(102 days)
Not Found
No
The description focuses on standard oscillometric technology and does not mention any AI or ML components.
No
The device is intended to measure blood pressure and pulse rate, which is a diagnostic/monitoring function, not a therapeutic one.
Yes
The device is intended to measure diastolic and systolic blood pressures and pulse rate, which are used to assess the physiological state of an individual, thus aiding in diagnosis.
No
The device description explicitly states it is a "Non-invasive blood pressure measurement system" that includes an inflatable cuff, a silicon integrated pressure sensor, an LCD, and an electronic interface module. These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- This device's function: The description clearly states that this is a "non-invasive blood pressure measurement system." It measures blood pressure and pulse rate by applying a cuff to the upper arm. This is a measurement taken on the body (in vivo), not a test performed on a specimen taken from the body.
The device is a medical device, but it falls under the category of non-invasive physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is for use by medical rofessionals 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 ann. The cuff circumference is imited to 22cm-48cm(be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left 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)
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) meets the following standards:
- · ANSI/AAMI SP-10 standard
- EN60601-1 Medical electrical equipment Part 1: General requirements for safety
- · EN60601-1-2 Electromagnetic Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K052676, K030358, K070395, K042418, K070828
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.
Not Found
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
天 津 九 安 医 疗 电 子 股 份 有 限 公 司
Andon Health Co., Ltd.
地址:天津市南开区雅安道金平路 10号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, NanKai District, Tianjin, China 郎纷(P.C.): 300190 传(Fax): 86-22-6052 6162 E-mail: andon@public.tpt.tj.cn ttt:1(Tel): 86-22-6052 6161
510(k) Summary
ldentification of the submitter:
| Submitter: | Andon Health Co., Ltd. |
|---|---|
| No 31, Changjiang Road, Nankai District, Tianjin, | |
| P.R. China, 300193 | |
| Telephone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 11/10/08 |
Identification of the product:
| Device proprietary Name: | Arm Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive blood pressure measurement systems |
| Classification name: | Noninvasive blood pressure measurement system |
| Class II per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) number |
|---|---|---|
| KD-322 | Andon Health Co., Ltd | K052676 |
| KD-622 | Andon Health Co., Ltd | K030358 |
| KD-525E | Andon Health Co., Ltd | K070395 |
| KD-575 | Andon Health Co., Ltd | K042418 |
| KD-593 | Andon Health Co., Ltd | K070828 |
| KD-595 | Andon Health Co., Ltd | K070828 |
| KD-596 | Andon Health Co., Ltd | K070828 |
| KD-598 | Andon Health Co., Ltd | K070828 |
Device description:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD
1
083395
天 津 九 安 医 疗 电 子 股 份 有 限 公 司 Andon Health Co., Ltd.
地址:天津市南开区雅安道金平路 10号华侨创业大厦7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin, China 邮编(P.C.): 300190 传真(Fax): 86-22-6052 6162 【!】(Tel): 86-22-6052 6161 E-mail: andon@public.tpt.ti.cn
with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.
Intended use:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E. KD-593. KD-595. KD-596, KD-598) is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device.
Summary comparing technological characteristics with predicate device:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-675, KD-525E, KD-593, KD-595, KD-596, KD-598) has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD. The modifications that were made are:
(1): Cuff size change into 22cm-48cm from 22cm-30cm.
(2): The Environmental parameters are changed.
The operational range for humidity ( |
| -- | -------------------------------------------- |
|---|
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K083395 |