(80 days)
KD-5902 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 quide manual, which is same as predicated device.
KD-5902 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-5902 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 can storage and show 60 times measuring result with the day and time. Specially, it can speak them out. Besides, KD-5902 has the function of blood pressure classification indicator.
Here's a breakdown of the acceptance criteria and study information for the KD-5902 Fully Automatic Electronic Blood Pressure Monitor, based on the provided 510(k) summary:
The provided document is a 510(k) summary for a blood pressure monitor. As such, the "acceptance criteria" and "device performance" are typically framed around meeting established standards for blood pressure devices rather than detailed performance metrics. The study described is often a validation against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10 standard | The device "meets the following standards," explicitly listing ANSI/AAMI SP-10. This standard is specifically for automated sphygmomanometers and outlines accuracy requirements for blood pressure measurement. |
| EN60601-1 Medical electrical equipment Part 1: General requirements for safety | The device "meets the following standards," explicitly listing EN60601-1. This standard is for the general safety and essential performance of medical electrical equipment. |
| EN60601-1-2 Electromagnetic Compatibility | The device "meets the following standards," explicitly listing EN60601-1-2. This standard specifies requirements for electromagnetic compatibility of medical electrical equipment and systems. |
| Substantial Equivalence to Predicate Device (KD-595) | The document asserts "substantial equivalence" to the predicate device (KD-595, K070828) across various technological characteristics including indications for use, target population, design (similar), materials, performance, biocompatibility, mechanical safety, energy used, where used, standards met, and electrical safety. |
2. Sample Size and Data Provenance
The 510(k) summary does not explicitly state the sample size used for any specific test set related to the performance evaluation (e.g., for the ANSI/AAMI SP-10 validation). It only states that the device "meets the following standards."
The document does not provide any information regarding data provenance (e.g., country of origin of the data, retrospective or prospective) for any testing or validation.
3. Number and Qualifications of Experts for Ground Truth
The 510(k) summary does not mention the use of experts or their qualifications for establishing ground truth within the context of performance testing. Blood pressure monitor validation per ANSI/AAMI SP-10 typically involves a specific protocol with trained operators and validated reference devices, but the details of this are not provided in this summary.
4. Adjudication Method
The 510(k) summary does not describe any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study in the provided 510(k) summary. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. This device is a direct measurement device rather than an interpretive tool.
6. Standalone Performance Study
A "standalone" performance study would be the validation against the ANSI/AAMI SP-10 standard. While the summary states the device "meets" this standard, it does not provide the details or results of such a standalone study. It merely asserts compliance.
7. Type of Ground Truth Used
For a blood pressure monitor, the "ground truth" for performance validation (e.g., against ANSI/AAMI SP-10) is typically established by:
- Simultaneous measurement with a validated reference device: Often, this involves direct intra-arterial measurement or auscultation by trained observers using a mercury sphygmomanometer, calibrated according to the standard's requirements.
The 510(k) summary does not explicitly detail the specific method for establishing ground truth but implies it through adherence to the ANSI/AAMI SP-10 standard.
8. Sample Size for the Training Set
The 510(k) summary does not mention a training set sample size. This type of device is an algorithm-based measurement device, but its core function (oscillometric measurement) is based on well-established principles and does not typically involve a "training set" in the machine learning sense for its primary function. It's pre-programmed with an algorithm rather than "trained" on data post-manufacture in a way that requires a separate training set.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information provided on how its ground truth was established.
{0}------------------------------------------------
510(k) Summary
ldentification of the submitter:
JAN 2 9 2009
083317
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 Contact: Liu Yi 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 manufacture 510(k) number KD-595 Andon Health Co., Ltd K070828
Device description:
KD-5902 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 can storage and show 60 times measuring result with the day and time. Specially, it can speak them out. Besides, KD-5902 has the function of blood pressure classification indicator.
Intended use:
KD-5902 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 quide manual, which is
{1}------------------------------------------------
same as predicated device.
Summary comparing technological characteristics with predicate device:
KD-5902 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:
JAN 2 9 2009
-
- Appearance
-
- Cuff size change into 22cm-48cm from 22cm-30cm.
Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device.
| FDA file reference number | 510K# K070828 |
|---|---|
| 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-5902 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, vectorized design.
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, Tianiin, P.R. China, 300193
Re: K083317
Trade/Device Name: KD-5902 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
{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 yours.
h
Bram D Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
SIOK submission for KD-5902 Fully Automatic Electronic Blood Pressure Monitor
Statement of Indications for Use
| 510(k) Number : | K083317 |
|---|---|
| ----------------- | --------- |
Applicant: Andon Health Co., Ltd
Device name:
KD-5902 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-5902 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
68331
(Please DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
(Division (Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko833377
Page 1 of
-9-
§ 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).