Quantum Pump Console

K173834 · Spectrum Medical , Ltd. · DTQ · May 25, 2018 · Cardiovascular

Device Facts

• Record ID: K173834
• Device Name: Quantum Pump Console
• Applicant: Spectrum Medical , Ltd.
• Product Code: DTQ · Cardiovascular
• Decision Date: May 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Device Story

Quantum Pump Console is a modular heart-lung machine for extracorporeal blood oxygenation during surgery. System comprises a frame, power supply with battery backup, roller pumps (4", 6", 8"), pump control module, diagnostic module, and central workstation. Operated by qualified medical professionals in surgical settings. Inputs include manual control via centralized touchscreen interface or integrated knobs on pump control module. Device transforms user inputs into mechanical pump operation to circulate blood. Output is controlled extracorporeal blood flow. Centralized interface replaces multiple individual pump screens found in traditional systems. Benefits include integrated control and monitoring of bypass procedures.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical testing, including electrical safety, electromagnetic compatibility (EMC), electrosurgery interference, hardware testing of printed circuit boards, and software verification and validation.

Technological Characteristics

Modular heart-lung machine; roller pumps (4", 6", 8"); centralized touchscreen workstation; integrated pump control module with knobs; battery backup. Software-controlled. Bench testing performed for electrical safety, EMC, and electrosurgery interference.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring extracorporeal blood oxygenation for up to 6 hours. Intended for use by qualified medical professionals experienced in heart-lung machine operation.

Regulatory Classification

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.

Predicate Devices

• Stöckert S5 System (K060053)

Submission Summary (Full Text)

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May 25, 2018

Spectrum Medical Ltd Mark Drain Chief Financial Officer Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GL2 9QL GB

Re: K173834

Trade/Device Name: Quantum Pump Console Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: April 24, 2018 Received: April 25, 2018

Dear Mark Drain:

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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Nicole G. Ibrahim -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) K173834

Device Name Quantum Pump Console

Indications for Use (Describe)

The Quantum Pump Console is indicated for use for up to 6 hours in 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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SpectrumMedical

K173834 page 1 of 3 Quantum Pump Console 510(k) Summary

### I. SUBMITTER

Spectrum Medical Ltd Harrier 4, Meteor Business Park Cheltenham Road East Gloucester GL2 9QL United Kingdom

Phone: [phone] Fax: [phone]

Contact Person: Mr. Mark Drain, Chief Financial Officer Date Summary Prepared: December 15, 2017

#### II. DEVICE

| Proprietary Name: | Quantum Pump Console |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Heart-Lung Machine |
| Classification Name: | Console, Heart-Lung Machine, Cardiopulmonary Bypass<br>(21 CFR 870.4220) |
| Regulatory Class: | II |
| Product Code: | DTQ |
| Panel: | Office of Device Evaluation (ODE) /<br>Division of Cardiovascular Devices (DCD)<br>Circulatory Support Devices Branch (CSDB) |

#### III. PREDICATE DEVICE

Stöckert S5 System (K060053) currently marketed by LivaNova

### IV. DEVICE DESCRIPTION

The Quantum Pump Console is a configurable heart-lung machine consisting of various components controlled by a central workstation. The system is intended to be used in any surgery in which the patient's blood is being oxygenated extracorporeally. The modular system consists of a frame, power supply with battery backup, roller pumps, pump control module, diagnostic module and a central workstation with the user interface.

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The roller pumps are available in three sizes (4", 6" and 8") and can be controlled via a centralized interface on the Quantum Workstation touchscreen or through the Quantum Pump Console, which contains five knobs and displays in one integrated console.

#### V. INTENDED USE / INDICATIONS FOR USE

The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Spectrum Medical Ltd's Quantum Pump Console and LivaNova's S5 System have the same intended use/indications for use, clinical setting, target patient population, principle of operation for the pumps and same pump speed and accuracy.

Whereas the S5 System uses multiple screens for its interface and each pump has an individual screen, the Quantum Pump Console uses a single, centralized touchscreen interface. The S5 System can only control the pumps with a rotating knob on each pump while the Quantum Pump Console can control the pumps with its centralized user interface or with rotating knobs on a single integrated pump control module.

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 Pump Console to the S5 System. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Pump Console to the S5 System:

- . 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 Pump Console to the S5 System.

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SpectrumMedical

Quantum Pump Console 510(k) Summary

# IX. CONCLUSIONS

Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Pump Console has been shown to be substantially equivalent to legally marketed predicate devices.