oxygen flow for specific medical procedures involving an extracorporeal circuit, but it is not described as directly diagnosing, curing, mitigating, treating, or preventing disease, which are criteria for a therapeutic device. It serves as an accessory to a workstation and provides ventilation capability, but it is not itself a standalone therapeutic tool.
No
The device is described as a gas control unit for providing regulated O2 outputs and flow measurements in an ECC circuit, implying a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states it is a "gas control unit" with physical components like input/output ports and interfaces with a workstation, and the performance studies include hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide regulated O2 outputs for a controlled flow of O2 into an ECC (Extracorporeal Circuit). This is a life support or therapeutic function, not a diagnostic one.
- Device Description: The device controls and measures gas flow (O2) within an extracorporeal circuit. It doesn't analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Lack of Diagnostic Function: The description focuses on gas control and measurement for a therapeutic procedure (extracorporeal circulation), not on identifying diseases, conditions, or states of health.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such functions.
N/A
Intended Use / Indications for Use
The Quantum Mini Ventilation Module is intended to provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation.
The following parameters are provided by the Quantum Mini Ventilation Module:
- Control of gas flow (O2)
- Extracorporeal gas flow measurements for O2 .
The Quantum Mini Ventilation Module is only to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.
Product codes
DTX
Device Description
The Quantum Mini Ventilation Module is a gas control unit that is intended to provide independently regulated oxygen outputs for a controlled flow for procedures involving an extracorporeal circuit.
The Quantum Mini Ventilation Module provides a simplified patient ventilation capability. The device consists of a single O2 input port that receives oxygen from the hospital infrastructure and two (2) oxygen outputs that are designed to provide O2 sweep and pO2 Reg.
The device interfaces with and is powered by any model of the Quantum workstation. The Quantum Mini Ventilation Module does not contain any user interface; instead, all measurements are displayed on the Quantum workstation.
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
experienced and trained clinician / 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
No animal testing was submitted to support the substantial equivalence of the Quantum Mini Ventilation Module to the Quantum Ventilation Module (QVM2).
The following non-clinical testing was performed to support the substantial equivalence of the Quantum Mini Ventilation Module to the legally marketed predicate device:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Hardware testing
- Software verification and validation
No clinical data were submitted to support the substantial equivalence of the Quantum Mini Ventilation Module to the Quantum Ventilation Module.
Key Metrics
Not Found
Predicate Device(s)
Quantum Ventilation Module (K202733)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4300 Cardiopulmonary bypass gas control unit.
(a)
Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.(b)
Classification. Class II (performance standards).
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2021
Spectrum Medical Ltd. Colleen Powell Director, Regulatory Affairs Harrier 4, Meteor Business Park, Cheltenham Road East Gloucestershire, Gloucester GL29QL United Kingdom
Re: K210669
Trade/Device Name: Quantum Mini Ventilation Module Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: Class II Product Code: DTX Dated: March 4, 2021 Received: March 5, 2021
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,
Nicole Gillette Assistant Director (Acting) 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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March 4.
2021
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K210669
Device Name Quantum Mini Ventilation Module
Indications for Use (Describe)
The Quantum Mini Ventilation Module is intended to provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation.
The following parameters are provided by the Quantum Mini Ventilation Module:
· Control of gas flow (02)
· Extracorporeal gas flow measurements for O2
The Quantum Mini Ventilation Module is only to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.
Type of Use (Select one or both, as applicable)X 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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SpectrumMedical
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 387082 |
| Fax: | +44 (0) 8452 808 127 |
| Date Summary Prepared: | March 4, 2021 |
| II. DEVICE | |
| Proprietary Name: | Quantum Mini Ventilation Module |
| Common Name: | Gas control unit for heart lung machine |
| Classification Name: | Gas Control Unit, Cardiopulmonary Bypass (21 CFR 870.4330) |
| Regulatory Class: | II |
| Product Code: | DTX |
| 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 Spectrum Medical Ltd.'s Quantum Ventilation Module (K202733).
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Quantum Mini Ventilation Module is a gas control unit that is intended to provide independently regulated oxygen outputs for a controlled flow for procedures involving an extracorporeal circuit.
The Quantum Mini Ventilation Module provides a simplified patient ventilation capability. The device consists of a single O2 input port that receives oxygen from the hospital infrastructure and two (2) oxygen outputs that are designed to provide O2 sweep and pO2 Reg.
The device interfaces with and is powered by any model of the Quantum workstation. The Quantum Mini Ventilation Module does not contain any user interface; instead, all measurements are displayed on the Quantum workstation.
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SpectrumMedical
V. INTENDED USE / INDICATIONS FOR USE
The Quantum Mini Ventilation Module is intended to provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation.
The following parameters are provided by the Quantum Mini Ventilation Module:
- . Control of gas flow (O2)
- Extracorporeal gas flow measurements for O2 .
The Quantum Mini Ventilation Module is only to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed Quantum Mini Ventilation Module and cleared Quantum Ventilation Module have the same intended use as both are designed to monitor parameters in extracorporeal circuits and provide gas delivery to the oxygenator. Both devices have the same manufacturer, clinical application, clinical setting, target user and target patient population. Both devices are powered by and display measurements on the Quantum workstation. Both devices are part of the gas line to the oxygenator in an extracorporeal circuit and can measure oxygen flow.
However, the proposed Quantum Mini Ventilation Module only has one gas supply (oxygen) compared to three gas supplies with the cleared device. The proposed device does not have vacuum management functionality and cannot provide any physiological measurements like the cleared Quantum Ventilation Module. Furthermore, the proposed device does not have a display and can only be controlled by the Quantum workstation, while the predicate device has rotary knobs and touchscreen display which can be used for control.
The proposed Quantum Mini Ventilation Module is substantially equivalent with regards to intended use, technology, and performance specifications to the currently cleared Quantum Ventilation Module. The differences between the devices 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 Mini Ventilation Module to the Quantum Ventilation Module (QVM2).
The following non-clinical testing was performed to support the substantial equivalence of the Quantum Mini Ventilation Module to the legally marketed predicate device:
- . Electrical safety
- Electromagnetic compatibility (EMC) ●
- Hardware testing
- Software verification and validation ●
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SpectrumMedical
VIII. PERFORMANCE DATA – CLINICAL TESTING
No clinical data were submitted to support the substantial equivalence of the Quantum Mini Ventilation Module to the Quantum Ventilation Module.
IX. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to the predicate device, the Quantum Mini Ventilation Module has been shown to be substantially equivalent to a legally marketed predicate device.