(73 days)
KD-5903, KD-5909 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-5903, KD-5909 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-5903 and KD-5909 are all designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle of KD-5903 and KD-5909 are based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, If any irreqular heartbeat is detected, it can be shown on the LCD. The memory capability of KD-5903 is 3×40 times, the memory capability of KD-5909 is 2×60 times.
This document describes the KD-5903 and KD-5909 Fully Automatic Electronic Blood Pressure Monitors, which are non-invasive blood pressure measurement systems.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure monitors generally stem from standards like ANSI/AAMI SP10. While the document mentions conformance to ANSI/AAMI SP10, it does not explicitly state the specific numerical acceptance criteria (e.g., mean difference and standard deviation limits for blood pressure measurements) within this summary.
However, the document states:
- "Performance: Identical" when comparing the KD-5903/KD-5909 to the predicate device KD-591.
- "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that performance was evaluated and found to be acceptable.
Without the specific numerical limits from ANSI/AAMI SP10, a direct table of acceptance criteria vs. reported performance cannot be fully constructed from the provided text. The summary confirms that the devices "conforms to the following standards: AAMI SP10:2002..." which implicitly means they meet the performance requirements of that standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "the test in this submission provides demonstration." A typical blood pressure monitor validation study following AAMI SP10 would involve a specific number of subjects (e.g., at least 85 subjects with specific blood pressure ranges).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the test set. For blood pressure monitor validation, this typically involves trained observers taking auscultatory measurements according to a standardized protocol, sometimes with double-blinded readings.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable here as this is astandalone automated blood pressure monitor and not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate that the KD-5903 and KD-5909 devices perform comparably to their predicate device and meet relevant standards (e.g., AAMI SP10) without human intervention in the measurement process. The statement "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness" confirms this.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For non-invasive blood pressure monitors, the ground truth is typically established by simultaneous auscultatory measurements performed by human observers using a reference sphygmomanometer, often following a highly standardized protocol (e.g., AAMI SP10 and ISO 81060-2 require comparison to mercury sphygmomanometer readings).
8. Sample Size for the Training Set
This device is not an AI/ML algorithm that is deep-learning based and requires a distinct training set. The performance is based on an oscillometric principle, which relies on a pre-defined algorithm and not a learnable model in the context of typical AI/ML systems. Therefore, the concept of a "training set sample size" as used for AI/ML is not applicable here.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and "ground truth for the training set" is not applicable in the context of this traditional oscillometric blood pressure monitor.
{0}------------------------------------------------
ROYOI
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
JUN - 4 2009
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 31, Changjiang Road, Nankai District, Tianjin,P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 03/16/2009 |
2.0 Device information
Trade name: Fully Automatic Electronic Blood Pressure Monitor Common name: Noninvasive blood pressure measurement system Classification name: Noninvasive blood pressure measurement system
3.0 Classification_
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification:
Panel: Cardiovascular
4.0 Predict device information
Manufacturer: Andon Health Co., Ltd. Device: KD-591 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K080319 5.0 Device description
KD-5903, KD-5909 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-5903 and KD-5909 are all designed and manufactured according to
{1}------------------------------------------------
ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle of KD-5903 and KD-5909 are based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, If any irreqular heartbeat is detected, it can be shown on the LCD. The memory capability of KD-5903 is 3×40 times, the memory capability of KD-5909 is 2×60 times.
6.0 Intended use
KD-5903, KD-5909 Fully Automatic Electronic Blood Pressure Nionitor 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.
The intended use and the indication for use of KD-5903 and KD-5909, as described in their labelings are the same as the predict device KD-591,
7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
The difference of technological characteristic between KD-5903 and its predicted device KD-591 is the appearance) the performance and the memory mode, the difference of technological characteristic between KD-5909 and its predicted device KD-591 is also the appearance, the performance and the memory mode.
{2}------------------------------------------------
8.0 Performance summary
KD-5903, KD-5909 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · IEC BEGO1-1-2. Medical Electrical Equipment Port 1-2. General Requirements for Safety - Collateral standard: Evectromagnetic Compability - Requirements and Tests (Edition 2:2001 with Amendment 1:2004: Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- · AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A1:2003 -- Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2. to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
9.0 Comparison to the predict device and the conclusion
Our device KD-5903 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-591 whose 510(k) number is K080319, KD-5909 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-591 whose 510(k) number is K080319.
KD-5903 and KD-591 are very similar in the intended use, the design principle, the material, the performance, the energy source, the applicable standards. Only their appearances and the memory mode are different. KD-5903 has 3 X 40 times memories, that is, 3 group memories, with 40 times memory each group. The operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate ranqe is changed from 30-180 times/min to 40-180 times/min.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
KD-5909 and KD-591 are very similar in the intended use, the design principle, the material, the performance, the energy source, the applicable standards. Only their appearances and the mombry mode are different. KD-5909 has 2 X 60 times memories, that is, 2 croup memories, with 60 times memory each
.
{3}------------------------------------------------
group. The operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JUN - 4 2009
Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300193
Re: K090772
Trade/Device Name: KD-5903, KD-5909 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: undated Received: May 7, 2009
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 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.
{5}------------------------------------------------
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Statement of Indications for Use
K090772 510(k) Number :
Device name:
KD-5903, KD-5909 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-5903, KD-5909 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 YES (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
htdill/sk. Pi B Zuckerman
(Division Sign-Off)
Division of Cardiovascular Devices
Page I of
-1-1
§ 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).