(153 days)
Surveyor S4 (K141020)
Not Found
No
The summary describes a device for acquiring and transmitting ECG signals for external processing, but does not mention any AI or ML capabilities within the device itself or the described processing.
No
The device is indicated for monitoring ECG signals and acquiring/transmitting electrocardiographic data, not for treating any condition.
No
The device is explicitly stated not to be a sole means of diagnosis ("It is not intended as a sole means of diagnosis.") and its primary function is monitoring ECG signals and transmitting data for further processing, not making a diagnosis itself.
No
The device description explicitly states that the Surveyor S2 is a "patient-worn, battery-powered telemetry transmitter" with a "2.8'' color display with a capacitive touch sensitive screen" and utilizes "ECG lead cables". These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Surveyor S2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Surveyor S2 Function: The Surveyor S2 is described as a patient-worn telemetry transmitter that acquires and transmits ECG signals from the patient's body. It is used for monitoring ECG signals and providing real-time acquisition and transmission of electrocardiographic data.
- No Specimen Analysis: The description explicitly states that the Surveyor S2 acquires signals directly from the patient's body (ECG leads). It does not involve the collection or analysis of any specimens taken from the body.
The device's function is focused on physiological signal acquisition and transmission for monitoring purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Surveyor S2 is indicated for use:
-
The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.
-
The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
-
The Surveyor S2 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 S2 is indicated for use to acquire and output electrocardiographic data.
-
The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
The Surveyor S2 is a patient-worn, battery-powered telemetry transmitter. The Surveyor S2 is intended to acquire ECG signals and transmits waveforms and corresponding status to a receiving S2 Communication Library. The S2 Communication Library, to be integrated in an external monitoring node for processing, exposes an API to obtain ECG signals and push session status, parameters and demographic information to the S2.
The ECG acquired signals are transmitted through the S2 communication Library to the Monitoring Node for further processing, presentation, storage, etc via the hospital/clinic wireless and wired network infrastructure. The Surveyor S2 is designed to be used within the existing network IT infrastructure.
The Surveyor S2 has a 2.8'' color display with a capacitive touch sensitive screen, allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and on-demand visual indication of the status of its connection to the monitoring node. The Surveyor S2 acquires and sends signals to the monitoring node where ECG signal processing and monitoring occurs. The Surveyor S2 displays ECG derived parameters (Heart Rate) and demographic data and monitoring state as received from the monitoring node through the S2 Communication Library.
The Surveyor S2 provides continuous data acquisition which can be visualized on the S2 itself for the ECG waveforms.
The Surveyor S2 utilizes ECG lead cables available in AHA or IEC, snap or clip, 4-wire Lead. ECG data delivered is 3-leads, lossless compressed, 2.5 µV LSB at 500 samples per second.
ECG data is augmented with electrode fail markers, lead identifications, hardware detected pacemaker spikes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, adolescents, and children patient populations.
Intended User / Care Setting
knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
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)
Non-clinical Test:
The Surveyor S2 was tested based on the following standards:
- IEC 60601-1:2005 Ed:3.1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Ed.4.0 Medical Electrical Equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests
- IEC 60601-2-27:2011 Ed.3.0/Cor.1:2012, Medical Electrical Equipment -Part 2 27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- ISO 10993-1:2009/Cor.1:2010, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- AAMI/ANSI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- IEC 60601-1-6:2010+A1:2013-Ed.3.1, Medical electrical equipment – Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366:2014-Ed.1.1, Medical devices Application of usability engineering to medical devices
- IEC 62304:2006 Ed. 1. medical device software - software life cycle processes.
- ISO 14971:2007 Ed 2 medical devices application of risk management to medical devices.
Performance testing for the Surveyor S2 includes software verification and validation test, software unit test, integration test, system test and testing to compliance standards for electrical and electromagnetic safety. Wireless coexistence testing and evaluation was performed following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device", and the device's immunity to proximity fields from radio frequency wireless communications equipment was validated. Traceability has been documented between all specifications to verification and validation test results.
Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining data.
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.
Surveyor S4 (K141020)
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
§ 870.2910 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 24, 2019
Mortara Instrument, Inc. Marco Manduchi OA/RA Manager 7865 North 86th Street Milwaukee, Wisconsin 53224
Re: K182297
Trade/Device Name: Surveyor S2 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: December 20, 2018 Received: December 26, 2018
Dear Marco Manduchi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182297
Device Name Surveyor S2
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The Surveyor S2 is indicated for use:
· The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.
· The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
· The Surveyor S2 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 S2 is indicated for use to acquire and output electrocardiographic data.
· The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
X 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 white heart shape with a blue background at the top. Below the heart shape, the text "Traditional 510(k) Premarket Notification" is displayed. The text is in a simple, sans-serif font and is left-aligned. The image appears to be a logo or header for a document related to medical device regulation.
510(k) Summary
[As described in 21 CFR 807.92]
| Submitted by: | Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person
Primary Contact: | Marco Manduchi
Regulatory Affairs Manager
Phone: +39 - 0512987821
marco.manduchi@welchallyn.com |
| Secondary Contact: | Mark Elliott
VP Global RA/QA
Phone: 414-354-1600
Mark.Elliott@Mortara.com |
| Date Prepared: | July 31, 2018 |
| Trade Name: | Surveyor S2 |
| Common Name | Transmitters and receivers, physiological
signal, radiofrequency |
| Classification
Reference: | Class II, Transmitters and receivers,
physiological signal, radiofrequency (21
CFR 870.2910, Product code DRG) |
| Predicate device: | Surveyor S4 Mobile Monitor
510(k) Number: K141020
Transmitters and receivers, physiological
signal, radiofrequency, 21 CFR 870.2910
Class II, DRG |
4
Image /page/4/Picture/0 description: The image shows a white heart shape inside a blue square. Below the square is the text "Special 510(k) Premarket Notification". The text is in a sans-serif font and is black.
Device Description
The Surveyor S2 is a patient-worn, battery-powered telemetry transmitter. The Surveyor S2 is intended to acquire ECG signals and transmits waveforms and corresponding status to a receiving S2 Communication Library. The S2 Communication Library, to be integrated in an external monitoring node for processing, exposes an API to obtain ECG signals and push session status, parameters and demographic information to the S2.
The ECG acquired signals are transmitted through the S2 communication Library to the Monitoring Node for further processing, presentation, storage, etc via the hospital/clinic wireless and wired network infrastructure. The Surveyor S2 is designed to be used within the existing network IT infrastructure.
The Surveyor S2 has a 2.8'' color display with a capacitive touch sensitive screen, allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and on-demand visual indication of the status of its connection to the monitoring node. The Surveyor S2 acquires and sends signals to the monitoring node where ECG signal processing and monitoring occurs. The Surveyor S2 displays ECG derived parameters (Heart Rate) and demographic data and monitoring state as received from the monitoring node through the S2 Communication Library.
The Surveyor S2 provides continuous data acquisition which can be visualized on the S2 itself for the ECG waveforms.
The Surveyor S2 utilizes ECG lead cables available in AHA or IEC, snap or clip, 4-wire Lead. ECG data delivered is 3-leads, lossless compressed, 2.5 µV LSB at 500 samples per second.
ECG data is augmented with electrode fail markers, lead identifications, hardware detected pacemaker spikes.
Indication for use
The Surveyor S2 is indicated for use:
- The Surveyor S2 is indicated for use in adult, adolescents, and children ● patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.
- o The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
5
Image /page/5/Picture/0 description: The image shows a white heart shape against a blue background. The heart is centered and fills most of the frame. The blue background surrounds the heart, creating a simple and clean design.
- . The Survevor S2 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 S2 is indicated for use to acquire and output electrocardiographic data.
- . The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
Technological Characteristics
The Survevor S2 employs the same functional scientific technology as its predicate device Surveyor S4 (K141020). It is a prescription device designed to acquire and transmit ECG in a clinical setting while allowing the patient to be ambulatory. The Surveyor S2 is suitable for use as a telemetry solution within centralized ECG monitoring node systems or other clinical settings for patients connected to telemetry transceivers.
The Surveyor S2 is designed and manufactured by Mortara Instrument according to 21 CFR Part 820. Surveyor S2 is substantially equivalent to Surveyor S4 (Predicate K141020) with the following technological differences:
- Surveyor S2 is designed to communicate with a S2 communication Library . a C++ software library intended to provide a consistent, tested and reusable interface for integrating the S2 Wi-Fi telemetry transmitter into a monitoring node.
- . S2 and S4 has a different WLAN module, but both use a Wi-Fi network interface. Surveyor S4 supports only IEEE 802.11 b/g/n at 2.4 GHz band whereas S2 supports IEEE 802.11 a/b/g/n on 2.4GHz and 5GHz band.
- . Surveyor S2 supports 4-wire lead
Moreover, modifications were made to the Surveyor S2 to provide the same functionality of the predicate device Surveyor S4 in a smaller size, to reduce the weight of the device, to improve the battery duration and to improve the touch screen responsiveness.
6
Image /page/6/Picture/0 description: The image shows a logo with a white heart shape inside a blue square. Below the logo, the text "Special 510(k) Premarket Notification" is displayed. The text is in a simple, sans-serif font and is left-aligned. The image appears to be a title or heading for a document related to medical device regulations.
Device Comparison Table:
| Predicate Device and Subject Device Comparison | |||
|---|---|---|---|
| Characteristic | Predicate device | Subject device | Change explanation |
| Device | Surveyor S4 | Surveyor S2 | Model Number |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Same |
| 510(k) number | K141020 | N/A | N/A |
| Software Version | V1.00 | V1.0.0 | Since the device has a different |
| model number has been created a | |||
| new software version. | |||
| Product Code | DRG | DRG | Same |
| Classification Name | Class II Transmitters and | ||
| receivers, physiological | |||
| signal, radiofrequency | Class II Transmitters and | ||
| receivers, physiological | |||
| signal, radiofrequency | Same | ||
| Regulation Number | 21 CFR 870.2910 | 21 CFR 870.2910 | Same |
| Intended use | The Surveyor S4 is | ||
| indicated for use: | |||
| The Surveyor S4 is | |||
| indicated for use in adult & | |||
| pediatric patient | |||
| populations. | |||
| The Surveyor S4 | |||
| facilitates the monitoring | |||
| of ECG signals. | |||
| The Surveyor S4 is a | |||
| prescription device | |||
| intended to be used by | |||
| knowledgeable healthcare | |||
| professionals within a | |||
| healthcare facility or | |||
| clinical pharmacology unit. | |||
| The Surveyor S4 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 is | |||
| indicated for use to | |||
| acquire and output | |||
| electrocardiographic data. | |||
| The Surveyor S4 is | |||
| indicated for use as a | The Surveyor S2 is | ||
| indicated for use: | |||
| The Surveyor S2 is | |||
| indicated for use in adult, | |||
| adolescents, and children | |||
| patient populations. | |||
| The Surveyor S2 facilitates | |||
| the monitoring of ECG | |||
| signals. | |||
| The Surveyor S2 is a | |||
| prescription device intended | |||
| to be used by | |||
| knowledgeable healthcare | |||
| professionals within a | |||
| healthcare facility or clinical | |||
| pharmacology unit. | |||
| The Surveyor S2 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 S2 is | |||
| indicated for use to acquire | |||
| and output | |||
| electrocardiographic data. | |||
| The Surveyor S2 is | |||
| indicated for use as a | |||
| radiofrequency physiological | Same | ||
| Surveyor S2 indications for use have | |||
| been revised for clarity 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. | |||
| Surveyor S2 is not provided with a | |||
| specific Mortara li-on battery | |||
| Charger. Surveyor S2 use a OEM | |||
| battery recharger. The new battery | |||
| charger has been tested for safety by | |||
| the supplier and to demonstrate | |||
| proper charging across each | |||
| charging port as well as | |||
| demonstrating proper LED functions | |||
| for the charger. | |||
| Characteristic | Predicate device | Subject device | Change explanation |
| radiofrequency | |||
| physiological signal | |||
| transceiver, receiving and | |||
| delivering real-time | |||
| acquisition and | |||
| transmission of | |||
| simultaneous | |||
| electrocardiographic 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. | signal transceiver, receiving
and delivering real-time
acquisition and transmission
of simultaneous
electrocardiographic data,
while allowing the patient to
be ambulatory within the
range of the antenna
network. | | |
| Standard
Compliance | IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-2-27:2011
IEC 60601-1-6:2010
IEC 62366:2007-10
ISO10993-1:2009
ISO10993-5: 2009
ISO10993-10: 2010
EN 62304:2006
ISO 14971:2007 | IEC 60601-1:2005 Ed 3.1
IEC 60601-1-2:2014 Ed 4.0
IEC 60601-2-27:2011 Ed
3.0
IEC 60601-1-6:2010 Ed 3.1
IEC 62366:2014 Ed.1.1
ISO 10993-1:2009 Ed 4
ISO 10993-5:2009 Ed 3
ISO 10993-10:2010 Ed 3
IEC 62304:2006 Ed 1,
ISO 14971:2007 Ed 2. | Equivalent, Surveyor S2 has been
designed in conformity with the
same standard of the predicate
Surveyor S4. Surveyor S2 follow
the new version of the IEC 60601-
1-2. |
| Network Interface
and Frequency
Transmission | Digital/Wireless network
interface per
IEEE 802.11 b/g/n 2.4
GHz band | Digital/Wireless network
interface per
IEEE 802.11a/g/n, 2.4 or
5GHz bands | S2 use the same network interface
of S4. S2 differently from S4 use
also 5Ghz Frequency
Transmission. This new feature
has been tested in the V&V
documentation. |
| Characteristic | Predicate device | Subject device | Change explanation |
| Target Population | Adults, pediatrics | Adults, adolescents, children | Equivalent.
Subject device includes a subset of the Adults to Children population of the predicate device.
Revised 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. |
| Where used | Health care facilities | Health care facilities | Same |
| ECG | 12-lead diagnostic ECG | 3-lead ECG | Equivalent, S2 uses the a 3-lead ECG, this function has been cleared in the K160685. Moreover, Surveyor S2 functionality with 3-lead ECG has been tested in the system V&V. |
| Patient Cable | LeadForm 10-wire ECG | Shielded 4-wire ECG | Equivalent, S2 uses the a 4-wire ECG cable, this cable has been cleared in the K160685. Moreover, Surveyor S2 functionality with 4-wires ECG cable has been tested in the system V&V. |
| ECG Sampling Rate | 500 Samples/sec | 500 samples/sec | Same |
| Graphic Display | Yes | Yes | Equivalent |
| Touch screen | Resistive Touch screen | Capacitive touch screen | Equivalent, this modification improves the responsiveness of the device, and allow the Surveyor S2 do not be calibrated. Capacitive touch screen responsiveness has been tested in the hardware verification. |
| Display Size | 4" | 2,8" | Equivalent, this modification reduces the dimension of the device. |
| Predicate Device and Subject Device Comparison | | | |
| Characteristic | Predicate device | Subject device | Change explanation |
| Battery Type | 3 AA disposable, or
rechargeable Li-Ion Pack | Rechargeable Li-Ion Pack | S2 is not powered by AA
disposable battery, but only by a
rechargeable Li-ion Pack. S2
rechargeable Li-ion Pack is
equivalent to S4. |
| Rechargeable
Battery Run-Time | 24 hrs | 32 Hrs | Similar. This new feature has
been tested. |
| Signal Processing | Signal fail detection and
waveform filtering for
local display | Signal fail detection and
waveform filtering for local
display | Same |
| Lead Check | Yes | Yes | Same |
| Internal Antenna | Yes | Yes | Same |
| Dimension | 5.5" x 3.1" x 1.3" (139 x
79 x 33 mm) | 3.5" x 2.8" x 1.1" (89 x 71 x
28 mm) | Surveyor S2 provide the same
functionality of the predicate
device Surveyor S4 in a smaller
size. |
| Weight | 300g with battery. | 200g with battery | Surveyor S2 provide the same
functionality of the predicate
device Surveyor S4 with a minor
weight. |
7
Image /page/7/Picture/0 description: The image shows a white heart shape against a blue background. The heart is centered in the image and takes up a significant portion of the frame. The blue background surrounds the heart, creating a simple and clean design. The image is well-lit, and the colors are vibrant.
8
Image /page/8/Picture/0 description: The image shows a white heart shape against a blue background. The heart is centered in the image and takes up a significant portion of the frame. The blue background surrounds the heart, creating a clear contrast between the two colors.
9
Image /page/9/Picture/0 description: The image shows a white heart shape against a blue background. The heart is centered in the image and takes up most of the space. The blue background surrounds the heart, creating a simple and clean design. The image is likely a logo or symbol representing love, care, or support.
Non-clinical Test
The Surveyor S2 was tested based on the following standards:
- IEC 60601-1:2005 Ed:3.1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Ed.4.0 Medical Electrical Equipment Part 1-2: ● General requirements for safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests
- IEC 60601-2-27:2011 Ed.3.0/Cor.1:2012, Medical Electrical Equipment -● Part 2 27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- ISO 10993-1:2009/Cor.1:2010, Biological evaluation of medical devices ● - Part 1: Evaluation and testing within a risk management process
- AAMI/ANSI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical ● devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: ●
10
Image /page/10/Picture/0 description: The image shows a white heart shape against a blue background. The heart is centered in the image and takes up a significant portion of the frame. The blue background is a solid color, providing a contrasting backdrop for the white heart.
Tests for irritation and skin sensitization
- IEC 60601-1-6:2010+A1:2013-Ed.3.1, Medical electrical equipment – Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366:2014-Ed.1.1, Medical devices Application of usability ● engineering to medical devices
- . IEC 62304:2006 Ed. 1. medical device software - software life cycle processes.
- ISO 14971:2007 Ed 2 medical devices application of risk management ● to medical devices.
Performance testing for the Surveyor S2 includes software verification and validation test, software unit test, integration test, system test and testing to compliance standards for electrical and electromagnetic safety. Wireless coexistence testing and evaluation was performed following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device", and the device's immunity to proximity fields from radio frequency wireless communications equipment was validated. Traceability has been documented between all specifications to verification and validation test results.
Clinical Performance Data
No clinical studies were utilized for the purpose of obtaining data.
Conclusion
Based on the information presented in this 510(k) premarket notification, the Surveyor S2 is considered substantially equivalent to devices in commercial distribution and its predicate devices Surveyor S4 (K141020).
The differences noted between the Surveyor S2 and the predicate device do not impact the device based on the successfully conducted testing of the device.