The subject is intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital.

Device Description

The Digital Wrist Blood Pressure Monitor, Model LD1143, is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable wrist cuff is wrapped around the wrist. The method to define systolic and diastolic pressure is. similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and to calculate pulse rate, which is a well-known technique in the market called the "oscillometric method". The device can analyze the signals promptly and display the results. The modified device has two new auxiliary features called WHO indication and date and time display.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD. Digital Wrist Blood Pressure Monitor, Model LD1143:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K092683) is a 510(k) summary for a modified device seeking substantial equivalence to a previously cleared predicate device. It primarily focuses on demonstrating that the modifications (new auxiliary features, dimensional changes, packaging) do not impact the device's safety or effectiveness. As such, explicit, quantitative acceptance criteria and detailed performance metrics in the format of a clinical study are not reported for the modified device itself in relation to specific blood pressure measurement accuracy.

Instead, the submission relies heavily on the "identical" nature of the core blood pressure measurement technology and the demonstration of compliance with general safety and performance standards. The "performance specifications" are stated as "Identical" to the predicate device.

However, based on the standards met, we can infer some implied performance criteria that would have been met by the predicate device and, by extension, are claimed to be met by the modified device due to the identical core technology:

Acceptance Criterion (Implied/Standard-Based)	Reported Device Performance (Implied or Stated)	Notes
Blood Pressure Measurement Accuracy	"Identical performance specifications" as predicate device cleared under K070825. Compliance with ANSI/AAMI SP10-2002 (Manual, Electronic or Automated Sphygmomanometers).	The text explicitly states that the "blood pressure measurement algorithm and its software codes of the modified devices remains unchanged." The predicate device would have met the accuracy requirements of ANSI/AAMI SP10-2002.
Pulse Rate Measurement Accuracy	"Identical performance specifications" as predicate device cleared under K070825. Compliance with ANSI/AAMI SP10-2002.	Similar to blood pressure, pulse rate measurement is part of SP10.
Basic Safety and Essential Performance	Compliance with IEC/EN 60601-1.	Confirms fundamental electrical and mechanical safety.
Electromagnetic Compatibility (EMC)	Compliance with IEC/EN/ANSI 60601-1-2.	Ensures the device operates correctly in its electromagnetic environment and doesn't interfere with other devices.
Biocompatibility	Compliance with ISO 10993-1.	For any patient-contacting materials.
General Functions Test	Passed	General operational verification.
Reliability Tests (Operation, Drop, Storage, Vibration)	Passed	Durability and robustness under various conditions.

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

The document does not describe a clinical study for the modified device (LD1143) with a dedicated test set involving actual patient measurements to assess blood pressure accuracy. The compliance is primarily demonstrated through:

Identical core technology: The blood pressure measurement algorithm and software codes remain unchanged from the predicate device (LD8).
Engineering and Bench Testing: "General Functions Test," "Reliability Test," "EMC Testing," and "IEC 60601-1 Safety Testing." The sample size for these engineering tests is not specified, but typically involves a limited number of devices.
Compliance with standards: ANSI/AAMI SP10-2002 is crucial here, as it defines the clinical accuracy requirements for blood pressure devices. The implication is that the predicate device (LD8) would have demonstrated compliance with this standard using a clinical study.

Therefore, for the modified device LD1143, there is no new clinical test set size or data provenance provided for blood pressure measurement accuracy. The safety and effectiveness are supported by the predicate's prior clearance and the unchanged core technology.

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

As there is no new clinical test set described for the modified device's blood pressure accuracy, there are no experts mentioned as being used to establish ground truth in this 510(k) summary for the LD1143.

For the predicate device (LD8) to meet ANSI/AAMI SP10-2002, a clinical study would have been required, typically engaging trained observers (experts) for reference blood pressure measurements (e.g., using a mercury sphygmomanometer). However, details about such experts for the predicate are not in this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set for blood pressure accuracy is described for the modified device in this submission.

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

Not applicable. This device is a blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, the "performance specifications" being "Identical" and the "blood pressure measurement algorithm and its software codes...unchanged" effectively means the standalone algorithm performance (without human intervention in the measurement process beyond cuff placement and initiation) is considered equivalent to the predicate device. The device itself is an automated system for measurement.

7. The Type of Ground Truth Used

For the predicate device (and by extension, the core technology of the modified device), the ground truth for blood pressure measurement accuracy would have been established through expert-obtained reference measurements, typically using a calibrated mercury sphygmomanometer or another accepted reference standard, in a clinical study conforming to standards like ANSI/AAMI SP10.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device for direct physiological measurement, not a machine learning or AI model that requires a "training set" in the computational sense. The device's algorithm for blood pressure determination is based on the "oscillometric method," a well-established technique.

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

Not applicable, for the reasons stated in point 8.

Summary

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Attachment 2

510k summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92. The assigned 510(k) number is:

A. General Information on submitter

Submitter's Name:
Address:

SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD.

NO. 8, TONGXING ROAD. ECONOMIC AND TECHNOLOGICAL DEVELOPMENT DISTRICT, NANTONG CITY, JIANGSU PROVINCE, 226007, CHINA

Telephone: 4. Contact Person: 5. Date Prepared: 6. Registration Number: 7. Owner Number of Registration:

B. General information of modified device

Name: 2. Trade Name: 3. Common Name: 4. Classification Name: 5. Product Code : 6. Class: II 7. Regulation Number:

08/15/2009 3005907323 9086965 Digital wrist BP monitor Digital wrist blood pressure monitor, model LD 1143 Electronic Sphygmomanometer

0086-513-8598 6718

Mr. Janusun Wang

System, measurement, blood pressure, non-invasive DXN 870.1130

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C. Identification of FDA Cleared Devices(predicate)

Name: Digital wrist blood pressure monitor, model LD 8 2. K Number: K070825
Date Cleared: May 25, 2007

D. Description of the Device

E. Intended Use Statement

LD1143 Fully Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals in hospital or by patients for self monitoring at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult, with the cuff around the wrist, which is same as predicate device.

F. Comparisons to the predicate

The modified device has the same intended use and identical fundamental scientific principle called oscillometric BP measurement method. It is identical in safety and effectiveness of the intended use to the 510(k) cleared device model L.D8. The modifications to our original 510(k) cleared device include dimensional specifications and adding new auxiliary features of WHO and date and time indication. The software codes of the modified device remains unchanged. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

The modifications that were made are:

Appearance

1. WHO blood pressure classification indication
1. Change into 90 sets of memory recalls from 30
1. Date and time display

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Packaging and wording in instruction manual

Please find the following tabulated comparisons supporting that the modified device is substantially equivalent to the predicate device with FDA 510K# K070825

Technological Characteristics Comparisons table

Intended use	identical
Fundamental scientific principle	Identical
Target population	Identical
Use at home or in hospital	Identical
Safety and effectiveness	Identical
Over the counter	Identical
Performance specifications	Identical
Stirility	Not applicable
Biocompatibility	Identical
Mechanical safety	Identical
Electrical safety	Identical
Standards met	Identical
Energy used or delivered	Identical
Environmental specifications	Identical
Ergonomics of the patient-user interface	Identical
Software	Similar
Packaging or labeling	Similar
Dimensional specification	Similar

G. Discussion of Similarities and Differences

The modified device is identical to the predicate in functionality and performance ,with the only differences being the additional features, such as WHO indication, date and time display and an increased measurement recall capacity to 90 sets of measurement. The modifications to our original 510(k) cleared device include the dimensional specifications, packaging and labeling and subprogram of software for WHO indication and date and time display. The blood pressure measurement algorithm and its software codes of the modified devices remains unchanged. The fundamental scientific technology of the

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modified device remains the same as that of the 510(k) cleared device. These differences have no impact on safety or effectiveness of the device.

H. Performance testing

The subjects have been tested and found otherwise to comply with the following standards:

IEC/EN 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

*IEC/EN/ANSI 60601-1-2, Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and Test

ISO 10993-1, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing
ANSI/AAMI SP10-2002. Manual. Electronic or Automated Sphygmomanometers

The following testing was conducted:

a. General Functions Test

b. Reliability Test - Operation Conditions

c. Reliability Test Drop Testing
d. Reliability Test Storage
e. Reliability Test Vibration Testing

f. EMC Testing

g. IEC 60601-1 Safety Testing

None of the testing demonstrated any design characteristics that violated the requirement of the Reviewer Guidance or resulted in any safety hazards

I. Conclusions:

The LD1143 Digital Wrist Blood Pressure Monitor is as safe and effective as the predicate device in terms of intended use in blood pressure measurement, based on electrical, mechanical an environmental testing results, and SP-10 standard requirements. FDA Good Manufacturing Practices requirements were also met. Therefore, our modified device is as safe and effective as the predicate device.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of a bird, possibly an eagle, with its wings spread, symbolizing protection and care.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Shaghai Little Doctor Electronic Co., Ltd. c/o Mr. Janusun Wang Regulatory Affairs Representative Medical Device Division No. 8. Tongxing Road Nantong, Jiangsu 226007 CHINA

SEP 2 5 2009

Re: K092683

Trade/Device Name: Little Doctor Digital Wrist BP Monitor LD 1143 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 19, 2009 Received: September 1, 2009

Dear Mr. Wang:

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. Janusun Wang

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

D.M.P.

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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Attachment 1

Indications for use

510(k) Number (if known) :

Device Name: Littledoctor Digital Wrist BP Monitor LD 1143

Indications for Use:

The subject is intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital.

Prescription Use Over-The-Counter Use AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of GDF Device Evaluation (ODE)

السعيده

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

Page 1 of 1

4--1

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).