The Diasys Integra II is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode. The procedure can be:

transfert to a computer for further analysis and report printing using the DiasySoft . software
printed out directly in a report form by a printer connected to the unit .
transfert to a remote computer through a modem connected to the unit .

Device Description

The DIASYS INTEGRA II is a non invasive automatic ambulatory blood pressure recorder. It has two I he DITC I o it it it & erating, the auscultatory mode and the oscillometric mode. The required mode is selected with the DiasySoft Software. If neither of these modes has been specially programmed, the Scienced with the Discount of the most appropriate mode for the patient, according to its own criteria : this is the Automatic mode.
The DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module. The measurements are saved and can be printed out directly in report form by a printer connected to the unit. If a computer is used, recording conditions and criteria can be set and the a printer of the procedure can be selected, organized, stored and printed out in a fully customised report.
The system is only for measurement, recording and display. It makes no diagnoses.

AI/ML Overview

Here's a breakdown of the requested information about the DIASYS INTEGRA II device's acceptance criteria and the supporting study, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing a rigorous clinical study with acceptance criteria and a full statistical analysis. Therefore, much of the requested information, particularly regarding specific study design elements like sample size calculations, expert qualifications for ground truth, MRMC studies, and detailed training set information, is not explicitly present in this document. The focus here is primarily on device specifications and a general statement of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present formal acceptance criteria in a dedicated table format with specific thresholds for accuracy. Instead, it compares the new device's specifications to those of predicate devices and states its claimed precision.

Acceptance Criterion (Implied/Stated)	Reported Device Performance (DIASYS INTEGRA II)
Blood Pressure (BP) Measurement Range	30 – 260 mmHg
Heart Rate (HR) Measurement Range	30 – 240 bpm
BP Precision	+/- 3 mmHg
Operating Modes	Oscillometric, Auscultatory, ECG-gated auscultatory
Recording Duration	200 measurements or 48 hours
Interval of Measurement	Adjustable from 2 to 99 minutes; Automatic adjustment to patient position
Maximal Cuff Pressure Inflation	Adjustable (max=270 mmHg)

Note on "Acceptance Criteria": In a 510(k) submission, "acceptance criteria" are often implicitly met if the new device's performance is deemed substantially equivalent to a legally marketed predicate device. The explicit "acceptance criteria" for precision are typically derived from industry standards (e.g., AAMI, ISO) for blood pressure monitors, which often specify accuracy within a certain range (e.g., mean difference and standard deviation). The +/- 3 mmHg for BP precision is a common standard, suggesting this was the established benchmark.

2. Sample Size for Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). 510(k) summaries often do not include the detailed study protocols or results of the underlying performance studies.

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

The document does not provide any information regarding the number of experts or their qualifications for establishing ground truth. For blood pressure devices, ground truth is typically obtained using a reference standard (e.g., mercury sphygmomanometer readings by trained observers).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. Such studies are more common for diagnostic imaging AI devices where human interpretation plays a significant role. This device is an automated measurement system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is described as an "automatic ambulatory blood pressure recorder," implying it operates in a standalone mode, providing automated measurements. The stated BP precision of "+/- 3 mmHg" would be the result of a standalone performance evaluation. However, the exact details of this standalone performance study are not provided.

7. The Type of Ground Truth Used

For blood pressure measurement devices, the ground truth is typically established through simultaneous measurements using a recognized reference standard, such as a mercury sphygmomanometer or another validated oscillometric device, often read by trained human observers following a standardized protocol (e.g., AAMI, ISO). The document does not explicitly state the type of ground truth used for its performance evaluation, but this is the widely accepted method for such devices.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is a hardware-based measurement system with embedded algorithms, and the concept of a "training set" as understood in machine learning (for an AI algorithm) is not directly applicable in the same way to its core functionality described. While its algorithms would have been developed and tuned, the specific size of a "training set" of patient data is not discussed in this context.

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

As with point 8, the document does not provide information about a training set or how its ground truth might have been established. Device development involves calibration and validation against known standards and potentially clinical data, but the term "training set" in the AI sense is not used here.

Summary

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Image /page/0/Picture/0 description: The image shows the word "NOVACOR" in a bold, sans-serif font. Above the word is a barcode-like graphic, consisting of a series of vertical lines of varying widths. The word is in all caps, with the letters evenly spaced.

MAR 9 - 7005

510(k) SUMMARY of SAFETY & EFFECTIVENESS

113

Submitter : NOVACOR France 4. Passage Saint Antoine 92508 Rueil Malmaison cedex - France

Phone : 00 33 1 41 39 05 78 Fax : 00 33 1 41 39 01 99 E-mail : dgrenier@novacor.fr

Contact person : Mrs. Dominique GRENIER – Regulatory Affairs Director

Device trade name : DIASYS INTEGRA II

Common/Usual name: Ambulatory blood pressure recorder

Classification name : Blood Pressure Measurement System

Predicate devices :

OSCAR 2 - Model 222 - SUNTECH MEDICAL INTRUMENTS Inc. - K003004. SENSOCOR TM DIASYS – SENSORMEDIX Inc. – K881771

Device description :

Device deseribution.
The DIASYS INTEGRA II is a non invasive automatic ambulatory blood pressure recorder. It has two I he DITC I o it it it & erating, the auscultatory mode and the oscillometric mode. The required mode is selected with the DiasySoft Software. If neither of these modes has been specially programmed, the Scienced with the Discount of the most appropriate mode for the patient, according to its own criteria : this is the Automatic mode.

The DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module. The measurements are saved and can be printed out directly in report form by a printer connected to the unit. If a computer is used, recording conditions and criteria can be set and the a printer of the procedure can be selected, organized, stored and printed out in a fully customised report.

The system is only for measurement, recording and display. It makes no diagnoses.

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4, passage Saint Antoine 92508 Rueil Malmaison Cedex 08 France Tel : +33 1 41 39 01 61 Fax : +33 1 41 39 01 99 KO42107

P -13

Intended use : DIASYS INTEGRA II and DIASYSOFT INTENDED USE :

The Diasys Integra II is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the The Diasys and gressure (BP) and the heart rate (HR). It also measures and records the systent position and the arterial rigidity (QKd) at the time of each BP measurement. The BP patient position and the areas agains (esscillometric mode, the auscultatory mode or the ECC-gated auscultatory mode.

The procedure can be:

transfert to a computer for further analysis and report printing using the DiasySoft software .
printed out directly in a report form by a printer connected to the unit .
transfert to a remote computer through a modem connected to the unit .

Comparison of technology characteristics to predicate devices :

Predicate devices :

OSCAR 2 MODEL 222 SUNTECH MEDICAL INSTRUMENTS Inc. K003004 i
SENSOCOR TM DIASYS SENSORMEDIX Inc. KESS1971 ..

		Predicate devices		New device
Comparison items		Oscar 2	Diasys 200	Diasys Integra II
Indications		ABP recording	Same	Same
	Design
●	Operating Mode	Oscillometric	Auscultatory	OscillometricAuscultatoryECG-gated auscultatory
●	Display result	Built-in LCDdisplayPC software	Built-in LCD displayDirect Print-out	Built-in LCD displayDirect Print-outPC software
●	Recording duration	250 measurements,48 hours	250 measurements or72 hours	200 measurements or 48 hours
●	Sampling periods	3 time periods	4 time periods(adjustable)	Up to 24 time periods(adjustable)
●	Interval ofmeasurement		Adjustable from 2 to99 minutes	● Adjustable from 2 to 99 minutes● Automatic adjustement topatient position
●	Maximal cuffpressure inflation			Adjustable (max=270 mmHg)
●	Additionnalmeasurements	Additionnalmeasurementstriggered by thepatient	● Additionnalmeasurementstriggered by thepatient● Palliativemeasurements	Additionnal measurementsmanually● Triggered by the patient● Trigger on pressure criteria● Triggered on getting-up● Palliative measurements

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4, passage Saint Antoine 92508 Rueil Malmaison Cedcx 08 France Tel : +33 1 41 39 01 61
Fax : +33 1 41 39 01 99

Ke42101

Specifications
Measurement• ranges	BPHR	25 – 260 mmHg40 – 200 bpm	30 – 290 mmHg30 – 180 bpm	30 – 260 mmHg30 – 240 bpm
• BP precision		+/- 3 mmHg		+/- 3 mmHg
Interface		PC serial cable	NO	• PC serial cable• Modem cable
PC Software		AccuWin Prosoftware	NO	• DiasySoft software• NovaModem software• NovaMail software• NovaDrive software
Main components		• Two 1.5 AAalkaline orrechargeablebatteries.• Multiple cuffsizes	Six 1.5 AA batteries3 cuff sizes (large,standard, pediatric)	• 1 NiMH rechargeablebattery• 3 cuff sizes (large,standard, pediatric)• ECG-Position cable• ECG electrodes• Battery charger

Conclusion :

The information presented in this submission provides reasonable assurance that the DIASYS INTEGRA II ABPM recorder will perform in a safe and effective manner.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures.

412 3 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Novacor c/o Ms. Dominique Grenier Regulatory Affairs Director 4. Passage Saint Antoine 92508 Rueil-Mailmaison Cedex FRANCE

Re: K042109 Trade Name: Diasys Integra II Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 01, 2005 Received: February 07, 2005

Dear Ms Grenier:

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 interstatc 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.

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Page 2 -- Ms. Dominique Grenier

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), please contact the Office of Compliance at (240) 276-0120. 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,

Bhimmon for

Brath 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

2042105 510(k) Number (if known):

Device Name: DIASYS INTEGRA II

Indications For Use:

transfert to a computer for further analysis and report printing using the DiasySoft . software
printed out directly in a report form by a printer connected to the unit .
transfert to a remote computer through a modem connected to the unit .

Prescription Use x (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)
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Division Sign-Off
Division of Cardiovascular Devices
510(k) Number	K082109

Bimmermo259

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).