(119 days)
Not Found
No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities.
No
The device is described as a monitor intended for "monitoring patient vital signs" and "monitoring, recording, and alarming basic vital signs." It does not actively treat or prevent disease, but rather provides information about the patient's condition.
No
The device monitors vital signs and indicates their values but does not diagnose a condition or disease.
No
The device description explicitly states it is a "portable patient monitor" and lists hardware parameters like SpO2, NIBP, and temperature, implying the inclusion of physical sensors and hardware components for measurement.
Based on the provided text, the Ultraview DM3 Monitor 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.
- Device Function: The Ultraview DM3 Monitor is described as a device for monitoring vital signs (SpO2, pulse rate, NIBP, and temperature) directly from the patient's body. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states "monitoring patient vital signs" and "monitoring, recording, and alarming basic vital signs on adult and pediatric patients." This aligns with a patient monitoring device, not an IVD.
Therefore, the Ultraview DM3 Monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs.
The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA
Device Description
The Ultraview DM3 Monitor is a portable patient monitor intended to be used by clinicians and medical qualified personnel for spot check and continuous monitoring of non-invasive blood pressure (NIBP), pulse oximetry (SpO2), and temperature.
Mentions image processing
Not Found
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
adult and pediatric patients
Intended User / Care Setting
health care professionals
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)
Software for the Ultraview DM3 Monitor was designed and developed according to Zoe Medical's software development process, and was verified and validated. Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification.
The Ultraview DM3 Monitor was tested for patient safety in accordance with applicable standards. Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification.
The Ultraview DM3 Monitor was tested for EMC in accordance with applicable standards. Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification.
The Ultraview DM3 Monitor was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and shipping and transportation testing.
Clinical performance testing was performed according to ISO 9919:2005 to demonstrate safety and effectiveness of the oximetry feature of the Ultraview DM3 Monitor.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Submitter
Zoe Medical Incorporated 460 Boston Street Topsfield, MA 01983-1223
Contact Name: James Chickering Contact Title: Regulatory Affairs Manager Phone: (978) 887-1410 X37 Fax: (978) 887-1406
Date Prepared: December 4, 2009
Trade Name
Ultraview DM3 Monitor
Common Name
Patient Physiological Monitor (with alarms)
Classification Name
Non-invasive Blood Pressure Measurement System
Classification Regulation
21 CFR 870.1130
Product Code
DXN
Substantially Equivalent Devices
| Ultraview DM3 Monitor | Predicate 510(k)
Number | Predicate Manufacturer / Model |
|---------------------------------------|----------------------------|-----------------------------------------------------------------|
| Non-invasive Blood Pressure component | K090556 | Spacelabs Healthcare /
élance Vital Signs Monitoring System |
| Pulse Oximetry component | K090556 | Spacelabs Healthcare /
élance. Vital Signs Monitoring System |
| Temperature component | K955846 | Cardinal Health /
Model 2082 Temp Plus III Thermometer |
Device Description
The Ultraview DM3 Monitor is a portable patient monitor intended to be used by clinicians and medical qualified personnel for spot check and continuous monitoring of non-invasive blood pressure (NIBP), pulse oximetry (SpO2), and temperature.
APR - 9 2010
1
Technology Comparison
The Ultraview DM3 Monitor utilizes the same or similar technology for each parameter as utilized by the predicate devices.
Intended Use
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs.
The Ultraview DM3 Monitor is intended for monitoring, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Performance Testing
| Category | Testing Summary |
|---|---|
| Sterilization Validation | The Ultraview DM3 Monitor is not sterilized or sterilizable, and |
| therefore this section does not apply to the monitor itself. | |
| Shelf Life Testing | The Ultraview DM3 Monitor is not sterilized or sterilizable, and |
| therefore this section does not apply to the monitor itself. | |
| Biocompatibility Testing | The Ultraview DM3 Monitor has no patient contact materials, and |
| therefore this section does not apply to the monitor itself. | |
| Software Testing | Software for the Ultraview DM3 Monitor was designed and |
| developed according to Zoe Medical's software development | |
| process, and was verified and validated. Test results indicated that | |
| the Ultraview DM3 Monitor complies with its predetermined | |
| specification. | |
| Electrical Safety | The Ultraview DM3 Monitor was tested for patient safety in |
| accordance with applicable standards. Test results indicated that the | |
| Ultraview DM3 Monitor complies with its predetermined specification. | |
| Electromagnetic Compatibility | |
| Testing | The Ultraview DM3 Monitor was tested for EMC in accordance with |
| applicable standards. Test results indicated that the Ultraview DM3 | |
| Monitor complies with its predetermined specification. | |
| Performance Testing - Bench | The Ultraview DM3 Monitor was tested in accordance with internal |
| requirements and procedures, and test results indicated that the | |
| device complies with the predetermined requirements. This testing | |
| includes performance and functional, environmental, and shipping | |
| and transportation testing. | |
| Performance Testing - Animal | Animal performance testing was not performed and is not necessary |
| to demonstrate safety and effectiveness of the Ultraview DM3 | |
| Monitor. | |
| Performance Testing - Clinical | Clinical performance testing was performed according to ISO |
| 9919:2005 to demonstrate safety and effectiveness of the oximetry | |
| feature of the Ultraview DM3 Monitor. |
Conclusion
Based upon a comparison of devices and performance testing results, the Ultraview DM3 Monitor is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR - 9 2010
Zoe Medical c/o Mr. James Chickering Regulatory Affairs Manager 460 Boston St. Topsfield, MA 01983
Re: K093802
Trade/Devicc Name: Ultraview DM3 Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN, DQA Dated: March 29, 2010 Received: April 06, 2010
Dear Mr. Chickering:
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.
3
Page 2 - Mr. James Chickering
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.html 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/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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: K093802
Device Name:
Ultraview DM3 Monitor
Indications for Use:
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs.
The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 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 | K093802 |
|---|---|
| --------------- | --------- |
Zoe Medical, Incorporated