(114 days)
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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.
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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 AAA or 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%.
Unfortunately, the provided document K091434 for the Truly Automatic Arm Blood Pressure Monitor does not contain the specific details required to answer your questions about acceptance criteria and the study proving the device meets them.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed technical report of performance testing against explicit acceptance criteria.
Here's what is (and isn't) present in the document regarding your questions:
1. A table of acceptance criteria and the reported device performance
- What's in the document: The summary provides "Accuracy Pressure: ± 3mmHg" and "Accuracy Pulse: ± 5%" under "Table 1" and "Table 2" when comparing to predicate devices. This represents the claimed accuracy, which would likely be the acceptance criteria, but no formal study data proving this performance is presented within this document.
- What's missing: The document does not present a table explicitly laying out acceptance criteria from a validation study alongside the performance results from that study. It merely lists the stated accuracy specifications as a comparison point during the substantial equivalence argument.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: This information is not present in the 510(k) summary. It does not describe any clinical or performance test setup, subject numbers, or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing: This information is not present. The device is a non-invasive blood pressure monitor, and its ground truth typically relies on a reference measurement method (like a mercury sphygmomanometer with auscultation), not necessarily "experts" in the context of image interpretation. However, the exact reference method and its application details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: This information is not applicable and not present. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a blood pressure monitor, reconciliation would be against the reference standard.
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
- Missing: Not applicable and not present. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- What's in the document: The device itself is a "standalone" automatic blood pressure monitor, meaning its measurement is solely algorithmic without human intervention in the measurement process (though a human operates the device). The document states it uses the "oscillometric method" and an "electronic pressure sensor."
- What's missing: While the device operates standalone, the document doesn't explicitly describe a "standalone performance study" in the context of comparing its algorithm-only performance against a human or a different standard. It just states its general operating principle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing: The document does not explicitly state the ground truth method used for any performance testing. For blood pressure monitors, the ground truth is typically obtained from simultaneous measurements using a validated reference method (e.g., a mercury sphygmomanometer with a trained observer using auscultation), adhering to standards like ANSI/AAMI SP10. This is implied to be the basis for claiming "Accuracy Pressure: ± 3mmHg," but the details are not provided.
8. The sample size for the training set
- Missing: Training sets specifically for an algorithm are not mentioned. The "oscillometric method" is described as a "well-known technique in the market." If there were any machine learning components, a training set would be relevant, but this document does not provide such details.
9. How the ground truth for the training set was established
- Missing: As no training set is described, this information is also absent.
In summary, the K091434 submission is a 510(k) summary focused on establishing substantial equivalence based on technical similarities and stated performance specifications, rather than detailing the full performance study data against explicit acceptance criteria. To find the information you're looking for, you would typically need to review the full 510(k) submission and its accompanying test reports, which are not included in this summary document.
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K091434
Truly Instrument Limited.
510(k) Summarv
SEP - 4 2009
Date of Summary Preparation: 4.20.2009
1. Submitter's Identifications
Submitter's Name: Truly Instrument Limited
Truly Industrial Area, Shanwei City, Guangdong Province, Address: 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
Models: DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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
a. Digibio Digital Blood Pressure Monitor, Model D11, K014141 b. Microlife Blood Pressure Monitor, Model BP3BT0-AP, K041411
4. Device Description
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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
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Truly Instrument Limited.
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 AAA or 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%.
5. Intended use of device
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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
Table 1: The difference between Truly Automatic Arm Blood Pressure Monitor DB series and Digibio Digital Blood Pressure Monitor, Model D11.
| Parameter | PredicateDevices D11 | DB21 | DB22 | DB23 | DB31 | DB32 | DB61M | DB62M | DB63M | DB71M |
|---|---|---|---|---|---|---|---|---|---|---|
| Measurementalgorithm | Oscillometricmethod | No change ,all same | ||||||||
| Method | ||||||||||
| Measurementsite of body | Arm | No change ,all same | ||||||||
| PressureSensor | MSP-2107 | No change, all same | ||||||||
| Cuff | No change ,all same | |||||||||
| Software | D11 software + Irregular heartbeat detection. | |||||||||
| 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. Determinationmethod of irregular heartbeat".DB22, DB23, DB61M, DB62M, DB63M, DB71M have the IH feature. | |||||||||
| Memory Size | 2 x 60 | 2X60 | 2X50 | 4X99 | 2X60 | 1X99 | 4X99 | 4X99 | 4X99 | 4X99 |
| MeasurementPressureRange | 20~280mmHg | No change ,all same | ||||||||
| MeasurementPulse Range | 40~195beats/min | No change ,all same |
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| Parameter | PredicateDevices D11 | DB21 | DB22 | DB23 | DB31 | DB32 | DB61M | DB62M | DB63M | DB71M |
|---|---|---|---|---|---|---|---|---|---|---|
| Mesauringresolution | 1 mmHg | No change, all same | ||||||||
| AccuracyPressure | $\pm$ 3mmHg | No change, all same | ||||||||
| AccuracyPulse | $\pm$ 5% | No change, all same | ||||||||
| PressurizationSource | Automaticinternal pump | No change, all same | ||||||||
| Ciff Deflation | Automaticdeflation | No change, all same | ||||||||
| OperatingEnvironment | 10 | No change, all same | ||||||||
| PowerVovtage | 4X 1.5V | No change, all same | ||||||||
| Hardwarecircuit | No change, all same | |||||||||
| Electronicelement | No change, all same | |||||||||
| PCB | Only | DB22 | PCB | is | solely, other PCB of modelDB21/23/31/32/61M/62M/63M/71M are same to D11 | |||||
| Display Type | Liquid crystaldisplay | No change, all same | ||||||||
| Cover | Difference |
Table 2: The difference between Truly Automatic Arm Blood Pressure Monitor DB series and Microlife Blood Pressure Monitor, Model BP3BT0-AP
| Parameter | PredicateDevicesBP3BT0-AP | DB21 | DB22 | DB23 | DB31 | DB32 | DB61M | DB62M | DB63M | DB71M |
|---|---|---|---|---|---|---|---|---|---|---|
| MeasurementMethod | OscillometricMethod | No change - the same | ||||||||
| PressureSensor | Capacitive | No change - the same | ||||||||
| MeasurementRange:BP | 30~280mmHg | 20 ~ 280 mmHg | ||||||||
| MeasurementRange:BP | 40~200beats/min | 40 ~ 195 beats/min | ||||||||
| Measuringresolution | 1mmHg | No change - the same |
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| Parameter | PredicateDevicesBP3BT0-AP | DB21 | DB22 | DB23 | DB31 | DB32 | DB61M | DB62M | DB63M | DB71M | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| AccuracyPressure | $\pm 3mmHg$ | No change - the same | |||||||||
| AccuracyPulse | $\pm 5%$ | No change - the same | |||||||||
| PressurizationSource | Automaticinternal pump | No change - the same | |||||||||
| Cuff Deflation | Automaticdeflation | No change - the same | |||||||||
| Memory Size | 99 | 2X60 | 2X50 | 4X99 | 2X60 | 1X99 | 4X99 | 4X99 | 4X99 | 4X99 | |
| IrregularHeartbeatDetection | More than$\pm 25%$ to themean intervalof pulseintervals | DB22, DB23, DB61M, DB62M, DB63M, DB71M have the IH feature. | |||||||||
| Power Source | 4 X1.5V | No change - the same | |||||||||
| OperatingEnvironment | 10 | No change - the same | |||||||||
| CuffAttachmentMethod | By plastic hoseconnected tomonitor | No change - the same | |||||||||
| Display Type | Liquid crystaldisplay | Liquid crystal display |
7. Conclusions
:
The subject devices have all features of the predicate device D11 except the new features such as irregular heartbeat detection. These differences do not affect the safety and effectiveness of the subject devices.
Irregular heartbeat detection technology is same as what is used Microlife Blood Pressure Monitor, Model BP3BT0-AP, K041411
Thus, the subject devices are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP - 4 2009
Truly Instrument Co., Ltd. c/o Mr. Yang Jian-Hao Manager Truly Industrial Area Shanwei, Guangdong 516600 China
Re: K091434
Trade/Device Name: Truly Automatic Arm Blood Pressure Monitor Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M and DB71M. Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: August 7, 2009
Dear Mr. Yang:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Mr. Yang Jian-Hao
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 go to http://www.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,
W.M.
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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09 14 34
TRULY®
Truly Instrument Limited
Indication for Use
510(k) Number (if known):
Device Name: Truly Automatic Arm Blood Pressure Monitor DB Series,
Models DB21,DB22,DB23,DB31,DB32,DB61M,DB62M,DB63M,DB71M Indication For Use:
Truly Automatic Arm Blood Pressure Monitor ,Models DB21, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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.
Prescription Use
Over the Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
K.M.D.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091434
HongKong: 2/F, Chung Shun Knitting Centre, 1-3 Wing Yip Street, Kwai Chung, N.T., Hong Kong FAX: (852) 2146 5756 TEL: (852) 2487 9803 (20 Lines) E-MAIL: healthcare@truly.com.hk URL: http://www.trulyinstrument.com China: Truly Industrial Area .ShanWei City. Guangdong Province ,China FAX:86-0660-3380377 TEL:86-0660-3380070
§ 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).