(232 days)
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
The Brocomfort Health Manager is a software for local home PC or 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 provided text is a 510(k) summary for the Biocomfort Health Manager 2.0, a software device intended to collect, store, and display measurements from home-use diagnostic medical devices. The document explicitly states the device's intended use and makes comparisons to a predicate device (Confidant 2.5) to establish substantial equivalence.
However, this document does not contain information on acceptance criteria for device performance or a study demonstrating the device meets those criteria. The "SE Discussion" section compares the new device to a predicate device on various characteristics, but this is to establish substantial equivalence based on functional and operational similarities and differences, not performance metrics against specific acceptance criteria.
Therefore, many of the requested items cannot be answered from the provided text.
Based on the available information:
1. Table of acceptance criteria and reported device performance:
* Not Available. The document does not specify any performance acceptance criteria or report device performance against such criteria. The discussion focuses on comparing the new device's features and intended use to a predicate device to establish substantial equivalence, not on quantitative performance metrics.
2. Sample size used for the test set and data provenance:
* Not Applicable / Not Available. No performance testing with a specific test set is described. The 510(k) summary focuses on establishing substantial equivalence through feature comparison with a predicate device.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not Applicable / Not Available. Since no performance study is described, there's no mention of a test set or ground truth established by experts.
4. Adjudication method for the test set:
* Not Applicable / Not Available. No performance study or test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* No. An MRMC study was not mentioned. The device is software for managing data from home-use devices, not an interpretative AI that would typically be involved in such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not Applicable / Not Available. The document describes a software device that collects, stores, and displays data. It does not describe an "algorithm" in the sense of an interpretative AI requiring standalone performance testing. The comparison is feature-based against a predicate.
7. The type of ground truth used:
* Not Applicable / Not Available. No performance ground truth is mentioned as no explicit performance study is detailed.
8. The sample size for the training set:
* Not Applicable / Not Available. Software for data management (not a machine learning algorithm requiring training on data to make predictions) is being described. Therefore, a training set is not pertinent to this submission type.
9. How the ground truth for the training set was established:
* Not Applicable / Not Available. (See point 8).
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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 KGBernhaeuser Strasse 1773765 Neuhausen a d FGermanyRegistration Number 3006493236Owner/Operator Number 10023755 | |
| Official Correspondent | Mrs Marion OttoQuality ManagerBiocomfort GmbH & Co KGPhone +49 7158 98016-48Fax +49 7158 98016-40E-mail otto@biocomfort de | |
| US Agent (Contact) | Mr Dieter SchillPresidentBiocomfort Inc23 Third AvenueBurlington, MA 01803 USAPhone +1 866 294 8267E-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 EquivalentDevice | Predicate Devices | |||
|---|---|---|---|---|
| Biocomfort HealthManager | Confidant 2 5 | Discussion of differences | ||
| [01] | Indication foruse | The Biocomfort HealthManager is a software forlocal home PC or Laptopin a non clinicalenvironment to collecthistorical data fromdefined peripheraldevices The software willreceive, store and displaymeasurements from homeuse diagnostic medicaldevices such bloodpressure meter and abody compositionanalyser The data willnot be used for medicaldiagnosis It is notintended to provideautomated treatmentdecisions, nor is it to beused as a substitute for aprofessional healthcarejudgement | Confidant 2 5 is intendedfor personal use by out-of-hospital patients as ameans to retrospectivelycollect and recordphysiologicmeasurementsfrom home monitoringdevices (including bloodglucose meters, bloodpressure cuffs and weightscales) The data istransmitted to a databaseserver where customizedmessages are generatedby the system andreturned to the patientThe returned messagescontain objectiveobservations andmotivational informationintended to help thepatient better understandand manage their healthConfidant 2 5 is anaccessory device thatcollects data from a rangeof supported home-monitoring devices The | Equivalence exceptNo transmission of datato data base server withtheHealth Manager softwareNo use of cell phonetechnology with theHealth ManagerSoftware |
| Substantial EquivalentDevice | Predicate Devices | |||
| Biocomfort HealthManager | Confidant 2 5 | Discussion of differences | ||
| data is collected from thesupported devices andsent to a central databaseserver, using standardwireless technologiesUpon receipt of newlysubmitted patient data,the Confidant Serversoftware will generateand send one or morefeedbackmessages directly to thepatient's cell-phone Thefeedback messages areselected by the systembased on the patient'scurrently submitted andrecent historic data | ||||
| Confidant 2 5 does notprovide diagnosis of anydisease or medicalcondition | ||||
| Confidant 2 5 is notintended to provideautomated treatmentdecisions, or to be usedas a substitute forprofessional healthcareJudgment Allpatient medical diagnosesand treatment are to beperformed under thesupervision and oversightof an appropriatehealthcare professional | ||||
| Confidant 2 5 is notintended for emergencycalls or for transmissionor indication of any real-time alarms or time-critical data This deviceis not intended as asubstitute for directmedical supervision oremergency intervention | ||||
| Confidant 2 5 is intended | ||||
| Substantial EquivalentDeviceBiocomfort HealthManager | Predicate Devices | Discussion of differences | ||
| for over-the-counter use | ||||
| [02] | Targetpopulation | Lay users | Lay users | Equivalent |
| [03] | ConnectedMedicalDevices | Blood Pressure MeterBody CompositionAnalyzer | Blood Pressure MeterBlood Glucose MeterWeight Scale Meter | Equivalent except forBody CompositionAnalyzer instead ofweight scale and theHealth Manager does notread data from a bloodglucose meter |
| [04] | Userinteraction | Additional requestsregarding user behaviour | Additional requestsregarding user behaviour | Equivalent |
| [05] | Presentation ofresults | In table and graphicalformPrintout of reports | In text and graphical form | Equivalent except withprintout function |
| [06] | HealthManagementGuidance | Graphical depiction ofhealth status via targetattainment graph andprovision of hints | Graphical depiction ofaverage measuring resultsand motivationalinformation | Equivalent |
| [07] | Operationenvironment | Windows based PCSoftware | Cell Phone basedSoftware | PC based softwareinstead of cell phonebased software |
| [08] | Transmissionof data | Data transmission onlybetween peripheralmeasuring devices andthe Health ManagerSoftware | Data transmission toperipheral measuringdevices and centraldatabase server | Equivalence exceptNo communication tocentral 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 (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
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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
§ 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).