(93 days)
Truly Automatic Arm Blood Pressure Monitor, Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 are a series device 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 display a warning signal with the reading once the irregular heartbeat is detected. Over-The-Counter Use
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB83, DB85, DB91, DB92, DB93 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 subject devices are powered by four AA alkaline batteries. The device 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%.
Here's a breakdown of the acceptance criteria and study details for the Truly Automatic Arm Blood Pressure Monitor, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Values (ANSI/AAMI SP10 Standard) | Reported Device Performance (Test Result) – Systolic Pressure | Reported Device Performance (Test Result) – Diastolic Pressure |
|---|---|---|---|
| Mean difference between test device and reference method | ≤ 5 mmHg | 3.3 mmHg | 4.5 mmHg |
| Standard deviation of differences | ≤ 8 mmHg | 5.2 mmHg | 4.6 mmHg |
| Between-observer agreement: ≥ 95% of readings agree to within x 10 mmHg | 95% | 100% | 100% |
| Between-observer agreement: ≥ 85% of readings agree to within x 5 mmHg | 85% | 95% | 99% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 90 subjects.
- Data Provenance: The study was a clinical study conducted with subjects in a hospital setting. It includes 15 hypertensive patients, implying a mixture of normotensive and hypertensive individuals. The location (country) of the study is not explicitly stated, but the submitter is based in China. The study appears to be a prospective clinical study, as indicated by the "Subjects" and "Method" sections.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two doctors.
- Qualifications of Experts: Not explicitly stated beyond "doctors." However, given they were using a standard mercury sphygmomanometer and performing "simultaneous and blinded blood pressure determinations," it can be inferred they are trained medical professionals capable of accurately measuring blood pressure.
4. Adjudication Method for the Test Set
- The method described is "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies a form of independent double reading, where both doctors recorded their measurements without knowledge of the device's reading or each other's readings, and then these independent readings were compared against device readings and among themselves. It is not a typical 2+1 or 3+1 adjudication as seen in AI studies, but rather a direct comparison of independent expert measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This study focused on the accuracy of the device against a reference method and between human observers, not on how human readers' performance improved with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, this was effectively a standalone performance study. The device's measurements were compared directly against the reference standard (mercury sphygmomanometer readings by experts) and the agreement between experts themselves, without any human-in-the-loop interaction or AI assistance for the expert readings.
7. Type of Ground Truth Used
- Expert Consensus / Reference Standard: The ground truth for blood pressure measurements was established by two doctors using a "standard mercury sphygmomanometer" as a "reference standard." This represents an expert-determined reference standard, often considered the gold standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" or "training data" for the device's algorithm. For traditional medical devices like blood pressure monitors, the underlying oscillometric algorithm would typically be developed and validated during the device's design phase using various physiological models and potentially earlier clinical data, but this specific 510(k) summary focuses on the clinical validation of the final device rather than the algorithm's development.
9. How the Ground Truth for the Training Set Was Established
- As no training set is explicitly mentioned in this summary, the method for establishing its ground truth is also not provided. The information provided pertains solely to the clinical validation of the completed device.
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Truly Instrument Limited
510(k) Summary
JAN 1 9 2012
Date of Summary Preparation: August. 16.2011
1. Submitter's Identifications
| Submitter's Name: | Truly Instrument Limited |
|---|---|
| Address: | Site 2, Truly Industrial Area, Shanwei City,Guangdong Province, China |
| Contact Person: | Manager Yang Jian-Hao |
| Telephone: | 86-0660-3380070 |
| Fax: | 86-0660-3380377 |
2. Name of the Device
| Device Classification Name: | System, Measurement, Blood-Pressure, Non-invasive |
|---|---|
| Trade Nam: | Truly Automatic Arm Blood Pressure Monitor |
| Models: | DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 |
| 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 Automatic Arm Blood Pressure Monitor, Model DB61M, K091434
4. Device Description
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB83, DB85, DB91, DB92, DB93 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 subject devices are powered by four AA alkaline batteries.
The device 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 Page 1 of 5
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TRULY Truly Instrument Limited
of irregular pulse rhythm when the difference of the time intervals is over 25%.
5. Intended use of device
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB82, DB83. DB91, DB91, DB93 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 display a warning signal with the reading once the irregular heartbeat is detected.
6. Summary of Substantial Equivalence
| Parameter | Predicate Devices DB61M | DB33 | DB81 | DB82 | DB83 | DB85 | DB91 | DB92 | DB93 | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| Intended use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual | Measuring systolic and diastolic blood pressure and pulse rate of adult individual | Same | |||||||
| Indicationsfor use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection. Over-The-Counter Use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection. Over-The-Counter Use | Same | |||||||
| TargetPopulation | Adult | Adult | Same | |||||||
| Anatomicalsites | Upper Arm | Upper Arm | Same | |||||||
| Where used(hospital,home,ambulance.etc) | Home | Home | Same | |||||||
| Energy usedand / ordelivered | 4x 1.5V AA Battery | 4x 1.5V AA Battery | Same | |||||||
| Humanfactors | Blood pressure | Blood pressure | Same | |||||||
| design | Refer to Table-2 | Same | ||||||||
| performance | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection | Same | |||||||
| materials | Refer to Table-2 | Same | ||||||||
| biocompatibi | Cuff | Cuff | Same |
Table-1: The comparison table
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| TRULY® Truly Instrument Limited | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Parameter | Predicate Devices DB61M | DB33 | DB81 | DB82 | DB83 | DB85 | DB91 | DB92 | DB93 | Result |
| lity | According to ISO-10993 | According to ISO-10993 | ||||||||
| Compatibilitywith theenvironmentand otherdevices | Operation Environment:10℃~ 40℃, 15% | Operation Environment:10℃~ 40℃, 15% | Same | |||||||
| sterility | N/A | N/A | Same | |||||||
| Electricalsafety | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | Same | |||||||
| Mechanicalsafety | Same | Same | Same | |||||||
| Chemicalsafety | N/A | N/A | Same | |||||||
| Thermalsafety | N/A | N/A | Same |
Table-2: The comparison table in Design and Materials
| Parameter | PredicateDevicesDB61M | DB33 | DB81 | DB82 | DB83 | DB85 | DB91 | DB92 | DB93 | |
|---|---|---|---|---|---|---|---|---|---|---|
| MeasurementalgorithmMethod | Oscillometricmethod | No change,all same | ||||||||
| Measurementsite of body | Arm | No change,all same | ||||||||
| PressureSensor | MSP-2107 | No change,all same | ||||||||
| Cuff | No change,all same | |||||||||
| Software | No change,all same | |||||||||
| Irregularheartbeatdetection | More than ±25% to the mean interval of pulse intervals.About the more detailed description of the IH detection algorithm, pleaserefer to "Software validation report I-5. Algorithm description 4.Determination method of irregular heartbeat". | |||||||||
| Memory Size | 4 x 99 | 2X60 | 1X40 | 1X40 | 4X99 | 4X99 | 4X99 | 4X99 | 4X99 | |
| MeasurementPressureRange | 20 ~ 280 mmHg | No change,all same | ||||||||
| MeasurementPulse Range | 40 ~ 195 beats/min | No change,all same | ||||||||
| Mesauringresolution | 1 mmHg | No change,all same | ||||||||
| Accuracy | ±3mmHg | No change,all same |
Page 3 of 5
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| Parameter | PredicateDevicesDB61M | DB33 | DB81 | DB82 | DB83 | DB85 | DB91 | DB92 | DB93 | |
|---|---|---|---|---|---|---|---|---|---|---|
| Pressure | ||||||||||
| AccuracyPulse | $\pm5%$ | No change,all same | ||||||||
| Pressurization Source | Automaticinternal pump | No change,all same | ||||||||
| CuffDeflation | Automaticdeflation | No change,all same | ||||||||
| OperatingEnvironment | 10 | No change,all same | ||||||||
| PowerVoltage | 4X 1.5V | No change,all same | ||||||||
| Hardwarecircuit | No change,all same | |||||||||
| Electronicelement | No change,all same | |||||||||
| PCB | No change,all same | |||||||||
| Display Type | Liquid crystaldisplay | Liquid crystal display,Only difference size | ||||||||
| Cover | Difference |
Truly Instrument I imited
7. Summary of Clinical study
l ). Subjects:
Ninety subjects including 15 hypertensive patients in the hospital were participated in clinical study.
2). Method:
A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors.
3). Criteria:
The ANSI/AAMI SP10 Standard recommended :
- a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg A. between test device and reference method.
- Between-observer agreement should be:95% or more of readings made B. simultaneously by observers agree to within x10mmHg and 85% or more agree to within x5 mmHg.
4). Result
Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables.
| Table-1 Between test device and reference method | ||
|---|---|---|
| Criteria | Test Result | |
| Systolic Pressure | Diastolic Pressure |
blog 1 Pativan toot daving and reference a
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Truly Instrument Limited
| Mean differences | x 5 mmHg | 3.3 mmHg | 4.5 mmHg |
|---|---|---|---|
| SD differences | x 8 mmHg | 5.2 mmHg | 4.6 mmHg |
| Table-2 Betwee-observer agreement | |||
|---|---|---|---|
| ----------------------------------- | -- | -- | -- |
| Criteria | Test Result | |
|---|---|---|
| Systolic Pressure | Diastolic Pressure | |
| At least 95% of readings agree towithin x 10mmHg | 100% | 100% |
| At least 85% of readings agree towithin x 5mmHg | 95% | 99% |
8. Conclusions
The new subject series devices of Truly Automatic Arm Blood Pressure Monitor continue to follow principles of hardware and software design of the predicate device DB61M(K091434), and the feature, safety, effectiveness are also as same as DB61M., just only in case and LCD''s size changes. Thus, the subject devices are substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Truly Instrument Co., Ltd. c/o: Mr. Jack Lee Truly (USA) INC 2620 Concord Avenue, Suite 106 Alhambra, CA 91803
JAN 1 9 2012
Re: K113083
Truly Automatic Arm Blood Pressure Monitor (DB33, DB81, DB82, DB83, DB91, DB92, DB93) - 8 models Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II Product Code: DXN Dated: January 13, 2012 Received: January 13, 2012
Dear Mr. Lee:
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 for ass based of 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, 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
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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 forth in the quant) of brovisions (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 17 you active pov.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Truly Instrument Limited
Indications for Use
510(K) Number (if Known)
Device Name: Truly Automatic Arm Blood Pressure Monitor DB Series:
Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 Indication For Use:
Truly Automatic Arm Blood Pressure Monitor, Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 are a series device 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 display a warning signal with the reading once the irregular heartbeat is detected.
AND/OR -Prescription Use _______________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K113083 |
|---|---|
| --------------- | --------- |
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§ 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).