(146 days)
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 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.
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.
The provided text is a 510(k) summary for the Bloom2 Cardiac Stimulator System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of diagnostic accuracy or clinical outcomes. Instead, it focuses on non-clinical performance and safety testing.
Therefore, most of the requested information cannot be extracted from this document, particularly regarding studies related to AI performance, expert adjudication, or ground truth establishment relevant to an AI/diagnostic device.
However, I can provide what is discussed regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC/EN 60601-1 3.1 Edition Safety Test Report | Bloom2 device fulfills the referenced standard |
| IEC 60601-1-1-2 Fourth Edition EMC Test Report | Bloom2 device fulfills the referenced standard |
| Software Life Cycle Processes Test Report | Not specified if it fulfills a named standard, but implicitly indicates software safety/functionality. |
| FCC CFR 47, Part 15, subpart EMC Test Report | Bloom2 device fulfills the referenced standard |
| ICES-001 for Class A Digital EMC Test Report | Bloom2 device fulfills the referenced standard |
| Canada Differences to IEC 60601-1 Test Report | Bloom2 device fulfills the referenced standard |
| Withstand normal shipping and storage environments and meet labeling standards (21 CFR 801, EN 1041, ISO 15223) | The packaged device will withstand normal shipping and storage and labeling shall meet the specified standards. (This is a statement of intent/design, not a report of specific test results within this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about sample size, test sets, or data provenance in the context of clinical or diagnostic performance is provided, as no such study was conducted. The non-clinical tests relate to the device itself and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no expert-adjudicated test set is detailed. The device is a stimulator, not an AI diagnostic tool requiring ground truth from medical experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a cardiac stimulator, not an AI system for diagnostic image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" would be the specifications and requirements of the safety and EMC standards (e.g., IEC 60601-1). The tests demonstrated that the device met these engineering and safety standards.
8. The sample size for the training set:
Not applicable, as no training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the 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 includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date prepared: | March 27, 2018 | ||
|---|---|---|---|
| Applicant: | Fischer Medical | ||
| Contact person: | Wes RogersPresident & CEOFischer MedicalWheat Ridge, Colorado 80233-3862 USAPhone: 303.280.2311Fax: 303.920.0836Email: sdwrogers@gmail.com | ||
| Trade name: | Bloom2 | ||
| Common name: | Electrophysiology Stimulator | Class: | 2 |
| Classificationname: | Generator, Pulse, Pacemaker, ExternalProgrammable | Product code: | JOQ |
| Predicatedevices: | K072200, StimLab™/EPS320™ Electrophysiology Stimulator System& Accessories and K991293, EPStim Bloom DTU-215B™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 testssubmitted or relied upon: | Performance analysis has shown the Bloom2 device toperform as intended and as well as the predicate devicesunder the same and/or similar conditions. These devices havebeen tested with settings set equal to those seen in typicalprocedures where these devices would be indicated for use.No differences have been observed between the performanceof the predicate devices and the device subject of this 510(k)Notification submission.Additionally, Certified Third Party testing conducted to 60601-1 & 60601-1-2 to verify electrical safety & electromagneticcompatibility. The following tests demonstrated that theBloom2 device fulfils the referenced standards:• IEC/EN 60601-1 3.1 Edition Safety Test Report• IEC 60601-1-1-2 Forth Edition EMC Test Report• Software Life Cycle Processes Test Report• FCC CFR 47, Part 15, subpart EMC Test Report• ICES-001 for Class A Digital EMC Test Report• Canada Differences to IEC 60601-1 Test Report |
|---|---|
| Clinical tests submitted orrelied upon: | None |
| Substantial equivalenceconclusion: | The Bloom2 device is substantially equivalent to the legallymarketed FDA cleared predicate devices, based on intendeduse, materials, and design. |
§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).