The statMAP Model 7200 Blood Pressure Measurement Device is a prescription device, and is indicated for use to measure systolic, diastolic, mean arterial pressure (MAP) and heart rate of persons ages 12 and over using the oscillometric method of measurement.

Device Description

The statMAP Model 7200 Blood Pressure (BP) Measurement Device is a hand-held device designed to provide semi-automatic or manual Blood pressure measurement on Adults, Pediatrics and Neonates. The design concept for the statMAP Model 7200 is a small, very compact BP measurement device that combines both the totally manual measurement methods, such as the manual auscultatory and the palpatory methods, and automatic electronic non-invasive blood pressure (NIBP) measurement devices using the oscillometric method of BP determination.

The statMAP Model 7200 allows for two basic modes of NIBP measurement, which are manual NIBP measurement and semi-automatic NIBP measurement.

AI/ML Overview

Acceptance Criteria and Device Performance Study for statMAP Model 7200

The provided documentation for the statMAP Model 7200 Blood Pressure Measurement Device does not explicitly state numerical acceptance criteria for its performance. Instead, it relies on "Comparison testing between statMAP Model 7200 and Predicate Device" and "Intra-device variability" to demonstrate performance, safety, and efficacy, with the overall conclusion of substantial equivalence to the predicate device.

However, based on the context of a 510(k) submission for a non-invasive blood pressure measurement system, the generally accepted performance standard for such devices is often based on accuracy relative to a reference method (e.g., auscultatory method or another validated NIBP device).

Assuming the "Comparison testing" refers to a study evaluating the accuracy against a predicate device, and inferring the device's performance is considered acceptable based on achieving "substantial equivalence," we can construct the following:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Inferred from clinical practice / regulatory expectations for NIBP devices)	Reported Device Performance (Inferred from "Comparison testing" and "substantial equivalence")
Blood Pressure Accuracy	Substantially equivalent to a legally marketed predicate device (e.g., within a specified mean difference and standard deviation of a reference method or predicate device for systolic, diastolic, and MAP)	Deemed "safe, effective and substantially equivalent to the predicate device" (Critikon Model 8100 Vital Signs Monitor via Comparison testing)
Heart Rate Accuracy	Substantially equivalent to a legally marketed predicate device	Deemed "safe, effective and substantially equivalent to the predicate device"
Intra-device Variability	Acceptable level of consistency across repeated measurements	Tested, presumed to meet acceptable levels leading to substantial equivalence conclusion

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify the sample size used for the "Comparison testing between statMAP Model 7200 and Predicate Device" or the "Intra-device variability" studies.
Data Provenance: Not explicitly stated. However, given that Ramsey Medical, Inc. is a U.S. company and the submission is to the FDA, it is highly probable that the data was collected in the United States. The studies are presented as testing for the purpose of a 510(k) submission, implying they were prospectively designed and conducted to evaluate the device.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as the comparison testing seems to be against a predicate device and/or possibly a standard reference method rather than expert consensus on images or clinical conditions.

4. Adjudication Method (Test Set)

The document does not specify an adjudication method. This is typically not relevant for NIBP device accuracy studies, which rely on direct comparison to a reference standard or predicate rather than subjective expert review needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms where human readers interpret medical images with and without AI assistance. The statMAP Model 7200 is a blood pressure measurement device, and its performance is assessed by direct measurement accuracy, not by aiding human interpretation of complex data.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done in the form of "Comparison testing between statMAP Model 7200 and Predicate Device" and "Intra-device variability." The device itself, without human interpretation of a complex output (other than reading the displayed numbers), is the subject of these tests. The "Comparison testing" effectively evaluates the algorithm's output against a reference.

7. Type of Ground Truth Used

The document implies the ground truth for the comparison testing was established using readings from a legally marketed predicate device (Critikon Model 8100 Vital Signs Monitor). It's also possible that a recognized reference method (e.g., manual auscultatory measurements by trained personnel, though not explicitly stated as the primary ground truth for the oscillometric comparison) was used as part of the "Comparison testing."

8. Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. Blood pressure measurement devices typically use algorithms developed and validated based on physiological principles and data, which may involve internal development and testing, but a distinct "training set" in the context of machine learning (as often discussed with AI/imaging devices) is not mentioned or implied for this type of device. The comparison testing described appears to be the final validation for the 510(k) submission.

9. How Ground Truth for Training Set was Established

As a training set is not explicitly mentioned, the method for establishing its ground truth is not provided.

Summary

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RAMSEY MEDICAL INC.

JUL 3 1 2008

K072109 ャリア

Page 5 - 1

510(k) SUMMARY

Date Prepared:	7/30/2007
Contact:	Ramsey Medical, Inc.4920 W. Cypress St., Ste. 110Tampa, FL 33607, U.S.A.(813) 289-5555800-231-6370 USFax (813) 289-5454
Contact Person:	Darryl ParmetEngineering Consultant(813) 382-9091Dparmet1@tampabay.rr.com
Device Trade Name:	statMAP Model 7200 Blood PressureMeasuring Device
Common Names:	Blood Pressure Measuring Device, Blood PressureMonitor
Classification Name:	Non Invasive Blood PressureMeasurement System

Includes the following parameters:

Systolic Pressure

Diastolic Pressure

Mean Arterial Pressure

Heart Rate

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RAMSEY MEDICAL INC.

Classification

Classification Name	21 CFR Section	Product Code	Class
Non-Invasive BloodPressure MeasurementSystem	870.1130	DXN	2

Predicate Devices

Ramscy Medical, Inc., is claiming substantial equivalence to the following legally marketed device:

Aspect	Device	510(k) number
Non-invasive BloodPressure	Critikon Model 8100 Vital SignsMonitor	K854434

Device Description

The statMAP Model 7200 allows for two basic modes of NIBP measurement, which are manual NIBP measurement and semi-automatic NIBP measurement. The statMAP Model 7200 measurement modes are summarized as follows:

1) Semi-automatic NIBP Determination

In this mode, the device performs an electronic determination of Blood Pressure (using the oscillometric method) and Heart Rate. The user controls only the inflation of the limb compression cuff while the deflate rate of the cuff is performed automatically by the integrated deflate valve controlled by the statMAP Model 7200 electronics. The BP and I IR values are displayed for the user as a set of illuminated LEDs at the edge of the dial face.

2) Manual BP determination

In this mode, the device functions as a palm style aneroid sphygmomanometer with an integral cuff inflation bulb and manual deflate valve. Blood pressures are determined by the operator using the traditional auscultatory method or the palpatory or the manual oscillometric mode.

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RAMSET MEDICAL INC.

(072109 73/3

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Intended Uses

The statMAP Model 7200 is designed for use in a variety of settings where Blood Pressure Measurement is required on Adults, Pediatrics, or Neonates: these include hospital departments such as intensive care units, medical/surgical nursing units. emergency department, labor and delivery, radiology, recovery, cardiac care units, and step-down units; statMAP Model 7200 is also designed for use in out-patient centers, physicians offices, the home, as well as EMS environments. The statMAP Model 7200 device will display Systolic, Diastolic, MAP and Heart Rate.

Comparison of Technological Characteristics

The statMAP Model 7200 and the predicate device share essentially the same intended use and technological characteristics.

Both devices employ the Oscillometric method of Blood Pressure Measurement and use an electronic deflate valve to step-deflate the cuff during the measurement cycle. Systolic, Diastolic, Mean Arterial Pressure, and Heart Rate are displayed.

The predicate device has a built-in pump for inflation whereas the statMAP Model 7200 relies on the user to manually inflate the cuff using its integrated inflation bulb. The statMAP Model 7200 also supports manual blood pressure measurement as a traditional aneroid sphygmomanometer.

The predicate device also has a programmable auto-cycling capability, while the statMAP is not designed for unattended operation.

Device testing

The statMAP Model 7200 has been comprehensively tested to demonstrate its performance, safety and efficacy, specifically:

EN 60601-1 Safety Medical Equipment .
IEC601-2-30 Particular Requirements for Automatic Cycling NIBP monitors .
. Mechanical Shock and Vibration - ISTA2A
Electromagnetic Compatibility EN60601-1-2 t
Battery Testing .
Comparison testing between statMAP Model 7200 and Predicate Device �
Intra-device variability .
Environmental testing (Temperature and Humidity) ●

Conclusions

In accordance with 21 CFR part 807.92(b) (3) and as presented in the pre-market notification, Ramsey Medical, Inc., concludes that the new device, statMAP Model 7200 is safe, effective and substantially equivalent to the predicate device.

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Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

JUL 31 2008

Ramsey Medical Inc. c/o Mr. Darryl Parmet Engineering Consultant 4920 West Cypress Street, Ste. 110 Tampa, FL 33607

Re: K072109

Trade/Device Name: statMAP Model 7200 Blood Pressure Measurement Device Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 26, 2008 Received: June 27, 2008

Dear Mr. Parmet:

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.

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 agencics. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 -- Mr. Darryl Parmet

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K072109

Device Name: statMAP Model 7200 Blood Pressure Measurement Device

Indications For Use:

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K072109

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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).