(60 days)
The Shanghai Little Doctor LD8 Digital Wrist 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 wrist.
The LD8 Digital Wrist Blood Pressure Monitor, Model LD8 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 wrist cuff is wrapped around the wrist. 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".
Here's an analysis of the provided text regarding the acceptance criteria and study for the LD8 Digital Wrist Blood Pressure Monitor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Electrical, Mechanical and Environment Performance Requirement (FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND) | "None of the testing demonstrated any design characteristics that violated the requirement of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the LD8 Digital Wrist Blood Pressure Monitor tested met all relevant requirements of the aforementioned tests." |
| Clinical Data and Analysis (ANSI/AAMI-SP-10 Standard, Section 4.4.2) | "All testing results met required parameters." |
The document implies that the device met all criteria set forth by these standards. Specific numerical acceptance thresholds for blood pressure accuracy (e.g., mean difference, standard deviation) as would typically be found in ANSI/AAMI SP-10 are not explicitly stated in this summary but are referred to as "required parameters".
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. It mentions "clinical testing" was performed according to "Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2". This standard would typically dictate the minimum number of subjects required (e.g., 85 subjects for validation).
The data provenance (country of origin, retrospective/prospective) is not specified. However, the manufacturer is "Little Doctor (Shanghai) Electronic Manufacture Co., Ltd" located in Shanghai, China, suggesting the clinical study may have been conducted there. The study is prospective, as it is clinical testing for device approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish a "ground truth" in the context of reference blood pressure measurements. For clinical validation of a blood pressure monitor, the ground truth is typically established by trained observers (often physicians or nurses) using a standardized mercury sphygmomanometer or an equivalent reference device, following a strict protocol. The document states their method is "similar to the auscultatory method," implying human observation as the reference.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method. In clinical validation of blood pressure monitors, if multiple observers are used for reference measurements, their readings are often averaged or specific protocols are followed to ensure consistency. However, this is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging diagnostics where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic accuracy. The LD8 Digital Wrist Blood Pressure Monitor is a standalone measurement device, not an interpretive diagnostic tool that requires human-in-the-loop assistance in the same way.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the blood pressure monitor itself is a standalone device. The clinical testing evaluates the performance of the device's algorithm and hardware in isolation (without human intervention in the measurement process, though a human initiates the measurement), as compared to reference measurements. The document describes the "oscillometric method" performed by the device to analyze signals and define blood pressure, indicating a standalone algorithm for measurement.
7. The Type of Ground Truth Used
The ground truth used for the clinical validation is based on a reference measurement method "similar to the auscultatory method" using an "electronic semiconductor sensor" rather than a stethoscope and mercury manometer, but its definition of systolic and diastolic pressure is aligned with this established manual method. For blood pressure device validation, the gold standard typically involves simultaneous readings by trained observers using a mercury sphygmomanometer (or a validated reference device like an expertly maintained oscillometric device) following specific protocols (like those outlined in ANSI/AAMI SP-10). The summary implies adherence to this standard, so it's reasonable to infer that a well-established, expert-derived reference measurement served as the ground truth.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or "training data" in the typical machine learning sense. The device utilizes an "oscillometric method" and a "software algorithm" for blood pressure measurement. While this algorithm would have been developed and likely optimized using data, the document does not specify the size or nature of such a dataset. For traditional medical devices like this, the algorithm is often based on established physiological principles and signal processing, rather than purely data-driven machine learning models that require distinct training and test sets as defined in AI product development.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" is not explicitly mentioned in the context of machine learning, the process of establishing ground truth for any underlying algorithm development is not detailed. However, for a device based on the oscillometric method, the algorithm's parameters and logic would have been designed and refined based on extensive physiological knowledge and comparisons to reference blood pressure measurements, similar to how the clinical test set ground truth would be established. This likely involved engineering and medical expertise to correlate oscillometric waveforms with auscultatory cuff pressure readings.
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EXHIBIT 1
510(k) SUMMARY
This summary of 510(k) and effectiveness information is being submitted in accordance with and requirement of SMDA1990 and 21CFR&807.92.
KO 70825 The assigned 510(k) number is:
Submitter's Identification 1.
Little Doctor (Shanghai) Electronic Manufacture Co., Ltd Floor 3dd. 1st Bldg, No 4514 Caoan Road Shanghai China
Phone: +86 021 63056696
Date summary prepared: 2006.9.15
Contact: Mr. David Zhang
Name of the Device: 2.
LD8 Digital Wrist Blood Pressure Monitor
3. Common or Usual Name:
Non- Invasive Blood Pressure Measurement System
Predicate Device Information 4.
The LD8 Digital Wrist Blood Pressure Monitor is substantially equivalent to the Digital Blood Pressure Monitor, Model UB-328, K040229.
5. Device Description:
The LD8 Digital Wrist Blood Pressure Monitor, Model LD8 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 wrist cuff is wrapped around the wrist. 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".
MAY 25 7000
pg 1 of 3
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6. Intended Use:
The LD8 Digital Wrist Blood Pressure Monitor is a device intended to measur systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable wrist cuff is wrapped around the wrist.
7. Comparison to the Predicate Device:
The LD8 Digital Wrist Blood Pressure and predicate device (Digital Blood Pressure Monitor, Model UB-328, K040229) are identical in functionality and performance with the difference being the external shape of the device, dimensional specification. 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. Discussions of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the LD8 Digital Wrist 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 Environment Performance Requirement.
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
- EMC Testing f.
- g. IEC 60601-1 Safety Testing
- h. FDA required Unit Intravariability Testing
None of the testing demonstrated any design characteristics that violated the requirement of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the LD8 Digital Wrist 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 LD8 Digital Wrist Blood Pressure Monitor according to " Clinical Data and Analysis ANSI/AAMI-SP-10 Standard, Section 4.4.2". All testing results met required parameters.
10. Conclusion:
We have demonstrated that the LD8 Digital Wrist 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 requirement were also met. Therefore, our subject device is as safe and effective as our predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2007
Little Doctor (Shanghai) Electronic Manufacture Co. Ltd c/o Mr. David Zhang QA Manager Floor 22, Zhi Yuan Bldg. No 768 Xie Tue Road Luwan District, Shanghai, China
Re: K070825
Trade/Device Name: LD8 Digital Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 9, 2007 Received: March 26, 2007
Dear Mr. Zhang:
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 - Mr. David Zhang
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 vours,
B.Jimmaster
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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Kc70825 pg lof I
Exhibit B
Indication for use
Page 1 of of 1
770825 510(k) Number (if known): Device Name: LD8 Digital Wrist Blood Pressure Monitor Indication For Use:
The Shanghai Little Doctor LD8 Digital Wrist 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 wrist.
escription Use
21 CFR 801 Subpart D)
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
OR
(21 CFR 807 Subpart C)
SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE DED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
ision-Off
Cardiovascular Devices
Number 6082.5
§ 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).