HEALTH MANAGER, VERSION 1.1

K081499 · Biocomfort Diagnostics GmbH & Co. KG · DRG · Jan 16, 2009 · Cardiovascular

Device Facts

• Record ID: K081499
• Device Name: HEALTH MANAGER, VERSION 1.1
• Applicant: Biocomfort Diagnostics GmbH & Co. KG
• Product Code: DRG · Cardiovascular
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

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

Device Story

Health Manager 2.0 is PC/laptop-based software for home use; manages data from up to 8 users. Device connects to peripheral diagnostic equipment (blood pressure meters, body composition analyzers) via a proprietary USB-dongle using radiofrequency (RF) transmission. Software receives, stores, and displays historical measurement data in table and graphical formats; includes report printout capability. Intended for personal health tracking; does not provide medical diagnosis, automated treatment decisions, or real-time alarms. Users operate the system locally; no data transmission to external servers or cloud databases. Output assists users in monitoring health trends via target attainment graphs and hints; intended to supplement, not replace, professional medical supervision.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Software-only device for Windows-based PC/laptop. Connectivity via proprietary USB-dongle using radiofrequency (RF) signal transmission. Data management for up to 8 users. Displays data in graphical/tabular formats with print capability. No hardware components other than the USB-dongle.

Indications for Use

Indicated for lay users in a non-clinical home environment to collect, store, and display historical physiological measurements from peripheral diagnostic devices (blood pressure meters and body composition analyzers). Not for medical diagnosis, automated treatment decisions, or as a substitute for professional healthcare judgment.

Regulatory Classification

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.

Predicate Devices

• Confidant 2.5 (K072698)

Submission Summary (Full Text)

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#### 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<br>Bernhaeuser Strasse 17<br>73765 Neuhausen a d F<br>Germany<br>Registration Number 3006493236<br>Owner/Operator Number 10023755 | |
| Official Correspondent | Mrs Marion Otto<br>Quality Manager<br>Biocomfort GmbH & Co KG<br>Phone [phone]<br>Fax [phone]<br>E-mail otto@biocomfort de | |
| US Agent (Contact) | Mr Dieter Schill<br>President<br>Biocomfort Inc<br>23 Third Avenue<br>Burlington, MA 01803 USA<br>Phone [phone]<br>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 | |

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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<br>Device | Predicate Devices | |
|------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Biocomfort Health<br>Manager | Confidant 2 5 | Discussion of differences |
| [01] | Indication for<br>use | The Biocomfort Health<br>Manager is a software for<br>local home PC or Laptop<br>in a non clinical<br>environment to collect<br>historical data from<br>defined peripheral<br>devices The software will<br>receive, store and display<br>measurements from home<br>use diagnostic medical<br>devices such blood<br>pressure meter and a<br>body composition<br>analyser The data will<br>not be used for medical<br>diagnosis It is not<br>intended to provide<br>automated treatment<br>decisions, nor is it to be<br>used as a substitute for a<br>professional healthcare<br>judgement | Confidant 2 5 is intended<br>for personal use by out-<br>of-hospital patients as a<br>means to retrospectively<br>collect and record<br>physiologic<br>measurements<br>from home monitoring<br>devices (including blood<br>glucose meters, blood<br>pressure cuffs and weight<br>scales) The data is<br>transmitted to a database<br>server where customized<br>messages are generated<br>by the system and<br>returned to the patient<br>The returned messages<br>contain objective<br>observations and<br>motivational information<br>intended to help the<br>patient better understand<br>and manage their health<br>Confidant 2 5 is an<br>accessory device that<br>collects data from a range<br>of supported home-<br>monitoring devices The | Equivalence except<br>No transmission of data<br>to data base server with<br>the<br>Health Manager software<br>No use of cell phone<br>technology with the<br>Health Manager<br>Software |
| | Substantial Equivalent<br>Device | Predicate Devices | | |
| | Biocomfort Health<br>Manager | Confidant 2 5 | Discussion of differences | |
| | | data is collected from the<br>supported devices and<br>sent to a central database<br>server, using standard<br>wireless technologies<br>Upon receipt of newly<br>submitted patient data,<br>the Confidant Server<br>software will generate<br>and send one or more<br>feedback<br>messages directly to the<br>patient's cell-phone The<br>feedback messages are<br>selected by the system<br>based on the patient's<br>currently submitted and<br>recent historic data | | |
| | | Confidant 2 5 does not<br>provide diagnosis of any<br>disease or medical<br>condition | | |
| | | Confidant 2 5 is not<br>intended to provide<br>automated treatment<br>decisions, or to be used<br>as a substitute for<br>professional healthcare<br>Judgment All<br>patient medical diagnoses<br>and treatment are to be<br>performed under the<br>supervision and oversight<br>of an appropriate<br>healthcare professional | | |
| | | Confidant 2 5 is not<br>intended for emergency<br>calls or for transmission<br>or indication of any real-<br>time alarms or time-<br>critical data This device<br>is not intended as a<br>substitute for direct<br>medical supervision or<br>emergency intervention | | |
| | | Confidant 2 5 is intended | | |
| | | Substantial Equivalent<br>Device<br>Biocomfort Health<br>Manager | Predicate Devices | Discussion of differences |
| | | | for over-the-counter use | |
| [02] | Target<br>population | Lay users | Lay users | Equivalent |
| [03] | Connected<br>Medical<br>Devices | Blood Pressure Meter<br>Body Composition<br>Analyzer | Blood Pressure Meter<br>Blood Glucose Meter<br>Weight Scale Meter | Equivalent except for<br>Body Composition<br>Analyzer instead of<br>weight scale and the<br>Health Manager does not<br>read data from a blood<br>glucose meter |
| [04] | User<br>interaction | Additional requests<br>regarding user behaviour | Additional requests<br>regarding user behaviour | Equivalent |
| [05] | Presentation of<br>results | In table and graphical<br>form<br>Printout of reports | In text and graphical form | Equivalent except with<br>printout function |
| [06] | Health<br>Management<br>Guidance | Graphical depiction of<br>health status via target<br>attainment graph and<br>provision of hints | Graphical depiction of<br>average measuring results<br>and motivational<br>information | Equivalent |
| [07] | Operation<br>environment | Windows based PC<br>Software | Cell Phone based<br>Software | PC based software<br>instead of cell phone<br>based software |
| [08] | Transmission<br>of data | Data transmission only<br>between peripheral<br>measuring devices and<br>the Health Manager<br>Software | Data transmission to<br>peripheral measuring<br>devices and central<br>database server | Equivalence except<br>No communication to<br>central data server |
| [09] | Connectivity | Radiofrequency | Radiofrequency | Equivalent |

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#### 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

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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

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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 [phone] 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 [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Historial Contracted on complete

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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

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#### 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