(197 days)
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No
The document describes a standard patient monitor with no mention of AI or ML capabilities.
No
The device is a monitor intended to measure and display physiologic parameters; it does not provide any therapeutic intervention.
Yes.
The device monitors physiologic parameter data (e.g., electrocardiogram, blood pressure, pulse oximetry, etc.) to assess a patient's medical condition. This data collection and analysis for health assessment aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "three or four trace patient monitor" that can be physically mounted and includes a "built-in thermal recorder," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Trio™ monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring physiologic parameter data on adult and pediatric patients." This involves measuring vital signs directly from the patient's body (ECG, blood pressure, SpO2, temperature, respiration).
- Device Description: The description details how the device connects to the patient to acquire these physiological signals.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. The Trio monitor does not perform this function.
The Trio monitor is a patient monitoring device, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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 but is not restricted to: electrocardiogram, invasive blood pressure, heart rate (derived from ECG and SpO2) noninvasive blood pressure, pulse oximetry, respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.
Product codes
MWI
Device Description
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.
Mentions image processing
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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
hospital use under the direct supervision of a licensed healthcare practitioner.
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
The Trio monitor complies with the voluntary standards identified in section six of this submission. During the development process of the Trio monitor, 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.
Key Metrics
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Predicate Device(s)
GE Medical Systems Dash 2000 Pro Patient Monitor
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
FEB 1 1 2004
510(k) Summary of Safety and Effectiveness
| Date: | July 22, 2003 |
|---|---|
| Submitter: | Patient Monitoring Division |
| Datascope Corp. | |
| Contact Person: | Susan E. Mandy |
| Director, Clinical & Regulatory Affairs | |
| Patient Monitoring Division | |
| Datascope Corp. | |
| Telephone: (201) 995-8025 | |
| Fax:(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 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, |
1
| built-in thermal recorder provides hard copies of all digital data and
| waveforms, as well as Tabular and Graphic Trend information. | |
|---|---|
| Intended Use: | 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 but is not restricted to: electrocardiogram, | |
| invasive blood pressure, heart rate (derived from ECG and SpO2) | |
| noninvasive blood pressure, pulse oximetry, respiration and temperature as | |
| summarized in the operating instructions manual. The information can be | |
| displayed, stored, trended and printed. | |
| Technology: | The Trio monitor employs the same functional technology as the predicate |
| device. | |
| Test Summary | The Trio monitor complies with the voluntary standards identified in |
| section six of this submission. During the development process of the Trio | |
| monitor, 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 as |
| safe, 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
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