(140 days)
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 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.
The provided text describes the SunTech CT40 Spot-check Vital Signs Device (Model 260), but it does not contain the specific acceptance criteria or the full study details that prove the device meets those criteria, as typically found in a clinical study report.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. While it lists standards related to accuracy for NIBP, SpO2, and temperature, the actual performance data and acceptance criteria for these measurements are not explicitly detailed in the provided information.
Therefore, I cannot fully complete all sections of your request based on the given input. However, I can extract what is available and highlight what is missing.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Missing Information: The specific numerical acceptance criteria for clinical accuracy (e.g., mean difference and standard deviation in mmHg for NIBP, or accuracy ranges for SpO2 and temperature) are not explicitly stated in the provided text. The "Performance" row in the comparison table mentions the performance is "the same as SunTech 247" for NIBP, ChipOx SpO2, and Covidien temperature, and "similar to Welch Allyn" for Massimo SpO2 and HuBDIC IR temperature, but it does not quantify these performances.
| Parameter | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Implied / Referenced) |
|---|---|---|
| NIBP (Blood Pressure) | Not explicitly stated (typically ISO 81060-2 limits) | "NIBP... are the same as SunTech 247." (Performance is inferred to meet the same standards as the predicate SunTech 247 device, which followed ISO 81060-2) |
| SpO2 (Oxygen Saturation) | Not explicitly stated (typically ISO 80601-2-61 limits) | "ChipOx SpO2... are the same as SunTech 247. Massimo SpO2 is the same as Welch Allyn." (Implied to meet ISO 80601-2-61 for both modules) |
| Body Temperature | Not explicitly stated (typically ISO 80601-2-56 limits) | "Covidien temperature are the same as SunTech 247. HuBDIC IR temperature is similar to Welsh Allyn IR Temperature." (Implied to meet ISO 80601-2-56) |
The document states that the device was tested to "ISO 81060-2: 2013, Non-invasive sphygmomanometers -Part 2: Clinical investigation of automated measurement type," "ISO 80601-2-56: 2009 +A1: 2013, Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement," and "ISO 80601-2-61: 2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment." These standards define the acceptance criteria for accuracy.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information: The document mentions "97-0143-XX-CV-81060-2" as the "NIBP Clinical Validation Study." However, the sample size for this test set, country of origin of the data, and whether it was retrospective or prospective are not provided in the excerpt. Only the existence of the study is noted.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Missing Information: This information is not available in the provided 510(k) summary. For blood pressure, ground truth is typically established by trained observers using a reference sphygmomanometer (mercury or auscultatory method), not "experts" in the sense of diagnosticians. For SpO2 and temperature, the ground truth would come from referencemethods. The qualifications of the individuals involved in collecting reference measurements for any clinical validation are not described here.
4. Adjudication Method for the Test Set
Missing Information: This information is not provided in the excerpt. For NIBP validation against a reference standard, agreement between multiple observers is usually assessed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
No, a MRMC comparative effectiveness study was not done. The device is a "spot-check vital signs device" and its performance is evaluated in a standalone manner against reference standards, not as an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, there is no AI assistance or effect size on human reader improvement to report.
6. If a Standalone (Algorithm Only) Performance Study was Done
Yes, a standalone study was done for the NIBP component. The document explicitly lists:
- "97-0143-XX-CV-81060-2 NIBP Clinical Validation Study"
This indicates that the NIBP measurement algorithm itself underwent clinical validation according to ISO 81060-2. The document also states that performance for SpO2 and temperature are "the same as" or "similar to" predicate devices, implying their algorithms also met the respective ISO standards (ISO 80601-2-61 for SpO2 and ISO 80601-2-56 for temperature).
7. The Type of Ground Truth Used
Based on the mentioned standards:
- For NIBP (ISO 81060-2): The ground truth for blood pressure measurements generally involves simultaneous auscultatory measurements by human observers using a mercury or other validated reference sphygmomanometer.
- For SpO2 (ISO 80601-2-61): The reference method for SpO2 is often considered to be co-oximetry measurements of arterial blood samples.
- For Temperature (ISO 80601-2-56): The reference method for body temperature depends on the site (rectal, oral, etc.) and is typically a highly accurate reference thermometer.
However, the document does not explicitly state the specific ground truth methods or their origin within the context of the CT40's studies. It merely references the standards that would dictate these methods.
8. The Sample Size for the Training Set
No training set is mentioned or applicable here. This device is a vital signs monitor, not an AI/machine learning diagnostic device that typically requires a large training dataset for model development. The algorithms for NIBP, SpO2, and temperature measurement are based on established physiological principles and signal processing, not on machine learning from a 'training set'.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no mention or indication of a training set as this is not an AI/ML-based diagnostic device.
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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
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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
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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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SunTech Medical, Inc. Abbreviated 510(k) Submission CT40 (Model 260) 510(k) Summary
(1) Submitter information
| Name: | SunTech Medical, Inc |
|---|---|
| Address: | 507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200 |
| Telephone: | 919.654.2334 |
| FAX: | 919.654.2301 |
| Contact person: | Charles Setzer (Official Correspondent).SunTech Medical507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200Tel: 919-654-2334Fax: 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
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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 | PRIMARYPREDICATE | SECONDARYPREDICATE |
|---|---|---|---|
| SunTech Medical Inc.CT40 (Model 260) | SunTech Medical Inc.247 (Model 247B)(K070750) | Welch-AllynSpot 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 | PRIMARYPREDICATE | SECONDARYPREDICATE |
| SunTech Medical Inc.CT40 (Model 260) | SunTech Medical Inc.247 (Model 247B)(K070750) | Welch-AllynSpot VITAL SIGNS LXi(K101680) | |
| Indications forUse | The SunTech CT40 (Model260) is a non-invasiveoscillometric spot checkvital signs device. TheCT40 is capable ofmeasuring and displayingbrachial systolic anddiastolic blood pressure,heart rate, percentoxygenated hemoglobin(SpO2) and bodytemperature on children 3years of age to adults. Thisdevice is intended for useby a qualified clinicianwhen it is necessary to takeone or more vital signsmeasurements on a patient.The CT40 is only formeasurement, recording,and display. It makes nospecific diagnoses. | The SunTech Medical 247NIBP, Temperature, andPulse Oximeter device isindicated for use inmeasuring and displayingSystolic and Diastolicblood pressures, heart rate,temperature, and functionalsaturation of arterialhemoglobin (SpO2) ofadult and pediatric patientsin hospitals, medicalfacilities, clinics,physicians offices, andother sub acuteenvironments. | Same as CT40 (Model260)Except Spot VITALSIGNS LXi includes BodyMass Index calculator thatrequires the manual inputof weight, height,respiration rate and painlevel.And the Spot VITALSIGNS LXi has NIBP andTemperature as standardfeature and SpO2 as anoption.The Spot VITAL SIGNSLXi displays MAP and theCT40 does not. |
| TargetPopulation | The CT40 (Model 260)device is intended to beused on adult and pediatricpatients over the age of 3yrs. | Same | Same |
| Location ofUse (primary) | Physician's office, clinic,research center (undersupervision of physician) | Same | Same |
| NIBP ModesofOperation | Automated OscillometricNIBP | Same | Same |
| SpO2PulseOximetryOptions | ChipOx from Corscience(Nellcor® compatible)Masimo® | ITEC(Nellcor® compatible) | Masimo®Nellcor® |
| Characteristic | NEW DEVICE | PRIMARYPREDICATE | SECONDARYPREDICATE |
| SunTech Medical Inc.CT40 (Model 260) | SunTech Medical Inc.247 (Model 247B)(K070750) | Welch-AllynSpot VITAL SIGNS LXi(K101680) | |
| BodyTemperatureoptions | Covidien® Fast TemporHuBDIC® IR Temp | Covidien® Fast Temp | Welch Allyn SureTemp®PlusorBraun ThermoScan® PRO4000 IR Temperature |
| Materials | Materials and constructionare the same as the 247device except: Updatedelectronics, LCD displayreplaces LED display | ABS plastic | Similar enclosure anddisplay. User interface issimilar but configuration isslightly different. |
| BiocompatibilityPatient contact | 1. BP Cuff: Same asSunTech2. SPo2 Sensor 1: Sameas SunTech3. SPo2 Sensor 2: Sameas Welch Allyn(Massimo)4. Temp Probe: Same asSunTech | 1. BP Cuff: SunTechOPD2. SPo2 Sensor 1:UniTech3. SPo2 Sensor 2:Massimo4. Temp Probe: Covidien | 1. BP Cuff: Welch Allyn2. SPo2 Sensor 1: Nellcor3. SPo2 Sensor 2:MassimoTemp Probe: Welch Allyn |
| HumanFactors | More complex thanSunTech 247. Similarcomplexity to WelchAllyn. | Simple 2 button interface.No | |
| Power | Mains Power 100-240VAC, 50-60Hz Supply&Rechargeable 7.2VLithium Ion Battery | Mains Power 100-240VAC, 50-60Hz Supply&Rechargeable 6V SLABattery | Mains Power 100-240VAC, 50-60Hz Supply&Rechargeable 6.4 VLithium Ion Battery |
| BloodPressureRange | Systolic: 40 - 260 mmHgDiastolic: 25 - 200 mmHg | Systolic: 60 - 270 mmHgDiastolic: 30 -170 mmHg | Systolic: 60 - 250 mmHgDiastolic: 30-160 mmHg |
| Characteristic | NEW DEVICE | PRIMARYPREDICATE | SECONDARYPREDICATE |
| SunTech Medical Inc.CT40 (Model 260) | SunTech Medical Inc.247 (Model 247B)(K070750) | Welch-AllynSpot VITAL SIGNS LXi(K101680) | |
| Measurement | Same | Determines brachial BPfrom oscillometricwaveform pulses capturedduring deflation of the cuff.The key clinical parametersare:1. Systolic and DiastolicBlood Pressure2. Heart Rate3. Temperature4. SpO2 | Determines brachial BPfrom oscillometricwaveform pulses capturedduring deflation of the cuff.The key clinical parametersare:1. Systolic and DiastolicBlood Pressure2. Heart Rate3. Temperature4. SpO2 |
| Performance | NIBP, ChipOx SpO2 andCovidien temperature arethe same as SunTech 247.Massimo SpO2 is the sameas Welch Allyn. HuBDICIR temperature is similar toWelsh Allyn IRTemperature. | ||
| Externalconnections | 1. 2 USB-A connections2. 802.11 a,b,g, wirelesscommunications3. Ethernet RJ45connector4. Micro USB | None | 1. 2 serial DB9connectors2. 802.11 a,b,g, wirelesscommunications3. Mini USB |
| ExternalConnectionDevices | 1. Bar code Scanner2. Future option forPrinter3. Connectivity toHospital EMR | None | 1. Weight Scales2. Connectivity toHospital EMR |
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(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.
§ 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).