(140 days)
Not Found
No
The document describes a standard vital signs monitor using established technologies (oscillometric, plethysmography, thermistor, infrared) and a microprocessor with firmware. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
Explanation: The device is described as a "spot check vital signs device" intended for "measurement, recording, and display" of vital signs. It explicitly states it "makes no specific diagnoses" and its measurements are for monitoring, not direct treatment.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The CT40 is only for measurement, recording, and display. It makes no specific diagnoses."
No
The device description clearly outlines a physical hardware device with components like an LCD display, control buttons, enclosure, battery, and ports for connecting sensors and peripherals. While it contains firmware (software), it is not solely software.
Based on the provided text, the SunTech CT40 (Model 260) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside the body (in vitro).
- SunTech CT40 Function: The description clearly states that the SunTech CT40 is a "non-invasive oscillometric spot check vital signs device." It measures vital signs (blood pressure, heart rate, SpO2, and temperature) directly from the patient's body without taking samples.
Therefore, the SunTech CT40 falls under the category of a non-invasive vital signs monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The SunTech CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DOA, FLL
Device Description
The CT40 (Model 260) is designed to non-invasively measure systolic and diastolic blood pressure, pulse rate, temperature, and oxygen saturation (SpO2) for adult and pediatric patients. All blood pressure, pulse, temperature, and SpO2 values are displayed on a large, easy-to-read LCD. The device has a rechargeable battery and may be use as a desktop unit or on a mobile stand.
The CT40 (Model 260) Spot-check Vital Signs Device can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The CT40 (Model 260) consist of a base unit with NIBP, display, control buttons and knob housed in an ABS plastic enclosure. The left side of the unit has a removable panel were a SpO2 module may be connected. And the right side of the unit has a removable panel where a temperature module may be connected.
For measuring blood pressure, a blood pressure cuff is placed around the patient's non-dominant upper arm. The cuff is automatically inflated and the blood pressure is determined by the oscillometric method, which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured.
The pulse oximetry function non-invasively measures the patient's percent oxygen saturation of arterial hemoglobin using principles of plethysmography via a SpO2 sensor placed on the patient's finger.
Temperature can be measured using one of two different kinds of temperature technology. The oral/axillary/rectal temperature probe contains a thermistor that generates a voltage based on changes in temperature, and these voltages are measured by the temperature circuitry. The touchless infrared temperature probe detects radiated infrared energy from the temporal artery.
The CT40 (Model 260) is a portable device, approximately 205 x 190 x 140 mm in size and weighs approximately 1440 g without battery. Control buttons allow the user to stop/start a BP measurement, save a set of measurements to memory, change between BP modes, and return to the home screen.
There is also a selection knob that is used to scroll and select different device options. The backlit LCD display shows the user device status and measurement information. The device uses a microprocessor with firmware, which is not accessible to the user. The unit is powered by AC mains power and rechargeable lithium-ion battery. Two USB-A port connections can be used to connect, an optional printer, barcode scanner or Wi-Fi dongle. There is also RJ11 Ethernet port for network connectivity, and a mini-USB port used to connect the device to a PC or laptop for advanced device configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachial, finger, oral, axillary, rectal, temporal artery
Indicated Patient Age Range
children 3 years of age to adults
Intended User / Care Setting
qualified clinician, hospitals, medical facilities, clinics, physicians offices, and other sub acute environments, research center (under supervision of physician)
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)
NIBP Clinical Validation Study (97-0143-XX-CV-81060-2).
The CT40 (Model 260) has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.
- IEC 60601-1: 2012, Medical electrical equipment Part 1: General requirements for basic safety ● and essential performance
- IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- . IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 80601-2-30: 2009 +A1: 2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ISO 81060-2: 2013, Non-invasive sphygmomanometers -Part 2: Clinical investigation of automated measurement type
- ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- ISO 80601-2-61: 2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- IEC62304:2006 Medical device software - Software life cycle processes
- IEC62366:2008 Medical devices - Part 1: Application of usability engineering to medical devices
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, arranged in a way that resembles a bird in flight. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2017
SunTech Medical, Inc. Chuck Setzer Quality & Regulatory Affairs Manager 507 Airport Blvd Suite 117 Morrisville, North Carolina 27560
Re: K160439
Trade/Device Name: SunTech CT40 Spot-check Vital Signs Device (Model 260) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DOA, FLL Dated: June 3, 2016 Received: June 7, 2016
Dear Chuck Setzer:
This letter corrects our substantially equivalent letter of July 06, 2016.
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. Isting 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
1
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 ), please 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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 vours
Mude Yellen
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)
Device Name
CT40 Vital Signs, Spot Check Vital Signs Device
Indications for Use (Describe)
The SunTech CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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3
SunTech Medical, Inc. Abbreviated 510(k) Submission CT40 (Model 260) 510(k) Summary
(1) Submitter information
| Name: | SunTech Medical, Inc |
|---|---|
| Address: | 507 Airport Boulevard |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Telephone: | 919.654.2334 |
| FAX: | 919.654.2301 |
| Contact person: | Charles Setzer (Official Correspondent). |
| SunTech Medical | |
| 507 Airport Boulevard | |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Tel: 919-654-2334 | |
| Fax: 919-654-2301 | |
| Date prepared: | February 12. 2016 |
(2) Name of Device
| Trade Name: | CT40; Model 260; CT40 Spot-check Vital Signs Device |
|---|---|
| Common Name: | NIBP, SpO2 and Temperature Device |
| Classification name: | Noninvasive Blood Pressure Measurement System, DXN 870.1130 |
(3) Legally-marketed predicate devices
The CT40 (Model 260) is an updated version of SunTech's 247 Spot Check Device (K070750). It includes the same measurement parameters, NIBP, SpO2 and temperature, as the 247 device.
The new CT40 (Model 260) has the same intended use of the 247 device. Both the CT40 and 247 devices have NIBP as a standard parameter and have optional SpO2 and Temperature modules that can be added if desired.
The CT40 also includes a touch-less IR thermometry option that the 247 does not have. For this added temperature option the Spot Vital Signs LXi by Welch-Allyn Inc. [510k # K101680] is used as a predicate device.
(4) Description
The CT40 (Model 260) is designed to non-invasively measure systolic and diastolic blood pressure, pulse rate, temperature, and oxygen saturation (SpO2) for adult and pediatric patients. All blood
4
pressure, pulse, temperature, and SpO2 values are displayed on a large, easy-to-read LCD. The device has a rechargeable battery and may be use as a desktop unit or on a mobile stand.
The CT40 (Model 260) Spot-check Vital Signs Device can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The CT40 (Model 260) consist of a base unit with NIBP, display, control buttons and knob housed in an ABS plastic enclosure. The left side of the unit has a removable panel were a SpO2 module may be connected. And the right side of the unit has a removable panel where a temperature module may be connected.
For measuring blood pressure, a blood pressure cuff is placed around the patient's non-dominant upper arm. The cuff is automatically inflated and the blood pressure is determined by the oscillometric method, which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured.
The pulse oximetry function non-invasively measures the patient's percent oxygen saturation of arterial hemoglobin using principles of plethysmography via a SpO2 sensor placed on the patient's finger.
Temperature can be measured using one of two different kinds of temperature technology. The oral/axillary/rectal temperature probe contains a thermistor that generates a voltage based on changes in temperature, and these voltages are measured by the temperature circuitry. The touchless infrared temperature probe detects radiated infrared energy from the temporal artery.
The CT40 (Model 260) is a portable device, approximately 205 x 190 x 140 mm in size and weighs approximately 1440 g without battery. Control buttons allow the user to stop/start a BP measurement, save a set of measurements to memory, change between BP modes, and return to the home screen.
There is also a selection knob that is used to scroll and select different device options. The backlit LCD display shows the user device status and measurement information. The device uses a microprocessor with firmware, which is not accessible to the user. The unit is powered by AC mains power and rechargeable lithium-ion battery. Two USB-A port connections can be used to connect, an optional printer, barcode scanner or Wi-Fi dongle. There is also RJ11 Ethernet port for network connectivity, and a mini-USB port used to connect the device to a PC or laptop for advanced device configuration.
An Abbreviated 510(k) is necessary because the CT40 (Model 260) uses recognized standards for establishing safety and effectiveness.
(5) Intended Use
The SunTech CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or
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more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.
(6) Indications for Use
The SunTech CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.
(7) Comparison to Predicate Devices
The device has similar construction as the primary and secondary predicate device. The primary device shares the similar specifications, measurement ranges and intended uses. The devices are manufactured from the same types of materials using the same production methods and are intended for the same patient populations.
| Characteristic | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SunTech Medical Inc.
CT40 (Model 260) | SunTech Medical Inc.
247 (Model 247B)
(K070750) | Welch-Allyn
Spot VITAL SIGNS LXi
(K101680) | |
| System Photo | Image: SunTech Medical Inc. CT40 (Model 260) | Image: SunTech Medical Inc. 247 (Model 247B) | Image: Welch-Allyn Spot VITAL SIGNS LXi (K101680) |
| Characteristic | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE |
| | SunTech Medical Inc.
CT40 (Model 260) | SunTech Medical Inc.
247 (Model 247B)
(K070750) | Welch-Allyn
Spot VITAL SIGNS LXi
(K101680) |
| Indications for
Use | The SunTech CT40 (Model
260) is a non-invasive
oscillometric spot check
vital signs device. The
CT40 is capable of
measuring and displaying
brachial systolic and
diastolic blood pressure,
heart rate, percent
oxygenated hemoglobin
(SpO2) and body
temperature on children 3
years of age to adults. This
device is intended for use
by a qualified clinician
when it is necessary to take
one or more vital signs
measurements on a patient.
The CT40 is only for
measurement, recording,
and display. It makes no
specific diagnoses. | The SunTech Medical 247
NIBP, Temperature, and
Pulse Oximeter device is
indicated for use in
measuring and displaying
Systolic and Diastolic
blood pressures, heart rate,
temperature, and functional
saturation of arterial
hemoglobin (SpO2) of
adult and pediatric patients
in hospitals, medical
facilities, clinics,
physicians offices, and
other sub acute
environments. | Same as CT40 (Model
260)
Except Spot VITAL
SIGNS LXi includes Body
Mass Index calculator that
requires the manual input
of weight, height,
respiration rate and pain
level.
And the Spot VITAL
SIGNS LXi has NIBP and
Temperature as standard
feature and SpO2 as an
option.
The Spot VITAL SIGNS
LXi displays MAP and the
CT40 does not. |
| Target
Population | The CT40 (Model 260)
device is intended to be
used on adult and pediatric
patients over the age of 3
yrs. | Same | Same |
| Location of
Use (primary) | Physician's office, clinic,
research center (under
supervision of physician) | Same | Same |
| NIBP Modes
of
Operation | Automated Oscillometric
NIBP | Same | Same |
| SpO2
Pulse
Oximetry
Options | ChipOx from Corscience
(Nellcor® compatible)
Masimo® | ITEC
(Nellcor® compatible) | Masimo®
Nellcor® |
| Characteristic | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE |
| | SunTech Medical Inc.
CT40 (Model 260) | SunTech Medical Inc.
247 (Model 247B)
(K070750) | Welch-Allyn
Spot VITAL SIGNS LXi
(K101680) |
| Body
Temperature
options | Covidien® Fast Temp
or
HuBDIC® IR Temp | Covidien® Fast Temp | Welch Allyn SureTemp®
Plus
or
Braun ThermoScan® PRO
4000 IR Temperature |
| Materials | Materials and construction
are the same as the 247
device except: Updated
electronics, LCD display
replaces LED display | ABS plastic | Similar enclosure and
display. User interface is
similar but configuration is
slightly different. |
| Biocompatibility
Patient contact | 1. BP Cuff: Same as
SunTech
2. SPo2 Sensor 1: Same
as SunTech
3. SPo2 Sensor 2: Same
as Welch Allyn
(Massimo)
4. Temp Probe: Same as
SunTech | 1. BP Cuff: SunTech
OPD
2. SPo2 Sensor 1:
UniTech
3. SPo2 Sensor 2:
Massimo
4. Temp Probe: Covidien | 1. BP Cuff: Welch Allyn
2. SPo2 Sensor 1: Nellcor
3. SPo2 Sensor 2:
Massimo
Temp Probe: Welch Allyn |
| Human
Factors | More complex than
SunTech 247. Similar
complexity to Welch
Allyn. | Simple 2 button interface.
No | |
| Power | Mains Power 100-240
VAC, 50-60Hz Supply
&
Rechargeable 7.2V
Lithium Ion Battery | Mains Power 100-240
VAC, 50-60Hz Supply
&
Rechargeable 6V SLA
Battery | Mains Power 100-240
VAC, 50-60Hz Supply
&
Rechargeable 6.4 V
Lithium Ion Battery |
| Blood
Pressure
Range | Systolic: 40 - 260 mmHg
Diastolic: 25 - 200 mmHg | Systolic: 60 - 270 mmHg
Diastolic: 30 -170 mmHg | Systolic: 60 - 250 mmHg
Diastolic: 30-160 mmHg |
| Characteristic | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE |
| | SunTech Medical Inc.
CT40 (Model 260) | SunTech Medical Inc.
247 (Model 247B)
(K070750) | Welch-Allyn
Spot VITAL SIGNS LXi
(K101680) |
| Measurement | Same | Determines brachial BP
from oscillometric
waveform pulses captured
during deflation of the cuff.
The key clinical parameters
are:
- Systolic and Diastolic
Blood Pressure - Heart Rate
- Temperature
- SpO2 | Determines brachial BP
from oscillometric
waveform pulses captured
during deflation of the cuff.
The key clinical parameters
are: - Systolic and Diastolic
Blood Pressure - Heart Rate
- Temperature
- SpO2 |
| Performance | NIBP, ChipOx SpO2 and
Covidien temperature are
the same as SunTech 247.
Massimo SpO2 is the same
as Welch Allyn. HuBDIC
IR temperature is similar to
Welsh Allyn IR
Temperature. | | |
| External
connections | 1. 2 USB-A connections - 802.11 a,b,g, wireless
communications - Ethernet RJ45
connector - Micro USB | None | 1. 2 serial DB9
connectors - 802.11 a,b,g, wireless
communications - Mini USB |
| External
Connection
Devices | 1. Bar code Scanner - Future option for
Printer - Connectivity to
Hospital EMR | None | 1. Weight Scales - Connectivity to
Hospital EMR |
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7
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9
(8) Testing and Validations
The CT40 (Model 260) has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.
- IEC 60601-1: 2012, Medical electrical equipment Part 1: General requirements for basic safety ● and essential performance
- IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- . IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 80601-2-30: 2009 +A1: 2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ISO 81060-2: 2013, Non-invasive sphygmomanometers -Part 2: Clinical investigation of automated measurement type
- ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- ISO 80601-2-61: 2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- IEC62304:2006 Medical device software - Software life cycle processes
- IEC62366:2008 Medical devices - Part 1: Application of usability engineering to medical devices
| Output Document | Description |
|---|---|
| 99-0131-XX-HQ3 | System Level Test Report / system level test cases and test results. |
| 99-0131-XX-HQ4 | Software Test Report / software test cases and test results. |
| 99-0131-XX-HQ5 | Hardware Test Report / hardware test cases and test results. |
| 99-0131-XX-HQ6 | Mechanical Test Report / mechanical test cases and test results. |
| 99-0131-XX-SVR_Wireless | Software Validation Report, Wireless |
| 97-0143-XX-CV-81060-2 | NIBP Clinical Validation Study |
| 80-0067-00-MO | CT40 User Manual |
Non-Clinical testing
(9) Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, SunTech Medical concludes that the CT40 (Model 260) is safe, effective and substantially equivalent to the predicate devices described herein.