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.

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)

AI/ML Overview

The provided 510(k) summary for the PressMate Advantage does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study report. The document is a premarket notification for substantial equivalence, focusing on comparisons to predicate devices and general regulatory compliance rather than in-depth performance study results.

However, based on the information provided, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "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."

And "The testing of the PressMate Advantage demonstrates that the performance is substantially equivalent to predicate devices cited above."

This indicates that acceptance criteria likely involved meeting relevant electrical safety and EMC standards (EN 60601) and demonstrating performance equivalent to the predicate devices (PressMate Model 8800 and Escort Model 102). However, specific numerical acceptance criteria (e.g., accuracy ranges for NIBP, SpO2) and the corresponding reported performance values for the PressMate Advantage are not provided in this summary.

Parameter/Criteria Type	Acceptance Criteria	Reported Device Performance
Electrical Safety	Compliance with EN 60601	Compliant (stated as "tested to")
EMC	Compliance with EN 60601	Compliant (stated as "tested to")
NIBP Performance	Substantially Equivalent to PressMate Model 8800 (K951048) and Escort Model 102 (K872291)	Stated as "substantially equivalent," but no specific numerical performance provided.
SpO2 Performance	Substantially Equivalent to PressMate Model 8800 (K951048) and Escort Model 102 (K872291)	Stated as "substantially equivalent," but no specific numerical performance provided.
ECG Performance	Substantially Equivalent to PressMate Model 8800 (K951048) and Escort Model 102 (K872291)	Stated as "substantially equivalent," but no specific numerical performance provided.
Body Temperature Performance	Substantially Equivalent to PressMate Model 8800 (K951048) and Escort Model 102 (K872291)	Stated as "substantially equivalent," but no specific numerical performance provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information on the sample size used for clinical performance testing, data provenance, or whether the study was retrospective or prospective. The focus is on non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable or not provided. The document describes non-clinical engineering and comparison testing, not a study involving human expert ground truth for medical interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable or not provided as there is no mention of clinical readings requiring adjudication.

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

This is not applicable. The device is an automated vital signs monitor, not an AI-assisted diagnostic tool for human readers. There is no mention of any MRMC study or AI.

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

The document refers to "Non-clinical tests" and "testing of the PressMate Advantage" demonstrating its performance. This implies standalone testing of the device's measurement capabilities. However, specific details of this testing (e.g., number of subjects, accuracy metrics) are not provided. The phrase "algorithm only" is not directly applicable as it's a hardware device with embedded software for measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For non-invasive blood pressure, SpO2, ECG, and temperature, the "ground truth" would typically involve validated reference devices (e.g., invasive arterial pressure lines for NIBP, CO-oximeters for SpO2, calibrated temperature probes). However, the document does not specify the type of ground truth used in its "Nonclinical Tests." It only states the device uses "the standard oscillometric technique for obtaining. NIBP Nellcor Sp02 technology for Oxygen saturation, standard ECG technology and YSI temperature probes," implying a comparison to these established gold standards.

8. The sample size for the training set

This is not applicable or not provided. The device in question is a vital signs monitor, not typically a machine learning model that requires a "training set" in the conventional sense. Its "training" would be through design, calibration, and engineering validation.

9. How the ground truth for the training set was established

This is not applicable or not provided for the same reasons as point 8.

Summary

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SEP 2 5 1998

K973637

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

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6. 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)

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.

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Public Health Service

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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

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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

Prescription Use 1 (Per 21 CFR 801.109)

Over-the Counter Use

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).