(28 days)
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No
The provided text does not mention AI, ML, or any related technologies. The device description focuses on standard physiological measurements.
No
The device is described as "not a diagnostic device" and only furnishes data for users to consult their personal physician, indicating it is not intended for treatment or diagnosing conditions.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional."
No
The description explicitly states the device measures blood pressure, pulse, body weight, etc., which requires physical sensors and hardware, not just software.
Based on the provided information, the higi Station is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The description explicitly states, "It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional." IVD devices are specifically intended for the diagnosis of diseases or other conditions.
- Nature of Measurements: The measurements taken (blood pressure, pulse, weight, body composition) are physiological parameters, not analyses of samples taken from the human body (like blood, urine, or tissue) which are typical for IVD devices.
Therefore, the higi Station falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, percent lean body mass, percent body fat, total body water and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional.
Product codes
DXN, MNW
Device Description
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station (with Body Composition and Fixed cuff housing)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
General public
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written in a sans-serif font.
October 10, 2017
higi SH LLC Colin Hill SVP Research & Development and Regulatory Affairs 800 Royal Oaks Dr. Suite 102 and 106 Monrovia, California 91016
Re: K172739
Trade/Device Name: higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station (with Body Composition and Fixed cuff housing) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, MNW Dated: September 8, 2017 Received: September 12, 2017
Dear Colin Hill:
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);
1
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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education (DICE) 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.
Sincerely,
M. A. Willemsen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
higi Station (with Body Composition and Pan and Tilt cuff housing) higi Station (with Body Composition and Fixed cuff housing)
Indications for Use (Describe)
The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, percent lean body mass, percent body fat, total body water and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart G) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|* | Over-The-Counter Use (21 CFR 801 Subpart C)
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