(375 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the added algorithms as simple conversions and calculations based on sensor data.
No.
The device is indicated for measuring, recording, displaying, and transmitting physiological data, which are diagnostic or monitoring functions, not therapeutic.
Yes
The Prizma device is indicated for home users to measure, record, display, and/or transmit various physiological parameters (ECG, heart rate, SpO2, pulse rate, body temperature), which are data points used in the diagnosis of a medical condition, meeting the definition of a diagnostic device.
No
The device description explicitly mentions "sensor capabilities" including ECG, photo-plethysmography, and IR thermometer, indicating the presence of hardware components for data acquisition.
Based on the provided information, the Prizma device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Prizma's Function: The Prizma device measures physiological parameters directly from the patient's body:
- ECG (electrical activity of the heart)
- Peripheral oxygen saturation (SpO2)
- Pulse rate
- Body temperature
These measurements are taken in vivo (within the living body) using sensors that interact with the skin. The device does not analyze samples taken from the body.
Therefore, the Prizma device falls under the category of physiological monitoring devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Prizma device is indicated for home users to measure, record, display and/or transmit ECG one-lead data, heart rate, peripheral oxygen saturation, pulse rate and body temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application. Intended population: adult patients.
Product codes (comma separated list FDA assigned to the subject device)
DXH, DQA, FLL
Device Description
The Prizma device described in this submission is based on the cleared Prizma device (K170181), and its physical design has not been modified. The following algorithm functions have been added to the system, thereby extending the indications for use: a) conversion of the previously cleared and reported skin temperature measurement into body temperature b) Pulse rate calculation using the oximeter function. The sensor capabilities of the new Prizma are as follows: - . One lead ECG sensor - ECG rhythm recording and heart rate measurement - . Photo-plethysmography - Peripheral capillary Oxygen Saturation (SPO2) measurement, pulse rate: - . IR thermometer - skin temperature converted into body temperature.
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
adult patients.
Intended User / Care Setting
home users
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)
Clinical Validation Prizma IR measured skin temperature to body temperature Temperature conversion by the subject Prizma was compared against the auxiliary temperature (under armpit) measured by mercury thermometer during 10 min as a reference temperature, in 167 patients (57 % percentage of which were febrile patients). Statistical characteristics (clinical bias, limits of agreement and clinical repeatability) were calculated in accordance with requirements in ISO 80601-2-56: 1st edition 2009.
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.
Prizma (K170181), SpO Medical, PulseOx 5500 Finger Device, K040178
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.
Card Guard Scientific Survival, Health-ePod, K083174
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
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 30, 2018
G-Medical Innovations Ltd. Asher Kassel RA, QA 5 Openheimer St. Park Rabin Rehovot 7670105. Israel
Re: K173589
Trade/Device Name: Prizma Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DQA, FLL Dated: October 8. 2018 Received: October 10, 2018
Dear Asher Kassel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K173589
Device Name Prizma
Indications for Use (Describe)
The Prizma device is indicated for home users to measure, record, display and/or transmit ECG one-lead data, heart rate, peripheral oxygen saturation, pulse rate and body temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application.
Intended population: adult patients.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
_ Over-The-Counter Use (21 CFR 801
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510(k) SUMMARY G-Medical Innovations Ltd., Prizma Device
Submitter
| Company: | G-Medical Innovations Ltd. |
|---|---|
| Address: | 5 Openheimer St., Park Rabin, Rehovot, 7670105, Israel |
| Phone: | |
| Facsimile: | 972-8-9584777 |
| 972-8-9584783 | |
| Contact person: | Asher Kassel |
| Date prepared: | 20 November 2017 (for original submission) |
| Date updated: | 25 July 2018 |
| Name of Device: | Prizma |
|---|---|
| Common or Usual Name: | Transmitters and Receivers, Electrocardiograph, Telephone |
| Oximeter | |
| Classification Name: | 870.2920 Telephone electrocardiograph transmitter and receiver |
| 870.2700 Oximeter | |
| 880.2910 Clinical electronic thermometer | |
| Regulatory Class: | 2 |
| Product Code: | DXH, DQA, FLL |
PREDICATE DEVICES
Prizma (K170181) – Primary predicate SpO Medical, PulseOx 5500 Finger Device, K040178 – for HR calculation in PPG signal
Reference Device
Card Guard Scientific Survival, Health-ePod, K083174 – for skin temperature conversion
DEVICE DESCRIPTION
The Prizma device described in this submission is based on the cleared Prizma device (K170181), and its physical design has not been modified.
4
The following algorithm functions have been added to the system, thereby extending the indications for use:
a) conversion of the previously cleared and reported skin temperature measurement into body temperature
b) Pulse rate calculation using the oximeter function.
The sensor capabilities of the new Prizma are as follows:
- . One lead ECG sensor - ECG rhythm recording and heart rate measurement
- . Photo-plethysmography - Peripheral capillary Oxygen Saturation (SPO2) measurement, pulse rate:
- . IR thermometer - skin temperature converted into body temperature.
INDICATIONS FOR USE
The Prizma device is indicated for home users to measure, record, display and/or transmit ECG one-
lead data, heart rate, peripheral oxygen saturation, pulse rate and body temperature data. The
device utilizes a mobile platform to initiate user actions (test, display and data transfer by email)
through the mobile application.
Intended population: adult patients.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Prizma device described in this submission are the same as in the cleared Prizma device (K170181). The main differences between the subject and previously cleared Prizma are modifications to the software that allow:
(1) calculation of body temperature from skin temperature measurements
(2) calculation of pulse rare via the pulse oximeter test
These features have been previously cleared in the Health-ePod, and the PulseOx 5500 finger device, respectively. The company performed the validation testing summarized below to show equivalent performance.
No safety and effectiveness questions are raised in comparing the subject Prizma to the predicates. Differences between the devices are supported by testing demonstrating at least equivalent performance; therefore we submit that the device is substantially equivalent to its predicate devices.
PERFORMANCE DATA
The Prizma was tested according to the following standards:
-
- IEC60601-2-47, Ed. 2.0: Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems.
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-
- ISO 80601-2-56, Ed. 1.0: Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
-
- ISO 80601-2-61, Ed. 1.0: Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
In addition, usability testing was conducted per IEC 62366-1:2015.
CLINICAL DATA
Clinical Validation Prizma IR measured skin temperature to body temperature
Temperature conversion by the subject Prizma was compared against the auxiliary temperature (under armpit) measured by mercury thermometer during 10 min as a reference temperature, in 167 patients (57 % percentage of which were febrile patients).
Statistical characteristics (clinical bias, limits of agreement and clinical repeatability) were calculated in accordance with requirements in ISO 80601-2-56: 1st edition 2009.
CONCLUSIONS
The Prizma device is not modified in physical design, materials and technology from the predicate Prizma, and is as safe and effective as the Health-ePod and PulseOx 5500 Finger medical devices. The Prizma has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. In addition, the minor technological differences between the Prizma and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Prizma is as safe and effective as the predicate devices. We therefore submit that the Prizma is substantially equivalent to the cleared predicate devices.