(31 days)
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.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Inrange Systems, Incorporated for their Inrange Remote Medication Management System (EMMA). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device. This is a regulatory clearance letter, not a performance study report.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided text. The document only outlines the device's indications for 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.
To answer your request, a different type of document, such as a clinical study report or a technical performance assessment, would be required.
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.