K Number
K063044
Device Name
CARDIOBELT ELECTRODE BELT
Date Cleared
2007-03-23

(170 days)

Product Code
Regulation Number
870.2360
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioBelt™ is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.
Device Description
The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.
More Information

No
The description focuses on the hardware (electrodes, belt, electronics, Bluetooth) and its function of transmitting ECG data. There is no mention of any algorithms, data processing beyond transmission, or terms related to AI/ML.

No
The device is described as an "electrode system" for "ECG monitoring" and "transmits ECG information." Its intended use is for "general electrocardiographic procedures," which are primarily diagnostic, providing data for a physician to interpret. While a physician's order is necessary, and it can be used for "ambulatory monitoring" and as a "screening tool to determine normal or pathologic ECG's," these functions are diagnostic and do not involve treating or ameliorating a disease or condition. The device itself does not exert any therapeutic effect.

No

The device description states that the CardioBelt™ transmits ECG information to a compatible Bluetooth enabled device. The "Intended Use / Indications for Use" section indicates it is "intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary". While it collects ECG data, there is no mention of the device itself performing analysis or interpretation for diagnostic purposes. The white paper mentions it was "useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's", but this implies it provides the data for a physician to interpret, not that the device itself makes a diagnosis.

No

The device description explicitly states it is a "reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver." This clearly indicates the presence of hardware components beyond just software.

Based on the provided information, the CardioBelt™ is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for "general electrocardiographic procedures where ECG monitoring is deemed necessary." This involves measuring electrical activity of the heart in vivo (within the living body).
  • Device Description: The device is an "electrode system" that is placed on the patient's chest to acquire ECG signals. This is a direct measurement from the body.
  • Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. The CardioBelt™ does not process or analyze such specimens.

The CardioBelt™ is a medical device used for physiological monitoring on the patient, not for testing samples from the patient.

N/A

Intended Use / Indications for Use

The CardioBelt™ is a reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

Product codes

74 DRX

Device Description

The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.

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

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Monebo's CardioBelt™ has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device.
The CardioBelt™ was tested and verified in accordance with 3510-0002-01 Rev1 CardioBelt Verification and Validation test plan.
Engineering testing was performed to test compliance with the system requirements and risk assessment documents. Supporting test reports can be found in the Monebo Document control center. The tests were performed in accordance with EC38, EN60601-1 and EN60601-2-27. The device is classified as a Type 3 device using the EC38 1.2 c type definition. The device biocompatibility was evaluated and found to be satisfactory. 8051-0002-01 Rev-1tracability matrix was developed to track the verification of the system requirements 8012-0002-00 and hazard mitigations. The testing was conducted per EC38 test methods and the tests include: Common Mode Rejection Tests, Frequency Response Tests, Input Dynamic Range Tests, Overall System Error Tests, Step Response Tests, System Noise Tests, Battery Life Tests, Communication Test, High and low Temperature Tests, Leakage Current Tests, Dielectric Strength Tests, Safe Current Tests, Ingress of Liquid Tests, EMC and Immunity Tests, Mechanical Shock Tests.
Validation was conducted in accordance with 3510-0002-00 Rev 1 Verification and Validation test plan. The device and manual were evaluated for safety and clinical utility. The validation report can be found in the Monebo document control center. The report indicates that the device meets the clinical requirements and that the documentation is sufficient for operating the device in a clinical or home care environment. A white paper is included for review. The white paper was generated from a study at Bad Oeynhausen Herzzentrum hospital in Germany. The study compared the performance of the single lead Cardiobelt to a 12 lead ECG (Gold Standard). The CardioBelt was found to be easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K043361, K960968, K012223

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

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510(k) Summary

Monebo CardioBelt™ Electrode Belt

MAR 2 3 2007

063044 K

Monebo Technologies, Inc Submitter: 1800 Barton Creek Blvd Austin, TX 78735-1606 Telephone: 512.732.0235 512.732.0285 Facsimile: Contact person: Dale J. Misczynski President and CEO

Date of Preparation: October 2, 2006

Device Name:Proprietary Name: CardioBelt™ Electrode Belt
Common Name:Electrocardiograph Electrode
Classification Name:Electrocardiograph Electrode

Regulatory Classification:

Class:II, 21 CFR 870.2360
Medical Specialty Panel:Cardiovascular
Product Code:74 DRX

Devices to Which Substantial Equivalence is Claimed:

Device Name:AccuHeartTm Electrode Belt
510(k) Number:K043361
Device Name:Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes
510(k) Number:K960968
Device Name:CardGuard CG-2211 SelfChek
510(k) Number:K012223

Device Description:

The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range).

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The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.

KO6304

Intended Use:

The CardioBelt™ is a reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

Functional and Safety Testing:

Monebo's CardioBelt™ has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device.

The CardioBelt™ was tested and verified in accordance with 3510-0002-01 Rev1 CardioBelt Verification and Validation test plan. The following is a summary of the testing performed on the device. Specific test records can be found in the Monebo Document Control center.

The system risk assessment 8024-0002-00Rev1 was performed and the device was characterized as a moderate level of concern. The system safety and risk analysis conducted for the CardioBelt provided a rigorous design and structural evaluation aimed at identifing potential failures or possible system flaws which could directly or indirectly affect the patient. The device is a single lead acquisition system that transmits ECG data via Bluetooth™ communication to a generic Bluetooth™ recording and/or analysis system. The device does not perform ECG analysis.

Engineering and Verification Testing:

Engineering testing was performed to test compliance with the system requirements and risk assessment documents. Supporting test reports can be found in the Monebo Document control center. The tests were performed in accordance with EC38, EN60601-1 and EN60601-2-27. The device is classified as a Type 3 device using the EC38 1.2 c type definition. The device biocompatibility was evaluated and found to be satisfactory. 8051-0002-01 Rev-1tracability matrix was developed to track the verification of the system requirements 8012-0002-00 and hazard mitigations. The testing was conducted per EC38 test methods and the tests include:

Common Mode Rejection Tests Frequency Response Tests Input Dynamic Range Tests Overall System Error Tests Step Response Tests System Noise Tests Battery Life Tests Communication Test

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K063044 p.314

External Testing and Certification:

Third party testing was performed to assess compliance for Electromagnetic Compatibility, Medical Equipment General Safety requirements and Essential performance requirements for ECG devices.

EMC Testing Laboratories, Inc was used to determine compliance with:
EN301-489-1ERM and EMC for Radio Equipment and Services
EN301-489-17EMC for 2.4Ghz Radio Equipment EMC
EN61000-4-2Electrostatic Discharge Testing
EN61000-4-3Radiated Electromagnetic Fields
EN61000-4-11Voltage Dips, Short Interrupts and Voltage Variations
CISPR22Measurements of Radio Frequency Interference
EN55022Radio Frequency Interference for Information Technology
EN61000-3-2Limits of harmonic current emissions
EN61000-3-3Limitation of voltage fluctuations and flicker in low voltage supply
systems
EN60601-1Medical electrical equipment - Part 1: General requirements for safety
EN60601-2-27Particular requirements for the safety, including essential
performance, of electrocardiographic monitoring equipment

High and low Temperature Tests Leakage Current Tests Dielectric Strength Tests Safe Current Tests Ingress of Liquid Tests EMC and Immunity Tests Mechanical Shock Tests

Third party verification reports are included with this submission and can be found in the Monebo Document Control Center. The reports indicate compliance with the general safety standards and with EN60601-1 and EN60601-2-27 ECG standards mentioned above.

Validation

Validation was conducted in accordance with 3510-0002-00 Rev 1 Verification and Validation test plan. The device and manual were evaluated for safety and clinical utility. The validation report can be found in the Monebo document control center. The report indicates that the device meets the clinical requirements and that the documentation is sufficient for operating the device in a clinical or home care environment. A white paper is included for review. The white paper was generated from a study at Bad Oeynhausen Herzzentrum hospital in Germany. The study compared the performance of the single lead Cardiobelt to a 12 lead ECG (Gold Standard). The CardioBelt was found to be easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's.

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Conclusions

Based on verification and validation testing the unit was found to meet the generally accepted safety testing requirements for an EC38 1.2 c type 3 ECG device. The device has a moderate level of concern based on the risk assessment 8024-0002-00. The Cardiobelt constitutes a safe and reliable means for transmitting ECG data. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended.

Monebo's CardioBelt is substantially equivalent to the AccuHeart Electrode Belt.

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Image /page/4/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2007

Monebo Technologies Inc. c/o Dale J. Misczynski President and CEO 1800 Barton Creek Blvd. Austin, TX 78735-1606

Re: K063044

Trade/Device Name: CardioBelt Electrode Belt Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II Product Code: DRX Dated: March 16, 2007 Received: March 19, 2007

Dear Mr. Misczynski:

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 such 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. Misczynski

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

B.H. Mumma 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

Applicant: Monebo Technologies, Inc

510(k) Number (if known)

Device Name: Monebo CardioBelt™ Electrode Belt

Indications for Use:

The CardioBelt™ is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over -the Counter -----

(Please Do Not Write Below This Line - Continue On Another Page if Needed) Concurrence of CDRH Office of Device Evaluation (ODE)

Blummo

Division of Cardlovas 510px) Number

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