(240 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No
This device is for measurement and monitoring of blood pressure, not for therapy or treatment.
Yes
Explanation: The device measures diastolic and systolic blood pressures and pulse rate, which are physiological parameters used to assess a patient'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 meter" and mentions components like an "inflatable cuff" and "low voltage indication," indicating it is a hardware device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves things like blood, urine, tissue, etc., and the tests are performed outside of the body (in vitro).
- This device measures blood pressure and pulse rate directly from the patient's arm. This is a non-invasive measurement taken on the body, not a test performed on a sample taken from the body.
The description clearly states it's a "non-invasive blood pressure measurement system" that uses an "inflatable cuff is wrapped around the upper arm." This is the definition of a device used for physiological measurement on a living person, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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 the cuff around the left arm according to the instruction in the user's guide manual.
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 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 upper arm. The cuff circumference is limited to 24~34 cm.
Product codes
DXN
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 oscillometric technique. The device also has low voltage indication, which will be triggered when the battery is low.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm / upper arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical professionals 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)
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, 1988+A1:1991+A2:1995
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
- 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
- ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K123882 Page 1 of 5
Sponsor: Ageless Health Industrial Ltd. AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-803, Subject Device: BA-805, BA-806, BA-811, BA-812, BA-813 File No.: 510(k) submission report (V1.0), Chapter 6
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.
1. Submitter Information
Sponsor Name: Ageless Health Industrial Ltd.
Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, China
Contact Person: Victor Wan (Vice-president)
Phone: 0769-81158038
Fax: 0769-82289331 E-mail: victor@agelh.com / c.ceng@foxmail.com Web: www.agelh.com
2. Subject Device Information
| Type of 510(k) submission: | 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 |
3. Predicate Device Information
| Sponsor: | Fudakang Industrial Co., Ltd. |
|---|---|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | Arm Automatic Blood Pressure Meter |
Report by Ageless Health Industrial Ltd.
1
K123882 Page 2 of 5
| Sponsor: | Ageless Health Industrial Ltd. | |
|---|---|---|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813 | |
| File No.: | 510(k) submission report (V1.0), Chapter 6 | |
| 510(k) number: | K110281 | |
| 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 oscillometric 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 the cuff around the left arm according to the instruction in the user's guide manual.
6. Test Summary
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, 1988+A1:1991+A2:1995
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
- � 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
- . ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
2
Page 3 of 5
| Sponsor: | Ageless Health Industrial Ltd. |
|---|---|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803 |
| BA-805, BA-806, BA-811, BA-812, BA-813 | |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |
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 of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Ageless Health Industrial Ltd. | Fudakang Industrial Co., Ltd. | -- |
| Product Name | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor | Arm Automatic Blood Pressure | ||
| Meter | -- | ||
| Intended Use and Indications for Use | |||
| 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 the cuff around the left arm | |||
| according to the instruction in the | |||
| user's guide manual. | Fudakang Arm Automatic Blood | ||
| Pressure Meter 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 the cuff around the left upper | |||
| arm according to the instruction in | |||
| the user's guide manual. | SE | ||
| Indications for | |||
| Use | 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 | |||
| 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 upper arm. The cuff | |||
| circumference is limited to 24~34 | |||
| cm. | Fudakang Arm Automatic Blood | ||
| Pressure Meter 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 upper arm. The cuff | |||
| circumference is limited to 22cm- | |||
| 30cm. | SE | ||
| Note 1 | |||
| ELECTRICAL REQUIREMENT | |||
| Power Supply | 6Vdc (4 "AA" batteries) | 6Vdc (4 "AA" batteries) | SE |
| PERFORMANCE SPECIFICATION | |||
| Measuring | |||
| Method | Oscillometry | Oscillometry | SE |
| Measuring | |||
| Range | Pressure: 0~280 mmHg | ||
| Pulse: 40~199 beats/minute | Pressure: 0~300 mmHg | ||
| Pulse: 30~180 beats/minute | Note 2 | ||
| Accuracy | Pressure: ±3 mmHg | ||
| Pulse: ±5% | Pressure: ±3mmHg | ||
| Pulse: ±5% | SE | ||
| Patient | |||
| Population | Adult | Adult | SE |
Report by Ageless Health Industrial Ltd.
3
K123882 Page 4 of 5
| Sponsor: | Ageless Health Industrial Ltd. |
|---|---|
| Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Measurement | |||
| Site of Body | Arm | Arm | SE |
| Cuff | |||
| Circumference | 24-34 cm | 22~30 cm | SE |
| Note 1 | |||
| Inflation and | |||
| Deflation | Automatic | Automatic | SE |
| Memory Size | 2 x 90 sets record | 60 or 90 sets record | SE |
| Note 3 | |||
| OPERATING & STORAGE CONDITIONS | |||
| Storage | |||
| Environment | Temperature: -20℃ ~ +65℃ | ||
| Humidity: 10~95%RH | Temperature: -20℃ ~ +60 ℃ | ||
| Humidity: |