KD-388BD Semi 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 memory capability of KD-388BD is 2×60 times.

AI/ML Overview

The provided text describes a 510(k) summary for the KD-388BD Semi Automatic Electronic Blood Pressure Monitor. While it mentions adherence to standards like AAMI SP10, it does not contain detailed information about specific acceptance criteria for blood pressure accuracy performance or a study proving the device meets those criteria, as typically found in clinical validation reports.

Here's a breakdown of the information that is available in the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states that the device "conforms to the following standards," including AAMI SP10:2002. AAMI SP10 is the key standard for non-invasive sphygmomanometers, and it outlines specific accuracy requirements for systolic and diastolic blood pressure measurements (e.g., mean difference ≤ ±5 mmHg with a standard deviation ≤ 8 mmHg). However, the document does not provide a table comparing these AAMI SP10 acceptance criteria with the actual performance data (mean difference, standard deviation) obtained from a study.

2. Sample Size Used for the Test Set and Data Provenance

Missing. The document only generally states, "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." It does not specify any sample size for a test set or the provenance of any data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Missing. There is no mention of experts or ground truth establishment for a test set. For blood pressure monitors, ground truth is typically established by trained observers using auscultation with a reference sphygmomanometer, following a defined protocol (e.g., AAMI SP10).

4. Adjudication Method

Missing. No adjudication method is mentioned as there is no description of a separate test set requiring such a process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not relevant for a blood pressure monitor, which measures a quantifiable physiological parameter rather than interpreting complex medical images or cases. Therefore, there is no mention of such a study or effect size.

6. Standalone (Algorithm Only) Performance

Partially Addressed, but without specific data. The device itself is a "Semi Automatic Electronic Blood Pressure Monitor," implying it's an automated device that provides a reading. Its performance, as per the AAMI SP10 standard it claims to conform to, would be a standalone assessment of its accuracy against a reference method. However, specific standalone performance data (e.g., mean difference and standard deviation of blood pressure readings against a reference) is not provided.

7. Type of Ground Truth Used

Implicitly, but not explicitly stated or detailed. For a blood pressure monitor, the "ground truth" used for validation against AAMI SP10 typically involves simultaneous or closely timed measurements by trained observers using a mercury or an equivalently validated reference sphygmomanometer (auscultatory method). The document states conformance to AAMI SP10, which implies this method would have been used, but it does not explicitly state it or provide details of the ground truth method or its establishment.

8. Sample Size for the Training Set

Missing. Training sets are generally relevant for machine learning algorithms. While an oscillometric device uses an algorithm, the document doesn't discuss a "training set" in the context of a machine learning model. It describes testing against a standard rather than training an AI model.

9. How the Ground Truth for the Training Set Was Established

Missing. As no training set is discussed, this information is also absent.

Summary of what is present:

Conformance to standards: The device claims to conform to AAMI SP10, IEC 60601-1, and IEC 60601-1-2. AAMI SP10 sets the performance criteria for non-invasive blood pressure monitors.
Predicate Device: KD-322 (K083395) is identified as the predicate device, with the new device (KD-388BD) being "substantially equivalent."
Minor differences from predicate: The document notes minor differences like appearance, additional memory, and a slight change in pulse rate range (30-180 to 40-180 times/min). It states that "[t]he test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies some level of testing was performed, likely to re-verify compliance with AAMI SP10 for the modified device, but the details are not provided.

*In conclusion, while the device claims conformance to AAMI SP10 (which defines the acceptance criteria for blood pressure monitors), the provided 510(k) summary does not contain the specific acceptance criteria in a table, nor does it present the detailed results of a study (sample size, performance metrics, ground truth methodology, etc.) that demonstrate the device explicitly meets those criteria. This level of detail is typically found in the full testing report, which is not part of this summary.

Summary

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510(k) Summary

K091738
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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

AUG 1 8 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: 05/27/2009

2.0 Device information

Trade name: Semi 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-322 Semi Automatic Electronic Blood Pressure Monitor 510(k) number: K083395

5.0 Device description

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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 memory capability of KD-388BD is 2×60 times.

6.0 Intended use

The intended use and the indication for use of KD-388BD, as described in their labelings are the same as the predict device KD-322.

7.0 Summary comparing technological characteristics with predicate device

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Similar
Performance	Similar
Biocompatibility	Similar
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-388BD Semi 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-388BD Semi Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Semi Automatic Electronic Blood Pressure Monitor KD-322 whose 510(k) number is K083395.

KD-388BD and KD-322 are 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 and TIME/DATE display are added. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-322. The pulse rate range is changed from 30-180 times/min to 40-180 times/min. KD-388BD also adds a new cuff.

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 Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 1 8 2009

Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300190

Re: K091738

Trade/Device Name: KD-388BD Semi 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: July 21, 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

6091738 510(k) Number :

KD-388BD Semi Automatic Electronic Blood Pressure Device name: Monitor

Indications for use:

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)

Mitchell Ste. for B Zuckerman

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

Page 1 of

Regulation Number and Section

§ 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).