(24 days)
KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches. 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 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.
The provided text describes a 510(k) summary for the KD-738 and KD-739 Fully Automatic Electronic Blood Pressure Monitors. However, it does not contain specific details about acceptance criteria or a dedicated study proving the device meets those criteria.
The document focuses on demonstrating substantial equivalence to a predicate device (KD-7909) and conformity to recognized standards. It states: "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 the testing was primarily to confirm similar performance to the predicate and compliance with standards rather than a detailed study against specific acceptance criteria for a novel device.
Given the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Acceptance Criteria implied by Standard) | Reported Device Performance (Implied by Conformity to Standards) |
|---|---|
| Accuracy of Diastolic Blood Pressure measurement | Conforms to AAMI SP10:2002 and its amendments |
| Accuracy of Systolic Blood Pressure measurement | Conforms to AAMI SP10:2002 and its amendments |
| Accuracy of Pulse Rate measurement | Conforms to AAMI SP10:2002 and its amendments |
| Cuff Pressure Range | Different from predicate KD-7909 (Specific range not provided in this document) |
| Overpressure Limit | Different from predicate KD-7909 (Specific limit not provided in this document) |
| Electrical Safety | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 |
| Mechanical Safety | Identical to predicate device (Implies conformity to relevant standards) |
| Biocompatibility | Identical to predicate device (Implies conformity to relevant standards) |
Note: The document explicitly states that the device conforms to "AAMI SP10:2002, Manual, electronic or automated sphygmanometers," and its amendments. This standard outlines accuracy requirements for blood pressure devices. For example, AAMI SP10 typically requires mean differences between the device and a reference method (e.g., auscultation) to be within ±5 mmHg with a standard deviation of no more than 8 mmHg. The document implies the device meets these types of criteria by stating conformity to the standard, but does not provide the specific numerical results from their testing against these criteria.
Missing Information:
The document primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards (IEC 60601-1, IEC 60601-1-2, and AAMI SP10). It does not detail a specific performance study with clearly defined acceptance criteria and corresponding results in the manner requested.
Therefore, the following information cannot be extracted from the provided text:
- 2. Sample Size Used for the Test Set and Data Provenance: Not specified.
- 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not specified, as a direct comparative study against expert ground truth is not detailed.
- 4. Adjudication Method: Not applicable/specified for this type of submission.
- 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or described. This type of study is usually for image-based diagnostic aids, not blood pressure monitors.
- 6. Standalone Performance (Algorithm Only): Not applicable for this device type, which is a physical measurement device.
- 7. Type of Ground Truth Used: Implied to be reference measurements as per AAMI SP10 (e.g., simultaneous auscultation by trained observers), but not explicitly detailed in the document.
- 8. Sample Size for the Training Set: Not applicable, as this is a traditional measurement device, not an AI/ML algorithm requiring a training set.
- 9. How the Ground Truth for the Training Set was Established: Not applicable.
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AUL 30 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: | 06/30/2009 |
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: ll Panel: Cardiovascular
4.0 Predict device information
Manufacturer: Andon Health Co., Ltd. Device: KD-7909 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: · K090768
5.0 Device description
KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
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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 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.
6.0 Intended use
KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
The intended use and the indication for use of KD-738 and KD-739, as described in its labeling are the same as the predict device KD-7909.
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Identical |
7.0 Summary comparing technological characteristics with predicate device
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KD-738 and KD-739 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
8.0 Performance summary
KD-738 and KD-739 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-738 and KD-739 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7909 whose 510(k) number is K090768.
The two devices are very similar in the intended use, the design principle, the material, the energy source the functions and the applicable standards. Their appearance are different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-7909. KD-738 and KD-739 also use a different MCU.
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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 8 0 2009
Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300193
Re: K092045
Trade/Device Name: KD-738, KD-739 Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 30, 2009 Received: July 06, 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.
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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/CDRH0ffices/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bin
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
K092045 510(k) Number :
Device name:
KD-738 and KD-739 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
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 GDRH, Office of Device Evaluation (ODE)
(Division Man-Off) Division of Cardiovascular Devices 6097048 510lki Number
Page 1 of 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).