The device is intended to be used as a radiofrequency physiological signal transmitter and receiver to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another. The received signal is reconditioned by the device into its original format so that it can be displayed.

Device Description

The Ambulatory X-12 Telemetry Module, designed and manufactured by Mortara Instrument. Inc. represents the state-of-the-art in Wireless Electrocardiographic Technology. Design innovations implemented in the Ambulatory X-12 Telemetry Module achieve real-time acquisition, RF transmission of simultaneous 12-lead ECG data with diagnostic quality to the Mortara Receiver Module while allowing the patient to be ambulatory.

The Ambulatory X-12 Telemetry Module combines unparalleled accuracy, flexibility, and ease of use in a small light-weight Ambulatory X-12 (transmitter) unit worn by the patient. The patient cable used in conjunction with the Ambulatory X-12 is a light-weight flexible design, which plugs into a polarized connector on the side of the transmitter. The cable is worn by the patient in a standard torso 12-lead hook-up, and connects directly to snap type electrodes.

The Large LCD screen clearly displays each lead's status or lead fault. Two letter codes for Power On(On) and Low Battery (Lb) are displayed during normal operation, with the ON/OFF switch located inside the battery compartment, to prevent transmitter from being inadvertently turned off during normal use. When turned ON, the power to the Ambulatory X-12 is supplied by two size AA Alkaline batteries.

Lead Check Mode is initiated by the TEST button and the CALL button is used to select individual leads. Once in Lead Check Mode an LC code is displayed along with a flashing torso lead indicator of the lead being tested and a bar graph indicating the lead quality.

ECG data is gathered and transmitted on a low power, FM modulated carrier using a proprietary encoding scheme. An electrocardiograph containing the Mortara Receiver Module demodulates and decodes the data. The Ambulatory X-12 Telemetry Module affords the patient complete freedom of movement. Unlimited range can also be obtained with the addition of the Mortara Antenna Network Box(s).

AI/ML Overview

Here's an analysis of the provided text regarding the Ambulatory X-12 Telemetry Module, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which is a regulatory submission for medical devices. It details the device's characteristics and its equivalence to previously approved devices. It does not typically contain detailed reports of clinical trials or specific performance studies proving acceptance criteria in the same way a research paper would. Instead, it relies on demonstrating adherence to recognized standards and comparison to predicate devices. Therefore, some information, especially regarding specific "studies" with detailed sample sizes, expert qualifications, and adjudication methods for proving acceptance criteria, may not be explicitly present or will be inferred from the stated compliance with standards.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ambulatory X-12 Telemetry Module are primarily established by its compliance with various national and international standards for electrocardiographic devices and medical electrical equipment. The device's performance is reported implicitly by stating its features and specifications that meet or exceed these standards, and by comparison with predicate devices.

Acceptance Criteria (Implied by Standards & Predicate Comparison)	Reported Device Performance
Diagnostic Quality ECG Data (AAMI EC 11-1991, IEC-601-2-25)	Real-time acquisition, RF transmission of simultaneous 12-lead ECG data with diagnostic quality.
Ambulatory Use (AAMI-EC 38-1994)	Allows the patient to be ambulatory. Small, light-weight transmitter unit. Complete freedom of movement.
Standard Torso 12-lead Hook-up Compatibility	Used with a standard torso 12-lead hook-up. Connects directly to snap-type electrodes. Acquires I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 simultaneously.
Safety (Electrical, Mechanical & Emissions) (IEC-601-1, IEC-601-1-2, UL 2601-1, FCC PART 15 Subpart C)	Compliance with these standards ensures safety. Specifically: Defibrillator protected when used with Mortara Instrument Patient Cable. Output Power: 50 mV/m at 3 meters (compared to 10 mV/m for HP predicate).
Input Channels	Simultaneous acquisition of all 12 leads.
Input Impedance	47 megohms (compared to >10 megohms for HP M1403A, 15 megohm min for Marquette CD-Telemetry LAN).
Input Dynamic Range	700mV (compared to ± 8mV for HP M1403A, ± 5mV for Marquette CD-Telemetry LAN). This appears to be a favorable performance characteristic, though the units are slightly different (700mV vs +/- XmV).
Electrode Offset Tolerance	350mV (compared to ± 400mV for HP M1403A, ± 450mV for Marquette CD-Telemetry LAN).
Digital Sampling Rate	500 s/sec/channel transmission for recording and analysis (compared to 120 samples/sec for Marquette CD-Telemetry LAN). Pacemaker artifact detection uses 10,000 s/sec/channel.
Radiofrequency Transmission (FCC Part 15)	Single frequency band of 915 MHz or 2500 MHz. 256 distinct, user-selectable channels. Output Power: 50 mV/m at 3 meters.
Specific Functions	Pacemaker detection and transmission; Lead off detection and transmission; Electrode impedance measurements. Large LCD screen, Lead Check Mode, CALL button for lead selection, bar graph for lead quality.
Environmental Conditions	Operating Temp. Range: 10 to 32° C. Storage Temp.: 0 to 45° C. Humidity Operation: 20 to 80%. Humidity Storage: 10 to 90%. Atmospheric Pressure: 700-1060 millibars. (Compared to various ranges for predicate devices).
Battery Life	2 AA alkaline batteries (30 Hours) (compared to 9 Volt Battery (2.5 Days) for HP M1403A, 1.5 Volt Battery (2) (60 hrs) for Marquette CD-Telemetry LAN). This shows similar battery life to competitors, noting that the Marquette has longer hours but may have a different power draw.
Compatibility with Other Devices	ELI 100, ELI 200, Portrait, ELI-XR, X-Scribe Stress System, and ELI 100 STM (Mortara's other products).

Study Details (Based on available 510(k) Summary Information)

The 510(k) summary primarily refers to non-clinical performance data and compliance with recognized standards rather than a single, specific clinical study to "prove" the device meets acceptance criteria. The "study" here refers to the process of verification and validation against these standards.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or ECGs. The "test set" for this type of device would involve laboratory testing and performance verification against the specified standards (e.g., AAMI EC 11, AAMI EC 38). These standards define test methods and acceptance limits (e.g., frequency response, noise, common mode rejection, input impedance, etc.), and the device would be tested against these physical and electrical parameters.
- Data Provenance: The data provenance is from the device manufacturer's internal verification and validation processes ("To ensure the safety and effectiveness of the Ambulatory X-12 Telemetry Module, verification and validation were performed in accordance with the following standards"). This is therefore primarily retrospective in the sense that it's reported after the testing has been completed by the manufacturer as part of their device development and regulatory submission. No country of origin for patient data is mentioned as this isn't a patient-based clinical study summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not applicable or explicitly stated in a 510(k) summary of this type. For performance characteristics like those governed by AAMI/IEC standards (e.g., frequency response, noise, amplitude accuracy), the "ground truth" is typically defined by the standard's specifications and measurements are taken using calibrated equipment. This is not a diagnostic AI device requiring expert adjudication of ground truth labels on medical images or waveforms for diagnostic accuracy.
Adjudication method for the test set:
- Adjudication Method: Not applicable. As noted above, this summary details compliance with technical standards rather than an interpretation study requiring expert adjudication of clinical outcomes or diagnoses. Device performance is determined by meeting objective, measurable criteria defined within the referenced standards.
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:
- MRMC Comparative Effectiveness Study: No. This device is a data acquisition and transmission module for ECG data, not an AI-powered diagnostic tool, nor does it involve human readers interpreting AI output. Therefore, an MRMC study and effect size of AI assistance are not relevant or discussed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device itself, as an ECG acquisition and transmission system, is a "standalone" system in its function. It gathers and transmits ECG data. Its "performance" is evaluated by how accurately and reliably it acquires and transmits the electrical signals according to the specified signal integrity and transmission characteristics defined by the relevant standards. This is not an "algorithm only" in the sense of a software-only diagnostic AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" is defined by the specifications and performance requirements within the referenced standards (e.g., AAMI EC 11-1991, AAMI-EC 38-1994, IEC-601 series). These standards specify acceptable ranges for electrical performance, noise levels, frequency response, common mode rejection, input impedance, safety, and electromagnetic compatibility. The device's measured performance against these defined limits serves as the ground truth for its compliance.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is hardware for signal acquisition and transmission, not a machine learning or AI algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary

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K974149

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510(k) Summary of Safety and Effectiveness

Intended Use

The Ambulatory X-12 Telemetry Module is designed to acquire, transmit, and receive diagnostic quality ECG data while allowing the patient to be ambulatory in a clinical setting. It can be used with any population, provided a standard torso 12-lead hook-up is used.

Device Description

The Ambulatory X-12 Telemetry Module , designed and manufactured by Mortara Instrument. Inc. represents the state-of-the-art in Wireless Electrocardiographic Technology. Design innovations implemented in the Ambulatory X-12 Telemetry Module achieve real-time acquisition, RF transmission of simultaneous 12-lead ECG data with diagnostic quality to the Mortara Receiver Module while allowing the patient to be ambulatory.

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Mortara Antenna Network Boxes are placed at multiple locations within an installation. An antenna is properly combined onto the transmission line in the Mortara Antenna Network Box. The Mortara Antenna Network Box also has a 10dB of gain to counter the loss of long cables. To maintain good operating range anywhere along an antenna network the loss through the cables to the receiver is offset equally by the gain in the Antenna Network Box(s).

Each Mortara Antenna Network Box requires DC power. The power can either be applied to the front panel connector or supplied through the RF cables. When one box is supplied power, the other boxes in the network can receive power through the RF cables. Potentially, a long network can be supplied with a single power source with no additional cabling required. However if there are branches in the network this will require additional power sources. It is recommended to use a 9 to 12 volt DC supply.

Utilizing a single frequency band of 915 MHz or 2500 MHz, the Ambulatory X-12 is capable of transmitting on any one of 256 distinct, user selectable, channels. This allows multiple Ambulatory X-12's to operate in the same general area by simply selecting different channels for each transmitter.

Non-Clinical Performance Data

To ensure the safety and effectiveness of the Ambulatory X-12 Telemetry Module, verification and validation were performed in accordance with the following standards

AAMI EC 11-1991	Diagnostic Electrocardiographic Devices
AAMI-EC 38-1994	Ambulatory Electrocardiographs
IEC-601-1	Medical Electrical Equipment,Part 1: General Requirements for safety
IEC-601-1-2	Medical Electrical EquipmentPart 1: General Requirements for Safety;2. Collateral Standard: Electromagnetic CompatibilityRequirements and Test
IEC-601-2-25	Medical Electrical EquipmentPart 2: Particular Requirements for Safety ofElectrocardiographs
UL 2601-1	Medical Electrical Equipment,Part 1: General Requirements for safety
FCC PART 15, Subpart C	FCC Rules and Regulations

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Comparison to Predicate Devices

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Tabular Comparison of Competitor's Devices

	Mortara Instrument	Hewlett Packard M1403A Digital UHFTelemetry System510k #: (K920429)	Marquette ElectronicsCD-Telemetry LAN510k #: (K891104)
Features	Ambulatory X-12	HP M1400A Transmitter	CD Telemetry Transmitter
Intended Use	Transmit 12 leads of patient data by adigital radio transmission.	Transmit 2 leads of patient data by adigital radio transmission to a receiverover an antenna network to a CentralStation.	Transmit 3 leads of patient data by adigital radio transmission to a receiverover an antenna network to aCentralscope
Target Population	Adults and Neonatal Patients	Adult or Neonatal Patients	Adult or Neonatal Patients
Product Labeling	Brochures and Operator's Manual	Brochures	Brochures
Standard LeadsAcquired	I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,V6	2 Leads transmitted	3 Leads Transmitted
Input Channels	Simultaneous acquisition of all 12 leads.	A three-electrode set for single-leadoperation. A four or five-electrode set fordual-lead operation	5 Lead Configuration
Leads Connector	Single Block 10 lead	Single Block 3/4/5 leads	5 individual leads
Input Impedance	47 megohms	Greater than 10 megohms (below 60 Hz)	15 megohm min differential at 10 Hz
	510(k) Summary of Safety and Effectiveness
Input Dynamic Range	700mV	$\pm$ 8mV	$\pm$ 5mV
Electrode OffsetTolerance	350mV	$\pm$ 400mV	$\pm$ 450mV
Signal Strength	Not Specified	30 meters with a signal strength of8 mV/meter	Not Specified
Dimensions	5.52 x 2.65 x 1.00 in.	4.65 x 2.62 x 1.09 in	6.00 x 3.00 x 1.20 in
Weight (Transmitter)	6.7 oz (without batteries)8.3 oz (with batteries)	6.9 oz (with batteries)	12 oz (unknown with/without batteries)
Case Material	High-impact ABS	High-impact ABS/polycarbonate andpolypropylene	High carbon antistatic plastic
Performance Testing	EC-38-1994EC-11-1991	Not Specified	Not Specified
Digital Sampling	500 s/sec/channel transmission forrecording and analysis	Not Specified	120 samples/sec
Special Functions	Pacemaker detection and transmission;Lead off detection and transmission;Electrode impedance measurements10,000 s/sec/channel used for PacemakerArtifact Detection	Pacemaker detection; Alarms;Lead off detection and transmission;Nurse call button;Generate a strip recording.	Pacemaker detection; Lead faildetection; LCD display;Battery Integrity transmitted;Alarm pause transmitted;Graph request transmitted;Power on/off.
Frequency Bands	915 Mhz or 2.45 Ghz	450 to 470 Mhz	174.050 to 215.950 MHz
Number of Channels	256 total, user selectable	266; not tunable	420 not tunable
Mechanical Safety	Defibrillator protected when used withMortara Instrument Patient Cable	Transmitter ECG input protected against400 joules discharge into a 50 ohm load.	± 5000 VDC, 400 joules into 50 ohmload
Output Power	50 mV/m at 3 meters	10 mV/m at 3 meters	1.50 uV/m at 3 meters
Energy Used and/orDelivered	2 AA alkaline batteries (30 Hours)	9 Volt Battery (2.5 Days)	1.5 Volt Battery (2) (60 hrs)
Current Compatibilitywith Other Devices	Other Devices: ELI 100, ELI 200, Portrait,ELI-XR, X-Scribe Stress System, andELI 100 STM	Other Devices: Patient Monitor/HolterRecorder Interface (Analog Output); STSegment Analysis;HP M1401A Receiver Mainframe;HP M1402A Receiver Module;HP M1408A Antenna/Combiner	Other Devices: CD Telemetry-LANReceiver Cabinet;CD Telemetry-LAN Antenna SystemCentralscope
Where Used	Hospitals, Clinics	Hospitals, Clinics	Hospitals, Clinics
Standards	FCC Part 15CAN/CSA 22.2 No. 601.1UL 2601-1IEC 601-1, 601-1-2, & 601-2-25CE Marking for the 93/42/EEC MedicalDevice Directive	UL 544,CSA C22.2 No. 125M 1984 Risk Class 3,TUEV Certification to IEC 601-1,BSI BS5724: part 1:1979	FCC Part 15, Subpart E (Paragraph15.241),UL 544 Listed.CE Marking for the 93/42/EEC MedicalDevice Directive
Electrical Safety	See Standards Above	Not Specified	Not Specified
Environmental	Operating Temp. Range: 10 to 32° C	Operating Temp. Range: 0 to 45° C	Operating Temp. Range: 0 to 50° C
	Storage Temp.: 0 to 45° C	Storage Temp.: -40 to 70° C	Storage Temp.: -20 to 60° C
	Humidity Operation: 20 to 80%Humidity Storage: 10 to 90%	Altitude: Operating up to 15,000 ft.	Altitude: Information Unavailable
	Atmospheric Pressure: 700-1060 millibars	Water Tight Seal (shower)	Water resistant; may submerge inwater at a 1 ft. Depth for 1 hr w/out
			damage.
Radio ChannelSpacing	80 kHz (915 MHz)320 kHz (2.15 GHz)	25 kHz	100 kHz
Modulation Type	Digital, frequency-shift keying	Digital, frequency-shift keying	PM/BPSK (Phase Modulated) digitaltransmission.

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JAN - 8

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Scott J. Pease Manager of Quality Assurance and Regulatory Affairs Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224

Re: K974149 Trade Name: Ambulatory X-12 Telemetry Module Regulatory Class: II (two) Product Code: 74 DRG Dated: October 31, 1997 Received: November 4, 1997

Dear Mr. Pease:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such ' assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. · Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Scott J. Pease

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1

510(k) Number (if known): K974149

Device Name: Ambulatory X-12 Telemetry Module

Indications For Use: The device is intended to be used as a radiofrequency physiological signal transmitter and receiver to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another. The received signal is reconditioned by the device into its original format so that it can be displayed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dasha Tiller

ision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Over-The-Counter Use

Optional Format 1-2-

તેરૂ

Prescription Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).