Bloom2 Programmable Electrophysiology Stimulator

K173439 · Fischer Medical · JOQ · Mar 29, 2018 · Cardiovascular

Device Facts

• Record ID: K173439
• Device Name: Bloom2 Programmable Electrophysiology Stimulator
• Applicant: Fischer Medical
• Product Code: JOQ · Cardiovascular
• Decision Date: Mar 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1750
• Device Class: Class 2

Intended Use

The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. The Bloom2 Cardiac System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.

Device Story

Bloom2 Cardiac Stimulator System is a programmable pulse generator for diagnostic cardiac stimulation during electrophysiology (EP) procedures. System components include a console (touchscreen interface), a stimulator unit (four independent output channels), and an increment/decrement floater (tactile controls). Operated by trained clinicians in an EP lab; device connects to patient via third-party catheters. Console allows parameter setup; floater provides tactile feedback during protocols. Stimulator delivers electrical pulses to heart tissue to facilitate diagnostic testing. Output allows clinicians to assess cardiac electrical activity and conduction properties. Device is not for long-term pacing support.

Clinical Evidence

No clinical data. Bench testing only. Performance analysis demonstrated equivalence to predicate devices. Electrical safety and electromagnetic compatibility verified via third-party testing to IEC/EN 60601-1 (3.1 Ed), IEC 60601-1-1-2 (4th Ed), and FCC/ICES standards.

Technological Characteristics

Programmable pulse generator with four independent output channels. Interfaces: touchscreen console and tactile floater. Connectivity: connects to third-party catheters. Standards: IEC/EN 60601-1, IEC 60601-1-1-2, FCC CFR 47 Part 15, ICES-001. Software life cycle processes followed.

Indications for Use

Indicated for patients undergoing electrophysiology testing in an electrophysiology laboratory. Not for long-term external pacing support in pacemaker-dependent patients.

Predicate Devices

• StimLab™/EPS320™ Electrophysiology Stimulator System (K072200)
• EPStim Bloom DTU-215B™ Electrophysiology Stimulator System & Accessories (K991293)

Submission Summary (Full Text)

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March 29, 2018

Fischer Medical % Charles Hart Principal Consultant HART Consulting LLC 615 Reid Place Castle Rock, Colorado 80108

Re: K173439

Trade/Device Name: Bloom2 Cardiac Stimulator System Regulation Number: 21 CFR 870.1750 Regulation Name: External Programmable Pacemaker Pulse Generator Regulatory Class: Class II Product Code: JOQ Dated: March 6, 2018 Received: March 6, 2018

Dear Charles Hart:

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 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);

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1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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,

M.A. Hillebrand

for 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) K173439

Device Name Bloom2 Cardiac Stimulator System

#### Indications for Use (Describe)

The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. The Bloom2 Cardiac System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

| Date prepared: | March 27, 2018 | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----|
| Applicant: | Fischer Medical | | |
| Contact person: | Wes Rogers<br>President & CEO<br>Fischer Medical<br>Wheat Ridge, Colorado 80233-3862 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Trade name: | Bloom2 | | |
| Common name: | Electrophysiology Stimulator | Class: | 2 |
| Classification<br>name: | Generator, Pulse, Pacemaker, External<br>Programmable | Product code: | JOQ |
| Predicate<br>devices: | K072200, StimLab™/EPS320™ Electrophysiology Stimulator System<br>& Accessories and K991293, EPStim Bloom DTU-215B™<br>Electrophysiology Stimulator System & Accessories | | |

### Device description:

The Bloom2™ Cardiac Stimulator System (Bloom²) is a programmable pulse generator used for electrophysiological testing of the human heart. The Bloom² has three main components, the Bloom2 Console, the Bloom2 Stimulator Unit and the Bloom2 Increment / Decrement Floater. The Console and the Floater contain the main user controls of the system. The Console consists of a touch screen and will allow the operator to setup the functions and parameters of the system. The user interface of the Console is based on the proven and familiar interface of the Bloom DTU-215B. The Floater provides additional user controls and will provide the operator with tactile feedback on those functions that the user is expected to use while going through their protocols. The Stimulator is the heart and brains of the system. The Stimulator has four, independent output channels that have a direct connection to the patient through third party catheters.

### Indications for use:

The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiological procedures. The Bloom2 Cardiac Stimulator System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.

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# 510(k) Summary

Shipping & Storage:

The packaged device will withstand normal shipping and storage environments and labeling shall meet 21CFR 801, EN 1041, and ISO 15223.

| Non-clinical tests<br>submitted or relied upon: | Performance analysis has shown the Bloom2 device to<br>perform as intended and as well as the predicate devices<br>under the same and/or similar conditions. These devices have<br>been tested with settings set equal to those seen in typical<br>procedures where these devices would be indicated for use.<br>No differences have been observed between the performance<br>of the predicate devices and the device subject of this 510(k)<br>Notification submission.<br>Additionally, Certified Third Party testing conducted to 60601-<br>1 & 60601-1-2 to verify electrical safety & electromagnetic<br>compatibility. The following tests demonstrated that the<br>Bloom2 device fulfils the referenced standards:<br>• IEC/EN 60601-1 3.1 Edition Safety Test Report<br>• IEC 60601-1-1-2 Forth Edition EMC Test Report<br>• Software Life Cycle Processes Test Report<br>• FCC CFR 47, Part 15, subpart EMC Test Report<br>• ICES-001 for Class A Digital EMC Test Report<br>• Canada Differences to IEC 60601-1 Test Report |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical tests submitted or<br>relied upon: | None |
| Substantial equivalence<br>conclusion: | The Bloom2 device is substantially equivalent to the legally<br>marketed FDA cleared predicate devices, based on intended<br>use, materials, and design. |