(80 days)
KD-7941 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.
KD-7941 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, diastolic 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 results. It has some other functions, such as 120 memory recall / 2 users, calculating average of last 3 readings and color changing area with LED lighting on outer case to indicate blood pressure classification level.
The provided text describes a 510(k) summary for the KD-7941 Fully Automatic Electronic Blood Pressure Monitor. However, it does not contain the detailed information about a study proving the device meets acceptance criteria as requested in the prompt.
Here's a breakdown of what is available and what is missing:
Information Present in the Document:
- Device Name: KD-7941 Fully Automatic Electronic Blood Pressure Monitor
- Intended Use: To monitor and display diastolic, systolic blood pressure, and pulse rate of adults using a wrist cuff, for use by medical professionals or at home.
- Predicate Device: KD-795 Andon Health Co., Ltd (K070826)
- Standards Met: ANSI/AAMI SP-10 standard, IEC 60601-1, IEC 60601-1-2.
- Regulatory Clearance: 510(k) clearance by FDA (K083319) based on substantial equivalence.
Information NOT Present in the Document (and therefore cannot be provided in response to the prompt's specific questions):
- A table of acceptance criteria and reported device performance: While it states the device "meet the following standards," it doesn't provide specific quantitative acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or the device's measured performance against those criteria.
- Sample size used for the test set and data provenance: No information on the number of subjects or the source of the data used for performance testing.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned, and generally not applicable for a standalone blood pressure monitor.
- Standalone (algorithm only) performance: This device is a measurement device, so its performance is standalone algorithm performance in essence, but no detailed breakdown of the algorithm's performance metrics is provided beyond meeting general standards.
- Type of ground truth used: Not explicitly stated, though for blood pressure monitors, this would typically involve comparison to a validated reference method (e.g., auscultatory readings by trained observers).
- Sample size for the training set: Not applicable for a device cleared via 510(k) without a machine learning component requiring a distinct training set. The "training" here would be the development and calibration against reference methods.
- How ground truth for the training set was established: Not mentioned.
Conclusion:
The provided 510(k) summary indicates that the KD-7941 Fully Automatic Electronic Blood Pressure Monitor meets the ANSI/AAMI SP-10 standard for blood pressure monitors, along with general electrical safety and EMC standards. However, it does not include the detailed study results, specific acceptance criteria values, or methodology (like sample size, ground truth establishment, expert qualifications, or MRMC studies) that your prompt requests. For devices like blood pressure monitors approved via 510(k) pathways, the FDA often relies on adherence to recognized performance standards (like AAMI SP10) rather than requiring extensive clinical trials with detailed statistical reporting of performance beyond what's needed to show substantial equivalence.
To answer your prompt with the requested level of detail, additional documentation (such as the full test report submitted to the FDA for ANSI/AAMI SP-10 compliance) would be necessary.
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510(k) Summary
KD83319
JAN 2.9 2009
ldentification of the submitter:
Submitter:
Fax number:
Contact:
Telephone number:
Date of Application:
Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 6161 86-22-6052 6162 Liu Yi 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 manufacture 510(k) number KD-795 Andon Health Co., Ltd K070826
Device description:
KD-7941 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, diastolic 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 results. It has some other functions, such as 120 memory recall / 2 users, calculating average of last 3 readings and color changing area with LED lighting on outer case to indicate blood pressure classification level.
Intended use:
KD-7941 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 of adult each time, with the cuff around the wrist according to the instruction in the user's guide manual, which is same as
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Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a code or identifier. The top line reads 'K083319', with each character clearly written in a simple, sans-serif style. Below this, the text 'P2/2' is written, possibly indicating a page number or a similar reference within a document.
predicated device.
Summary comparing technological characteristics with predicate device:
KD-7941 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:
- Appearance
-
- No voice
-
- Change into 120 memory recall / 2 users (2x60) from 1x60
-
- Memory average function: calculating the average of last 3 readings
-
- Change microprocessor
-
- Color changing area with LED lighting on outer case to indicate blood pressure classification level.
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 | Identical |
Device testing:
KD-7941 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with flowing lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/4 description: The image is a black and white photograph that appears to be of a landscape. The image quality is poor, and the details are not clear. There are some dark spots and lines in the image, which may be due to damage or imperfections in the original photograph.
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: K083319
Trade/Device Name: KD-7941 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 29, 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
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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 (OS) 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 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 Dl Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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<083319
Statement of Indications for Use
| 510(k) Number : | K083319 |
|---|---|
| ----------------- | --------- |
Applicant: Andon Health Co., Ltd
Device name:
KD-7941 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-7941 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)
(Division Sign-Off) n of Cardiovascular Devices 510(k) Number Ko83319
Page 1 of
§ 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).