(81 days)
Not Found
No
The document describes a cloud-based system for displaying and analyzing medical data, but there is no mention of AI or ML technologies being used for the analysis. The analysis described appears to be standard data processing and display.
No
The device is described as a "medical device data system that displays and analyzes data received from iHealth home monitoring devices as well as manually input data." It retrospectively displays and analyzes medical data and is not for emergency use or real-time monitoring, indicating it does not provide direct therapy.
No
The device is a medical device data system that displays and analyzes data. It is not intended for diagnostic purposes or real-time monitoring.
Yes
The device description explicitly states "lHealth cloud is a cloud based, web software system" and that it is accessed from commercially available PC systems. While it receives data from iHealth home monitoring devices, the device itself is described as the software system for displaying and analyzing this data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retrospectively display and analyze related medical data." This focuses on managing and presenting data collected from other devices, not on performing diagnostic tests on biological samples.
- Device Description: The description clearly states it's a "medical device data system that displays and analyzes data received from iHealth home monitoring devices as well as manually input data." It acts as a data management and analysis tool for data generated elsewhere.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Performing diagnostic tests.
- Providing diagnostic results based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to handle and display data from other devices, which is not the core function of an IVD.
N/A
Intended Use / Indications for Use
IHealth cloud's intended use is to retrospectively display and analyze related medical data. The Web Application is not intended for emergency use or real-time monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DXN, NBW, MNW
Device Description
lHealth cloud is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. IHealth cloud accepts data both electronically as well as from manually input.
IHealth cloud is a medical device data system that displays and analyzes data received from iHealth home monitoring devices as well as manually input data. iHealth home monitoring devices include the apps and the device, such as KD-931, KD-936, KD-972 and Scale HS3 and HS5, AG-631, AG-632, AM3, PO3 and iHealth MyVitals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Road, Ya' an street TIANJIN, 300193 |
| Phone number: | 86-22-60526161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: | 4/24/2013 |
2.0 Device information
| Trade name: | iHealth cloud |
|---|---|
| Common name: | Patient Vital Signs Monitor Viewing Station |
| Classification name: | Patient Vital Signs Monitor Viewing Station |
3.0 Classification
Production code: DXN, NBW, MNW Regulation number: 21 CFR 870.2770, 21 CFR 862.1345, 21 CFR 870.1130 Classification: II Panel: 870 Cardiovascular, 862 Clinical Chemistry
4.0 Predict device information
| Manufacturer: | Watermark Medical |
|---|---|
| Device: | Connected Care Clinical Application |
| 510(k) number: | K120320 |
5.0 Device description
lHealth cloud is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. IHealth cloud accepts data both electronically as well as from manually input.
IHealth cloud is a medical device data system that displays and analyzes data received from iHealth home monitoring devices as well as manually input data. iHealth home monitoring devices include the apps and the device, such as KD-931, KD-936, KD-972 and Scale HS3
1
and HS5, AG-631, AG-632, AM3, PO3 and iHealth MyVitals. 6.0 Intended use
IHealth cloud's intended use is to retrospectively display and analyze related medical data. The Web Application is not intended for emergency use or real-time monitoring.
7.0 Performance summary
The software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding Medical device software.
2
Public Health Service
July 19, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Andon Health Co., Ltd Yi Liu President No. 3 Jinping Road, Ya' An Street Tianjin, China 300193
K131203 Trade/Device Name: IHealth Cloud Regulation Number: 21 CFR 870.2770 Regulation Name: Patient Vital Signs Monitor Viewing Station Regulatory Class: Class II Product Code: DXN, NBW, MNW Dated: May 20, 2013 Received: May 30, 2013
Dear Yi Liu:
Re:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Yi Liu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ihealth Cloud FDA 510(k) Files
Indication for Use
510(k) Number (if known):
Device Name: Ihcalth Cloud
Indication For Use:
IHealth cloud's intended use is to retrospectively display and analyze related medical data. The Web Application is not intended for emergency use or real-time monitoring.
Prescription Use Yes (21 CFR Part 801 Subpart D) Over the Counter Use Yes (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Digitally signed by Owen P.
Faris -S
Date: 2013.07.19 16:15:42
-04'00'
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)__
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