(274 days)
This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients in health care facilities. This product is intended to be used by trained health care professionals. It is not intended for home use.
The BeltBeat is a comprehensive ambulatory system solution for ECG monitoring in intermediate care units for adult and pediatic patients. The foundation of the system is a transmitter (BeltBeat WF400) that can capture and transmit ECG signals that are then processed and displayed on the Information Center (BealtBeat STC). The Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions.
The monitoring software BeltBeat STC displays in a computer screen ECG waveforms and heart rate numerics, and may be configured to generate patient alarms and alert messages. Additionally, full recording of patient data is available. The software is capable of monitoring up to 12 patients (BeltBeat WF400 units) simultaneously.
BeltBeat system is intended for 5-lead ECG monitoring.
This 510(k) submission for the BeltBeat ECG monitoring system does not contain the detailed information necessary to complete the requested tables and descriptions regarding acceptance criteria and a study proving the device meets those criteria. The provided summary focuses on regulatory classifications, device description, indications for use, and substantial equivalence to predicate devices, but lacks specific performance data, study design details, or acceptance criteria.
Therefore, many sections below will state "Not provided in the document" or "Information not available."
Here's the summary based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Monitoring | Not provided in the document (e.g., accuracy of heart rate detection, signal quality) | Not provided in the document (general statement regarding "acquisition and display of ECG signals") |
| Alarms | Not provided in the document (e.g., sensitivity/specificity for alarming specific events, timeliness of alarms) | "generates alarms and alert messages" |
| Recording | Not provided in the document (e.g., completeness of data recording, data integrity) | "Full recording of patient data is also available" |
| System Performance | Not provided in the document (e.g., wireless transmission reliability, simultaneous patient monitoring capability) | "monitors up to 12 patients simultaneously", "real-time transmission" |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided in the document. The submission mentions "Verification, Validation and Testing (VV&T) documents" but does not detail the specific tests conducted or the sample sizes of patients or data used.
- Data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not provided in the document.
- Qualifications of experts: Not provided in the document.
4. Adjudication method for the test set
- Adjudication method: Not provided in the document.
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
- This device is an ECG monitoring system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study would generally not be applicable in the context of improving human reader performance with AI assistance for interpreting images or complex data. The document does not describe any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the BeltBeat system as a "comprehensive ambulatory system solution for ECG monitoring" that "captures and transmits ECG signals that are then processed and displayed on the Information Center (BealtBeat STC)." It notes that the "Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions." This implies that the system processes and analyzes ECG signals to trigger alarms and display data. However, the document does not explicitly state or describe a standalone performance study of these algorithms with specific metrics (e.g., sensitivity/specificity of arrhythmia detection without clinician intervention). The focus is on the integrated system providing information to clinicians.
7. The type of ground truth used
- Type of ground truth: Not provided in the document. For an ECG monitor, ground truth would typically involve a verified "gold standard" ECG recording, possibly with expert annotation of events, or physiological measurements.
8. The sample size for the training set
- Sample size for training set: Not provided in the document. The submission references "Verification, Validation and Testing (VV&T) documents" but does not detail a training set for machine learning or algorithmic development. Given the 2009 submission date, advanced machine learning requiring large training sets may not have been the primary method for signal processing and alarm generation.
9. How the ground truth for the training set was established
- How ground truth was established: Not provided in the document.
Summary of Study Information based on Provided Document:
The 510(k) summary for the BeltBeat device (K083715) outlines its purpose as an ambulatory ECG monitoring system. It mentions that "All Verification, Validation and Testing (VV&T) documents - constitute a part of the device DMR and are available upon request." However, this summary itself does not contain any specific performance studies, acceptance criteria, or detailed data from such studies. It primarily focuses on defining the device, its intended use, principles of operation, and demonstrating substantial equivalence to pre-existing predicate devices (Welch Allyn Micropaq Monitor and Philips Transmitters M2601B + IntelliVue Information Center). The document lacks the detailed scientific or engineering study results that would typically include acceptance criteria, sample sizes, and ground truth methodologies.
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SEP 1 5 2009
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BeltBeat 510/k} Summary of Safety and Effectiveness
| Submitter | Bonus Comunicaciones SRL | ||
|---|---|---|---|
| Address | Fonrouge 1561 - Ciudad Autónoma de Buenos Aires - Argentina | ||
| Contact: | Héctor Foggia, RA Manager | ||
| Phone: | +54 11 4630-1600 ext. 133 | Fax: +54 11 4630-1619 | |
| E-mail: | hfoggia@bonuscom.com.ar | ||
| Device | |||
| Trade Name: | BeltBeat |
| Regulation No. | Class | ProductCode | Regulation Description |
|---|---|---|---|
| 870.2300 | II | DRT | Cardiac monitor (including cardiotachometer and ratealarm) |
| 870.2910 | II | DRG | Radiofrequency physiological signal transmitter andreceiver. |
Device Definition
The BeltBeat is a comprehensive ambulatory system solution for ECG monitoring in intermediate care units for adult and pediatic patients. The foundation of the system is a transmitter (BeltBeat WF400) that can capture and transmit ECG signals that are then processed and displayed on the Information Center (BealtBeat STC). The Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions.
The monitoring software BeltBeat STC displays in a computer screen ECG waveforms and heart rate numerics, and may be configured to generate patient alarms and alert messages. Additionally, full recording of patient data is available. The software is capable of monitoring up to 12 patients (BeltBeat WF400 units) simultaneously.
BeltBeat system is intended for 5-lead ECG monitoring.
The most likely locations for patients monitored by this system are: cardiac rehabilitation facilities, postoperative recovery rooms, ambulatory surgery, intermediate care, emergency departments, telemetry departments and in-hospital transport.
This system is not intended for home use, or any other use outside health care facilities.
BeltBeat WF400 monitor is not intended for use with pediatric patients (or infants) weighing less than 22 lbs (10 kgs).
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KOB3712
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BeltBeat 510(k) Summary of Safety and Effectiveness
Referenced Standards
- EC13:2002/(R)2007
- 60601-1-4 +A1:2000
- 60601-2-27:2005
- ISO 13485:2003
- ISO 14971:2007
Indications for Use, Intended Use
This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients in health care facilities. This product is intended to be used by trained health care professionals. It is not intended for home use.
Principles of operation
This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients, in health care facilities.
A patient wearable device BettBeat WF400 acquires ECG signals and transmits them through a Wireless Local Area Network (WLAN), to be processed and displayed by the monitoring software BeltBeat STC. Patient should therefore remain within a defined WLAN coverage area, in order not to interrupt the ECG signals transmission and recording.
Wireless technology provides flexibility and freedom of movement, increasing the patient's comfort.
Time Optimization, since every central station allows up to 12 patients to be monitored . simultaneously.
- Flexibility, the system can be configured to adapt to every users' needs. .
- Safety and Control, by means of patient alarms and alert messages.
- Stand-by mode available, for energy saving. ●
- Versatility of printing, Several parameters can be configured before printing reports.
BeltBeat is a telemetric cardiac monitoring system, designed with state-of-the-art technology for acquisition and display of ECG signals. A standard wireless connection allows real-time transmission to a monitoring central station.
Multiple leads of up to 12 patients can be monitored simultaneously, and different configurations can be selected in a simple manner.
Full recording of patient data is also available, allowing physicians to analyze cardiac off-line.
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Substantially Equivalent Devices
-
- "Welch Allyn Micropaq Monitor (Model 406 / 408) Software version 1.6X + Acuity Central Station"
-
- "Philips Transmitters M2601B + IntelliVue Information Center (Philips Telemetry System)"
Conclusions
All Verification, Validation and Testing (VV&T) documents - constitute a part of the device DMR and are available upon request.
The Truthful and Accurate Statement complies with 21 CFR 807.87(j).
We trust that the submitted information will enable the reviewer to process the material promptly. The time factor is crucial for Bonus' commercial interests.
This dossier contains one paper copy of the 510(k) submission together with an electronic copy that is an exact duplicate of the paper copy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 5 2009
Bonus Comunicaciones SRL Mr. Héctor Foggia Regulatory Affairs Manager Fonrouge 1561 Ciudad Autonoma de Buenos Aires Argentina C1440CYO
Re: K083715
Trade/Device Name: BeltBeat Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS, DRG and DRT Dated: Undated Received: September 09, 2009
Dear Mr. Foggia:
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.
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.
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Page 2 - Mr. Héctor Foggia
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.M.T.
- 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):
Device Name: BeltBeat
Indications for Use:
This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients in health care facilities. This product is intended to be used by trained health care professionals. It is not intended for home use.
Prescription Use 1×1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.F.
Page 1 of 1
(Posted November 13, 2003)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).