(109 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No.
The device is intended to measure blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as a "Wrist Blood Pressure Monitor" intended to "measure and diastolic pressure and diastolic pressure, as well as the pulse rate". Blood pressure monitoring is a diagnostic activity used to assess a patient's health status and identify conditions like hypertension.
No
The device description explicitly states it is a "battery driven automatic on-invasive blood pressure monitor" and mentions components like an "inflatable cuff" and "face shell and keys," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device measures blood pressure and pulse rate via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist. This is a physical measurement taken directly from the patient's body.
- Device Description: The description reinforces that it's a non-invasive blood pressure monitor that uses the oscillometric technique.
- Lack of In Vitro Activities: There is no mention of analyzing samples (like blood, urine, tissue, etc.) outside of the body. IVD devices are designed to perform tests on such samples.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
AOJ-35 series wrist blood pressure monitor is designed as a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg.
The device also has low voltage indication, which will be triggered when the battery is low.
All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical facilities or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
- Biocompatibility testing:
- Tests: Cytotoxicity, Skin Sensitization, Skin Irritation.
- Worst case: Tissue contacting for duration of less than 24 hours.
- Electrical safety and electromagnetic compatibility (EMC):
- Compliance: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2.
- Bench Testing:
- Compliance: ISO 80601-2-30 for performance effectiveness.
- Software Verification and Validation Testing:
- Level of concern: "major" level of concern, since a failure or latent flaw in the software could directly result in serious injurv or death to the patient or operator.
Clinical data:
- Study Type: Clinical validation of automated measurement type on the monitor.
- Standard: ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2.
- Sample Size: 100 subjects (49 female and 51 male).
- Subject Age: All subjects are aged greater than 12 years old.
- Key Results:
- The wrist size distribution meets the requirements described in clause 5.1.4 of the standard.
- The blood pressure distribution matches the requirements defined in clause 5.1.5 of the standard.
- The mean value is less than 5.0 mmHg, and standard deviation is also less than 8.0 mmHg after final analyzed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Blood pressure accuracy: +/- 3 mmHg
- Pulse rate accuracy: +/- 5% of reading
- Mean blood pressure value is less than 5.0 mmHg
- Blood pressure standard deviation is less than 8.0 mmHg
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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February 18, 2022
Shenzhen AOJ Medical Technology Co., Ltd. Queena Chen Regulatory Director Room 301&4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China
Re: K213503
Trade/Device Name: Wrist Blood Pressure Monitor, models AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 20, 2021 Received: December 22, 2021
Dear Queena Chen:
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.
1
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 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.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213503
Device Name
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D and AOJ-35E
Indications for Use (Describe)
The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd.
Room 301&4F, Block A, Building A,
Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang
Street, Bao'an District, 518126, Shenzhen, China
TEL: 86 755-27786026 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Queena Chen |
| Prepare date: | December 18, 2021 |
| 2. Device name and
classification: | Device Name: Wrist Blood Pressure Monitor
Models: AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D and AOJ-35E
Regulation No.: 21 CFR 870.1130
Review Panel: Cardiovascular
Classification Name: Cardiovascular Diagnostic Devices
Product code: DXN
Regulatory Class: Class II |
| 3. Reason for
Submission: | New Application. No prior submission for this device before. |
| 3. Class III device
statement | Not applicable, the subject device is a Class II device. |
| 4. Predicate Devices: | Primary predicate: Dongguan E-TEST Technology Co., Ltd., BW-602 Automatic
Wrist Electronic Blood Pressure Monitor cleared under K193628.
Reference predicate: Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30B
Electronic Blood Pressure Monitor cleared under K191180. |
| 5. Device Description: | The predicates has not been subject to any recall before.
AOJ-35 series wrist blood pressure monitor is designed as a battery driven
automatic on-invasive blood pressure monitor. It can automatically complete the
inflation, deflation and measurement, which can measure systolic and diastolic
blood pressure as well as the pulse rate of adult person at wrist within its claimed
range and accuracy via the oscillometric technique. The result will be displayed in
the international unit mmHg.
The device also has low voltage indication, which will be triggered when the battery
is low.
All the models included in this submission follow the same software, same
measurement principle and same specifications. The main differences are color of
the face shell and keys, which will not affect the safety and effectiveness of the
device. |
| 6. Indications for
Use: | The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and
diastolic pressure, as well as the pulse rate of adult person via non-invasive
oscillometric technique by an inflatable cuff wrapped around the wrist at medical
facilities or at home. |
4
7. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices.
Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
| ITEM | Proposed Device | Predicate Device | Comparison
Result |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | AOJ-35A series | BW-602/K193628 | |
| Manufacturer | Shenzhen AOJ Medical
Technology Co., Ltd. | DONGGUAN E-TEST
TECHNOLOGY CO., LTD | --- |
| Intended
Use/Indications for
Use | The Wrist Blood Pressure
Monitor is intended to measure
the systolic pressure and
diastolic pressure, as well as the
pulse rate of adult person via
non-invasive oscillometric
technique by an inflatable cuff
wrapped around the wrist at
medical facilities or at home. | Automatic Wrist 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 and
systolic blood pressures and
pulse rate of an adult individual
by using a non-invasive
technique in which an inflatable
cuff is wrapped around the
wrist. The cuff circumference is
limited to 13.5 cm19.5 cm. | Different |19.5cm | 13.5
| Operational Specifications | | | |
| Principle | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Patient population | Adult | Adult | Same |
| Measurement site | Wrist | Wrist | Same |
| Blood pressure
Measurement range | 0 - 295 mmHg | 0 - 294 mmHg | Different |
| Blood pressure
accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Pulse rate
measurement range | 40-199 bpm | 40-199 bpm | Same |
| Pulse rate accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same |
| Cuff size | 13.519.5cm | Same |40°C
| Display | Blood Pressure (Systolic and
Diastolic), Pulse rate, Time,
Date, BP Indicating Bar, Low
Battery Icon, Heart Icon,
Memory Record Number | Blood Pressure (Systolic and
Diastolic), Pulse rate, Date,
Time, BP Indicating Bar, Low
Battery Icon, Heart Icon,
Memory Record Number | Same |
| Screen | LCD | LCD | Same |
| Auto shutdown | YES | YES | Same |
| Operating
environment | Temperature: 5°C
Humidity: 15%-90% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Temperature: 5°C~40°C
Humidity: 15%-90% RH,
Atmospheric pressure:
86 kPa - 106 kPa | Different |
| Storage environment | Ambient Temperature:
20°C to 55°C | Ambient Temperature:
20°C to 65°C | Same |
| | Relative Humidity: 10-93% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Relative Humidity: 15-95% RH,
Atmospheric pressure:
86 kPa - 106 kPa | |
| Battery type | 3Vdc (2 *AAA batteries) | 3Vdc (2 *AAA batteries) | Same |
| Weight | Approx. 126 g without battery | Approx. 150 g without battery | Different |
| Dimensions | AOJ-35A/AOJ-35B/AOJ-35D:
90 mm x 66 mm x 28.5 mm
AOJ-35C/AOJ-35E:
79.6 mm x 70 mm x 26.8 mm | 72.69 mm x 64 mm x 28 mm | |
| Patient Contacting | Surface-contacting,
Less than 24 h | Surface-contacting,
Less than 24 h | Same |
| Biocompatibility
evaluation | Cytotoxicity, skin sensitization
and irritation | Cytotoxicity, skin sensitization
and irritation | Same |
| Electrical safety | IEC 60601-1
IEC 60601-1-11
ISO 80601-2-30 | IEC 60601-1
IEC 60601-1-11
ISO 80601-2-30 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
Table 1 Comparison between predicate BW-602 and the subject device
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Table 2 Comparison between predicate AOJ-30B and the subject device
| ITEM | Proposed Device
AOJ-35A series | Predicate Device
AOJ-30B/K191180 | Comparison
Result |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Shenzhen AOJ Medical Technology Co., Ltd. | Shenzhen AOJ Medical Technology Co., Ltd. | --- |
| Intended
Use/Indications for
Use | The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home. | The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home. | Same |
| Operational Specifications | | | |
| Principle | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Patient population | Adult | Adult | Same |
| Measurement site | Wrist | Arm | Same |
| Blood pressure
measurement range | 0 - 295 mmHg | 0 - 295 mmHg | Same |
| Accuracy | ± 3 mmHg | ± 3 mmHg | Same |
| Heart rate
measurement range | 40-199 bpm | 40-199 bpm | Same |
| Accuracy | ± 5% of reading | ± 5% of reading | Same |
| Cuff size | 13.519.5cm | 2236cm | Different |
| Display | Blood Pressure (Systolic and Diastolic), Pulse rate, Date, Time, WHO BP Classification Indicating Bar, Low Battery | Blood Pressure (Systolic and Diastolic), Pulse rate, Date, Time, WHO BP Classification Indicating Bar, Low Battery | Same |
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| Icon, Heart Icon, Memory Record Number | Icon, Heart Icon, Memory Record Number | ||
|---|---|---|---|
| Auto shutdown | YES | YES | Same |
| Operating environment | Temperature: 5°C~ 40°C | ||
| Humidity: 15%-90% RH, | |||
| Atmospheric pressure: | |||
| 70 kPa - 106 kPa | Temperature: 5°C~ 40°C | ||
| Humidity: 15%-90% RH, | |||
| Atmospheric pressure: | |||
| 70 kPa - 106 kPa | Same | ||
| Storage environment | Ambient Temperature: | ||
| -20°C to 55°C | |||
| Relative Humidity: 10-93% RH, | |||
| Atmospheric pressure: | |||
| 70 kPa - 106 kPa | Ambient Temperature: | ||
| -20°C to 55°C | |||
| Relative Humidity: 10-93% RH, | |||
| Atmospheric pressure: | |||
| 70 kPa - 106 kPa | |||
| Battery type | 3Vdc (2 *AAA batteries) | 6Vdc (4 *AA batteries) | Different |
| Weight | Approx. 126 g without battery | Approx. 483.8 g without battery | Different |
| Dimensions | AOJ-35A/AOJ-35B/AOJ-35D: | ||
| 90 mm x 66 mm x 28.5 mm | |||
| AOJ-35C/AOJ-35E: | |||
| 79.6 mm x 70 mm x 26.8 mm | 138 mm x 120 mm x 59 mm | ||
| Patient Contacting | Surface-contacting, | ||
| Less than 24 h | Surface-contacting, | ||
| Less than 24 h | Same | ||
| Biocompatibility evaluation | Cytotoxicity, skin sensitization and irritation | Cytotoxicity, skin sensitization and irritation | Same |
| Electrical safety | IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| ISO 80601-2-30 | IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| ISO 80601-2-30 | Same | ||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | Same |
As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The differences between the subject and predicate devices will not raise different questions of safety or effectiveness. Moreover, as demonstrated in the bench testing, the different technological characteristics do not affect the safety and effectiveness of the subject device.
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- □ Cytotoxicity
- □ Skin Sensitization
- □ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
7
Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and the IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Reguirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the device, consisting of all the accessories in the system. The system complies with the ISO 80601-2-30 Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injurv or death to the patient or operator.
Clinical data:
The clinical testing has been conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type on the monitor. There are 100 subjects involved in the stufy, of which 49 femal and 51 male. All the subjects are aged greater than 12 years old. And the wrist size distribution meets the requirements described in clause 5.1.4 of the standard as shown in Table 3. Also the blood pressure distribution matches the requirements defined in clause 5.1.5 of the standard shown in the following Table 4. And themean value is less than 5.0 mmHg, and standard deviation is also less than 8.0 mmHg after final analyzed.
| Size distribution | Pecentage | Compared to the requirements in standards |
|---|---|---|
| Upper half of the cuff | 54% | At least 40%, complied |
| Lower half of the cuff | 46% | At least 40%, complied |
| Upper quarter of the cuff | 29% | At least 20%, complied |
| Lower quarter of the cuff | 24% | At least 20%, complied |
| Upper octal of the cuff | 11% | At least 10%, complied |
| Lower octal of the cuff | 10% | At least 10%, complied |
Table 3 Size distribution of the subjects
Table 4 Blood pressure distribution of the subjects
| Range | Percentage | Compared to the requirements in standards | |
|---|---|---|---|
| Systolic blood | |||
| pressure | ≤100 mmHg | 12% | At least 5%, complied |
| ≥160 mmHg | 13% | At least 5%, complied | |
| ≥140 mmHg | 33% | At least 20%, complied | |
| Diastolic blood | |||
| pressure | ≥100 mmHg | 16% | At least 5%, complied |
| ≤60 mmHg | 10% | At least 5%, complied | |
| ≥85mmHg | 38% | At least 20%, complied |
Summarv
Based on the non-clinical performance data as documented in the device development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
8
9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-35 series Wrist Blood Pressure Monitor is substantially equivalent to the predicate devices.