(87 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and basic data storage/averaging functions, with no mention of AI or ML.
No
The device is a blood pressure monitor intended for measurement and monitoring, not for treating or rehabilitating a condition, which is characteristic of a therapeutic device.
Yes
The device is described as a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult". Measuring and providing these physiological parameters is a form of diagnostic information. Furthermore, it explicitly mentions "blood pressure level classification", which categorizes the measured values for interpretation.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The KD-7906 Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the wrist and using an oscillometric technique. This is a non-invasive measurement performed on the body.
The device description clearly states it's a "non-invasive blood pressure measurement system" and that it measures blood pressure by "Buckling a cuff around the wrist". This is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
KD-7906 Fully 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 wrist according to the instruction in the user's guide manual, which is same as predicated device.
KD-7906 Fully 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Prescription use Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) YES
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-7906 Fully 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 blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the wrist, which cuff circumference is limited to 6.1023 inches to 9.8425 inches. the device can analyze the signals promptly and display the test results. Besides, It can store and show 2*60 times measuring result with the day and time. And it has the function of blood pressure level classification and calculating the average of the last 3 readings.
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 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)
KD-7906 Fully Automatic Electronic Blood Pressure Monitor meet the following standards:
- · ANSI/AAMI SP-10 standard
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety
- IEC 60601-1-2 Electromagnetic Compatibility
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.
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
510K submission of KD-7906 Fully Automatic Electronic Blood Pressure Monitor
510(k) Summary
ldentification of the submitter:
JAN 2 9 2009
Submitter: Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 6161 Telephone number: Fax number: 86-22-6052 6162 Liu Yi Contact: Date of Application: 10/29/08
Identification of the product:
Device proprietary Name: Fully 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 KD-795
manufacture Andon Health Co., Ltd 510(k) number K070826
Device description:
KD-7906 Fully 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 blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the wrist, which cuff circumference is limited to 6.1023 inches to 9.8425 inches. the device can analyze the signals promptly and display the test results. Besides, It can store and show 2*60 times measuring result with the day and time. And it has the function of blood pressure level classification and calculating the average of the last 3 readings.
Intended use:
KD-7906 Fully 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 wrist
1
Image /page/1/Picture/1 description: The image shows the text "K083247 p2/2" in a handwritten style. The text is black and the background is white. The text is slightly slanted to the right.
according to the instruction in the user's guide manual, which is same as predicated device.
Summary comparing technological characteristics with predicate device:
KD-7906 Fully Automatic Electronic Blood Pressure Monitor 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:
-
- No voice
-
- Appearance
-
- Change 120 memory recall / 2 users (2x60) from 1x60
-
- Memory average function: calculating the average of last 3 readings
Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device.
| FDA file reference number | 510K# K070826 |
|---|---|
| Technological Characteristics | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Energy used and/or delivered | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | ldentical |
Device testing:
KD-7906 Fully Automatic Electronic Blood Pressure Monitor meet the following standards:
- · ANSI/AAMI SP-10 standard
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety
- IEC 60601-1-2 Electromagnetic Compatibility
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2009
Andon Health Co., Ltd. c/o Ms. Liu Yi No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193
Re: K083247
Trade/Device Name: KD-7906 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 19, 2008 Received: December 30, 2008
Dear Ms. Yi:
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. 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.
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.
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
3
Page 2 - Ms. Liu Yi
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 Biometrics' (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 vours.
$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510K submission of KD-7906 Fully Automatic Electronic Blood Pressure Monitor
(08324)
Statement of Indications for Use
510(k) Number :
Applicant: Andon Health Co., Ltd
Device name: KD-7906 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-7906 Fully 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Prescription use Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
YES
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sigm-Off) Division of Cardiovascular Devices 510(k) Number Koszá 47
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