(301 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and data storage, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is strictly for measurement and monitoring of blood pressure and pulse rate, and does not provide any therapeutic intervention.
Yes
The device measures systolic pressure, diastolic pressure, and pulse rate, which are physiological parameters used to assess a person's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and describes physical components like inflation, deflation, display, and data storage functions, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Arm Blood Pressure Monitor measures blood pressure and pulse rate using a non-invasive oscillometric technique. This involves applying a cuff to the arm and detecting pressure changes caused by blood flow. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the body, not to analyze biological samples.
Therefore, the device described is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arm 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 at medical facilities or at home.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
AOJ-33series arm blood pressure monitor is designed as a battery driven automatic non-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 upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. 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. AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm
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)
Clinical data: AOJ-33A was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. the clinical validation data on AOJ-33A can cover AOJ-33B. The Same Arm Sequential Method was chosen and performed on AOJ-33A. This study included 100 adult subjects (49 female, 51 male) with an age range of 12 to 60 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30B Electronic Blood Pressure Monitor cleared under K191180.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 26, 2023
Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301 & 4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China
Re: K222994
Trade/Device Name: Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 12, 2023 Received: June 13, 2023
Dear Jack Wang:
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 mediation-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.
Robert T. Kazmierski - S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222994
Device Name
Arm Blood Pressure Monitor, models AOJ-33A, AOJ-33B
Indications for Use (Describe)
The Arm 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 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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3
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: | Jack Wang | | | |
| Prepare date: | September 16, 2022 | | | |
| 2. Device name and
classification: | Device Name: Arm Blood Pressure Monitor
Models: AOJ-33A and AOJ-33B
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: | Reference predicate: Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30B
Electronic Blood Pressure Monitor cleared under K191180. | | | |
| 5. Device Description: | The predicates have not been subject to any recall before.
AOJ-33series arm blood pressure monitor is designed as a battery driven automatic
non-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 upper arm within its claimed
range and accuracy via the oscillometric technique. The result will be displayed in
the international unit mmHg or Kpa. | | | |
| | The device has the data storage function in order for data reviewing, including the
systolic pressure, diastolic pressure, pulse rate and measurement time. The device
also has low voltage indication, which will be triggered when the battery is low. | | | |
| | The proposed device is intended to be used in medical facilities or at home. And the
effectiveness of this sphygmomanometer has not been established in pregnant
(including pre-eclamptic) patients. | | | |
| | The product is provided non-sterile, and not to be sterilized by the user prior to use. | | | |
| | 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. | | | |
4
K222994
AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.
- Indications for The Arm 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 Use: oscillometric technique at medical facilities or at home.
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
AOJ-33 series | Predicate Device
AOJ-30B/K191180 | Comparison
Result |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Shenzhen AOJ Medical Technology
Co., Ltd. | Shenzhen AOJ Medical Technology
Co., Ltd. | Same |
| Intended Use/Indications
for Use | The Arm 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. | 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 |
| Contraindications | Not Known | Not Known | Same |
| Application scenario | Medical Facilities and Home Use | Medical Facilities and Home Use | 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 | Upper arm | Upper arm | Same |
| Blood pressure
measurement range | 30-255 mmHg | 30-255 mmHg | Same |
| Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Heart rate measurement
range | 40-199 bpm | 40-199 bpm | Same |
| Accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same |
| Cuff size | 22 - 42 cm | 22 - 36 cm | Different |
| Display | Blood Pressure (Systolic and
Diastolic), Pulse rate, Date, Time,
WHO BP Classification | Blood Pressure (Systolic and
Diastolic), Pulse rate, Date, Time,
WHO BP Classification | Same |
| | | | |
| | Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number | Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number | |
| Auto shutdown | YES | YES | Same |
| Operating environment | Temperature: 5°-40°C Humidity:
15%-90% RH, Atmospheric pressure: 70 kPa -106 kPa | Temperature: 5°-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 | Lithium-ion battery, D.C. 3.7V | 6Vdc (4 * 1.5V AAA batteries) | Different |
| Weight | AOJ-33A: About 225g
AOJ-33B: About 225g | Approx. 483.8 g without battery | Different |
| Dimensions | AOJ-33A:123 mm (Length) x 59 mm
(Width) x 28mm (Height) (48.43
inches x 23.23 inches x11.02
inches )
AOJ-33B: 125 mm (Length) x 48
mm (Width) x 28 mm (Height)
(49.21 inches x 18.9 inches x 11.02
inches) | 138 mm * 120 mm * 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 |
| Data transmission | Has wireless function with Bluetooth
and available for AOJ-33B only | Not available | Different |
Table 1 Comparison between predicate AOJ-30B and the subject device
5
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.
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.
6
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)
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 far basic safety and essential performance -Collateral Standard: Requirements for medical 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 - Requirements 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 fbr this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
AOI-33A was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. the clinical validation data on AOJ-33A can cover AOJ-33B. The Same Arm Sequential Method was chosen and performed on AOJ-33A. This study included 100 adult subjects (49 female, 51 male) with an age range of 12 to 60 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.
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-33 series Arm Blood Pressure Monitor is substantially equivalent to the predicate devices.