(28 days)
KD-7962 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-7962 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 2×90 times. If any irregular heartbeat is detected, it can be shown on the LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use. It also has the function of averaging the last three measurements.
The provided text describes a 510(k) summary for the KD-7962 Fully Automatic Electronic Blood Pressure Monitor. However, it does not contain explicit details about acceptance criteria, specific study results demonstrating device performance against those criteria, or the methodology of such a study.
The document primarily focuses on establishing substantial equivalence to a predicate device (KD-7961) by comparing technological characteristics and conformity to standards.
Here's an attempt to answer your questions based on the available information, noting where information is not present in the provided text:
Acceptance Criteria and Device Performance for KD-7962 Fully Automatic Electronic Blood Pressure Monitor
The provided 510(k) summary indicates that the KD-7962 device conforms to the ANSI/AAMI SP10 standard for manual, electronic, or automated sphygmomanometers. This standard dictates the performance requirements for blood pressure monitors. While the specific numerical acceptance criteria from AAMI SP10 are not detailed in this document, the device's conformance to this standard implies it meets those criteria.
The submission claims that any differences in performance parameters (cuff pressure range, overpressure limit) between the KD-7962 and its predicate KD-7961 "do not raise any new questions of safety and effectiveness," suggesting that the new device's performance is acceptable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on AAMI SP10 Standards - Implicit) | Reported Device Performance (Summary indicates conformance) |
|---|---|
| Blood Pressure Accuracy: | The device "conforms to... AAMI SP10:2002" |
| - Mean difference (device vs. reference) | (Specific values not provided in this document) |
| - Standard deviation (device vs. reference) | (Specific values not provided in this document) |
| Pulse Rate Accuracy: | The device "conforms to... AAMI SP10:2002" |
| - Accuracy of pulse rate measurement | (Specific values not provided in this document) |
| Cuff Pressure Range: | Differences in this parameter were addressed |
| Overpressure Limit: | Differences in this parameter were addressed |
| Electrical Safety (IEC 60601-1): | Conforms to IEC 60601-1 standards |
| EMC (IEC 60601-1-2): | Conforms to IEC 60601-1-2 standards |
Note: The actual numerical acceptance criteria for blood pressure and pulse rate accuracy as defined by AAMI SP10 (e.g., mean difference ≤ ±5 mmHg with a standard deviation ≤ 8 mmHg) are not explicitly stated in this 510(k) summary, nor are the specific numerical performance results of the KD-7962.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not provided in the document.
- Data Provenance: This information is not provided in the document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference sphygmomanometer (e.g., a mercury sphygmomanometer or an auscultatory method) alongside the device under test.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, this type of study is not relevant for a fully automated blood pressure monitor like the KD-7962, which does not involve human interpretation of medical images or complex data where AI assistance would be applicable to improve human reader performance.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study must have been conducted to demonstrate conformity to the AAMI SP10 standard. The device is a "Fully Automatic Electronic Blood Pressure Monitor," implying its primary function is standalone measurement without continuous human expert intervention for each reading. The document states, "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implicitly refers to performance testing that would have included evaluation against the AAMI SP10 standard.
7. Type of Ground Truth Used
Based on the nature of blood pressure monitors, the ground truth would typically be established using reference blood pressure measurements obtained simultaneously with expert observers (e.g., trained clinicians or technicians using a validated auscultatory method or a calibrated reference sphygmomanometer). This is the standard methodology for validating automated blood pressure devices according to AAMI SP10.
8. Sample Size for the Training Set
- Training Set Sample Size: This information is not provided in the document. For a traditional oscillometric blood pressure monitor, there typically isn't a "training set" in the machine learning sense. Instead, the device's algorithms are developed and calibrated based on physiological principles and then validated against a test set.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training: This information is not provided and is largely not applicable in the context of traditional, non-machine learning blood pressure monitors. The device's internal algorithms are based on established oscillometric principles and calibrated during development, rather than "trained" on a dataset with ground truth in the way an AI model would be. Calibration and development would likely involve testing against reference measurements performed by experts, but this isn't typically referred to as "training set ground truth."
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KD-7962 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
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
JUL 3 0-2009
| 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: | 06/26/2009 |
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: II Panel: Cardiovascular
4.0 Predict device information
Manufacturer: Andon Health Co., Ltd. Device: KD-7961 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K090769
5.0 Device description
KD-7962 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 2×90 times. If any irregular heartbeat is detected, it can be shown on the LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use. It also has the function of averaging the last three measurements.
6.0 Intended use
KD-7962 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-7962, as described in its labeling are the same as the predict device KD-7961.
| 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 | Similar |
7.0 Summary comparing technological characteristics with predicate device
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8.0 Performance summary
KD-7962 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-7962 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7961 whose 510(k) number is K090769.
The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance and some functions such as 2×90 times memory and averaging the last three measurements are different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-7961.
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 consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 2009
Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300193
Re: K091997
Trade/Device Name: KD-7962 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: June 26, 2009 Received: July 02, 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/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/ReportalProblem/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
Bram D. Zudkerman, 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
Kog1997 510(k) Number :
Device name:
KD-7962 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-7962 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) 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)
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Númber 49 1997
Page 1 of
§ 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).