The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.

The BioModule 3-M1 collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods.

The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

Device Description

The BioModule 3-M1, a physiological sensor / transmitter is composed of:

proprietary hardware and firmware, enclosed in
a user case (puck) with a re-chargeable battery. .
. a adhesive electrode set and
A cradle (to recharge battery and transfer internally stored date to an ancillary computer).

The BioModule 3-M1 is a physiological transmitter manufactured by Zephyr Technology Corporation with disposable, off the shelf electrodes that transmits data to a qualified receiving station. The BioModule 3-M1 is positioned against the patient's skin with light pressure then pressed to adhere.

AI/ML Overview

The document provided is a 510(k) summary for the BioModule 3-M1, a physiological monitoring telemetry device. It focuses on establishing substantial equivalence to a predicate device (BioHarness 3.0, K113045) rather than on presenting a detailed study proving performance against specific acceptance criteria for the algorithm's accuracy.

Therefore, many of the requested details about acceptance criteria, specific study design elements (like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies), and "reported device performance" in terms of algorithm accuracy, are not present in this type of regulatory submission.

The document primarily states general safety and effectiveness and claims that the device has been tested to confirm these. It emphasizes the similarity in technological characteristics and principles with its predicate device.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for ECG detection or heart rate measurement) or quantitative reported device performance metrics against such criteria.
Instead, it states: "A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life." This is a general statement about manufacturing quality control rather than a clinical performance study.
The primary "performance" discussed is the capability to "detect and transmit single lead ECG signals" and that "Breathing rate values are accurately transmitted only during sedentary periods." These are functional descriptions, not quantitative performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document does not describe a test set or clinical study with patient data. It refers to "factory tests."

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 / Not provided. Since there's no described test set with clinical data requiring expert ground truth, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No clinical test set or adjudication process is mentioned.

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

No, an MRMC comparative effectiveness study was NOT done (or at least not described in this document). The device is a physiological sensor/transmitter, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies that "factory tests" were done to verify signal accuracy. However, no specific standalone algorithm performance study (e.g., sensitivity/specificity for arrhythmia detection) is described. The focus is on the device's ability to capture and transmit physiological signals reliably, rather than the performance of a sophisticated AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided. Given the nature of "factory tests," the "ground truth" would likely be derived from calibrated signal generators or known physiological inputs, rather than clinical data requiring expert consensus or pathology.

8. The sample size for the training set

Not provided. The document does not describe a machine learning training set.

9. How the ground truth for the training set was established

Not applicable / Not provided. No training set is mentioned.

Summary of what is present:

Device Description: BioModule 3-M1, a physiological sensor/transmitter composed of hardware, firmware, user case, adhesive electrode set, and a cradle. It captures electrical pulses from the skin via electrodes, converts them to digital signals, processes them, and transmits them.
Intended Use/Indications for Use: Monitoring ambulatory patients in alternate care settings, providing physiological information (ECG, heart rate, respiration rate, body orientation, activity) as part of a general ward monitoring system. Breathing rate is accurate only during sedentary periods.
Predicate Device: Zephyr Technology, BioHarness 3.0, K113045.
Substantial Equivalence Claim: The BioModule 3-M1 is "substantially equivalent" to BioHarness 3.0, with "incidental and not significant" differences. Both use electrodes, convert analog to digital signals, use microprocessors/firmware/signal processing, and transmit signals for ECG waveforms.
Safety and Effectiveness Justification: "Factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."

In essence, this 510(k) summary focuses on demonstrating that the new device is fundamentally similar to an already cleared predicate device, and that its basic function and manufacturing processes ensure safety and effectiveness, rather than detailing a clinical study with stringent acceptance criteria for an AI algorithm's specific performance metrics.

Summary

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K123658 page 1 of 2

5. 510(k) Summary

Consultant

(per 21 CFR 807.92)

08 November 2012 Sponsor Mr. Sailor Mohler Quality Manager Zephyr Technology Corporation 1 Annapolis Street, Suite 200 Annapolis MD 21401 USA Office: 443-569-3603 sailor.mohler@zephyranywhere.com

Proprietary Name: Common Name Device Classification Name

Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659 203 329 2700 F 203 329 2345 rkeen@fda-complianceconsultants.com

BioModule 3-M1 BioModule 3-M1 (1) Electrocardiograph Electrode (2) Arrhythmia Detector and Alarm (1) 21CFR870.2360 (2) 21CFR870.1025 (1) DRX . (2) MHX Cardiovascular Class II # 233836 Zephyr Technology, BioHarness 3.0, K113045, transmits physiological data in a complex array of packet data.

Classification Number:

Product Code

Reviewing Group Device Classification Establishment registration No. Predicate Device"

Trademark Notice: All Trademarks used other than those of Zephyr Technology Corporation are registered to their respective owners.

Confidentiality Notice: All data contained in this application and all documents provided with this document may contain trade secrets or proprietary data which the sponsor requests are treated in accordance with law.

Device Description

The BioModule 3-M1, a physiological sensor / transmitter is composed of:

� proprietary hardware and firmware, enclosed in
a user case (puck) with a re-chargeable battery. .
. a adhesive electrode set and
A cradle (to recharge battery and transfer internally stored date to an ancillary computer). �

Indications for Use

··

: Page 13

BioModule 3-M1

APR 2 4 2013

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5. 510(k) Summary

(per 21 CFR 807.92)

and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.

The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

Intended Use

The intended use of the BioModule 3-M1 is to provide a General Ward Monitoring facility for detecting, storing and transmitting physiological date to a qualified receiving station. The scientific concept on which this device is based is the principle that low level electrical pulses from the heart are measurable of the surface of the skin. This device functions by capturing these electrical pulses via electrodes and delivering these signals to sophisticated electronics for processing. The calibration is established by the factory and yields accurate and calibrated signals that can maintain calibration over its useful life.

Substantial Equivalence

Zephyr Technology Corporation has determined that the BioModule 3-M is substantially equivalent to the performance of a predicate Device, BioHarness 3.0 [K113045]. The differences between these systems are incidental and not significant. Both devices use a similar technological characteristics and principles.

Both devices use electrodes to capture signals from the skin, .
both devices convert analog physiological signals to digital signals,
. both devices use micro-processors, firmware and signal processing;
both devices transmit the signals to receivers that detect and present the information as ECG . waveforms.

Safety and Effectiveness

There are no substantial differences between the BioModule 3-M1 and the predicate Device, BioHarness. 3.0 [K113045]. BioModule 3-M1 defined in this 510(k) submission and the predicate device are virtually identical except minor changes for use in a different marketplace.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life. The BioModule 3-M1 has benefited from design, development, testing and production procedures that conform to Quality. Systems.

Zephyr Technology Corporation continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting device to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

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BioModule 3-M1

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 24, 2013

Zephyr Technology Corporation c/o: Richard Keen (Agent) Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659

Re: K123658

Trade Name: Biomodule 3-M1 Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II Product Code: DRX Dated: February 28, 2013 Received: March 15, 2013

Dear Richard Keen:

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.

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Page 2 - Richard Keen

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 (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 no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

for

Sincerely yours.

Owen P. Earis -S

Bram D. Zuckerman, M.D. . Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K123658

4. Indications for Use Statement

510(K) Number number assigned Name: Respiration Rate Upgrade (RRU)

INDICATIONS FOR USE

The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambaltory patients in alternate care settings. The device consists of adhesive electronics and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.

The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) " Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over - The - Counter Use or XXXX (Per 21 CFR 801.109) (Optional Format 1-2-96

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) P. Faris -S 4.24 -04'00' Page 12 BioModule 3-M ]

Regulation Number and Section

§ 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.