(118 days)
KD-525E 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-30cm.
KD-525E Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study (K070395)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Accuracy (Blood Pressure Measurement) | The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. | The specific accuracy ranges (e.g., mean difference and standard deviation for systolic/diastolic BP) as defined by ANSI/AAMI SP10-2002 are not explicitly stated in the document, only that the device meets them. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not specified in the provided text. The document only mentions "Clinical tests were performed."
- Data Provenance: Not specified. It's not mentioned if the data was collected retrospectively or prospectively, nor the country of origin.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified. The document only states "Clinical tests were performed."
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. For blood pressure monitors, the "ground truth" is typically established by comparing the device's readings against a reference method (e.g., auscultation by trained observers) as outlined in standards like ANSI/AAMI SP10. The text does not detail the specific methodology used for establishing reference measurements or any adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this submission. This type of study is more relevant for diagnostic imaging AI systems where human interpretation is a key component. This device is a standalone blood pressure monitor.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes, the described "Clinical tests" evaluate the standalone performance of the KD-525E Fully Automatic Electronic Blood Pressure Monitor. The device itself is an automated system; its performance directly reflects the algorithm's capability. The comparison is against the accuracy requirements of ANSI/AAMI SP10-2002.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating the accuracy of the blood pressure monitor would have been established using a reference measurement method as defined by the ANSI/AAMI SP10-2002 standard. This typically involves simultaneous or closely timed measurements by trained observers using a mercury sphygmomanometer (or another validated reference) via auscultation. The standard specifies statistical comparisons between the automated device readings and these reference measurements.
8. Sample Size for the Training Set
- Sample Size: Not applicable/not specified. As an oscillometric blood pressure monitor, this device likely uses a pre-programmed algorithm based on general physiological principles for measuring blood pressure, rather than "training" on a specific dataset in the way a modern AI/machine learning model would. Therefore, a "training set" in that context is not relevant.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. For the reason stated above, there isn't a "training set" in the common AI/ML sense with associated ground truth for this type of device. The algorithm's development and validation would rely on established oscillometric principles and calibration against precise pressure measurements.
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510(k) Summary
JUN - 7 2007
ldentification of the submitter:
Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 Telephone number: 86-22-6052 8012 86-22-6052 6162 Fax number: Liu Yi Contact: Date of Application: 29/01/07
Identification of the product:
| Device proprietary Name: | KD-525E Fully Automatic Electronic Blood |
|---|---|
| Pressure Monitor | |
| Common name: | Noninvasive blood pressure measurementsystems |
| Classification name: | Noninvasive blood pressure measurement systemClass II per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) number |
|---|---|---|
| KD-622 | Kodon (Tianjin) Electronic and ElectricalApparatus Co., Ltd. | K030358 |
Device description:
KD-525E Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.
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Intended use:
KD-525E 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 anyone each time, except infants and unconscious people, with the air 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-525E Fully Automatic Electronic Blood Pressure Monitor is the basic of KD-622 Memory Automatic blood pressure monitor. KD-525E has a bump to inflate automatically. Comparing with KD-622 memory automatic blood pressure monitor, KD-525E has no memory function.
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.
Non-clinical Tests:
non-clinical tests coincide the following standards, including All Electromagnetic Compatibility test, Product Safety test and Biocompatibility test.
IEC601-1-2: 2001
Medical electrical equipment-----Part 1-2:General requirements for safety; Collateral standards: Electromagnetic compatibility; Requirements and test.
IEC60601-1: 1998+A1:1991+A2:1995
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
ISO 10993-5
Biological evaluation of medical device --- part 5: Test for in vitro cytotoxicity.
ISO 10993-10
Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human figures. The figures are interconnected, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2007
Kondon (Tianiin) Electonic & Electrical Apparatus Co., LTD c/o Mr. Liu Yi President of the Board of Directors, No. 31 Changjiang Road, Tianjin, PR CHINA 3000193
Re: K070395
KD-525E 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: May 21, 2007 Received: May 21, 2007
Dear Mr. 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.
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Page 2 - Mr. Liu Yi
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Bhimimor for
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 ( if known): _
KD702395
Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD Applicant:
KD-525E Fully Automatic Electronic Blood Pressure Device name: Monitor
Indications for use:
KD-525E 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-30cm.
Prescription use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use YES (21 CFR 807 Subpart C)
( PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummer
ular Devices 101k) Number
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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).