(147 days)
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study that proves the device meets them.
The document describes the submission of a "Truly Automatic Arm Blood Pressure Monitor" (Models DB66-1, DB68) for 510(k) clearance, asserting its substantial equivalence to a predicate device (DB62, K161846).
Acceptance Criteria and Reported Device Performance
The core acceptance criteria for a non-invasive blood pressure monitor are its accuracy for both pressure and pulse readings. The document refers to compliance with ISO 81060-2:2013, which sets the standards for clinical validation of automated sphygmomanometers.
Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from ISO 81060-2:2013, implied) | Reported Device Performance (from "Table-2: The comparison table in Design and Materials") |
|---|---|---|
| Accuracy Pressure | Mean difference $\le \pm 5$ mmHg and standard deviation $\le 8$ mmHg (for both systolic and diastolic blood pressure) | $\pm$ 3mmHg (This is directly stated as "Accuracy Pressure" for the device, which is well within the ISO standard's requirements for mean difference, and implies the device meets the deviation as well, as confirmed by the clinical study summary.) |
| Accuracy Pulse | $\pm$ 5% | $\pm$ 5% |
| Measurement Pressure Range | 20 ~ 280 mmHg | 20 ~ 280 mmHg |
| Measurement Pulse Range | 40 ~ 195 beats/min | 40 ~ 195 beats/min |
| Measurement Resolution | 1 mmHg | 1 mmHg |
Study Proving Device Meets Acceptance Criteria:
The document states:
"Testing Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device."
This directly indicates that a clinical validation study, adhering to the ISO 81060-2 standard, was performed, and the device successfully met its requirements.
Detailed Information about the Study:
Given the provided text, some of the requested information is not explicitly detailed. However, based on common practice for ISO 81060-2 clinical validation studies for blood pressure monitors, we can infer some aspects and state what is present in the document.
1. A table of acceptance criteria and the reported device performance:
- See table above. The document explicitly states the device's accuracy for pressure ($\pm$ 3mmHg) and pulse ($\pm$ 5%), and confirms "the required limits for mean difference and standard deviation are fulfilled by the subject device" according to ISO 81060-2.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size. However, ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. It can be assumed that the study met this minimum requirement to claim compliance.
- Data Provenance (Country of origin, retrospective/prospective): The document does not explicitly state the country of origin or if the study was retrospective or prospective, but clinical validation studies for regulatory submission are almost invariably prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts. For oscillometric blood pressure devices validated against ISO 81060-2, ground truth (reference blood pressure) is established by two trained observers using a mercury or auscultatory sphygmomanometer following a specific protocol. These observers are trained to accurately read the reference device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not explicitly state the adjudication method. For ISO 81060-2, the ground truth is typically established by two independent observers taking simultaneous readings. If their readings differ by more than a specified amount, a third measurement (or a different method of reconciliation) might be employed, though two simultaneous, blinded observers are standard for the reference method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools (e.g., radiology AI), not for a standalone non-invasive blood pressure monitor. The device is measuring a physiological parameter directly, not interpreting complex medical images for human assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, this was a standalone performance test. The clinical validation per ISO 81060-2 assesses the accuracy of the automated device (algorithm + hardware) against a reference standard (manual auscultatory method). While a human applies the cuff and initiates the measurement, the device's measurement process itself is automated ("algorithm only" in the context of its function).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by simultaneous auscultatory measurements performed by trained observers using a reference sphygmomanometer (typically mercury or validated aneroid) on the contralateral arm or simultaneously on the same arm if protocol allows, per ISO 81060-2. This is the "expert consensus" of blood pressure measurement via a gold standard clinical method.
8. The sample size for the training set:
- The document does not provide information on a training set sample size. For medical devices primarily validated through performance testing against an ISO standard (like blood pressure monitors), the term "training set" in the context of machine learning (AI development) isn't directly applicable in the same way. The device's underlying "oscillometric method" is a long-established algorithm, not typically a deep learning model requiring a large training dataset in the same vein as image classification AI. The development of the algorithm might involve internal data, but it's not described here.
9. How the ground truth for the training set was established:
- As noted above, the concept of a "training set" with ground truth in the AI sense isn't directly applicable or described for this traditional medical device. The "ground truth" for the validation (test set) study was established through the gold-standard auscultatory method by trained observers. If any internal algorithm refinement involved data, it would likely follow similar principles of comparison to expert-measured reference values.
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December 23, 2019
Truly Instrument Limited % Max Wong Official Correspondent Truly (U.S.A) Inc 2620 Concord Avenue, Suite 106 Alhambra, California 91803
Re: K192023
Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 29, 2019 Received: November 29, 2019
Dear Max Wong:
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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Arm Blood Pressure Monitor
Indications for Use (Describe)
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication
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.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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Image /page/3/Picture/0 description: The image shows the text 'K192023' in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, making the text easily readable.
Image /page/3/Picture/1 description: The image shows the word "TRULY" in red, bold letters. To the right of the word is a circled R, indicating that the word is a registered trademark. A black line is located underneath the word.
510(k) Summary
V1.0
Date of Summary Preparation: May 21.2019
1. Submitter's Identifications
| Submitter's Name: | Truly Instrument Limited |
|---|---|
| Address: | Site 2, Truly Industrial Area, Shanwei City,Guangdong Province, China |
| Contact Person: | Manager Su-HaiSen |
| Telephone: | 86-0660-3363561 |
| Fax: | 86-0660-3380377 |
2. Name of the Device
| Device Classification Name: | System, Measurement, Blood-Pressure, Non-invasive |
|---|---|
| Trade Name: | Arm Blood Pressure Monitor |
| Models: | DB66-1, DB68 |
| Classification Panel: | cardio-vascular |
| Common/Usual Name: | Automatic Arm Blood Pressure Monitor |
| Product Code: | DXN |
| Device Classification: | Class II |
| Contraindications : | N/A |
3. The Predicate Devices
TRULY Instrument Limited.
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB Series, Model DB62 510 K Number : K161846
4. Device Description
Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of
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Image /page/4/Picture/1 description: The image contains the word "TRULY" in large, bold, red letters. To the right of the word, there is a circled "R" symbol, indicating that the word is a registered trademark. The word is slightly slanted to the right, giving it a dynamic appearance. The background is plain white.
irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
5. Intended use of device
Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication .
6. Technological Characteristics of our new DEVICE COMPARED TO THE
PREDICATE DEVICE:
The technological characteristics of Automatic Arm Blood Pressure Monitor, models DB66-1, DB68 are substantially equivalent to Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62.( K161846). There is the same Owner, TRULY instrument Limited. Which FDA owner number is 9054344. In addition, there are the same design specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.
| Parameter | Predicate Devices DB62 | DB66-1 | DB68 | Explanation of thedifferences |
|---|---|---|---|---|
| Intended use | Measuring systolic and diastolic bloodpressure and pulse rate of adult individual | Measuring systolic and diastolic bloodpressure and pulse rate of adult individual | Measuring systolic and diastolic bloodpressure and pulse rate of adult individual | Identical |
| The trade name | Automatic Arm Bluetooth Blood PressureMonitor | Arm Blood Pressure Monitor | Identical | |
| 510(K) Number | K161846 | |||
| Applicant | Truly Instrument Limited. | Truly Instrument Limited. | Identical | |
| Regulatory Class | Class II | Class II | Identical | |
| Panel | Cardiovascular | Cardiovascular | Identical | |
| Product Code | DXN | DXN | Identical | |
| Indications foruse | Truly Automatic Arm Bluetooth BloodPressure Monitor DB62 is intended tomeasure the systolic and diastolic blood | Truly Automatic Arm Bluetooth BloodPressure Monitor DB62 is intended tomeasure the systolic and diastolic blood | Identical |
Table-1: The comparison table
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| TRULY®r | |
|---|---|
| ------------- | -- |
| Parameter | Predicate Devices DB62 | DB66-1 | DB68 | Explanation of the differences |
|---|---|---|---|---|
| pressure and pulse rate of an adultindividual by using a non-invasivetechnique in which an inflatable cuff iswrapped around the upper arm.The devices' features include irregularpulse rhythm detection duringmeasurement, and will display a alertsignal with the reading when irregularheartbeat is detected.The devices' feature include Bluetoothfunction to transmit data to an externalBluetooth device with wirelesscommunication .. Over-The-Counter Use | pressure and pulse rate of an adultindividual by using a non-invasivetechnique in which an inflatable cuff iswrapped around the upper arm.The devices' features include irregularpulse rhythm detection duringmeasurement, and will display a alertsignal with the reading when irregularheartbeat is detected.The devices' feature include Bluetoothfunction to transmit data to an externalBluetooth device with wirelesscommunication .. Over-The-Counter Use | |||
| TargetPopulation | Adult | Adult | Identical | |
| Anatomical sites | Upper Arm | Upper Arm | Identical | |
| Where used(hospital, home,ambulance. etc) | Home | Home | Identical | |
| Energy used and/ or delivered | 4x 1.5V AA Battery | Polymer batteryDC3.7V,500mAh | 4x 1.5V AABattery | EquivalentThe change in thespecification isdocumented andtested,does notaffect the intendeduse or thefundamentalscientifictechnology. |
| Human factors | Blood pressure | Blood pressure | Identical | |
| performance | Measuring systolic and diastolic bloodpressure and pulse rate of adult individual,Including irregular pulse rhythm detection | Measuring systolic and diastolic bloodpressure and pulse rate of adultindividual, Including irregular pulserhythm detection | Identical | |
| biocompatibility | CuffAccording to ISO-10993 | CuffAccording to ISO-10993 | Identical | |
| Compatibility withthe environmentand other devices | Operation Environment:10°C~40°C,15% | Operation Environment:10°C~40°C,15% | Identical |
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| Parameter | Predicate Devices DB62 | DB66-1 | DB68 | Explanation of thedifferences |
|---|---|---|---|---|
| Electrical safety | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | Identical | |
| Sterilization | N/A | N/A | Identical | |
| Chemical safety | N/A | N/A | Identical | |
| sterility | N/A | N/A | Identical | |
| Thermal safety | N/A | N/A | Identical | |
| design | Refer to Table-2 | |||
| materials | Refer to Table-2 |
Table-2: The comparison table in Design and Materials
| Parameter | Predicate Devices DB62 | DB66-1 | DB68 |
|---|---|---|---|
| Measurement algorithmMethod | Oscillometric method | No change ,all same | No change ,all same |
| Measurement site ofbody | Arm | No change ,all same | No change ,all same |
| Max Cuff pressure | 300mmHg | No change ,all same | No change ,all same |
| Bluetooth | BG312 | H04J08C | |
| Irregularheartbeatdetection | More than $\pm$ 25% to themean interval of pulseintervals.About the more detaileddescription of the IH detectionalgorithm, please refer to"Software validation reportI-5. Algorithm description 4.Determination method ofirregular heartbeat". | No change ,all same | No change ,all same |
| Measurement PressureRange | 20 ~ 280 mmHg | No change ,all same | No change ,all same |
| Measurement PulseRange | 40 ~ 195 beats/min | No change ,all same | No change ,all same |
| Mesauring resolution | 1 mmHg | No change ,all same | No change ,all same |
| Accuracy Pressure | $\pm$ 3mmHg | No change ,all same | No change ,all same |
| Accuracy Pulse | $\pm$ 5% | No change ,all same | No change ,all same |
| Cuff Deflation | Automatic deflation | No change ,all same | No change ,all same |
| Pressurization Source | Automatic internal pumpDC6V | Automatic internal pumpDC3V | Automatic internal pumpDC6V |
| Power Voltage | 4X 1.5V | Polymer batteryDC3.7V,500mAh | 4x 1.5V AA Battery |
| Operating Environment | 10 | No change ,all same | No change ,all same |
| Storage Environment | -20°C~60°C,10%~95%RH | No change ,all same | No change ,all same |
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| Truly Instrument Limited | |||
|---|---|---|---|
| Parameter | Predicate Devices DB62 | DB66-1 | DB68 |
| Memory Size | 4 x 99 | 99 | 99 |
| Display Type | Liquid crystal display | Liquid crystal display ,Only difference size | |
| Cover | Difference |
7. Summary of Clinical study
Testing Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device.
8. Non-Clinical Tests Performed:
-
- Test Summary:
8-1. Electric Safety , EMC and FCC test reports.
- Test Summary:
| General safety | IEC 60601-1:2005+A1:2012Medical electrical equipment-Part1: General requirements for safety and essential performanceIEC60601-1-11:2015Medical electrical equipment-Part 1-11: General Requirement forbasic safety and essential performance- Collateral Standard:Requirements for medical electrical systems used in the homehealthcare environmentEN60950-1:2013Information technology equipment-Safety- Part1:Generalrequirements |
|---|---|
| EMC conformity | IEC 60601-1-2:2014Medical Electrical Equipment - Part 1-2: General requirements forsafety - collateral standard: Electromagnetic compatibility -Requirements and Tests |
| FCC conformity | FCC 47 part 15 subject B class B |
| ERM conformity | EN301489-1:2017;EN301489-17:2017 |
| RF conformity | EN300328:2016 |
| Health | EN62479:2010 |
8-2. Reliability & Clinical Test
| IEC80601-2-30:20019+A1:2013 | Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essentialperformance of automated non-invasive sphygmomanometer |
|---|---|
| ISO 81060-2:2013 | Non-invasive sphygmomanometers – Part 2: Clinical validation |
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Image /page/8/Picture/1 description: The image contains the word "TRULY" in large, red, bold letters. To the right of the word is a small, red circle with the letter R inside, indicating a registered trademark. There is a black line underneath the word "TRULY".
of automated measurement type
8.3 Biocompatibility Test
| ISO10993-1:2009 | Biological evaluation of medical devices-Part 1: evaluation andtesting |
|---|---|
| ISO10993-5:2009 | Biological evaluation of medical devices-Part 5: Test forcytotoxicity in vitro methods |
| ISO10993-10:2010 | Biological evaluation of medical devices-Part 10: Tests for irriationand sensitization |
9. Conclusions
The new subject devices of Arm Blood Pressure Monitor continue to follow principles of hardware and software design of the predicate device DB62(K161846), and the feature, safety, effectiveness are also as same as DB62., Thus, the subject devices are substantially equivalent to the predicate devices.
§ 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).