(127 days)
KD-5910 and KD-5918 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-5910 and KD-5918 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 of KD-5910 is 60 times, the memory capability of KD-5918 is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD, KD-5918 also has the voice function.
This document describes a 510(k) premarket notification for the KD-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitors. The submission focuses on demonstrating substantial equivalence to a predicate device (KD-5901) rather than a de novo clinical study with specific acceptance criteria and performance metrics against ground truth.
Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment are not directly applicable or explicitly stated in this type of submission. The information provided heavily relies on comparisons to the predicate device and conformity to established standards.
Here's an attempt to answer the questions based solely on the provided text, highlighting where information is absent:
Description of Acceptance Criteria and the Study
The submission does not explicitly define specific numerical acceptance criteria for device performance (e.g., accuracy thresholds for blood pressure readings) in a format typically seen in clinical studies with a de novo device. Instead, the "acceptance criteria" are implied by conformity to established industry standards for non-invasive blood pressure monitors, specifically ANSI/AAMI SP10 and its amendments, and the demonstration of "substantial equivalence" to a predicate device.
The "study" conducted to prove the device meets these criteria is primarily through testing for conformity to these standards and showing that any differences from the predicate device "do not raise any new questions of safety and effectiveness." This is a comparative effectiveness claim based on technical characteristics and standards adherence, rather than a clinical trial where device performance is measured against an established ground truth in a patient population.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Implied) | Stated Requirement/Performance |
|---|---|
| Safety & Effectiveness (General) | "Do not raise any new questions of safety and effectiveness" compared to the predicate device (KD-5901). |
| Standards Conformity | The devices conform to: - IEC 60601-1 (Medical Electrical Equipment Safety) - IEC 60601-1-2 (Electromagnetic Compatibility) - AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers) - AAMI/ANSI SP10:2002/A1:2003 (Amendment 1 to SP10) - AAMI/ANSI SP10:2002/A2:2006 (Amendment 2 to SP10) (Performance within the limits specified by these standards is implied.) |
| Technological Characteristics Equivalence | The devices are "very similar" or "identical" to the predicate in: Design principle, material, energy source, applicable standards, biocompatibility, mechanical safety, electrical safety, EMC. ("Performance" is also listed as "identical" to the predicate, implying similar accuracy and function). |
| Intended Use | Identical to the predicate device. |
| Cuff Circumference | Limited to 22cm-48cm (new cuff compared to predicate, but still within a defined range). |
| Irregular Heartbeat Detection | Capability to show irregular heartbeat on LCD (KD-5910 & KD-5918). |
| Memory Capability | KD-5910: 60 times; KD-5918: 2x60 times. |
| Voice Function | KD-5918 has voice function; KD-5910 does not. (This is a difference, not a performance metric per se, but part of functional comparison). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific patient-based "test set" sample size or data provenance. The "test" mentioned in the submission is related to demonstrating conformity to standards, which typically involves laboratory testing and possibly limited clinical validation as part of the standard's requirements, but the specifics are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The submission focuses on technical and standards conformity, and substantial equivalence, not a clinical study with expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
No MRMC comparative effectiveness study was performed or mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is inherently a "standalone" system in the sense that it measures and displays blood pressure readings autonomously. The performance discussed is the device's intrinsic mechanical and electronic function according to established standards (e.g., AAMI SP10). However, a specific "standalone algorithm-only performance study" in a clinical context against a reference standard (like an arterial line) is not detailed beyond the general statement of conforming to AAMI SP10, which itself dictates clinical validation methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth implicitly used for a device like this, in the context of AAMI SP10, would typically be invasive blood pressure measurements (e.g., arterial catheter) in a clinical setting, or auscultatory readings from trained observers using a mercury sphygmomanometer as a reference standard. However, the document does not explicitly state which ground truth was used for specific tests, only that the device conforms to the AAMI SP10 standard, which requires such validation.
8. The sample size for the training set
This device is not an AI/ML device that requires a "training set" in the conventional sense. Its operational principle is based on oscillometric and silicon integrate pressure sensor technology, which are deterministic algorithms, not learned models.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI/ML device with a training set.
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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
DEC 2 9 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: 08/07/2009
2.0 Device information
Fully Automatic Electronic Blood Pressure Monitor Trade name: 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: Device: KD-5901 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K090768
5.0 Device description
KD-5910 and KD-5918 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,
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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 of KD-5910 is 60 times, the memory capability of KD-5918 is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD, KD-5918 also has the voice function.
6.0 Intended use
KD-5910 and KD-5918 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-5910 and KD-5918, as described in its labeling are the same as the predict device KD-5901.
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 |
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8.0 Performance summary
KD-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitor conform 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-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5901 whose 510(k) number is K090768.
KD-5910 and KD-5901 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different. KD-5910 does not have the voice function. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5901. KD-5910 also has a different MCU.
KD-5918 and KD-5901 is very similar in the intended use, the design principle, the material. the energy source and the applicable standards. Only their appearance and some functions such as 2×60 times memory are different.
KD-5910 and KD-5918 all add a new cuff compared with the predicted device.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 31 Changjiang Road, Nankai District Tianjin, 300190 CHINA
DEC 2 9 2009
Re: K092588
KD-5910 and KD-5918 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: December 1, 2009
Dear Mr. Liu:
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.
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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); medical device reporting (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.M.
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 :
Device name: KD-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-5910 and KD-5918 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.
Part 21 CFR 801 Subpart D)
Prescription use (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)
W.M.P.
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number K092588
§ 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).