The subjects are 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 Blood Pressure Monitors, Model LD1103 and LD 1133, are 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 cuff is wrapped around the upper arm. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital BP Monitor, Model LD1103 and LD1133:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the modified devices (LD1103 and LD1133) are "identical in safety and effectiveness of the intended use to the 510(k) cleared device model LD578" and that "The modified devices are identical to the predicate in functionality and performance".

The primary acceptance criteria for blood pressure monitors generally revolve around accuracy against a reference measurement. The document explicitly references compliance with ANSI/AAMI SP10-2002, Manual, Electronic or Automated Sphygmomanometers. This standard outlines accuracy requirements for blood pressure devices.

However, the specific numerical acceptance criteria (e.g., mean difference and standard deviation of differences between the device and a reference standard) from ANSI/AAMI SP10-2002 are not explicitly detailed in the provided text. Instead, the document makes a blanket statement of compliance.

Therefore, based only on the provided text, the table would look like this:

Acceptance Criteria Category	Specific Criteria (from ANSI/AAMI SP10-2002)	Reported Device Performance
Accuracy	(Not explicitly detailed in text, but generally involves mean difference and standard deviation of differences against a reference standard, as per ANSI/AAMI SP10-2002)	"found otherwise to comply with... ANSI/AAMI SP10-2002"
Safety	IEC/EN 60601-1, ISO 10993-1	"comply with the following standards"
EMC	IEC/EN/ANSI 60601-1-2	"comply with the following standards"
Functionality	General Functions Test	Passed
Reliability	Operation, Drop, Storage, Vibration	Passed

Note: Without direct access to the ANSI/AAMI SP10-2002 standard and the full test report, the specific numerical accuracy criteria and performance for blood pressure measurement cannot be extracted directly from this summary. The manufacturer claims compliance with the standard, which implies meeting its accuracy requirements.

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

The provided text does not explicitly state the sample size used for the performance testing related to ANSI/AAMI SP10-2002. It only mentions, "The subjects have been tested...".

Sample Size for Test Set: Not explicitly stated.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention the number of experts used or their qualifications to establish ground truth for the performance testing. In studies complying with ANSI/AAMI SP10, ground truth for blood pressure is typically established by multiple trained observers (e.g., physicians or specially trained technicians) using a auscultatory method with a mercury sphygmomanometer. However, this detail is not present in the summary.

4. Adjudication Method

The provided text does not describe any adjudication method used for establishing ground truth.

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

Was an MRMC study done? No.
Effect size of human readers with vs. without AI assistance: Not applicable, as this device is a standalone blood pressure monitor and not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The document focuses on the device's ability to measure blood pressure and pulse rate independently. The "Performance testing" section details various tests, including compliance with ANSI/AAMI SP10-2002, which is a standard for standalone blood pressure device accuracy. The modifications made to the device did not change the core "blood pressure measurement algorithm and its software codes."

7. Type of Ground Truth Used

The typical ground truth for validating automated blood pressure monitors against standards like ANSI/AAMI SP10 is auscultatory blood pressure measurements performed by trained observers using a mercury sphygmomanometer or an equivalent reference device. While not explicitly stated as "auscultatory," the reference to "the method to define systolic and diastolic pressure is similar to the auscultatory method" and compliance with SP10 strongly implies this type of ground truth.

8. Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning or AI algorithms that "learn" from data. While the device uses an "oscillometric method" based on an electronic semiconductor sensor and an algorithm, this submission focuses on a modification of an already cleared device where the "blood pressure measurement algorithm and its software codes of the modified devices remain unchanged." Therefore, there isn't a specific "training set" mentioned or relevant for this particular submission of a modified device. The original algorithm would have been developed and validated, but details of that process are not part of this 510(k) summary for a modified device.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" is not relevant for this particular modification submission, as the core algorithm remained unchanged. Details on how the original algorithm's ground truth was established are not provided in this document.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads 'K093359', and below that, it says 'Pg 1 of 4'. The handwriting appears to be somewhat rough, with the numbers and letters not perfectly formed.

Attachment 2

510k summary

NOV 2 7 2009

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:

SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD.

Address:

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:
Owner Number of Registration:

B. General information of modified devices

Name:
Trade Name:
Common Name:
Classification Name:
Product Code :

0086-513-8598 6718 Mr. Janusun Wang 10/20/2009 3005907323 9086965

Digital BP monitor Digital blood pressure monitor, model LD 1103 and LD 1133 Electronic Sphygmomanometer System, measurement, blood pressure, non-invasive DXN

(-2

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Class: 7. Regulation Number:

II 870.1130

C. Identification of FDA Cleared Devices(predicate)

Digital blood pressure monitor, model LD 578 1. Name:

K Number: K061279
Date Cleared: August 18, 2006

D. Description of the Device

E. Intended Use Statement

LD1103 and LD 1133 Digital Blood Pressure Monitor are intended for use by medical professionals in medical care facilities 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 upper arm, which is same as predicate device.

F. Comparisons to the predicate

The modified devices have the same intended use and identical fundamental scientific principle called oscillometric BP measurement method. They are identical in safety and effectiveness of the intended use to the 510(k) cleared device model LD578. 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 modifications that were made are:

1. Appearance
1. WHO blood pressure classification indication
1. Increase the number of memory recalls
1. Date and time display
1. Inflation and exhaust components

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C - 2

Packaging and wording in instruction manual

Please find the following tabulated comparisons supporting that the modified devices are substantially equivalent to the predicate device with FDA 510K# K061279

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

Technological Cha

G. Discussion of Similarities and Differences

The modified devices are 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 recall capacity of measurement results. The modifications to our original 510(k) cleared device include the dimensional specifications, inflation and exhaust components, 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 remain unchanged. The fundamental scientific technology of the modified device remains the same as that of the 5l0(k) cleared device. These differences have no impact on safety or effectiveness of the device in use for blood pressure measurement.

H. Performance testing

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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 Sphyamomanometers

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 LD1103 and LD 1133 Digital Blood Pressure Monitor are as safe and effective as the predicate device in intended use for blood pressure measurement, based on electrical, mechanical and environmental testing results, and SP-10 standard requirements. Therefore, these two modified devices are substantially equivalent to the predicate device in use for BP measurement.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of a bird or eagle, with its wings forming a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

Shanghai Little Doctor Co. Limited C/O Janusun Wang, Regulatory Affairs Representative Shanghai Little Doctor Co. Limited No. 8, Tongxing Road Nantong, Jiangsu 226007 China

NOV 2 7 2009

Re: K093359

Trade/Device Name: 1103 Digital Blood Pressure Monitor, Model ID 1103 and 1133 Digital Blood Pressure Monitor, Model ID 1133 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: October 19, 2009 Received: October 28, 2009

Dear Janusun 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.

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

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Page 2 - Janusun Wang

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/Reportal?roblem/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.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

Kos3359 510(k) Number (if known):

Device Name: Littledoctor Digital BP Monitor LD 1103 and LD 1133

Indications for Use:

The subjects are 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 FrescriptTon Use -------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)

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

Concurrence of CDBH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K993359

Page 1 of __

1 of 1

C -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).