(173 days)
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures 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 cuff circumference is six sizes.
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for a blood pressure monitor. It serves as a regulatory approval and states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the necessary safety and effectiveness standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AGE Automatic Upper Arm Blood Pressure Monitor are primarily established by compliance with recognized standards for safety and performance. The document explicitly states the required accuracy for pressure and pulse measurements.
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance | Verdict (as stated in document, usually "SE" for Substantial Equivalence) |
|---|---|---|
| Accuracy (Pressure): ±3 mmHg | Pressure: ±3 mmHg | SE |
| Accuracy (Pulse): ±5% | Pulse: ±5% | SE |
| Measuring Method | Oscillometry (same as predicate) | SE |
| Measurement Range for Pressure | 0~280 mmHg (same as predicate) | SE |
| Operating Range for Pressure (Cuff Pressure) | 0~280 mmHg (same as predicate) | SE |
| Cuff Display Range | 0~280 mmHg (same as predicate) | SE |
| Pressure Resolution | 1mmHg or 0.1kPa (same as predicate) | SE |
| Patient Population | Adult (same as predicate) | SE |
| Measurement Site of Body | Upper Arm (same as predicate) | SE |
| Inflation and Deflation | Automatic (same as predicate) | SE |
| Electrical, Mechanical and Thermal Evaluation | Compliance with IEC 60601-1, IEC 60601-1-2 | SE |
| Biocompatibility Evaluation | Compliance with ISO 10993-5, -10 | SE |
| Performance Standard | Compliance with ISO 81060-2 | SE (Note 5 states it's equivalent to AAMI SP10 used by predicate) |
| Intended Use & Indications for Use | Same as predicate (with minor cuff circumference difference, addressed in Note 1) | SE |
| Power Supply | DC 6V (4 X AA 1.5V alkaline batteries) (Substantially equivalent to predicate) | SE |
| Memory Size | 2 x 90 sets record (BA-822X is 90 sets) (Note 2 states differences do not affect safety/effectiveness) | SE |
| Software Version | V01 (Note 3 states it's updated based on predicate, no change in PWB control circuit) | SE |
| Operating & Storage Conditions | Temperature, Humidity, Atmospheric Pressure ranges (Note 2 states minor differences do not affect safety/effectiveness) | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the device's safety and performance were evaluated by "lab bench testing" and "clinical validation" according to ISO 81060-2.
- Sample Size: The document does not specify the precise sample size used for the clinical validation. ISO 81060-2, the standard followed, dictates specific subject requirements for clinical validation of automated sphygmomanometers (e.g., specific age groups, blood pressure ranges, and a minimum number of subjects, typically at least 85 subjects with appropriate distribution). However, the number of subjects used in this specific study is not provided in the excerpt.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) submission for a device manufactured in China, it's plausible the clinical study was conducted in China or another region that uses ISO standards, likely a prospective study to collect human blood pressure measurements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to compliance with ISO 81060-2 for clinical validation. This standard typically requires "reference measurements" (ground truth) to be obtained by healthcare professionals using a standardized method (e.g., mercury sphygmomanometry with a stetho-scope).
- Number of Experts: ISO 81060-2 usually requires at least two trained observers (experts) for simultaneous, blind auscultatory measurements to establish the reference blood pressure. The document itself does not specify the exact number of experts.
- Qualifications of Experts: The standard implies that these experts are trained and competent in auscultatory blood pressure measurement. While "radiologist with 10 years of experience" is an example qualification, for blood pressure measurement, the standard would typically require medical professionals trained in auscultatory blood pressure measurement, such as physicians, nurses, or trained technicians, without specifying years of experience in this excerpt.
4. Adjudication Method for the Test Set
For the clinical validation against ISO 81060-2, the ground truth is established by simultaneous auscultatory measurements by two trained observers.
- Adjudication Method: While not explicitly detailed, ISO 81060-2 requires a pre-defined method for handling discrepancies between the two observers' readings. Common methods include:
- Averaging the two readings if they are within a specific tolerance.
- Using a third, independent observer if the initial two readings differ by more than a specified amount (e.g., 2+1 methodology).
- No adjudication is typically not acceptable for establishing ground truth in this type of study; a consensus or defined reconciliation process is necessary to minimize observer bias. The exact method used for this device's validation is not detailed in the provided text.
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 device is an automatic blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improving with AI assistance" is not applicable. The study's purpose was to validate the accuracy of the automated device itself against a human-read reference standard.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in spirit, a standalone performance study was done. The device itself is an automated system that measures blood pressure. The clinical validation conducted under ISO 81060-2 assesses the accuracy of the device's algorithm (its automated measurement) compared to the "gold standard" of human-observed auscultatory blood pressure. There isn't a "human-in-the-loop" in the operation of the device for each measurement; it's designed to be automated.
7. The Type of Ground Truth Used
- The ground truth for the clinical performance evaluation (per ISO 81060-2) would be expert consensus auscultatory blood pressure measurements, typically performed simultaneously and blindly by two trained observers using a mercury sphygmomanometer or equivalent calibrated device. This is the accepted clinical gold standard for such validations.
8. The Sample Size for the Training Set
- Not applicable / Not provided. This document describes a 510(k) submission for a traditional medical device (an automated blood pressure monitor) that operates based on oscillometric principles, not explicitly on machine learning or deep learning algorithms that require separate "training sets." The device's underlying algorithm is likely fixed and validated, not something that "learns" from a training dataset in the AI sense. Therefore, there's no mention of a "training set" as one would find for an AI/ML medical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As explained in point 8, this device does not appear to utilize a machine learning model that would require a "training set" with established ground truth in the context of AI/ML development. Its accuracy is validated against a reference standard in a clinical study.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
Ageless Health Industrial Co., Ltd % Cecelia Ceng Regulatory Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 CN
Re: K153552
Trade/Device Name: AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X (X can be A, B, C, D, E, F). Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 25, 2015 Received: December 11, 2015
Dear Cecelia Ceng:
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. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (21 CFR 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 yours. Shawn W. Forrest -S 2016.06.01 22:58:44 -04'00'
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) K153552
Device Name
AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-801X, BA-802X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X (X can be A, B, C, D, E, F).
Indications for Use (Describe)
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures 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 cuff circumference is six sizes.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☐ Registration Use (Part 21 CFR 601 Subpart D)☒ One-Time Central Use (21 CFR 601 Subpart G) | ☐ Registration Use (Part 21 CFR 601 Subpart D) | ☒ One-Time Central Use (21 CFR 601 Subpart G) |
| ☐ Registration Use (Part 21 CFR 601 Subpart D) | ☒ One-Time Central Use (21 CFR 601 Subpart G) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Chapter 6. 510(k) Summary
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 870.1130.
Submitter Information 1.
Sponsor Name: Dongguan Ageless Health Industrial Co., Ltd Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongquan City, Guangdong Province, China Contact Person: Victor Wan (Vice-president) Phone: +86-769-81158038 Fax: +86-769-82289331 E-mail: victor@agelh.com
Application Correspondent:
Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: requlatory@glomed-info.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | AGE Automatic Upper Arm Blood Pressure Monitor |
| Classification Name: | Noninvasive blood pressure measurement system |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |
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| Sponsor: | Dongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | AGE Automatic Upper Arm Blood Pressure Monitor |
| 510(k) number: | K123882 |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |
4. Device Description
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
5. Intended Use
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Test Summary 6.
AGE Automatic Upper Arm Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005 + � A1:2012
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- � AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. (Cardiovascular)
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7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Product Name | AGE Automatic Upper Arm BloodPressure Monitor | AGE Automatic Upper Arm BloodPressure Monitor | -- |
| Intended Use and Indications for Use | |||
| Intended Use | AGE Automatic Upper Arm BloodPressure Monitor is intended foruse by medical professionals or athome to monitor and displaydiastolic, systolic blood pressureand pulse rate on adult each time,with the cuff around the left upperarm according to the instruction inthe user's guide manual. | AGE Automatic Upper Arm BloodPressure Monitor is intended foruse by medical professionals or athome to monitor and displaydiastolic, systolic blood pressureand pulse rate on adult each time,with the cuff around the left upperarm according to the instruction inthe user's guide manual. | SE |
| Indications forUse | AGE Automatic Upper Arm BloodPressure Monitor is for use bymedical professionals or at homeand is a non-invasive bloodpressure measurement systemintended to measure the diastolicand systolic blood pressures andpulse rate of an adult individual byusing a non-invasive technique inwhich an inflatable cuff is wrappedaround the upper arm. The cuffcircumference is six sizes. | AGE Automatic Upper Arm BloodPressure Monitor is for use bymedical professionals or at homeand is a non-invasive bloodpressure measurement systemintended to measure the diastolicand systolic blood pressures andpulse rate of an adult individual byusing a non-invasive technique inwhich an inflatable cuff is wrappedaround the upper arm. The cuffcircumference is limited to 24~34cm. | SENote 1 |
| ELECTRICAL REQUIREMENT | |||
| Power Supply | DC 6V (4 X AA 1.5V alklinebatteries) | 6Vdc (4 "AA" batteries) | SE |
| PERFORMANCE SPECIFICATION | |||
| MeasuringMethod | Oscillometry | Oscillometry | SE |
| Measurementrange forpressure | 0~280 mmHg | 0~280 mmHg | SE |
| OperatingRange forPressure (CuffPressure) | 0~280 mmHg | 0~280 mmHg | SE |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Cuff DisplayRange | 0~280 mmHg | 0~280 mmHg | SE |
| Pressureresolution | 1mmHg or 0.1kPa | 1mmHg or 0.1kPa | SE |
| Accuracy | Pressure: ±3 mmHgPulse: ±5% | Pressure: ±3mmHgPulse: ±5% | SE |
| PatientPopulation | Adult | Adult | SE |
| MeasurementSite of Body | Upper Arm | Upper Arm | SE |
| Inflation andDeflation | Automatic | Automatic | SE |
| Memory Size | 2 x 90 sets record (BA-822X is 90sets ) | 2 x 90 sets record | SENote 2 |
| SoftwareVersion | V01 | V1.1 | SENote 3 |
| Indicators | Blood Pressure (Systolic andDiastolic), Pulse, Date, Time, WHOBP Classification Indicating Bar,Low Battery Icon, Heart Icon,Memory Record Number | Blood Pressure (Systolic andDiastolic), Pulse, Date, Time, WHOBP Classification Indicating Bar,Low Battery Icon, Heart Icon,Memory Record Number | SE |
| PhysicalDimensionsWeight | Please refer to "Table 1 Physical Dimensions and weight for each model"of "Chapter 6" | SENote 4 | |
| CuffCircumference | size A: 17cm--22cm (SMALLADULT CUFF)size B: 22cm--30cm (ADULTCUFF-1)size C: 24cm--34cm (ADULTCUFF-2)size D: 22cm--42cm (L-LARGEADULT CUFF)size E: 30cm--42cm (LARGEADULT CUFF)size F: 42cm--50cm (EXTRALARGE ADULT CUFF) | 24~34 cm | SENote 1 |
| OPERATING & STORAGE CONDITIONS | |||
| StorageEnvironment | Temperature: -20°C ~ +65°CHumidity: 10 | Temperature: -20°C ~ +65°CHumidity: 10 | SE |
| WorkingEnvironment | Temperature: 5°C ~ 40°CHumidity: 15 | Temperature: 5°C ~ 40°CHumidity: 10 | SENote 2 |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| kPa | |||
| COMPLIANCE STANDARDS | |||
| Electrical,Mechanical andThermalEvaluation | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | SE |
| BiocompatibilityEvaluation | All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 -5, -10. | All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 -5, -10. | SE |
| Performance | ISO 81060-2 | AAMI SP10 | SENote 5 |
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Note 1
Although there is difference for measurement cuff circumference of subject device and predicate device, both of them are complied with ISO 81060-2. This difference does not affect the safety and effectiveness.
Note 2
Although some specifications of operating & storage conditions, memory size are different for subject device and predicate device, they are both complied with IEC 60601-1. The differences do not affect the safety and effectiveness. The storage and operating pressure ranges of subject device and predicate device are same, and the storage and operating pressure ranges of predicate device was provided by the manufacturer.
Note 3
The software version of subject device is updated based on the predicate device, there is no different in PWB control circuit and software among models. The software is same as K123882.
Note 4
These differences of physical dimensions and weight have been verified and validated to demonstrate that it does not affect the safety and effectiveness of subject device.
Note 5
Although the standards of performance have updated and substituted from AAMI SP10 to ISO 81060-2, all of the requirements in these three standards are intended for blood pressure monitor. Therefore,
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both of them met the requirements. The differences do not affect the safety and effectiveness.
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| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| ModelName | Appearance Picture | Size andWeight | Model Name | Appearance Picture | Size andWeight |
| BA-801X | Image: Blood pressure monitor | 115mm (L)103mm (W)67.5mm (H)460g | BA-801 | Image: Blood pressure monitor | 115mm (L)103mm (W)67.5mm (H)460g |
| BA-802X | Image: Blood pressure monitor | 115mm (L)103mm (W)67.5mm (H)460g | BA-802 | Image: Blood pressure monitor | 115mm (L)103mm (W)67.5mm (H)460g |
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| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| ModelName | Appearance Picture | Size andWeight | Model Name | Appearance Picture | Size andWeight |
| BA-803X | Image: Blood pressure monitor | 119mm (L)100mm (W)63.2mm (H)456g | BA-803 | Image: Blood pressure monitor | 119mm (L)100mm (W)63.2mm (H)456g |
| BA-805X | Image: Blood pressure monitor | 118.3mm (L)100mm (W)62.9mm (H)465g | BA-805 | Image: Blood pressure monitor | 118.3mm (L)100mm (W)62.9mm (H)465g |
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| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| ModelName | Appearance Picture | Size andWeight | Model Name | Appearance Picture | Size andWeight |
| BA-806X | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L)112mm (W)70mm (H)472g | BA-806 | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L)112mm (W)70mm (H)472g |
| BA-811X | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L)112mm (W)67mm (H)468g | BA-811 | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L)112mm (W)67mm (H)468g |
LCD
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| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| ModelName | Appearance Picture | Size andWeight | Model Name | Appearance Picture | Size andWeight |
| BA-812X | Image: Blood pressure monitor | 113.5mm (L)92mm (W)48mm (H)418g | BA-812 | Image: Blood pressure monitor | 113.5mm (L)92mm (W)48mm (H)418g |
| BA-813X | Image: Blood pressure monitor | 115.3mm (L)92mm (W)48mm (H)412g | BA-813 | Image: Blood pressure monitor | 115.3mm (L)92mm (W)48mm (H)412g |
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| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| ModelName | Appearance Picture | Size andWeight | Model Name | Appearance Picture | Size andWeight |
| BA-821X | Image: Blood pressure monitor with LCD screen showing readings, with labels for 'Set', 'Power', and 'Memory' buttons. | 150mm (L)100mm(W)70mm (H)610g | |||
| BA-822X | Image: Blood pressure monitor with LCD screen, with labels for 'LCD', 'Memory', and 'Power' buttons. | 153mm (L)90mm(W)58mm (H)380g |
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| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| ModelName | Appearance Picture | Size andWeight | Model Name | Appearance Picture | Size andWeight |
| BA-823X | Image: Blood pressure monitor with arm cuff. The display reads 120/90. Labels point to LCD, Set, Power, and Memory. | 140mm (L)95mm(W)70mm (H)420g | |||
| BA-826X | Image: Blood pressure monitor with arm cuff. The display reads 120/80. Labels point to LCD, Set, Memory, and Power. | 140mm (L)115mm(W)60mm (H)500g |
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8. Conclusion
The subject device AGE Automatic Upper Arm Blood Pressure Monitor has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
9. Summary Prepared Date 26 April 2016
§ 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).