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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ultraview DM3 Monitor, structured to address your specific points.

Acceptance Criteria and Device Performance for Ultraview DM3 Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific numerical acceptance criteria for performance metrics (like accuracy or precision). It lists general categories of testing and concludes that the device "complies with its predetermined specification."

Since explicit numerical acceptance criteria and corresponding reported performance values are not provided in this document, the table below reflects what can be inferred.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from documentation)	Reported Device Performance
Non-Invasive Blood Pressure (NIBP)	Performance equivalent to predicate device (Spacelabs Healthcare / élance Vital Signs Monitoring System) as per pre-determined specifications.	"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."
Pulse Oximetry (SpO2)	Performance equivalent to predicate device (Spacelabs Healthcare / élance Vital Signs Monitoring System) and conforming to ISO 9919:2005.	"Clinical performance testing was performed according to ISO 9919:2005 to demonstrate safety and effectiveness of the oximetry feature of the Ultraview DM3 Monitor."
Temperature	Performance equivalent to predicate device (Cardinal Health / Model 2082 Temp Plus III Thermometer) as per pre-determined specifications.	"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."
Software Functionality	Compliance with Zoe Medical's software development process and predetermined specifications.	"Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification."
Electrical Safety	Compliance with applicable electrical safety standards.	"Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification."
Electromagnetic Compatibility (EMC)	Compliance with applicable EMC standards.	"Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification."
Bench Performance	Compliance with internal requirements and procedures for performance, functional, environmental, and shipping/transportation testing.	"Test results indicated that the device complies with the predetermined requirements."

Important Note: The document consistently states "complies with its predetermined specification" or "complies with its predetermined requirements" which indicates acceptance was met for these general categories. However, the exact numerical specifications themselves (e.g., NIBP accuracy range, SpO2 bias and precision) are not disclosed in this summary.

2. Sample Size for the Test Set and Data Provenance

Sample Size for the Test Set: Not explicitly stated for NIBP or Temperature. For Pulse Oximetry (SpO2), the document mentions "Clinical performance testing was performed according to ISO 9919:2005." ISO 9919:2005 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment) typically requires a minimum of 10 healthy adult volunteers whose arterial blood hemoglobin oxygen saturation can be reduced and stabilized over a specific range to perform accuracy testing. While the exact number isn't in this document, this is the standard typically applied.
Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether the study was retrospective or prospective, except for the clinical performance testing for oximetry, which by its nature (involving human subjects in a controlled setting) would be prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated. The provided document details a 510(k) submission for a physiological monitor, not a device requiring expert interpretation of diagnostic images or signals. The "ground truth" for a monitor like this typically comes from reference devices or direct physiological measurements, not expert consensus in the diagnostic sense.
Qualifications of Experts: Not applicable or not specified, as "experts" for ground truth are not mentioned in the context of interpretation, but rather skilled personnel performing measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret ambiguous cases in diagnostic studies (e.g., radiology for AI algorithms). For a vital signs monitor, the comparison is usually against a reference standard, not a consensus of human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: No, this type of study was not performed and is not relevant for the Ultraview DM3 Monitor. This device is a physiological monitor that measures vital signs, not an AI-assisted diagnostic tool that helps human readers interpret data. The comparison is between the device's measurements and a reference standard, not between human performance with and without AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: Yes, the described "Performance Testing - Bench" and "Clinical performance testing... to demonstrate safety and effectiveness of the oximetry feature" can be considered standalone performance assessments. These tests evaluate the device's ability to accurately measure physiological parameters independently, without necessarily involving human intervention in the data processing itself, beyond setting up the device and potentially interpreting its output clinically. The document states that the software was "verified and validated" confirming its standalone function.

7. The Type of Ground Truth Used

Type of Ground Truth:
- For SpO2 (Pulse Oximetry): Likely arterial blood gas analysis (co-oximetry) as a reference standard, which is the gold standard for SpO2 accuracy testing as per ISO 9919:2005.
- For NIBP (Non-Invasive Blood Pressure): Likely a reference NIBP device that has been validated against an invasive arterial manometer or a double-auscultation method using qualified observers, following recognized standards (e.g., ANSI/AAMI/ISO 81060-2).
- For Temperature: Likely reference thermometers that are calibrated to a known standard.
- For Software, Electrical Safety, EMC, Bench Performance: Ground truth is established by the specifications of applicable standards (e.g., ISO, AAMI, IEC standards) and the manufacturer's own predetermined internal requirements.

8. The Sample Size for the Training Set

Sample Size for the Training Set: Not applicable or not specified. This document pertains to a traditional physiological monitor, not a device developed using machine learning or AI that would typically have distinct "training sets." The device's algorithms for NIBP, SpO2, and temperature processing are based on established physiological principles and signal processing, not a data-driven training process in the AI sense.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for the Training Set Was Established: Not applicable. As explained above, this device does not utilize a training set in the context of machine learning. The "ground truth" for the development of its algorithms would stem from established medical and engineering principles, physiological models, and empirical testing during the design phase, rather than a formally labeled "training set" with ground truth generated by experts.

Summary

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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

APR - 9 2010

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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, andtherefore this section does not apply to the monitor itself.
Shelf Life Testing	The Ultraview DM3 Monitor is not sterilized or sterilizable, andtherefore this section does not apply to the monitor itself.
Biocompatibility Testing	The Ultraview DM3 Monitor has no patient contact materials, andtherefore this section does not apply to the monitor itself.
Software Testing	Software for the Ultraview DM3 Monitor was designed anddeveloped according to Zoe Medical's software developmentprocess, and was verified and validated. Test results indicated thatthe Ultraview DM3 Monitor complies with its predeterminedspecification.
Electrical Safety	The Ultraview DM3 Monitor was tested for patient safety inaccordance with applicable standards. Test results indicated that theUltraview DM3 Monitor complies with its predetermined specification.
Electromagnetic CompatibilityTesting	The Ultraview DM3 Monitor was tested for EMC in accordance withapplicable standards. Test results indicated that the Ultraview DM3Monitor complies with its predetermined specification.
Performance Testing - Bench	The Ultraview DM3 Monitor was tested in accordance with internalrequirements and procedures, and test results indicated that thedevice complies with the predetermined requirements. This testingincludes performance and functional, environmental, and shippingand transportation testing.
Performance Testing - Animal	Animal performance testing was not performed and is not necessaryto demonstrate safety and effectiveness of the Ultraview DM3Monitor.
Performance Testing - Clinical	Clinical performance testing was performed according to ISO9919:2005 to demonstrate safety and effectiveness of the oximetryfeature 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.

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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

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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)
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Division of Cardiovascular Devices

510(k) Number	K093802
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Zoe Medical, Incorporated

Regulation Number and Section

§ 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).