AMBULATORY X-12 TELEMETRY MODULE
Device Facts
| Record ID | K974149 |
|---|---|
| Device Name | AMBULATORY X-12 TELEMETRY MODULE |
| Applicant | Mortara Instrument, Inc. |
| Product Code | DRG · Cardiovascular |
| Decision Date | Jan 8, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Ambulatory X-12 Telemetry Module acquires, transmits, and receives diagnostic quality 12-lead ECG data; enables patient mobility in clinical settings. System comprises lightweight transmitter worn by patient, patient cable with snap electrodes, and Mortara Receiver Module. Transmitter digitizes ECG signals at 500 samples/sec/channel; uses proprietary encoding and FM modulation for RF transmission (915 MHz or 2.45 GHz). Antenna Network Boxes with 10dB gain extend range. Device features LCD for lead status/faults, lead check mode, and pacemaker detection (10,000 samples/sec/channel). Operated by clinicians in hospitals/clinics. Output displayed on receiver-connected electrocardiograph; assists clinicians in cardiac monitoring and diagnostic decision-making. Benefits include continuous monitoring without restricting patient movement.
Clinical Evidence
Bench testing only. Verification and validation performed per AAMI EC 11-1991, AAMI EC 38-1994, IEC 601-1, IEC 601-1-2, IEC 601-2-25, UL 2601-1, and FCC Part 15, Subpart C.
Technological Characteristics
Materials: High-impact ABS. Sensing: 12-lead ECG via snap electrodes; 47 megohm input impedance. Energy: 2 AA alkaline batteries. Connectivity: RF transmission (915 MHz/2.45 GHz) to receiver module; antenna network boxes for range extension. Dimensions: 5.52 x 2.65 x 1.00 in. Weight: 8.3 oz with batteries. Digital sampling: 500 s/sec/channel (ECG), 10,000 s/sec/channel (pacemaker detection). Modulation: Digital frequency-shift keying.
Indications for Use
Indicated for adult and neonatal patients requiring ambulatory ECG monitoring in clinical settings using a standard torso 12-lead hook-up.
Regulatory Classification
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.
Predicate Devices
- Hewlett Packard M1403A Digital UHF Telemetry System (K920429)
- Marquette Electronics CD-Telemetry LAN (K891104)
Submission Summary (Full Text)
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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.
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).
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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,<br>Part 1: General Requirements for safety |
| IEC-601-1-2 | Medical Electrical Equipment<br>Part 1: General Requirements for Safety;<br>2. Collateral Standard: Electromagnetic Compatibility<br>Requirements and Test |
| IEC-601-2-25 | Medical Electrical Equipment<br>Part 2: Particular Requirements for Safety of<br>Electrocardiographs |
| UL 2601-1 | Medical Electrical Equipment,<br>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 UHF<br>Telemetry System<br>510k #: (K920429) | Marquette Electronics<br>CD-Telemetry LAN<br>510k #: (K891104) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Ambulatory X-12 | HP M1400A Transmitter | CD Telemetry Transmitter |
| Intended Use | Transmit 12 leads of patient data by a<br>digital radio transmission. | Transmit 2 leads of patient data by a<br>digital radio transmission to a receiver<br>over an antenna network to a Central<br>Station. | Transmit 3 leads of patient data by a<br>digital radio transmission to a receiver<br>over an antenna network to a<br>Centralscope |
| Target Population | Adults and Neonatal Patients | Adult or Neonatal Patients | Adult or Neonatal Patients |
| Product Labeling | Brochures and Operator's Manual | Brochures | Brochures |
| Standard Leads<br>Acquired | I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,<br>V6 | 2 Leads transmitted | 3 Leads Transmitted |
| Input Channels | Simultaneous acquisition of all 12 leads. | A three-electrode set for single-lead<br>operation. A four or five-electrode set for<br>dual-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 Offset<br>Tolerance | 350mV | $\pm$ 400mV | $\pm$ 450mV |
| Signal Strength | Not Specified | 30 meters with a signal strength of<br>8 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)<br>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 and<br>polypropylene | High carbon antistatic plastic |
| Performance Testing | EC-38-1994<br>EC-11-1991 | Not Specified | Not Specified |
| Digital Sampling | 500 s/sec/channel transmission for<br>recording and analysis | Not Specified | 120 samples/sec |
| Special Functions | Pacemaker detection and transmission;<br>Lead off detection and transmission;<br>Electrode impedance measurements<br>10,000 s/sec/channel used for Pacemaker<br>Artifact Detection | Pacemaker detection; Alarms;<br>Lead off detection and transmission;<br>Nurse call button;<br>Generate a strip recording. | Pacemaker detection; Lead fail<br>detection; LCD display;<br>Battery Integrity transmitted;<br>Alarm pause transmitted;<br>Graph request transmitted;<br>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 with<br>Mortara Instrument Patient Cable | Transmitter ECG input protected against<br>400 joules discharge into a 50 ohm load. | ± 5000 VDC, 400 joules into 50 ohm<br>load |
| Output Power | 50 mV/m at 3 meters | 10 mV/m at 3 meters | 1.50 uV/m at 3 meters |
| Energy Used and/or<br>Delivered | 2 AA alkaline batteries (30 Hours) | 9 Volt Battery (2.5 Days) | 1.5 Volt Battery (2) (60 hrs) |
| Current Compatibility<br>with Other Devices | Other Devices: ELI 100, ELI 200, Portrait,<br>ELI-XR, X-Scribe Stress System, and<br>ELI 100 STM | Other Devices: Patient Monitor/Holter<br>Recorder Interface (Analog Output); ST<br>Segment Analysis;<br>HP M1401A Receiver Mainframe;<br>HP M1402A Receiver Module;<br>HP M1408A Antenna/Combiner | Other Devices: CD Telemetry-LAN<br>Receiver Cabinet;<br>CD Telemetry-LAN Antenna System<br>Centralscope |
| Where Used | Hospitals, Clinics | Hospitals, Clinics | Hospitals, Clinics |
| Standards | FCC Part 15<br>CAN/CSA 22.2 No. 601.1<br>UL 2601-1<br>IEC 601-1, 601-1-2, & 601-2-25<br>CE Marking for the 93/42/EEC Medical<br>Device Directive | UL 544,<br>CSA C22.2 No. 125M 1984 Risk Class 3,<br>TUEV Certification to IEC 601-1,<br>BSI BS5724: part 1:1979 | FCC Part 15, Subpart E (Paragraph<br>15.241),<br>UL 544 Listed.<br>CE Marking for the 93/42/EEC Medical<br>Device 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%<br>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 in<br>water at a 1 ft. Depth for 1 hr w/out |
| | | | damage. |
| Radio Channel<br>Spacing | 80 kHz (915 MHz)<br>320 kHz (2.15 GHz) | 25 kHz | 100 kHz |
| Modulation Type | Digital, frequency-shift keying | Digital, frequency-shift keying | PM/BPSK (Phase Modulated) digital<br>transmission. |
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JAN - 8
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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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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)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dasha Tiller
ision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Over-The-Counter Use
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Optional Format 1-2-
તેરૂ
Prescription Use
(Per 21 CFR 801.109)
