(113 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and transmission, not analysis or interpretation using AI/ML.
No
The primary function of the device is to collect and transmit vital signs data retrospectively for review by healthcare professionals, not to directly treat or diagnose a disease or condition. While it aids in patient monitoring, it explicitly states it is "not intended for real-time, emergency, or critical care monitoring."
No
The device collects vital signs data and transmits it for retrospective review by healthcare professionals. It explicitly states it is "not intended for real-time, emergency, or critical care monitoring," and its function as a "communication hub" for transmitting data for later review does not classify it as a device that diagnoses conditions.
No
The device description explicitly states it is designed to optionally collect data via "Bluetooth medical peripherals," including a scale and glucose meter. These are hardware components, indicating the device is not solely software.
Based on the provided text, the MiPal device 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.
- MiPal's function: The MiPal collects vital signs data (blood pressure, pulse rate, weight, SpO2, glucose) from the patient's body using non-invasive methods and external peripherals. It then transmits this data.
- No sample analysis: The description does not mention any analysis of biological samples taken from the patient. The device is focused on collecting and transmitting physiological measurements.
Therefore, the MiPal falls under the category of a medical device that collects and transmits physiological data, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. It is not intended for real-time, emergency, or critical care monitoring of patient vital signs. The MiPal is intended for use with adult and pediatric patients over twelve years of age.
SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DXN, FRI, DQA, NBW
Device Description
The MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.
The MiPal is designed to optionally collect NiBP, pulse, and SpO2. It may also collect other vitals through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:
- Scale
- Glucose meter
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 and pediatric patients over twelve years of age.
Intended User / Care Setting
qualified health care professionals.
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)
The verification and validation results demonstrated that the MiPal was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.
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.
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
§ 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
K120470/S001
| Submitter: | Watermark Medical | JUN - 8 2012 | ||||||
|---|---|---|---|---|---|---|---|---|
| Address: | 1750 Clint Moore Road, Suite 101 | |||||||
| Boca Raton, FL 33487 | ||||||||
| Corporate Contact: | Frank Katarow, Chief Operating Officer | |||||||
| WaterMark Medical | ||||||||
| Telephone: | 877-710-6999 | |||||||
| Establishment Registration #: | 3008208119 | |||||||
| Submission Contact: | Michael J. Leigh, consultant | |||||||
| 12715 Falcon Drive | ||||||||
| Brookfield, Wisconsin 53005 | ||||||||
| Ph: (262) 957-6797 | ||||||||
| Trade Name: | MiPal | |||||||
| Predicate Device: | Honeywell HomMed Genesis OTC, K061087 | |||||||
| Common Name: | Patient Vital Signs Monitor | |||||||
| Classification Name: | Regulation | Product | Classification Name | Device |
Code
DRG
DXN
FRI
DQA
NBW
Transmitters And Receivers, Physiological
Noninvasive Blood Pressure Measurement
Signal, Radiofrequency Medical device product codes also supported by MiPal by means of separate medical devices
Patient Weight Scale
Glucose Test System
Class
II
II
I
II
II
Number
870.2910
870.1130
880.2700
870.2700
862.1345
510(k) Summary for Watermark Medical Mobile Application
Device Description:
The MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.
System
Oximeter
The MiPal is designed to optionally collect NiBP, pulse, and SpO2. It may also collect other vitals through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:
- Scale
- o Glucose meter
1
Intended Use:
MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The MiPal is intended for use with adult and pediatric patients over twelve years of age.
SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.
Performance Data:
The verification and validation results demonstrated that the MiPal was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird in flight, composed of three curved lines that suggest the shape of a bird's wing and head. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 1 2012
Watermark Medical, Inc c/o Michael J. Leigh Consultant 12715 Falcon Drive Brookfield, Wisconsin 53005
Re: K120470/S001
Trade Name: MiPal, Patient Vital Signs Monitor Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II (two) Product Code: DRG Dated: May 22, 2012 Received: May 31, 2012
Dear Mr. Leigh:
This letter corrects our substantially equivalent letter of June 8, 2012.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosule) to regally manager of the Medical Device American be on to commence provision of May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have occh recultion in assess approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that do not require app to the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, boyer coursements for annual registration, listing of general controls provisions of the i 100 libeling, and prohibitions against misbranding and
3
Page 2 - Mr. Michael J. Leigh
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120470/S001
Watermark Medical MiPal Device Name:
Indications For Use:
MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. It is not intended for real-time, emergency, or critical care monitoring of patient vital signs. The MiPal is intended for use with adult and pediatric patients over twelve years of age.
SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Cardiovascular Devices
| 510(k) Number |
|---|
| --------------- |