(36 days)
No
The description focuses on data collection, transmission, and rule-based messaging based on parameters set by a healthcare provider. There is no mention of AI/ML algorithms for data analysis, pattern recognition, or message generation.
No.
The Hermes System collects and transmits medical measurements and sends educational/motivational messages, but it explicitly states it is not intended to provide automated treatment decisions, substitute for professional healthcare judgment, or provide direct medical supervision or emergency intervention. Its function is to facilitate communication and provide support, not to directly treat or diagnose.
No
The Hermes System collects and transmits medical measurements but explicitly states it "is not intended to provide automated treatment decisions, nor to be used as a substitute for professional healthcare judgment." It acts as a data collection and communication tool, not a device that interprets data for diagnosis.
Yes
The device description explicitly states that "Hermes is a software system composed of two components, a Collector module and a Server module," both of which are described as software programs. While it interacts with off-the-shelf measurement devices, the Hermes system itself is defined as software.
Based on the provided information, the Hermes System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Hermes System Function: The Hermes System collects and transmits measurements from external devices (glucometer, blood pressure cuff, weight scale). It does not directly analyze or test biological specimens from the patient.
- Intended Use: The intended use is to collect and transmit existing medical measurements and provide educational/motivational messages. It explicitly states it's not for diagnosis, treatment decisions, or real-time alarms.
The Hermes System acts as a data collection and communication tool for existing medical measurements, rather than performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider.
The Hermes System is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient.
The Hermes System 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.
Hermes 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.
Product codes
DRG
Device Description
The Hermes System is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Hermes is used by the patient to collect data from one or more off-the-shelf measurement devices. Hermes currently supports a glucometer, a noninvasive blood pressure cuff and a weight scale.
Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up, data management, and message delivery capabilities.
Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hermes can send email to the patient's doctor and/or guardian if good habits are not maintained.
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
out-of-hospital patients, licensed physician or other authorized healthcare provider
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
extensive collection of tests has been conducted and successfully completed, including usability and pilot studies, software unit, integration, system and load/performance testing and document verification.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive performance testing was conducted. Based on performance testing and comparison to the predicate device, the Hermes System is substantially equivalent and presents no new concerns about safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
જીની જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના
7 April 2005
K050929
SECTION E SUMMARY
MAY 2 0 2005
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Palaistra Systems Inc. summary for the Hermes System.
| SUBMITTER'S NAME: | Palaistra Systems Inc. |
|---|---|
| ADDRESS: | 2530 Meridian Parkway, Suite 300 |
| CONTACT PERSON: | Daniel R. Plonski |
| CONTACT PERSON | |
| TITLE | Director of Product Management |
| TELEPHONE NUMBER: | (919) 806-4323 |
| FAX NUMBER: | (919) 806-4802 |
| DATE OF SUBMISSION: | March 25, 2005 |
ldentification of device 1
Proprietary Name: The Hermes System Common Name: Physiological Transmitter and Receiver Classification Status: Class II per regulations 870.2910 Product Codes: DRG
Equivalent devices 2
Palaistra Systems Inc. believes the Hermes System is substantially equivalent to the following legally marketed devices:
Description of the device 3
The Hermes System is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Hermes is used by the patient to collect data from one or more off-the-
1
shelf measurement devices. Hermes currently supports a glucometer, a noninvasive blood pressure cuff and a weight scale.
Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up, data management, and message delivery capabilities.
Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hermes can send email to the patient's doctor and/or guardian if good habits are not maintained.
ধ Intended use
The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider.
The Hermes System 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.
Hermes 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.
Technological characteristics, comparison to predicate device. ર્ક
The Hermes System provides equivalent functionality as the following legally marketed devices:
2
Three characteristics differentiate The Hermes System from the predicate devices:
-
- Data Collection Platform -- The Hermes Collector runs on a cell phone while both of the predicate devices run on proprietary hardware.
-
- Communications technology Hermes uses the Bluetooth protocol to communicate with the off-the-shelf measurement devices. The Telehealth Gateway also uses Bluetooth. Carematix uses a non-Bluetooth RF protocol. Hermes uses secure wireless network technology to send data to the healthcare facility server. Both of the predicate devices use a standard phone line.
-
- Patient Feedback Messages -- Hermes provides feedback messages to patients to reinforce good health habits. The Telehealth device dges not provide feedback and the Carematix device provides some capability fo send email messages to the patient.
Discussion of functional and safety testing. ર
An extensive collection of tests has been conducted and successfully completed, including usability and pilot studies, software unit, integration, system and load/performance testing and document verification.
Conclusion 7
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Palaistra Systems Inc. that the Hermes System is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concems about safety and effectiveness.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2005
Palaistra Systems, Inc. c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street NW Buffalo, MN 55313
Re: K050929
Trade Name: The Hermes System Regulation Number: 21 CFR 870.2910 Regulation Name: Physiologic Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: May 5, 2005 Received: May 6, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > ro(x) premainer's substantially equivalent (for the indications
referenced above and have determined the device is substantials merketed in in referenced above and nave decemblied the arrood predicate devices marketed in interstate for use stated in the encrosury manatinent date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edgeral Food. Drug commerce prior to May 28, 1970, the chooliners with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval applicians of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Y ou may, therefore, market the device, subject to meeting for annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the Net Herace required.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. The Color Role to Room of Chama may be subject to such additional controls: Existing major regars be found in the Code of Pederal Regarming your device in the Federal Register.
4
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualles of a successful other requirements of the Act
that FDA has made a determination that your device complies with other requirements of t that FDA has made a decemination that your as read by other Federal agencies. You must or any Federal statutes and regulations daminders bot not limited to: registration and listing (21
comply with all the Act's requirements, including, but not is a set comply with all the Act 3 requirements, notices, and manufacturing practice requirements as setser CFK Part 807), labemig (21 CFR Part 807), good manation (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 198 forlh in the quality systems (Q5) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections of 1 vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your douice to legal I his letter will anow you to begin maketing of substantial equivalence of your device to a legally premarket nother in the PDA midning of sabstantial equived 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
s to and the many and and and and and any to the rowletion entitled If you desire specific advice for your active of your and and please note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the m Comact the Office of Compilance at (210) 21 Certify of CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Other general miorination on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blzimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K050929
Device Name: The Hermes System
Indications For Use:
The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider.
The Hermes System is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the toonfielegies and ity. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient.
Continued on next page.
Prescription Use _ X (Part 21 CFR 801 Subpart D) 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 CDRH, Office of Device Evaluation (ODE)
Blummen
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Kr)50907
Page 1 of 2
6
Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone Server module. The data collection, transmission and message display capabilities. The and provides is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the setup, data management, and message delivery capabilities.
Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hermes can send email to the patient's doctor and/or guardian if good habits are not maintained.
The Hermes System is not intended for emergency calls or for transmission or The Hernes Oystern is not intended to entires of time-critical data. This device is not intended as a indibation or any ro medical supervision or emergency intervention.
Hermes is not intended to provide automated treatment decisions, nor to be used as a hemles is not intendou to profithcare judgment. All patient medical diagnoses and substitute for professional nealthours for smootision and oversight of an appropriate healthcare professional.