(366 days)
No
The summary describes a standard vital signs monitor and does not mention AI, ML, or any related concepts.
No
The device is a vital signs monitor that measures and displays physiological parameters, but it does not treat or prevent any specific disease or condition. These are monitoring functions, not therapeutic ones.
No
The device monitors several vital signs, which falls under general patient monitoring. There is no indication that it is used to diagnose diseases or conditions.
No
The device description explicitly states it "measures, displays and (optionally) prints" parameters, implying the presence of hardware components for measurement and display, not just software processing. The performance studies also mention testing the "complete system" and electrical safety/EMC requirements, which are typically associated with hardware.
Based on the provided information, this device 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 PressMate Advantage monitors physiological parameters directly from the patient's body (blood pressure, oxygen saturation, ECG, respiration rate, body temperature). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring vital signs in a clinical setting, which is a direct patient monitoring function, not an in vitro diagnostic function.
Therefore, the PressMate Advantage is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.
Product codes
DXN
Device Description
The PressMate Advantage Monitor measures, displays and (optionally) prints the following parameters:
- NIBP (systolic, Diastolic, Mean and Pulse Rate)
- ECG
- Body Temperature
- Sp02 ( Oxygen Saturation and Pulse Rate)
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 Neonate
Intended User / Care Setting
clinical setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to determine the complete system and has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601. The testing of the PressMate Advantage demonstrates that the performance is substantially equivalent to predicate devices cited above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 5 1998
C
510(K) Summary for The PressMate Advantage
1. Date this summary was prepared:
September 15, 1997
2. Submitter's Name and Address:
Colin Medical Instruments Corporation 5850 Farinon Drive San Antonio, Texas 78249
3. Contact Person:
Mr. Mark Rison Senior Director, RA/QA Telephone: 1-800-829-8100 Telefax: 1-210-696-8808
4. Device Name
Trade/ Proprietary Name:
PressMate Advantage
Common Name:
Automated Non-Invasive Blood Pressure Monitor / Vital Signs Monitor with / without optional ECG / RR and Sp02
Classification Names:
Non- Invasive Blood Pressure Measurement System
5. Predicate Devices
The legally marketed devices to which equivalence is being claimed are:
PressMate Model 8800 Non-Invasive Blood Pressure Monitor K# (K951048) Manufactured by Colin Medical Instruments Corporation
Escort Model 102 K# (K872291) Portable Vital Signs Monitor Manufactured by: Medical Data Electronics Incorporated
1
6. Device Description
The PressMate Advantage Monitor measures, displays and (optionally) prints the following parameters:
C
-
NIBP (systolic, Diastolic, Mean and Pulse Rate)
-
ECG
-
Body Temperature
-
Sp02 ( Oxygen Saturation and Pulse Rate)
7. Intended Use:
The PressMate Advantage monitors non-invasive blood pressure (NIBP), oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an adult, pediatric, or neonate in a clinical setting
8. Comparison of Technological Characteristics:
The PressMate Advantage uses the standard oscillometric technique for obtaining. NIBP Nellcor Sp02 technology for Oxygen saturation, standard ECG technology and YSI temperature probes.
9. Nonclinical Tests Used in Determination of Substantial Equivalence:
The design of the PressMate Advantage has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to determine the complete system and has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601.
10. Conclusions From Nonclinical Testing:
The testing of the PressMate Advantage demonstrates that the performance is substantially equivalent to predicate devices cited above.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern. The logo is black and white.
SEP 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard K. Mann Sr. Director QA/RA Colin Medical Instruments Corp. 5850 Farinon Drive University Technology Park San Antonio, TX 78249
Re: K973637 Press-Mate Advantage Requlatory Class: II (Two) Product Code: DXN Dated: June 30, 1998 Received: July 2, 1998
Dear Mr. Mann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Howard K. Mann
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Intended Use
Device Name: PressMate Advantage
Indications For Use:
The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette E. Cooper Ce
ivision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
OR
Prescription Use 1 (Per 21 CFR 801.109)
Over-the Counter Use