(31 days)
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No
The summary describes a system for remote medication management with scheduling, notification, and dispensing features, but there is no mention of AI or ML in the intended use, device description, or any other section.
No
Explanation: The device manages and delivers medications which are therapeutic, but the device itself does not directly treat or cure a disease or condition. It is an aid in managing therapeutic regimens.
No
This device is designed for medication management and delivery, not for diagnosing medical conditions. Its functions include storing medications, scheduling doses, notifying patients, dispensing medications, and providing event history to medical providers.
No
The description explicitly mentions a "delivery unit" which is a hardware component used to store and release medications. This indicates the system is not solely software.
Based on the provided information, the Inrange Remote Medication Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of the Inrange system is to aid medical providers in managing therapeutic regimens by storing, scheduling, notifying, releasing, and tracking prescribed medications. This involves managing the administration of medications to the patient, not analyzing samples from the patient.
- Lack of IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection of biomarkers, pathogens, or other substances in the body.
- Diagnostic or screening purposes based on sample analysis.
The Inrange system is a medication management device, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The system provides a means: for the patient's prescribed medications to be stored in a delivery unit; for a medical provider to remotely schedule the patient's prescribed medications; to provide notification to the patient when the prescribed medications are due to be taken; to release the prescribed medications to a tray of the delivery unit accessible to the patient's command; and to provide to the medical provider a history of the event.
Product codes
NZH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medical providers in the home or clinic
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.6315 Remote Medication Management System.
(a)
Identification. A remote medication management system is a device composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and to record a history of the event for the health care professional. The system is intended for use as an aid to health care professionals in managing therapeutic regimens for patients in the home or clinic.(b)
Classification. Class II (special controls). The special control is: The FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System.” See § 880.1(e) for availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
Inrange Systems, Incorporated Christopher E. Bossi President 3316 5th Avenue - Suite 100 Altoona, Pennsylvania 16602
Re: K150174
Trade/Device Name: Inrange Remote Medication Management System (EMMA) Regulation Number: 21 CFR 880.6315 Regulation Name: Remote Medication Management System Regulatory Class: II Product Code: NZH Dated: January 27, 2015 Received: January 29, 2015
Dear Mr. Bossi:
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. 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.
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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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150174
Device Name
Inrange Remote Medication Management System (EMMA)
Indications for Use (Describe)
The Inrange Remote Medication Management System is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. The system provides a means: for the patient's prescribed medications to be stored in a delivery unit; for a medical provider to remotely schedule the patient's prescribed medications; to provide notification to the patient when the prescribed medications are due to be taken; to release the prescribed medications to a tray of the delivery unit accessible to the patient's command; and to provide to the medical provider a history of the event.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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