(197 days)
The Trio™ monitor is intended for hospital use under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
Mindray Bio-Medical Co. Ltd., previously known as Caymans Mindray Medical Electronic Company of Shenzen, China, manufactures the Trio monitor for Datascope Corp.
The Trio monitor is a three or four trace patient monitor that can be mounted on a rolling stand, wall mount bracket, bed rail, or operated as a tabletop device. The patient parameters that can be monitored on the Trio are: ECG (3-lead or 5- lead selectable), Temperature, SpO2, Invasive Blood Pressure, Respiration and Non-Invasive Blood Pressure. Digital displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry, Non- Invasive Blood Pressure, Respiration Rate, Invasive Blood Pressure (optional) and Temperature. Waveform displays are provided for ECG, built-in thermal recorder provides hard copies of all digital data and waveforms, as well as Tabular and Graphic Trend information.
The provided document is a 510(k) summary for the Datascope Corp. "Trio Monitor," a physiological patient monitor. It describes the device, its intended use, classification, and the predicate device. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria to the level of granularity requested in some of your questions.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems Dash 2000 Pro Patient Monitor) based on the "same functional technology" and a summary of development activities like performance testing and validation. It states a "conclusion" that "The results of these measurements demonstrated that the Trio monitor is as safe, as effective and performs as well as the predicate device," but without detailing what those "measurements" were, what the specific acceptance criteria were, or the performance outcomes.
Therefore, many of your questions cannot be answered from the provided text. I will indicate where information is not available.
Here's a breakdown of the available and missing information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that "The Trio monitor complies with the voluntary standards identified in section six of this submission" and that "Performance testing" was completed, but it does not list specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity for individual parameters) or the quantitative results of these tests for the Trio Monitor itself. It only concludes that it performs "as well as the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. There is no information regarding the sample size of any test sets or the provenance (country, retrospective/prospective) of data used for validation.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable/Not available. Since the specific performance tests and ground truth establishment methodology are not detailed, information about experts and their qualifications for establishing ground truth is not present. This device is a physiological monitor, not typically an AI diagnostic algorithm, so "experts" in the context of ground truth for a diagnostic AI study might not be directly relevant here. For physiological monitors, performance is usually assessed against independently validated reference measurements (e.g., arterial line for NIBP, calibrated thermometers for temperature).
4. Adjudication Method for the Test Set
Not applicable/Not available. As above, without details of specific test sets and ground truth establishment, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, not specified. The document does not mention an MRMC study. This type of study is more common for diagnostic imaging AI rather than a physiological patient monitor. The focus here is on the technical performance of the device itself, not necessarily on human interpretation of its outputs.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The context of a physiological monitor suggests that its performance would be evaluated in a standalone manner (device measuring physiological parameters) rather than with a human-in-the-loop for interpreting its direct outputs like heart rate or SpO2 values. However, the exact methodology of this "standalone" testing is not detailed.
7. The Type of Ground Truth Used
Not available in the provided document. While it implies that "measurements" were taken to demonstrate performance, the specific types of ground truth (e.g., comparison to gold standard reference devices, clinical outcomes) used for each monitored parameter (ECG, NIBP, SpO2, Temp, Respiration, etc.) are not described.
8. The Sample Size for the Training Set
Not applicable/Not available. This device predates the widespread use of sophisticated machine learning/AI models that require "training sets" in the modern sense. The "Trio monitor employs the same functional technology as the predicate device," suggesting traditional signal processing and algorithms, not a learning-based system with a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As explained in point 8, the concept of a "training set" for an AI algorithm is not relevant to the information provided for this device.
{0}------------------------------------------------
FEB 1 1 2004
510(k) Summary of Safety and Effectiveness
| Date: | July 22, 2003 |
|---|---|
| Submitter: | Patient Monitoring DivisionDatascope Corp. |
| Contact Person: | Susan E. MandyDirector, Clinical & Regulatory AffairsPatient Monitoring DivisionDatascope Corp.Telephone: (201) 995-8025Fax:(201) 995-8605 |
Device trade name: Trio Monitor
Common/usual name: Physiological Patient Monitor
Classification name:
| 21 CFR 870.1100 | Blood pressure alarm |
|---|---|
| 21 CFR 870.1130 | Noninvasive blood pressure measurement systems |
| 21 CFR 870.1110 | Blood pressure computer |
| 21 CFR 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm) |
| 21 CFR 870.2340 | Electrocardiograph |
| 21 CFR 870.2700 | Oximeter |
| 21 CFR 880.2910 | Clinical electronic thermometers |
| Predicate Device: | GE Medical Systems Dash 2000 Pro Patient Monitor |
| Device Description: | Mindray Bio-Medical Co. Ltd., previously known as Caymans MindrayMedical Electronic Company of Shenzen, China, manufactures the Triomonitor for Datascope Corp.The Trio monitor is a three or four trace patient monitor that can bemounted on a rolling stand, wall mount bracket, bed rail, or operated as atabletop device. The patient parameters that can be monitored on the Trioare: ECG (3-lead or 5- lead selectable), Temperature, SpO2, InvasiveBlood Pressure, Respiration and Non-Invasive Blood Pressure. Digitaldisplays are provided for Heart Rate, Pulse Rate, Pulse Oximetry, Non-Invasive Blood Pressure, Respiration Rate, Invasive Blood Pressure(optional) and Temperature. Waveform displays are provided for ECG, |
{1}------------------------------------------------
| built-in thermal recorder provides hard copies of all digital data andwaveforms, as well as Tabular and Graphic Trend information. | |
|---|---|
| Intended Use: | The Trio monitor is intended for hospital use under the direct supervisionof a licensed healthcare practitioner. The intended use of the monitor is tomonitor physiologic parameter data on adult and pediatric patients.Physiologic data includes but is not restricted to: electrocardiogram,invasive blood pressure, heart rate (derived from ECG and SpO2)noninvasive blood pressure, pulse oximetry, respiration and temperature assummarized in the operating instructions manual. The information can bedisplayed, stored, trended and printed. |
| Technology: | The Trio monitor employs the same functional technology as the predicatedevice. |
| Test Summary | The Trio monitor complies with the voluntary standards identified insection six of this submission. During the development process of the Triomonitor, the following activities were completed: |
| Requirements specification review | |
| Hardware and software testing | |
| Code design and code reviews | |
| Environmental testing | |
| Safety testing | |
| Performance testing | |
| Risk Analysis | |
| Hardware and Software validation | |
| Conclusion | The results of these measurements demonstrated that the Trio monitor is assafe, as effective and performs as well as the predicate device. |
.
. .
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2004
Datascope Corp. c/o Ms. Susan E. Mandy Director, Clinical & Regulatory Affairs 800 MacArthur Blvd. Mahwah, NJ 07430
Re: K032338 Trade Name: Trio™ Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: December 23, 2003 Received: December 24, 2003
Dear Ms. Mandy:
We have reviewed your Section 510(k) premarket notification of intent to market the arrived inte we nave reviewed your becamined the device 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 encrosule) to regally to regally the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the United in AMA devices that have been reclassified in access approval of a premarket approval application (PMA). and Costience Act (Act) that do not require approvial controls provisions of the Act. The You may, therefore, market the devrees, bacjes to the morements for annual registration, listing of general controls provisions of the free, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to such additional controlier 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharting your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Susan Mandy
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Dana P. Vochner
( 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): K032338
Device Name:
Indications For Use:
INDICATION FOR USE STATEMENT
The Trio™ monitor is intended for hospital use under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Dung R. Laune 1
(Division Sign-Off) Division of Cardiovascular Devices
610(k) Number_K032338
Page 1 of _ _ _ _ _
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).