(51 days)
Not Found
No
The description focuses on telemedicine workflow, video conferencing, documentation, and a simple dose calculator based on clinician-entered weight. There is no mention of AI or ML capabilities.
No
The device is described as a telemedicine solution and a dose calculator. It aids clinicians in the consultative process and assists in workflow and documentation, but it does not directly treat or diagnose a disease or condition. Its function is to support clinical decision-making and communication, not to deliver a therapeutic effect itself.
No
The device is a dose calculator and telemedicine solution, not a diagnostic device. It aids in the consultative process and supports treatment decisions, but it explicitly states it does not overrule or replace physician judgment or diagnosis, and no medical decision should be based solely on its results.
Yes
The device description focuses entirely on the software platform's features (workflow, video conferencing, documentation, imaging integration) and its function as a telemedicine solution. While it integrates with medical imaging, the description does not indicate that the device itself includes any hardware components or performs hardware-based functions beyond processing data within the software environment. The predicate device is also a software-based dose calculator.
Based on the provided information, the REACH Access Telemedicine Dose Calculator is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used by clinicians to calculate drug doses for patients based on their weight and clinical status. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device's function is a dose calculator. While it's part of a larger telemedicine system, its core function described in the intended use is to calculate drug doses based on clinician-provided weight. This is a computational tool, not a diagnostic test performed on a specimen.
- The predicate device is a "WEIGHT BASED DOSE CONVERTER". This further reinforces that the device's function is related to drug dosage calculation, not in vitro diagnostic testing.
The device is a software tool intended to aid clinicians in the process of determining appropriate drug doses for patients during telemedicine consultations. It does not perform any diagnostic testing on patient specimens.
N/A
Intended Use / Indications for Use
The REACH Access Telemedicine Dose Calculator is designed for used by trained clinicians to calculate any individual patient's dose for a given agent based on a weight determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the ordering clinician and the software provides no validation as to the appropriateness of the entered weight-based dose. The REACH Access Telemedicine Dose Calculator is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program. The REACH Access Telemedicine is intended to be used as an aid in the consultative process and does not overrule or replace physician judgment or diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
NDC, LLZ, OUG
Device Description
REACH Access is a highly integrated Telemedicine solution that combines workflow, video conferencing, electronic clinical documentation, and medical imaging into a comprehensive and secure internet-based service. It enables healthcare organizations to form virtual collaborative care teams which are created based on patient need rather than availability of specialists. With a flexible, template-based design tool, REACH Access can build template sets which support clinician workflow and documentation relevant to numerous protocols. REACH Access templates support a specific point-in-time consult. This means the workflow processes and clinical content is captured and coordinated with the integrated audio/video conference to allow a remote provider to collaborate with caregivers at a different location in the care of a patient.
The normal process is the patient is assessed and treated in the Emergency Department (ED) by ED staff and the video conference support of a specialist consultant. After reviewing key patient data and assessing the patient, the remote consultant renders an impression, recommends the treatment order as indicated, and helps determine the appropriate disposition. This usually concludes the consultant's part in the session. The ED continues to render care by completing the recommended treatment order and monitoring patient vital signs and other assessments. The disposition commonly consists of transferring the originating hospital to the Hub with which the consultant is associated. However, if there is adequate local support, the decision may be made to admit the patient to the local facility.
This process/workflow is similar to what may be required for other point-in-time consults needed to provide additional remote assistance to caregivers for other patient problems or conditions at the patient point of care. A protocol/template can be part of a coordinated collection of toolsets. The flexible template design process in REACH Access addresses the need for multiple protocols to support the various phases of care. The flexibility of the tool allows for the unique presentation of data for a specific condition; e.g., stroke, in the format most relevant to the patient's current need/condition. This flexibility can be replicated to address similar capability. This can be handled through a combination of both individual and a series of protocols arranged in clinically logical groups.
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
Trained clinicians
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
REACH Access Telemedicine Dose Calculator: Validation and Verification
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
PICIS WEIGHT BASED DOSE CONVERTER, K121542
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a series of faces in profile, often interpreted as representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2014
REACH Health, Incorporated Ms. Beth DeStasio Director, Regulatory Affairs & Strategy 10745 Westside Way Alpharetta, GA 30009
Re: K142123
Trade/Device Name: REACH Access Telemedicine Dose Calculator Regulation Number: 21 CFR 868.1890 Regulation Name: Drug Dose Calculator Regulatory Class: II Product Code: NDC, LLZ, OUG Dated: August 4, 2014 Received: August 5, 2014
Dear Ms. DeStasio:
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.
1
Page 2 - Ms. DeStasio
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Mary S. Runner -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) K142123
Device Name REACH Access Telemedicine Dose Calculator
Indications for Use (Describe)
The REACH Access Telemedicine Dose Calculator is designed for used by trained clinicians to calculate any individual patient's dose for a given agent based on a weight determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the ordering clinician and the software provides no validation as to the appropriateness of the entered weight-based dose. The REACH Access Telemedicine Dose Calculator is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program. The REACH Access Telemedicine is intended to be used as an aid in the consultative process and does not overrule or replace physician judgmosis.
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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3
Image /page/3/Picture/1 description: The image is a logo for Reach Health, a telemedicine company. The logo features a blue circle with a gray plus sign in the center, followed by the word "REACHHEALTH" in black and blue letters. Below the company name is the tagline "POWERING TELEMEDICINE" in gray letters. The logo is simple and modern, and it conveys the company's focus on healthcare and technology.
5. 510(k) Sumn
| Submitter: | REACH Health, Inc. |
|---|---|
| Address: | 10745 Westside Way |
| Alpharetta, GA 30009 | |
| Phone number: | (678) 436-8214 |
| Fax number: | (678) 710-9064 |
| Contact person: | Beth DeStasio |
| Phone number: | (678) 436-8214 |
| Fax number: | (678) 710-9064 |
| Date prepared: | 8/1/2014 |
| Trade name: | REACH Access Telemedicine Dose Calculator |
| Common name: | Drug Dose Calculator |
| Primary Product Code: | NDC |
| Classification Number: | 21 CFR 868.1890 |
| Class: | II |
| Secondary Product Codes: | LLZ (Picture archiving and communications system), OUG (Medical |
| Device Data System) | |
| 510(k) Number: | K142123 |
Substantial equivalence claimed to: PICIS WEIGHT BASED DOSE CONVERTER, K121542
Description:
REACH Access is a highly integrated Telemedicine solution that combines workflow, video conferencing, electronic clinical documentation, and medical imaging into a comprehensive and secure internet-based service. It enables healthcare organizations to form virtual collaborative care teams which are created based on patient need rather than availability of specialists. With a flexible, template-based design tool, REACH Access can build template sets which support clinician workflow and documentation relevant to numerous protocols. REACH Access templates support a specific point-in-time consult. This means the workflow
processes and clinical content is captured and coordinated with the integrated audio/video conference to allow a remote provider to collaborate with caregivers at a different location in the care of a patient.
The normal process is the patient is assessed and treated in the Emergency Department (ED) by ED staff and the video conference support of a specialist consultant. After reviewing key patient data and assessing the patient, the remote consultant renders an impression, recommends the treatment order as indicated, and helps determine the appropriate disposition. This usually concludes the consultant's part in the session. The ED continues to render care by completing the recommended treatment order and monitoring patient vital signs and other assessments. The disposition commonly consists of transferring the originating hospital to the Hub with which the consultant is associated. However, if there is adequate local support, the decision may be made to admit the patient to the local facility.
4
This process/workflow is similar to what may be required for other point-in-time consults needed to provide additional remote assistance to caregivers for other patient problems or conditions at the patient point of care. A protocol/template can be part of a coordinated collection of toolsets. The flexible template design process in REACH Access addresses the need for multiple protocols to support the various phases of care. The flexibility of the tool allows for the unique presentation of data for a specific condition; e.g., stroke, in the format most relevant to the patient's current need/condition. This flexibility can be replicated to address similar capability. This can be handled through a combination of both individual and a series of protocols arranged in clinically logical groups.
Indications for Use:
The REACH Access Telemedicine Dose Calculator is designed for used by trained clinicians to calculate any individual patient's dose for a given agent based on a weight determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight-based dose. The REACH Access Telemedicine Dose Calculator is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program. The REACH Access Telemedicine Dose Calculator is intended to be used as an aid in the consultative process and does not overrule or replace physician judgment or diagnosis.
5
Substantial Equivalence:
The REACH Access Telemedicine Dose Calculator is substantially equivalent to the predicate Device, the Picis Weight Based Dose Converter.
| REACH Access | Picis (K121542) | |
|---|---|---|
| Manufacturer | REACH Health, Inc. | Picis Incorporated |
| 510(k) | NA | K121542 |
| Indication for | ||
| use | The REACH Access Telemedicine | |
| Dose Calculator is designed for | ||
| used by trained clinicians to | ||
| calculate any individual patient's | ||
| dose for a given agent based on a | ||
| weight determined by the clinician. | ||
| Drug dosing for a patient must be | ||
| made only after careful | ||
| consideration of the full clinical | ||
| status of the patient by the | ||
| ordering clinician and the software | ||
| provides no validation as to the | ||
| appropriateness of the entered | ||
| weight-based dose. The REACH | ||
| Access Telemedicine Dose | ||
| Calculator is a convenience | ||
| feature for trained clinicians based | ||
| upon accurately entered data. No | ||
| medical decision should be based | ||
| solely upon the results provided by | ||
| this software program. The | ||
| REACH Access Telemedicine | ||
| Dose Calculator is intended to be | ||
| used as an aid in the consultative | ||
| process and does not overrule or | ||
| replace physician judgment or | ||
| diagnosis. | The Picis Weight Based Dose | |
| Converter is designed for use by | ||
| trained clinicians to calculate any | ||
| individual patients dose for a given | ||
| agent based on a weight based | ||
| dose determined by the clinician. | ||
| Drug dosing for a patient | ||
| must be made only after careful | ||
| consideration of the full clinical | ||
| status of the patient by the | ||
| ordering clinician and the | ||
| software provides no validation | ||
| as to the appropriateness of the | ||
| entered weight based dose. | ||
| The Picis Weight Based Dose | ||
| Converter is not a substitute for | ||
| clinical reasoning. The Picis | ||
| Weight Based Dose Converter | ||
| is a convenience feature for | ||
| trained clinicians based upon | ||
| accurately entered data. No | ||
| medical decision should be based | ||
| solely upon the results provided | ||
| by this software program. | ||
| Target | ||
| Population | In-hospital patients | In-hospital patients |
| User Population | Trained healthcare professionals | Trained healthcare professionals |
| Dose | ||
| Computation | Software based application used | |
| to compute total drug dose | Software based application used | |
| to compute total drug dose | ||
| Algorithms | Uses simple mathematical | |
| equation to calculate dosing based | ||
| on patient weight | Uses simple mathematical | |
| equation to calculate dosing | ||
| based on patient weight and | ||
| numerical dose and units | ||
| Testing | Validation and Verification | Validation and Verification |
6
Substantial Equivalence Discussion
The REACH Access Telemedicine Dose Calculator is substantially equivalent to the predicate Device, the Picis Weight Based Dose Converter. The REACH Access Telemedicine Dose Calculator has the same intended uses, technological characteristics and principles of operation as the predicate device. The minor technological differences between the REACH Access Telemedicine Dose Calculator and the predicate device raise no issues of safety or effectiveness. Both devices calculate an individual patient's dose for a given agent based on a weight based dose determined by the clinician.
Conclusion:
The performance of the REACH Access Telemedicine Dose Calculator is substantially equivalent to that of the Picis Weight Based Dose Converter and raises no safety or effectiveness issues and performs as well or better than the predicate device.