The Shanghai Little Doctor LD-578 Fully Automatic Digital Blood Pressure Monitor, is a device intended to measure the systelic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Device Description

The LD-578 Fully Automatic Digital Blood Pressure Monitor, Model LD-578 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our 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 calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

AI/ML Overview

The provided text outlines the acceptance criteria and the study conducted for the LD-578 Fully Automatic Digital Blood Pressure Monitor.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Reference)
Clinical Performance:
Clinical Data and Analysis ANSI/AAMI-SP-1000 Standard - Section 1-10	All testing results met required parameters (Section 9)
Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2	All testing results met required parameters (Section 9)
Non-Clinical Performance:
FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (Electrical, Mechanical, Environmental Performance Requirements)	Met all relevant requirements; no safety hazards (Section 8)
General Functions Test	Met all relevant requirements (Section 8)
Reliability Test-Operation Conditions	Met all relevant requirements (Section 8)
Reliability Test-Drop Testing	Met all relevant requirements (Section 8)
Reliability Test-Storage	Met all relevant requirements (Section 8)
Reliability Test-Vibrating Testing	Met all relevant requirements (Section 8)
EMC Testing	Met all relevant requirements (Section 8)
IEC 60601-1 Safety Testing	Met all relevant requirements (Section 8)
FDA required Unit Intravariability Testing	Met all relevant requirements (Section 8)

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

The document states, "We have performed clinical testing on the LD-578 Fully Automatic Digital Blood Pressure Monitor according to 'Clinical Data and Analysis ANSI/AAMI-SP-1000 Stondord -Section 1-1 0' - Alto 'Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2'."

Sample Size: The exact sample size used for the clinical test set is not explicitly mentioned in the provided text.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only indicates that "clinical testing" was performed.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing. The clinical testing refers to adherence to the ANSI/AAMI-SP-10 standard, which typically outlines methods for validating blood pressure monitors against a reference method, often involving trained observers.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for the test set. Clinical validation of blood pressure devices against a standard often involves comparison to a reference standard (e.g., auscultation by multiple trained observers), but specific adjudication protocols are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is a "Fully Automatic Digital Blood Pressure Monitor," implying it autonomously measures blood pressure, and the focus is on its accuracy compared to established standards rather than human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, a standalone performance assessment was conducted. The device is described as "Fully Automatic Digital Blood Pressure Monitor" employing an "oscillometric method" to define systolic and diastolic blood pressure and calculate pulse rate. The clinical testing, according to ANSI/AAMI-SP-10, is a standalone validation of the device's accuracy without human interpretation of the device's output.

7. The Type of Ground Truth Used

The clinical testing was performed according to ANSI/AAMI-SP-10 standard. This standard typically requires the device's readings to be compared against a reference method, which is often auscultation performed by trained observers (expert consensus) using a mercury manometer or another validated reference sphygmomanometer. The document states, "Our 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." This indicates that the ground truth for clinical validation would be established by the auscultatory method.

8. The Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. For blood pressure monitors, the "oscillometric method" is a well-known and established technique rather than a machine learning algorithm that requires a distinct training phase. The device's algorithm would have been developed and refined based on existing physiological knowledge and potentially pre-clinical data, but a formal "training set" in the context of supervised learning is not discussed.

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

As no explicit "training set" is mentioned in the context of developing a machine learning algorithm, there is no information on how its ground truth was established. The "oscillometric method" is a recognized technique, and its parameters would be defined through physiological research and engineering principles, not through a 'ground truthing' of a training dataset in the AI sense.

Summary

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510(K) SUMMARY

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

The assigned 510(k) number is: Kol 1279

AUG 1 8 2006

1. Submitter's Identification:

Little Doctor (Shanghai) Electronic Manufacture Co., Ltd Floor 30,1st Bldg ,No 4514 Caoan Road Shanghai China

Tel: 0086-021-63056696

Date Summary Prepared: May 1, 2006

Contact: Mr. David Zhang

2. Name of the Device:

LD-578 Fully Automatic Digital Blood Pressure Monitor

3. Common or Usual Name:

Non-Invasive Blood Pressure Monitor System

4. Predicate Device Information:

The LD-578 Fully Automatic Digital Blood Pressure Monitor, is substantially equivalent to the AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, AMPLIFE Corporation.

ട. Device Description:

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6. Intended Use:

The LD-578 Fully Automatic Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

7. Comparison to the Predicate Device:

The LD-578 Fully Automatic Digital Blood Pressure and predicate device (AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, K043440) are identical in functionality and performance with the difference being the external shape of the device, dimensional specification and clock function. These differences have no impact on safety or performance of the device. The blood pressure measurement algorithm and its functional technology are identical.

Both the subject and predicate devices use the well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate.

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the LD-578 Fully Automatic Digital Blood Pressure Monitor in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

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-Vibrating Testing
EMC Testing ﺖ
g. IEC 60601-1 Safety Testing
h. FDA required Unit Intravariability Testing

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the LD-578 Fully Automatic Digital Blood Pressure Monitor tested met all relevant requirements of the aforementioned tests.

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9. Discussion of Clinical Tests Performed:

We have performed clinical testing on the LD-578 Fully Automatic Digital Blood Pressure Monitor according to "Clinical Data and Analysis ANSI/AAMI-SP-1000
Stondord -Saction 1-1 0" - Alto "Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2". All testing results met required parameters.

10. Conclusions:

We have demonstrated that the LD-578 Fully Automatic Digital Blood Pressure Monitor is as safe and effective as the predicate device based on electrical, mechanical and environmental testing results, and SP-10 standard requirements. FDA guidance document requirements were also met. Therefore, our subject device is as safe and effective as our predicate device.

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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 consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the eagle. The eagle is depicted with three curved lines forming its body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

Little Doctor (Shanghai) Electronic Manufacture Co., Ltd. c/o Susan Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K061279

Trade Name: LD-578 Fully Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR §870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 31, 2006 Received: August 1, 2006

Dear Ms. Goldstein-Falk:

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 such 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 - Ms. Susan Goldstein-Falk

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Meder May
C.R.P. Zalaegerszeg, M.B.

Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Indications for Use

Page _ 1 of 1

510(k) Number (if known): _kO6 12 79

Device Name: LD-578 Fully Automatic Digital Blood Pressure Monitor

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use __ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division sign-Off
Division of Cardiovascular Devices
K number K661279

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).