(146 days)
Not Found
No
The document mentions a proprietary ECG algorithm (Mortara VERITAS™ ECG algorithm) and a proprietary SpO2 algorithm, but does not explicitly state or imply the use of AI or ML within these algorithms or the device's functionality. The description focuses on signal processing and parameter calculation.
No.
The device is a monitor that acquires, analyzes, and outputs physiological signals, primarily for diagnostic and monitoring purposes, not for direct therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended as a sole means of diagnosis." While it processes physiological signals and parameters, it sends this data to a central station for further processing, including alarm processing and annunciation, and it lacks alarming capabilities and is not intended to be the only source for diagnosis.
No
The device description explicitly states it is a "battery operated patient worn transceiver" and mentions hardware components like a "touch sensitive, color display," "proprietary ECG lead cables," and "Multiple SpO2 sensor styles." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Surveyor S4 Mobile Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Surveyor S4 Function: The Surveyor S4 Mobile Monitor acquires, analyzes, and outputs physiological signals directly from the patient's body (ECG and SpO2). It does not analyze specimens derived from the body.
- Intended Use: The intended use clearly states it's for acquiring, analyzing, and outputting multi-lead ECG and SpO2 signals for monitoring purposes in conjunction with a central station. It is not intended for the examination of bodily specimens.
Therefore, the Surveyor S4 Mobile Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surveyor S4 Mobile Monitor is indicated for use:
· The Surveyor S4 is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.
- The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm
- The Surveyor S4 can deliver data from a 3/5 lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station.
• The Surveyor S4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.
· The Surveyor S4 mobile monitor is indicated for use in adults, adolescents and children.
• The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DQA, DPS
Device Description
The Surveyor™ S4 Mobile Monitor is a battery operated patient worn transceiver that communicates via IEEE 802.11 Wi-Fi technology to the Surveyor™ Central Station (K131929) which is the primary monitoring display and alarm source.
The Surveyor S4 transmitter has a touch sensitive, color display allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and Surveyor Central Station slot information. The Surveyor S4 can display physiological waveforms, measured parameters, demographic data and other status information. The Surveyor S4 acquires, filters, and processes ECG or ECG and SpO2 parameters and sends filtered signals and parameters to the Surveyor Central Station where alarm processing and annunciation occurs.
The Surveyor Central is designed to communicate with the Surveyor S4 within a healthcare facilities Wi-Fi network infrastructure. The Surveyor Central provides primary monitoring of telemetry patients when used with the Surveyor S4. The central station displays numeric values, waveforms, alarm generation and management, data storage, individualized patient management, report generation and printing functionality.
The Surveyor S4 provides continuous data acquisition which can be visualized on the S4 itself for the following parameters:
- o Electrocardiography (ECG) including heart rate and ECG waveforms
- · Saturation percentage of peripheral oxygen (SpO2), including SpO2 plethysmogram waveform, pulse rate, and signal quality index.
- o No alarm status or processing information of ECG or SpO2 is shown on the Surveyor S4 device.
- o The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias, by utilizing Mortara VERITAS™ ECG algorithm and sends ECG data packets, including arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole to the Surveyor Central Station for alarm processing and annunciation.
- o The Surveyor S4 utilizes proprietary ECG lead cables available in AHA or IEC, snap or clip, 3-Lead, 5-Lead, and diagnostic 12 Lead configurations.
SpO2 - o The Surveyor S4 processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm and sends data packets for SpO2 to the Surveyor Central Station for alarm processing and annunciation.
- o Multiple SpO2 sensor styles allow connection of adults, adolescents, and children. SpO2 sensors are specified for use with the Surveyor S4 and available through Mortara Instrument.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, adolescents and children.
Intended User / Care Setting
knowledgeable healthcare professionals within a healthcare or clinical setting.
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)
A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61. The study met the requirements of ISO 80601-2-61-2011 Clause 201.12.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Mortara Instrument, Inc. Sarah Weber Senior Regulatory Affairs Manager 7865 North 86th Street Milwaukee. Wisconsin 53224
Re: K160685
Trade/Device Name: Surveyor S4 Mobile Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DQA, DPS Dated: June 28, 2016 Received: June 29, 2016
Dear Sarah Weber:
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. Iisting 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Munde Jellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
Device Name Surveyor S4 Mobile Monitor
Indications for Use (Describe)
The Surveyor S4 Mobile Monitor is indicated for use:
· The Surveyor S4 is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.
-
The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm
-
The Surveyor S4 can deliver data from a 3/5 lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station.
• The Surveyor S4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.
· The Surveyor S4 mobile monitor is indicated for use in adults, adolescents and children.
• The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a logo above the text "Traditional 510(k) Notification". The logo is a blue shape that resembles a heart with a flat bottom. The text is in a simple, sans-serif font and is centered below the logo.
Section 5
510(k) Summary Statement
1. Submitter
| Mortara Instrument, Inc.
| 7865 North 86th Street | Primary Contact |
|---|---|
| Milwaukee, WI 53224 | Sarah Weber |
| Senior Regulatory Affairs | |
| Manager | |
| sarah.weber@mortara.com | |
| Telephone 414-354-1600 | |
| Fax 414-354-4760 | Secondary Contact |
| Margaret Mucha | |
| Director of Global Regulatory | |
| Affairs | |
| meg.mucha@mortara.com |
2. Product Names
| Device Trade Name | Surveyor S4 Mobile Monitor |
|---|---|
| Common/ Usual Name | Monitor, Physiological, Patient |
| (With Arrhythmia Detection or | |
| Alarms) | |
| Oximeter | |
| Electrocardiograph | |
| Classification | Monitor, Physiological, Patient (With |
| Arrhythmia Detection or Alarms) | |
| 870.1025 | |
| MHX | |
| Oximeter | |
| 870.2700 | |
| DQA | |
| Electrocardiograph | |
| 870.2340 | |
| DPS |
4
Image /page/4/Picture/0 description: The image shows a blue heart shape. The heart is formed by two curved lines that meet at the top and bottom. The heart is solid blue, and the background is white. The heart is centered in the image.
Traditional 510(k) Notification Note: There are no previous submissions for this device
3. Predicate Device to which this is Substantially Equivalent
| Surveyor S4 Mobile Monitor | K141020 |
|---|---|
| ApexPro Telemetry System | K080251 |
The primary predicate device is Surveyor S4 Mobile Monitor, K141020.
The S4 predicate device has not been subject to a design-related recall. The ApexPro predicate device does has not been under recall since 2011, Z-1522-2011.
4. Device Description
The Surveyor™ S4 Mobile Monitor is a battery operated patient worn transceiver that communicates via IEEE 802.11 Wi-Fi technology to the Surveyor™ Central Station (K131929) which is the primary monitoring display and alarm source.
The Surveyor S4 transmitter has a touch sensitive, color display allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and Surveyor Central Station slot information. The Surveyor S4 can display physiological waveforms, measured parameters, demographic data and other status information. The Surveyor S4 acquires, filters, and processes ECG or ECG and SpO2 parameters and sends filtered signals and parameters to the Surveyor Central Station where alarm processing and annunciation occurs.
The Surveyor Central is designed to communicate with the Surveyor S4 within a healthcare facilities Wi-Fi network infrastructure. The Surveyor Central provides primary monitoring of telemetry patients when used with the Surveyor S4. The central station displays numeric values, waveforms, alarm generation and management, data storage, individualized patient management, report generation and printing functionality.
The Surveyor S4 provides continuous data acquisition which can be visualized on the S4 itself for the following parameters:
- o Electrocardiography (ECG) including heart rate and ECG waveforms
- · Saturation percentage of peripheral oxygen (SpO2), including SpO2 plethysmogram waveform, pulse rate, and signal quality index.
- o No alarm status or processing information of ECG or SpO2 is shown on the Surveyor S4 device.
5
Image /page/5/Picture/0 description: The image shows a white heart shape inside of a blue square. The heart shape is formed by two curved lines that meet at the bottom and form a point at the top. The blue square provides a background for the heart shape, making it stand out. The logo is simple and clean, with a focus on the heart shape.
Traditional 510(k) Notification
- o The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias, by utilizing Mortara VERITAS™ ECG algorithm and sends ECG data packets, including arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole to the Surveyor Central Station for alarm processing and annunciation.
- o The Surveyor S4 utilizes proprietary ECG lead cables available in AHA or IEC, snap or clip, 3-Lead, 5-Lead, and diagnostic 12 Lead configurations.
SpO2
- o The Surveyor S4 processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm and sends data packets for SpO2 to the Surveyor Central Station for alarm processing and annunciation.
- o Multiple SpO2 sensor styles allow connection of adults, adolescents, and children. SpO2 sensors are specified for use with the Surveyor S4 and available through Mortara Instrument.
5. Intended Use
The Surveyor S4 Mobile Monitor is indicated for use:
·The Surveyor S4 Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals.
The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.
- · The Surveyor S4 processes Heart Rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm.
- · The Surveyor S4 can deliver data from a 3/5-lead cable and_diagnostic 12-lead ECG data to a receiving Surveyor Central_station
- The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.
ECG
6
Image /page/6/Picture/0 description: The image shows a logo with a heart shape in the center, formed by two curved lines. The heart is white, and the background is blue. Below the logo, the text "Traditional 510(k) Notification" is written in a simple, sans-serif font. The text is black and appears to be centered beneath the logo.
· The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children.
· The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.
6. Technological Characteristics
The Surveyor S4 Mobile Monitor employs the same functional scientific technology as its predicate device Surveyor S4 Mobile Monitor (K141020). It is a prescription device designed to acquire and transmit diagnostic quality ECG in a clinical setting while allowing the patient to be ambulatory. The Surveyor S4 Mobile Monitor is suitable for use as a telemetry solution within centralized ECG monitoring systems or other clinical settings for patients connected to telemetry transceivers
The Surveyor S4 Mobile Monitor is designed to work with ECG when used with a compatible multi-parameter Telemetry Central Station System such as the Mortara Surveyor Central Station (K131929) and other compatible receiving devices.
The Surveyor S4 Mobile Monitor was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. The Surveyor S4 Mobile Monitor is substantially equivalent to The Surveyor S4 Mobile Monitor (Predicate K141020) with the following technological differences:
- . Added 3/4/5 lead ECG
- Added shielded 3/4/5- wire ECG patient cable ●
- Added SpO2 functionality ●
- Added SpO2 sensor with optional extender cable .
| 510(k) | K080251 | K141020 | Present Submission | Change
explanation |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BRAND | ApexPro | Surveyor S4 Mobile
Monitor (Primary) | Surveyor S4 Mobile
Monitor | |
| COMPANY | GE Medical
Systems
Information
Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | |
| Software
Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)
Number | K080251 | K141020 | Present Application | |
| Indications for
Use | The ApexPro
Telemetry
System is | The Surveyor S4 Mobile
Monitor is indicated for
use: | The Surveyor S4 Mobile
Monitor is indicated for use:
• The Surveyor S4 | |
| | | | | Equivalent.
Indications revised |
| 510(k) | K080251 | K141020 | Present Submission | Change explanation |
| BRAND | ApexPro | Surveyor S4 Mobile Monitor (Primary) | Surveyor S4 Mobile Monitor | |
| COMPANY | GE Medical Systems Information Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | |
| Software Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K) Number | K080251 | K141020 | Present Application | |
| | intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are | The Surveyor S4 Mobile Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 Mobile Monitor facilitates the monitoring of ECG signals. The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. The Surveyor S4 Mobile Monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The Surveyor S4 Mobile Monitor is indicated for use to acquire and output electrocardiographic data. The Surveyor S4 Mobile Monitor is indicated for use as a | Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG, SpO2 and other physiological signals. The Mortara Surveyor S4 Mobile Monitor facilitates the real-time monitoring of clinical parameters when used in conjunction with alarm annunciating devices such as a Central Station for telemetric monitoring. The Surveyor S4 can deliver diagnostic 12-lead ECG data to a receiving station. The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure. The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children. The Surveyor S4 Mobile Monitor is a prescription device intended to | for clarity and to provide patient population categories in accordance with FDA guidance "Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated May 1, 2014. Added SpO2 functionality. |
| 510(k) | K080251 | K141020 | Present Submission | |
| BRAND | ApexPro | Surveyor S4 Mobile
Monitor (Primary) | Surveyor S4 Mobile
Monitor | |
| COMPANY | GE Medical
Systems
Information
Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Change
explanation |
| Software
Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)
Number | K080251 | K141020 | Present Application | |
| | typically
deployed in
sub-acute
care areas in
hospitals or
clinical sites
where patient
mobility can
enhance the
effectiveness
of the medical
procedures
administered.
The
physiological
parameters
monitored
include ECG,
noninvasive
blood
pressure,
non-invasive
temperature
and SpO2.
The ApexPro
Telemetry
System is
intended to
provide ECG
data
via Ethernet
to the
computer
platform for
processing.
The
ApexPro
Telemetry
System is
also intended
to provide
physiologic
data over the
Unity Network
to clinical
information
systems for
display. | radiofrequency
physiological
signal
transceiver,
receiving and
delivering real-
time acquisition
and transmission
of simultaneous
electrocardiograp
hic data, while
allowing the
patient to be
ambulatory
within the range
of the antenna
network.
The Mortara Li-Ion
Battery Charger is
intended for charging
only the Mortara
Rechargeable Li-Ion
battery pack. | be used by
knowledgeable
healthcare
professionals
within a healthcare
or clinical setting.
It is not intended
as a sole means
of diagnosis. | |
| 510(k) | K080251 | K141020 | Present Submission | |
| BRAND | ApexPro | Surveyor S4 Mobile
Monitor (Primary) | Surveyor S4 Mobile
Monitor | |
| COMPANY | GE Medical
Systems
Information
Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Change
explanation |
| Software
Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)
Number | K080251 | K141020 | Present Application | |
| Operating
System | Proprietary | Linux derivative | Linux derivative | Equivalent |
| Network
Interface | Digital/608-
614 Mhz | Digital/Wireless network
interface per
IEEE 802.11g/n | Digital/Wireless network
interface per IEEE
802.11g/n | Equivalent
Both devices
use a digital,
wireless form of
communication
but utilize
different
frequency
ranges and
signaling
protocol. |
| Target
Population | Adult,
pediatric | Adult, pediatric | Adults, adolescents,
children | Equivalent.
Subject device
includes a
subset of the
Adults to
Neonate
population of the
predicate
device.
Revised patient
population
categories in
accordance with
FDA quidance
"Providing
Information
about Pediatric
Uses of Medical
Devices -
Guidance for
Industry and
Food and Drug
Administration
Staff" dated
May 1, 2014. |
| ECG | 3, 5, or 6-lead
ECG | 12-lead diagnostic ECG | 3/4/5-lead, and12-lead
diagnostic ECG | Equivalent |
| 510(k) | K080251 | K141020 | Present Submission | |
| BRAND | ApexPro | Surveyor S4 Mobile
Monitor (Primary) | Surveyor S4 Mobile
Monitor | |
| COMPANY | GE Medical
Systems
Information
Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Change
explanation |
| Software
Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)
Number | K080251 | K141020 | Present Application | |
| ECG Sampling
Rate | 240
samples/seco
nd | 500 Samples/second | 500 samples/sec | Equivalent
The subject
device is
equivalent to the
previous
submission of
the same
device. |
| SpO2 | Yes | No | Yes | New
functionality
added |
| Graphic
Display | No | Yes | Yes | Equivalent |
| Frequency
Transmission | 608-614
WMTS or
1,395-1,400
WMTS,
dependent on
transmitter
model | IEEE 802.11g/n, 2.4
GHz band | IEEE 802.11g/n, 2.4
GHz band | Equivalent |
| Transmission
Type | Channelized | Digital wireless in
accordance with
IEEE 802.11g/n | Digital wireless in
accordance with
IEEE 802.11g/n | Equivalent |
| Battery Type | 2 AA | 3 AA disposable, or
rechargeable Li-Ion Pack | 3 AA disposable, or
rechargeable Li-Ion Pack | Equivalent |
| Lead Check | Yes | Yes | Yes | Equivalent |
| Internal
Antenna | No | Yes | Yes | Equivalent |
| Compatible
Systems | CARESCAPE
Central Station
(K133882) | Surveyor Central Station
(K131929) | Surveyor Central Station
(K131929) | Equivalent |
| Patient Cable | 3, 5, and 6-wire
Multi-Link
Leadwires | LeadForm 10-wire ECG | LeadForm 10-wire ECG
Shielded 3/4/5-wire ECG | Equivalent |
| 510(k) | K080251 | K141020 | Present Submission | Change explanation |
| BRAND | ApexPro | Surveyor S4 Mobile
Monitor (Primary) | Surveyor S4 Mobile
Monitor | |
| COMPANY | GE Medical
Systems
Information
Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | |
| Software
Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)
Number | K080251 | K141020 | Present Application | |
| SpO2 Cable | Masimo
uSpO2 pulse
oximetry
utilizing
Masimo SET
Measure-
through
Motion and
low perfusion
pulse
oximetry
technology
with
compatible
LNCS style
sensors. | N/A | SpO2 sensors - disposable,
clip, SoftTipTM
w/ optional extender cable | |
| | | | | Equivalent
Added SpO2 as
a new feature to
subject device. |
Comparison Matrix:
7
8
9
10
11
7. Determination of Substantial Equivalence – Non-clinical
Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content fo Premarket Submissions for Software Contained in Medical Devices" and "Off-the-Shelf Software Use in Medical Devices."
The Surveyor S4 Mobile Monitor was designed and tested for compliance with the applicable clauses of the following standards:
Image /page/11/Picture/4 description: The image shows a logo above the text "Traditional 510(k) Notification". The logo is a blue square with a white heart shape inside. The text is centered below the logo and is in a simple, sans-serif font.
- . IEC 60601-1:2005 Ed:3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-49: 2011 Medical electrical equipment Part . 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- IEC 60601-1-2:2007 Medical Electrical Equipment Part . 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests
12
- ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- IEC 60601-2-25:2011-10 Edition 2.0, Medical Electrical . Equipment. Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm, ST segment measurement algorithms, ventricular fibrillation algorithm, and irregular rhythm (atrial fibrillation) algorithm
8. Determination of Substantial Equivalence – Clinical
A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61. The study met the requirements of ISO 80601-2-61-2011 Clause 201.12.1.
9. Conclusion
Changes to the Surveyor S4 Mobile Monitor include:
- · Added SpO2 functionality
- . Added SpO2 extender cable
- Added shielded 3/4/5-wire ECG .
Mortara Instrument, Inc. considers the Surveyor S4 Mobile Monitor to be as safe, as effective and performance is substantially equivalent to the predicate devices.