(188 days)
No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities. The performance studies listed are standard bench tests for medical devices, not studies related to AI/ML performance.
No.
The device is a monitor that measures vital signs, which provides diagnostic information but does not actively treat any medical condition.
No
The device is intended to monitor vital signs parameters like non-invasive blood pressure, pulse rate, oxygen saturation, and temperature. While this information is crucial for patient assessment, it primarily provides physiological measurements rather than diagnosing a specific condition or disease.
No
The device description explicitly states it is a "portable device" that "includes an integrated printer" and operates from "an external AC mains power source or an internal lead-acid rechargeable battery," indicating it is a hardware device with integrated software.
Based on the provided information, the DINAMAP® ProCare Series Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DINAMAP ProCare Series Monitor directly measures vital signs (blood pressure, pulse rate, oxygen saturation, temperature) from the patient's body using non-invasive methods (cuffs, probes).
- The intended use and device description clearly state that it monitors vital signs of the patient at the bedside or during transport. There is no mention of analyzing biological samples.
- The parameters measured (blood pressure, pulse rate, oxygen saturation, temperature) are physiological measurements taken directly from the living patient.
Therefore, the DINAMAP ProCare Series Monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DINAMAP® ProCare Series Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
Product codes
DXN, DSK, DSJ, DQA, DPZ, FLL, DSF, MWI
Device Description
The DINAMAP ProCare Series Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate ●
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry o
- . DPC XXX: Non-invasive Blood Pressure and Pulse Rate, Temperature
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry ● and Temperature.
This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.
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, pediatric or neonatal
Intended User / Care Setting
health care professionals.
numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
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
Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series Monitor:
- · AAMI/ANSI SP10
- · Mechanical and Environmental
- · Electromagnetic Compatibility
- · Battery Power
- · Electrical Safety
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K0/4255
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circle, and there are three stylized swirls or flourishes spaced evenly around the perimeter of the circle.
JUL = 2 2002
GE Medical Systems Information Technologies
General Electric Company 4502 Woodland Corporate Blvd , Tampa, FL 33614 813 887-2000
SUMMARY OF SAFETY AND EFFECTIVENESS Dec 21, 2001
DINAMAP® ProCare Series Monitor
A. Submitter
GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614
B. Company Contact
Thomas J English Director, Regulatory Affairs Phone: 813-887-2170 Fax: 813-887-2413
C. Common Name
Physiological or Vital Signs Monitor, Patient Monitor
| Classification Name | Product Code | 21 CFR |
|---|---|---|
| System, Measurement, Blood Pressure, Noninvasive | DXN | 870.1130 |
| Computer, Blood Pressure | DSK | 870.1110 |
| Alarm, Blood Pressure | DSJ | 870.1100 |
| Oximeter | DQA | 870.2700 |
| Oximeter, Ear | DPZ | 870.2710 |
| Thermometer, Clinical Electronic | FLL | 880.2910 |
| Recorder, Paper Chart | DSF | 870.2810 |
D. Predicate/Legally Marketed Devices
DINAMAP® Pro Series Monitor 100-400-K992638 Critikon Company, LLC
Welch Allyn Vital Signs Monitor-K951193 Welch Allyn Protocol/Tycos Industries Inc.
E. Device Description
The DINAMAP ProCare Series Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate ●
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry o
- . DPC XXX: Non-invasive Blood Pressure and Pulse Rate, Temperature
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry ● and Temperature.
00010
1
This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.
F. Intended Use
The DINAMAP® ProCare Series Monitor is intended to monitor a single adult. pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
G. Technological Characteristics
The DINAMAP® ProCare Series Monitor has the same technological characteristics as the predicate device, the DINAMAP® Pro Series 100-400 Monitor. There are no new technologies used on the DINAMAP® ProCare Series Monitor.
H. Parameter Technology
The DINAMAP® ProCare Series Monitor has the following parameter technologies: •NIBP oscillometric algorithm wholly implemented from the DINAMAP Pro Series 100- 400 Monitor or an NIBP ascultatory algorithm tested according to the ANSI/AAMI SP10 standard..
- · Wholly implemented Alaris thermometry technology
- · Wholly implemented Masimo SpO2 technology
I. Testing
Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series Monitor:
- · AAMI/ANSI SP10
- · Mechanical and Environmental
- · Electromagnetic Compatibility
- · Battery Power
- · Electrical Safety
K. Substantial Equivalence
| ProCare Series | Predicate Device & Model | 510(k) Numbers |
|---|---|---|
| Monitor | DINAMAP Pro Series 100-400 | K992638 |
| SpO2 | •Masimo SET Pulse Oximeter | K992238 |
| Temperature | Alaris Medical System | K955846 |
| NIBP | •DINAMAP Pro Series 100-400 | K992638 |
| • Welch Allyn Vital Signs Monitor | K951193 |
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2002
GE Medical Systems Information Technologies c/o Mr. Thomas English Director, Regulatory Affairs 4502 Woodland Corporate Blvd. Tampa, FL 33614
Re: K014255
Trade Name: DINAMAP® ProCare Series Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without Arrhythmia Detection) Regulatory Class: Class II (two) Product Code: MWI Dated: April 2, 2002 Received: April 3, 2002
Dear Mr. English:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Thomas English
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.
Dosen Teh
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
December 21, 2001
Page 1 of 1
510(K) Number (if known): K014255
Device Name: DINAMAP® ProCare Series Monitor
Indications for Use:
The DINAMAP® ProCare Series Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
(Please Do Not Write Below This Line-Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Or
Over-The Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
DeVittur
510(k) Number
00008