(30 days)
Not Found
No
The description explicitly states the device uses the "oscillometric method," a well-established, non-AI technique for blood pressure measurement. There is no mention of AI, ML, or related concepts in the document.
No.
The device measures blood pressure and pulse rate, which is a diagnostic function, not a therapeutic intervention.
Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status. While it doesn't diagnose specific diseases, providing these measurements aids in the diagnostic process by offering data points for clinical evaluation, fulfilling the function of a diagnostic tool.
No
The device description explicitly states it is a "Digital Blood Pressure Monitor" that uses an inflatable cuff and an electronic semiconductor sensor, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive method that does not involve analyzing specimens taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, not to analyze biological samples.
- Device Description: The description clearly outlines a non-invasive method using a cuff and sensor, not the analysis of in vitro samples.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
medical professionals in medical care facilities or by patients for self monitoring at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
- 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
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.
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:
-
- Appearance
-
- WHO blood pressure classification indication
-
- Increase the number of memory recalls
-
- Date and time display
-
- Inflation and exhaust components
2
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
3
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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4
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
5
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
6
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
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