(431 days)
No
The summary describes standard physiological measurements (weight, impedance, pulse rate, center of pressure) and data transmission. There is no mention of AI or ML being used for data analysis, interpretation, or decision-making.
No.
The device is intended for non-invasive monitoring and management of patients with fluid management-related health conditions by measuring and tracking body weight, peripheral impedance, pulse rate, and center of pressure. It does not provide any treatment or therapy.
No.
The device is intended for monitoring and management of patients with fluid management-related health conditions, measuring and tracking body weight, peripheral impedance, pulse rate, and center of pressure, but explicitly states that "Data from the device should be used in the context of all clinical data to make determinations of a patient's status," indicating it does not provide a definitive diagnosis on its own.
No
The device description clearly outlines physical hardware components including a platform, electrodes, load cells, a display, and batteries, indicating it is not solely software.
Based on the provided information, the Bodyport Cardiac Scale is not an In Vitro Diagnostic (IVD) device.
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.
- Bodyport Cardiac Scale Function: The Bodyport Cardiac Scale measures physiological parameters directly from the user's body (body weight, peripheral impedance, pulse rate, and center of pressure) through physical contact (standing on the scale). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring and management of patients with fluid management conditions by measuring these physical parameters. This aligns with a non-invasive monitoring device, not an IVD.
- Device Description: The description details the physical interaction with the user and the measurement of electrical signals and physical loads through the feet. There is no mention of collecting or analyzing biological specimens.
Therefore, the Bodyport Cardiac Scale falls under the category of a non-invasive medical device for monitoring physiological parameters, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment.
Intended users are people over 21 years of age who can stand for the measurement and weigh less than 180 kg (397 lbs).
The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's status.
Product codes (comma separated list FDA assigned to the subject device)
DSB
Device Description
The Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and body weight scale that measures body weight, peripheral impedance, pulse rate, and center of pressure through the feet of a user standing on its surface. The device is powered by four (4) AA alkaline batteries.
The device is comprised of a physical platform on which the user stands with bare feet. Four electrodes located on the top surface of the platform are used to measure of the user's lower body (foot-to-foot). The impedance signal is obtained by applying a small, safe battery-generated current (
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2022
Bodyport Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K211585
Trade/Device Name: Bodyport Cardiac Scale Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: May 31, 2022 Received: June 1, 2022
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211585
Device Name Bodyport Cardiac Scale
Indications for Use (Describe)
The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment.
Intended users are people over 21 vears of age who can stand for the measurement and weigh less than 180 kg (397 lbs).
The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's status.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
(5) 510(k) Summary
| 510(k) Owner/ Submitter: | Bodyport Inc.
970 Folsom Street
San Francisco, California 94107 (USA)
P: (650) 200-1557 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Corey Centen
P: (415) 990-5415
E: corey@bodyport.com |
| Date Prepared: | July 21, 2022 |
| Trade Name: | Bodyport Cardiac Scale (or Bodyport Scale) |
| Device Type/ Common Name: | Plethysmograph, Impedance |
| Classification Name: | Impedance plethysmograph |
| Classification Regulation: | 870.2770 |
| Class: | II |
| Panel: | Cardiovascular |
| Product Code: | DSB |
| Predicate Device(s): | Noninvasive Medical Technologies, Inc.'s ZOE Fluid Status
Monitor Model ZOE3 (K133301) |
| Reference Device(s): | N.I. Medical, Ltd.'s NICaS 2001 Noninvasive Cardio-Respiratory
System (K942227)
ImpediMed Limited's SOZO (K172507) |
Device Description:
The Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and body weight scale that measures body weight, peripheral impedance, pulse rate, and center of pressure through the feet of a user standing on its surface. The device is powered by four (4) AA alkaline batteries.
The device is comprised of a physical platform on which the user stands with bare feet. Four electrodes located on the top surface of the platform are used to measure of the user's lower body (foot-to-foot). The impedance signal is obtained by applying a small, safe battery-generated current (