(87 days)
KD-5961 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 left upper arm according to the instruction in the user's guide manual, which is same as predicated device.
KD-5961 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 upper arm. The cuff circumference is limited to 22cm-48cm.
KD-5961 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 left upper arm, which cuff circumference is limited to 22cm-48cm, the device can analyze the signals promptly and display the test results. It has some other functions, such as LCD backlighting, touch button, 120 memory recall / 2 users and calculating average of last 3 readings.
This document is a 510(k) premarket notification for the KD-5961 Fully Automatic Electronic Blood Pressure Monitor. It aims to demonstrate substantial equivalence to a predicate device (KD-591, K080319). The document focuses on regulatory compliance and does not contain a study designed to prove the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic or diagnostic might.
Here's a breakdown based on your request, highlighting what is and isn't present in this specific regulatory filing:
1. Table of acceptance criteria and the reported device performance:
The document implicitly refers to acceptance criteria by stating that the device "meets the following standards" and by claiming "Performance: Identical" to the predicate device. However, it does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in terms of accuracy or clinical metrics.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Conformance to ANSI/AAMI SP-10 standard (blood pressure monitors) | "KD-5961 Fully Automatic Electronic Blood Pressure Monitor meets the following standards: ANSI/AAMI SP-10 standard." |
| Conformance to EN60601-1 (medical electrical safety) | "KD-5961 Fully Automatic Electronic Blood Pressure Monitor meets the following standards: EN60601-1 Medical electrical equipment Part 1: General requirements for safety." |
| Conformance to EN60601-1-2 (electromagnetic compatibility) | "KD-5961 Fully Automatic Electronic Blood Pressure Monitor meets the following standards: EN60601-1-2 Electromagnetic Compatibility." |
| Performance identical to predicate device (KD-591, K080319) | "Performance: Identical" (in comparison table) |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size for a test set or data provenance in terms of country of origin or whether it was retrospective/prospective. The approval is based on demonstrating substantial equivalence to a predicate device, primarily through technological comparison and adherence to recognized standards, rather than a new clinical performance study with a distinct test set. The ANSI/AAMI SP-10 standard itself outlines performance requirements and testing methodologies for blood pressure monitors, which would include testing on a specified number of subjects, but these details are not provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The approval is based on compliance with established standards, not on expert-adjudicated ground truth from a clinical study within this 510(k) submission. For the ANSI/AAMI SP-10 standard validation, it typically involves comparison to a reference standard obtained by trained observers (often physicians or technicians) using auscultation.
4. Adjudication method for the test set:
Not applicable based on the information provided. There is no explicit adjudication method described for a test set in this 510(k) summary related to establishing ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a Fully Automatic Electronic Blood Pressure Monitor, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images. Hence, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is described as "Fully Automatic Electronic Blood Pressure Monitor" and measures blood pressure using oscillometric technology, displaying results on an LCD. This inherently represents standalone algorithmic performance for blood pressure measurement, as it doesn't require human interpretation of complex data for the reading itself. The performance is expected to meet the accuracy requirements of the ANSI/AAMI SP-10 standard in its automated function.
7. The type of ground truth used:
While not explicitly stated in this document for the KD-5961 itself, the ground truth for validating blood pressure monitors against standards like ANSI/AAMI SP-10 typically involves simultaneous or near-simultaneous measurements using a reference standard method, most commonly auscultation performed by trained observers with a mercury sphygmomanometer.
8. The sample size for the training set:
Not applicable and not provided. This device is based on a well-established oscillometric measurement principle and is not an AI/machine learning model that requires a distinct "training set" in the conventional sense for learning patterns. Its "training" is in its design and calibration to meet the physiological measurement principles and accuracy standards.
9. How the ground truth for the training set was established:
Not applicable. As noted above, the device doesn't use a "training set" in the machine learning context. The underlying principles and validation methods for blood pressure measurement, which would include comparison to reference standards like auscultation, are well-established within the ANSI/AAMI SP-10 standard.
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510(k) Summary
JAN 2 9 2009
Identification 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-591 Andon Health Co., Ltd K080319
Device description:
KD-5961 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 left upper arm, which cuff circumference is limited to 22cm-48cm, the device can analyze the signals promptly and display the test results. It has some other functions, such as LCD backlighting, touch button, 120 memory recall / 2 users and calculating average of last 3 readings.
Intended use:
KD-5961 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 left upper arm according to the instruction in the user's guide manual, which is same as predicated device.
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Image /page/1/Picture/1 description: The image shows a line of text that reads "Summary comparing technological characteristics with predicate device:". The text is black and underlined. The text appears to be the title or heading of a document or report.
KD-5961 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
-
- Change into touch button from original one.
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- LCD backlighting
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- Change into 120 memory recall / 2 users (2x60) from 1x60
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- Memory average function: calculating 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# K080319 |
|---|---|
| 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-5961 Fully Automatic Electronic Blood Pressure Monitor 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
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged around the perimeter of the seal.
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: K083246
Trade/Device Name: KD-5961 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 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,
signature
Bram/D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number :
Andon Health Co., Ltd Applicant:
Device name: KD-5961 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-5961 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 upper arm. The cuff circumference is limited to 22cm-48cm.
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)
islon Sign-Off) n of Cardlovascular Devices () Number KOB394G
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).