(71 days)
KD-556 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-556 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. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is 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, the memory capability is 2×60 times. If any irregular-heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-556 Fully Automatic Electronic Blood Pressure Monitor:
Based on the provided 510(k) summary, the device is being cleared based on substantial equivalence to a predicate device, the KD-556 Fully Automatic Electronic Blood Pressure Monitor (K090963). The documentation indicates that the two devices are identical in performance, and the new submission primarily addresses the addition of a new cuff size. Therefore, the "study that proves the device meets the acceptance criteria" largely relies on the predicate device's performance and the demonstration that the minor difference (new cuff) does not raise new safety or effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with AAMI SP10:2002 Standard (manual, electronic or automated sphygmanometers) | Device "conforms to" and "is designed and manufactured according to" AAMI SP10:2002, and its amendments A1:2003 and A2:2006. |
| Compliance with IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety) | Device "conforms to" IEC 60601-1:1988, Amendment 1, 1991-11, Amendment 2, 1995. |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | Device "conforms to" IEC 60601-1-2 (Edition 2:2001 with Amendment 1:2004, Edition 2.1). |
| Performance (Accuracy of BP and Pulse Rate Measurement) | "Performance" is stated as "Identical" to the predicate device (K090963). No specific performance metrics (e.g., mean difference, standard deviation) are provided in this summary. The assumption is that the predicate device met the accuracy requirements of AAMI SP10. |
| Cuff Circumference | The device supports a cuff circumference of 22cm-48cm, an expansion from the predicate device's offering (which likely covered 22cm-30cm, as the new submission adds 22cm-30cm). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details about a specific clinical test set for the KD-556 device in this submission. The basis for clearance is:
- Substantial Equivalence: The primary assertion is that this device is "identical" in performance to the predicate device K090963.
- Engineering/Bench Testing: The submission states, "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This "test" likely refers to bench testing to validate the new cuff size's performance in adherence to AAMI SP10, rather than a separate clinical trial with a defined patient sample size. No sample size or data provenance (country, retrospective/prospective) is mentioned for any new testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Since the submission relies on substantial equivalence and compliance with engineering standards (AAMI SP10, IEC 60601-1, IEC 60601-1-2), there is no mention of a human-read test set requiring experts to establish ground truth. Compliance with AAMI SP10 typically involves comparison against a reference standard (e.g., a mercury sphygmomanometer) by trained observers, but the details of such a study are not provided in this summary.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with human readers requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device for measuring blood pressure, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this type of device and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The device itself is "standalone" in that it performs the measurement and displays results without human interpretation of raw data (other than reading the displayed numbers). The performance evaluation, as indicated by conformity to AAMI SP10, would be a standalone evaluation of the device's accuracy against a reference standard. However, the details of this standalone performance test (e.g., specific accuracy metrics, sample size) are not provided in this summary, as it largely defers to the predicate device's performance.
7. The Type of Ground Truth Used
For non-invasive blood pressure monitors assessed against AAMI SP10, the "ground truth" (or reference standard) is typically established by:
- Auscultation (or sometimes intra-arterial measurement): Using a mercury sphygmomanometer with a trained observer (or two observers for consensus) listening to Korotkoff sounds, potentially against a simultaneously recorded invasive arterial pressure for stricter validation.
- The AAMI SP10 standard itself specifies the methodology for clinical validation, including the use of reference measurements.
However, this submission does not explicitly state the ground truth used, as it relies on the predicate device's compliance.
8. The Sample Size for the Training Set
Not applicable. This device is an electronic blood pressure monitor based on oscillometric technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its operational principle is based on pre-programmed algorithms for oscillometric measurement, not on a dataset used for model training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for a machine learning model.
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JUL 31 2009
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
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: 05/18/2009
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: 11 Panel: Cardiovascular
4.0 Predict device information
Manufacturer: · Andon Health Co., Ltd. Device: KD-556 Fully Automatic Electronic Blood Pressure-Monitor 510(k) number: K090963
5.0 Device description
KD-556 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.
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It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle is 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, the memory capability is 2×60 times. If any irregular-heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.
6.0 Intended use
KD-556 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.
The intended use and the indication for use of KD-556, as described in its labeling are the same as the predict device KD-556(K090963).
7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Identical |
| Patients contact Materials | Identical |
| Performance | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Identical |
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8.0 Performance summary
KD-556 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 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - 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-556 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K090963.
The two devices are identical in the intended use, the design principle, the material, the appearance, the functions, the performance, the energy source and the applicable standards. KD-556 only adds a new cuff (cuff circumstance: 22cm-30cm) when compared with the predicted device( K090963).
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2009
Andon Health Co., Ltd. c/o Ms. M. Elizabeth Bierman, Partner Morgan, Lewis & Bockius LLP 1111 Pennsylvania Ave., NW Washington, DC 20004-2541
K091500 Re:
Trade/Device Name: KD-556 Fully Automatic Electronic Blood Pressure Monitor. Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: July 2, 2009
Dear Ms. Bierman:
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 - Ms. M. Elizabeth Bierman
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,
M. G. Willemann
عرب 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
Kog 1500 510(k) Number :
Device name:
KD-556 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-556 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 systelic 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)
Over-The-Counter Use AND/OR 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)
M. L. Willkenne
ardiovascular Devices
510(k) Number K091500
Page 1 of ﺴﺮ
§ 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).