(176 days)
Not Found
No
The description focuses on standard oscillometric technology and basic data storage/display, with no mention of AI/ML terms or capabilities.
No
The device is intended for measurement and monitoring of blood pressure and pulse rate, not for treating a condition or illness.
No
The device is a blood pressure monitor that measures blood pressure and pulse rate. While these measurements can be used by medical professionals to inform diagnoses, the device itself is not described as providing a diagnosis or diagnostic interpretation of the measurements. It performs measurements and provides a classification based on WHO standards, but it does not diagnose a condition.
No
The device description explicitly mentions hardware components like an inflatable cuff, LCD, and electronic interface module, indicating it is a physical device, not software-only.
Based on the provided information, the KD-391 Semi Automatic Electronic Blood Pressure Monitor 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 KD-391 measures blood pressure and pulse rate using a non-invasive technique involving a cuff on the upper arm. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's a "non-invasive blood pressure measurement system."
Therefore, the KD-391 falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-391 Semi Automatic Electronic 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 upper arm according to the instruction in the user's guide manual.
KD-391 Semi Automatic Electronic 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 22cm-48cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-391 Semi Automatic Electronic Blood Pressure Monitor 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, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Besides, the devices have the function of blood pressure level classification which is according to WHO standard.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
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.
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).
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§ 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
510(k) Summary
JUL 3 1 2008
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: | 29/01/08 |
Identification of the product:
| Device proprietary Name: KD-391 Semi Automatic 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 |
Device description:
KD-391 Semi Automatic Electronic Blood Pressure Monitor 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, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Besides, the devices have the function of blood pressure level classification which is according to WHO standard.
Intended use:
KD-391 Semi Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic
1
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.
Comparison of technological characteristics of new device to predicate devices:
KD-391 Electronic Blood Pressure Monitors 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.
Cuff pressure should be displayed on the LCD during inflating process. The user pressurizes the cuff by the inflating bulb manually, which is same with the predicated device.
Comparing with KD-322 Semi Automatic Electronic Automatic Blood Pressure Monitor, KD-391 has some new functions, such as memory 60 times recent test results with time and date, which display on a large LCD, blood pressure level classification according to WHO standard and cuff size range, which from 22cm-48cm.
The accuracy and effectiveness of the extra large cuffs used in KD-391 Blood Pressure Monitor has been validated through the ANSI/AAMI SP-10 standard.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
See the submission for more details.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Adon Health Co., Ltd c/o Ms. Mona 7th Floor Hua Qiao Chuang Ye Plaza No 10, JinPing Road, Ya An Road Nankai District, Tianjin, China 300190
JUL 3 1 2008
Re: K080326
Trade/Device Name: KD-391 Semi Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 26, 2008 Received: June 30, 2008
Dear Ms. Mona:
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 (Act 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 requirements for annual registrations, institutions and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -- Ms. Mona
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number ( if known):
080726
Applicant: Andon Health Co., Ltd
Semi Automatic Electronic Blood Pressure Device name: KD-391 Monitor
Indications for use:
KD-391 Semi Automatic Electronic 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 22cm-48cm.
Prescription use Part 21 CFR 801 Subpart D) Over-The-Counter Use YES (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K080326 |
|---|---|
| --------------- | --------- |
| Page 1 of | 1 |
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