(232 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and display, not advanced analytical capabilities.
No.
The software collects, stores, and displays measurements from diagnostic devices but explicitly states it "will not be used for medical diagnosis" and "is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement," indicating it does not provide therapy.
No
The software collects and displays historical data from other diagnostic devices but explicitly states, "The data will not be used for medical diagnosis." Therefore, the device itself is not a diagnostic device.
Yes
The device is described solely as software for a PC or Laptop, and its function is to collect, store, and display data from external medical devices. There is no mention of hardware components being part of the Brocomfort Health Manager itself.
Based on the provided information, the Brocomfort Health Manager is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software collects and displays data from home-use diagnostic medical devices (like blood pressure meters and body composition analyzers). It also clearly states that the data will not be used for medical diagnosis and is not a substitute for professional healthcare judgment. IVDs are specifically intended for use in the diagnosis of disease or other conditions.
- Device Description: The description focuses on managing and programming peripheral devices and storing/displaying their measurements. This aligns with a data management and display function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.) or performing any tests on these samples, which are core functions of IVDs.
The software acts as a data aggregator and display tool for data generated by other devices, which themselves might be considered medical devices (like the blood pressure meter and body composition analyzer), but the software itself does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Biocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment to collect historical data from defined peripheral devices. The software will receive, store and display measurements from home use diagnostic medical devices such blood pressure meter and a body composition analyser. The data will not be used for medical diagnosis. It is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement.
Product codes
DRG
Device Description
The Brocomfort Health Manager is a software for local home PC or Device Description Laptop in a non clinical environment. HM can manage up to 8 users. With the HM the Biocomfort devices can be bound with the USB-Dongle from Biocomfort. After the devices are bound and programmed with HM, the user can measure with the devices.
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
Lay users; local home PC or Laptop in a non clinical environment.
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)
Not Found
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the word "biocomfort" in a sans-serif font on the top line. Below that is the number "Ko81499" in a handwritten style. The number appears to be a code or identifier.
510(k) Summary
| The assigned 510(k) number is | K081499 | JAN 1 6 2009 |
|---|---|---|
| Date Prepared | September 23, 2008 | |
| Submitter Information | Biocomfort Diagnostics GmbH & Co KG | |
| Bernhaeuser Strasse 17 | ||
| 73765 Neuhausen a d F | ||
| Germany | ||
| Registration Number 3006493236 | ||
| Owner/Operator Number 10023755 | ||
| Official Correspondent | Mrs Marion Otto | |
| Quality Manager | ||
| Biocomfort GmbH & Co KG | ||
| Phone +49 7158 98016-48 | ||
| Fax +49 7158 98016-40 | ||
| E-mail otto@biocomfort de | ||
| US Agent (Contact) | Mr Dieter Schill | |
| President | ||
| Biocomfort Inc | ||
| 23 Third Avenue | ||
| Burlington, MA 01803 USA | ||
| Phone +1 866 294 8267 | ||
| E-mail schill@biocomfort com | ||
| Device Trade Name | Health Manager 2 0 | |
| Common Name | Transmitters and receivers, physiological signal, radiofrequency | |
| Device Classification Name | Radiofrequency physiological signal transmitter and receiver | |
| Product Code | DRG | |
| Device Classification No | Part 870 2910 | |
| Regulatory Status | Class II | |
| Predicate Devices | ||
| Device Trade Name | Confidant 2 5 | |
| 510(k) Number | K072698 | |
| Device Classification Name | Radiofrequency physiological signal transmitter and receiver | |
| Product Code | DRG | |
| Device Classification No | Part 870 2910 | |
| Regulatory Status | Class II |
1
The Brocomfort Health Manager is a software for local home PC or Device Description Laptop in a non clinical environment HM can manage up to 8 users With the HM the Biocomfort devices can be bound with the USB-Dongle from Biocomfort After the devices are bound and programmed with HM, the user can measure with the devices
The Biocomfort Health Manager is a software for local home PC or Intended Use Laptop in a non clinical environment to collect historical data from defined peripheral devices The software will receive, store and display measurements from home use diagnostic medical devices such blood pressure meter and a body composition analyser The data will not be used for medical diagnosis It is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement
SE Discussion
| | | Substantial Equivalent
Device | Predicate Devices | |
|------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Biocomfort Health
Manager | Confidant 2 5 | Discussion of differences |
| [01] | Indication for
use | The Biocomfort Health
Manager is a software for
local home PC or Laptop
in a non clinical
environment to collect
historical data from
defined peripheral
devices The software will
receive, store and display
measurements from home
use diagnostic medical
devices such blood
pressure meter and a
body composition
analyser The data will
not be used for medical
diagnosis It is not
intended to provide
automated treatment
decisions, nor is it to be
used as a substitute for a
professional healthcare
judgement | Confidant 2 5 is intended
for personal use by out-
of-hospital patients as a
means to retrospectively
collect and record
physiologic
measurements
from home monitoring
devices (including blood
glucose meters, blood
pressure cuffs and weight
scales) The data is
transmitted to a database
server where customized
messages are generated
by the system and
returned to the patient
The returned messages
contain objective
observations and
motivational information
intended to help the
patient better understand
and manage their health
Confidant 2 5 is an
accessory device that
collects data from a range
of supported home-
monitoring devices The | Equivalence except
No transmission of data
to data base server with
the
Health Manager software
No use of cell phone
technology with the
Health Manager
Software |
| | Substantial Equivalent
Device | Predicate Devices | | |
| | Biocomfort Health
Manager | Confidant 2 5 | Discussion of differences | |
| | | data is collected from the
supported devices and
sent to a central database
server, using standard
wireless technologies
Upon receipt of newly
submitted patient data,
the Confidant Server
software will generate
and send one or more
feedback
messages directly to the
patient's cell-phone The
feedback messages are
selected by the system
based on the patient's
currently submitted and
recent historic data | | |
| | | Confidant 2 5 does not
provide diagnosis of any
disease or medical
condition | | |
| | | Confidant 2 5 is not
intended to provide
automated treatment
decisions, or to be used
as a substitute for
professional healthcare
Judgment All
patient medical diagnoses
and treatment are to be
performed under the
supervision and oversight
of an appropriate
healthcare professional | | |
| | | Confidant 2 5 is not
intended for emergency
calls or for transmission
or indication of any real-
time alarms or time-
critical data This device
is not intended as a
substitute for direct
medical supervision or
emergency intervention | | |
| | | Confidant 2 5 is intended | | |
| | | Substantial Equivalent
Device
Biocomfort Health
Manager | Predicate Devices | Discussion of differences |
| | | | for over-the-counter use | |
| [02] | Target
population | Lay users | Lay users | Equivalent |
| [03] | Connected
Medical
Devices | Blood Pressure Meter
Body Composition
Analyzer | Blood Pressure Meter
Blood Glucose Meter
Weight Scale Meter | Equivalent except for
Body Composition
Analyzer instead of
weight scale and the
Health Manager does not
read data from a blood
glucose meter |
| [04] | User
interaction | Additional requests
regarding user behaviour | Additional requests
regarding user behaviour | Equivalent |
| [05] | Presentation of
results | In table and graphical
form
Printout of reports | In text and graphical form | Equivalent except with
printout function |
| [06] | Health
Management
Guidance | Graphical depiction of
health status via target
attainment graph and
provision of hints | Graphical depiction of
average measuring results
and motivational
information | Equivalent |
| [07] | Operation
environment | Windows based PC
Software | Cell Phone based
Software | PC based software
instead of cell phone
based software |
| [08] | Transmission
of data | Data transmission only
between peripheral
measuring devices and
the Health Manager
Software | Data transmission to
peripheral measuring
devices and central
database server | Equivalence except
No communication to
central data server |
| [09] | Connectivity | Radiofrequency | Radiofrequency | Equivalent |
2
3
Discussion of the Substantial Equivalence Decision.
The comparison shows that both devices are substantial equivalent The only differences are that the predicate device transmits the data to a database server which is not the intention of the Biocomfort Health Manager and that the Health Manager does not use cell phone technology or cell phone based software
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with an eagle's head facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Brocomfort Inc c/o Mr Dieter Schill President 23 Third Ave Burlington, MA 01803
Re K081499
Health Manager 2 0 Regulation Number 21 CFR 870 2910 Regulation Name Radiofrequency physiological signal transmitter and receiver Regulatory Class II Product Code DRG Dated November 18, 2008 Received November 21, 2008
Dear Mr Schill
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 pror 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 adulteratıon
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
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 - Mr Dieter Schill
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveyllance. please contact CDRH's Office of Surveillance and Brometric's (OSB's) D1v1s10n of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assustance 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 yours,
Historial Contracted on complete
100 100 100 10 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
The Beller of the 2-27 The The Start of the Broom Black of
Bram D Zuckerman, M D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
GATTAL BARE THE STERES TEMER TELLER COLLER STO BE
6
Indications for Use
510(k) Number (if known) K081499
Device Name Health Manager 2 0
The Brocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment to collect historical data from defined peripheral devices The software will receive, store and display measurements from home use diagnostic medical devices such blood pressure meter and a body composition analyser The data will not be used for medical diagnosis It is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement
Prescription Use (Part 21 CFR 801 Subpart D)
The first and still of the find of the find the find the for any of the
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR Device Evaluation (ODE)
B Zuckerman
(Division Sign-Off) / 11/6/01
Division of Cardiovascular Devices
12 2008 11 2 8 1 2 8 2 3 2 2 3 2 3 1 2 3 2 3 2 3 1 2 3 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 2 3 1 2 3 1 2 3
Fridate of 3 - while interest
510(k) Number K081499
05 - Indications for Use - Page 1 of 1
REPORTED