The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements.

The PC-based BeatScope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.

Device Description

Portapres is a portable, battery-powered device to record continuous non-invasive arterial blood pressure. Portapres is intended for 24-hour continuous recordings in ambulatory subjects. The device includes a Neoprene belt to be worn around the waist, with compartments for the Main Unit with electronics and memory card, a Pump Unit with an air pump, and a NiCd or Li battery pack. Connected to the waist belt Main Unit and Pump Unit is a Wrist Unit, used to interface with the signals from the electronics and air supply in the waist belt to the finger cuffs. The Wrist Unit then connects to a finger cuff, which consists of an inflatable air bladder and an infrared photoplethysmograph. The plethysmograph measures the finger arterial volume which varies with the patient's blood pressure. The Wrist Unit controls the pressure in the cuff bladder so as to keep the arterial volume constant at a level (the setpoint) determined during startup. The Wrist Unit contains a pressure transducer that measures the cuff pressure as an indirect measure of the patient's blood pressure. Also connected to the Wrist Unit is a hydrostatic height correction unit that compensates for the hydrostatic component of the blood pressure in the finger when this is not at heart level. This allows the patient free hand movement in ambulatory applications.

Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The microprocessor has an internal flash memory card for storage of blood pressure wave form data.

The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FMS Portapres Ambulatory Noninvasive Blood Pressure Monitor, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for blood pressure accuracy (e.g., standard deviation, mean difference) as might be found in a more detailed validation report or a standard like ANSI/AAMI SP10.

However, the document states that the Portapres is "substantially equivalent in design (methodology) and indications for use" to predicate devices. This implies that its performance is expected to be comparable to these legally marketed devices, which would have themselves met relevant performance standards for blood pressure accuracy.

The 510(k) summary does not include a table of reported device performance metrics such as mean difference and standard deviation against a reference standard. Therefore, I cannot populate a table with specific numerical performance data directly from this document.

Missing Information: Specific numerical acceptance criteria for blood pressure measurement accuracy (e.g., AAMI/ANSI SP10 standards) and the Portapres's direct performance against those criteria are not provided in this summary. The summary focuses on substantial equivalence to predicate devices, assuming those devices met the necessary performance standards.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) that directly demonstrates the device's accuracy against a gold standard.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. It states: "Portapres and Finapres are substantially equivalent in design, methodology, software, manufacture, materials, intended use and principle of operation." This implies that prior testing and validation of the predicate devices (Ohmeda 2300 Finapres, Ohmeda 2350 Finapres, Task Force Monitor 3040, RODA Monitoring System) are being leveraged.

Missing Information: Direct test set sample size, country of origin, or retrospective/prospective nature of data for the Portapres itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no direct test set demonstrating the device's accuracy is described, there is no information provided regarding experts used to establish ground truth. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference standard (e.g., auscultatory method with a mercury sphygmomanometer) during a clinical validation study.

Missing Information: Number and qualifications of experts are not mentioned as no direct study for the Portapres's accuracy is detailed.

4. Adjudication Method for the Test Set

As no specific test set or study validating the Portapres's accuracy is described, no adjudication method is mentioned.

Missing Information: Adjudication method is not provided.

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

The summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. Blood pressure monitors are primarily direct measurement devices, and their validation focuses on agreement with reference standards, not on improvement in human reader performance.

Missing Information: No MRMC study was conducted or reported.

6. Standalone Performance Study

The 510(k) summary does not explicitly describe a standalone performance study (i.e., algorithm only without human-in-the-loop performance) for the Portapres.

The claim of substantial equivalence implies that the device's performance, by virtue of its "design, methodology, software," is comparable to its predicates, which would have undergone their own standalone validation. The Portapres itself is a device that generates data (blood pressure waveform and derived parameters), and its standalone performance would be its accuracy in doing so compared to a reference standard. The summary does not provide direct evidence of this for the Portapres specifically.

Missing Information: A specific standalone performance study report for the Portapres is not detailed in this summary.

7. Type of Ground Truth Used

Given that no direct study for the Portapres's accuracy is detailed, the specific type of ground truth used to validate the Portapres cannot be explicitly stated from this document.

However, for non-invasive blood pressure monitors, the gold standard (ground truth) for validation typically involves:

Auscultatory method: Manual blood pressure measurement performed by trained observers using a stethoscope and sphygmomanometer, often with double or triple auscultation and averaging.
Intra-arterial catheterization: Invasive measurement, used less commonly for routine non-invasive device validation but considered highly accurate.

The summary's reliance on substantial equivalence suggests that the predicate devices were validated against such ground truths.

Missing Information: The specific type of ground truth used for the Portapres's validation is not detailed.

8. Sample Size for the Training Set

The 510(k) summary does not provide information about a training set or its sample size. The device described, the Portapres, is a measurement device that employs algorithms for continuous blood pressure estimation and hemodynamic parameter calculation (like Modelflow for cardiac output). While such algorithms might be "trained" or developed using data, this summary does not provide details of that process or associated sample sizes.

Missing Information: Training set sample size is not provided.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, information on how its ground truth was established is not provided. The algorithms (e.g., Modelflow) would have been developed and validated using physiological data over many years, but these details are not part of this 510(k) submission for the device itself.

Missing Information: Ground truth establishment for a training set is not provided.

Summary of Limitations of the Provided Document:

This 510(k) summary primarily focuses on establishing "substantial equivalence" to existing predicate devices. It does not contain a detailed report of a new clinical validation study for the Portapres itself, which would typically include explicit acceptance criteria, sample sizes, methodology for ground truth establishment, and reported performance metrics. The FDA's acceptance in this case is based on the argument that the new device's design, methodology, and intended use are similar enough to previously cleared devices that it can be presumed to be safe and effective without requiring a full, new, independent clinical validation study report within the summary document.

Summary

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510(k) SUMMARY FMS PORTAPRES AMBULATORY NONINVASIVE BLOOD PRESSURE MONITOR

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92

I. NAME OF SUBMITTER

FMS, Finapres Medical Systems BV Simon Stevinweg 48 NL-6827 BT Arnhem The Netherlands

Phone Number: +31 26 384 9080

Contact Person: Gerard J. Langewouters, PhD. General Manager FMS

U. S Agent for FMS: Richard Meissel Propel Biomedical Consulting 15500 Rockfield Boulevard, Suite A-1 Irvine, CA 92618 Phone Number: 949-768-0444 Fax Number: 949-768-8400

Date Prepared:

9/27/02

II. DEVICE NAME AND CLASSIFICATION

Proprietary Name:	Portapres Ambulatory Continuous Non Invasive BloodPressure Monitor
Common or Usual Name:	Continuous Non-Invasive Blood Pressure Monitor
Classification:	Class II; CFR 870.1130, Product Code DXN

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III. PREDICATE DEVICES

The Portapres is substantially equivalent in design (methodology) and indications for use to the following devices that have been or still are in commercial distribution:

Ohmeda 2300 Finapres® Blood Pressure Monitor, Ohmeda Medical, Englewood, . CO 80112-5810, K822055
Ohmeda 2350 Finapres® Blood Pressure Monitor, Ohmeda Medical, Englewood, ● CO 80112-5810, K880572
Task Force Monitor 3040, CNSystems Medizintechnik GMBH, Europe, AU, ● K014063
(BeatScope software): RODA Monitoring System, Metracor Technologies, Inc., San Diego, CA 921221, K011238

Portapres and Finapres are substantially equivalent in design, methodology, software, manufacture, materials, intended use and principle of operation. The Portapres, the Finapres, and the Task Force Monitor devices are intended for use for continuous monitoring of finger arterial blood pressure, the Portapres in an ambulatory model and the Finapres and Task Force Monitor in stationary models. FMS considers the use of the Portapres to be substantially equivalent to its predicate devices, the Ohmeda 2300 and 2350 Finapres and the CNSystems Task Force Monitor, and considers the BeatScope software cardiac output technology to be equivalent to the RODA Monitoring System cardiac output technology.

IV. DESCRIPTION

Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The

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microprocessor has an internal flash memory card for storage of blood pressure wave form data.

The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.

V. INTENDED USE

VI. TECHNOLOGICAL CHARACTERISTICS

No new technology, materials, or change in efficacy have been introduced by FMS in the manufacture of the FMS Portapres Ambulatory Continuous Noninvasive Blood Pressure Monitor. The design, form, and materials of the monitor are equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with the negative space forming a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

FMS, Finapres Medical Systems BV c/o Ms. Christine Emanuel TECSA Technical Services 1205 De La Vina Street Santa Barbara, CA 93101

Re: K023338

Trade Name: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: March 5, 2003 Received: March 10, 2003

Dear Ms. Emanuel:

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 annùal 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

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Page 2 - Ms. Christine Emanuel

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 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,

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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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.

*For a new submission, do NOT fill in the 510(k) number blank.

INDICATIONS FOR USE

Applicant: FMS, Finapres Medical Systems BV

510(k) Number (if known): N/A*

Device Name: Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor

Indications For Use:

The PC-based BeatScope software used with the data from the device provides Modelflowbased computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.

(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

Prescription Use ✗
Per 21 CFR 801.109

510(k) Number K023338
OR
Over-the-Counter _

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).