DIASYS INTEGRA II

K042109 · Novacor France · DXN · Mar 9, 2005 · Cardiovascular

Device Facts

• Record ID: K042109
• Device Name: DIASYS INTEGRA II
• Applicant: Novacor France
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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 also 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 Story

Non-invasive ambulatory blood pressure (ABP) recorder; measures systolic, diastolic, mean BP, heart rate, patient position, and arterial rigidity (QKd). Operates via oscillometric, auscultatory, or ECG-gated auscultatory modes. Device contains electronic system and pneumatic inflation/deflation module; weighs 195g. Used in clinical or ambulatory settings; operated by healthcare professionals. Data stored on device; output via direct printer connection, PC serial cable, or remote modem transfer. DiasySoft software used for analysis, report customization, and procedure management. Provides BP monitoring data to assist clinicians in patient management; device does not provide automated diagnoses.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing of measurement performance.

Technological Characteristics

Non-invasive ABP recorder; pneumatic inflation/deflation module; 1 NiMH rechargeable battery. Measurement ranges: BP 30-260 mmHg, HR 30-240 bpm. Connectivity: PC serial cable, modem. Includes ECG-position cable and electrodes for ECG-gated mode. Software-based data management.

Indications for Use

Indicated for non-invasive ambulatory blood pressure monitoring in patients requiring systolic, diastolic, mean BP, heart rate, patient position, and arterial rigidity (QKd) assessment. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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MAR 9 - 7005

## 510(k) SUMMARY of SAFETY & EFFECTIVENESS

113

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

Phone : [phone] Fax : [phone] E-mail : [e-mail]

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 : [phone] Fax : [phone] 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 | Oscillometric<br>Auscultatory<br>ECG-gated auscultatory |
| ● | Display result | Built-in LCD<br>display<br>PC software | Built-in LCD display<br>Direct Print-out | Built-in LCD display<br>Direct Print-out<br>PC software |
| ● | Recording duration | 250 measurements,<br>48 hours | 250 measurements or<br>72 hours | 200 measurements or 48 hours |
| ● | Sampling periods | 3 time periods | 4 time periods<br>(adjustable) | Up to 24 time periods<br>(adjustable) |
| ● | Interval of<br>measurement | | Adjustable from 2 to<br>99 minutes | ● Adjustable from 2 to 99 minutes<br>● Automatic adjustement to<br>patient position |
| ● | Maximal cuff<br>pressure inflation | | | Adjustable (max=270 mmHg) |
| ● | Additionnal<br>measurements | Additionnal<br>measurements<br>triggered by the<br>patient | ● Additionnal<br>measurements<br>triggered by the<br>patient<br>● Palliative<br>measurements | Additionnal measurements<br>manually<br>● Triggered by the patient<br>● Trigger on pressure criteria<br>● Triggered on getting-up<br>● Palliative measurements |

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4, passage Saint Antoine 92508 Rueil Malmaison Cedcx 08 France Tel : [phone]
Fax : [phone]

Ke42101

| Specifications | | | | |
|-------------------------|----------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement<br>• ranges | BP<br>HR | 25 – 260 mmHg<br>40 – 200 bpm | 30 – 290 mmHg<br>30 – 180 bpm | 30 – 260 mmHg<br>30 – 240 bpm |
| • BP precision | | +/- 3 mmHg | | +/- 3 mmHg |
| Interface | | PC serial cable | NO | • PC serial cable<br>• Modem cable |
| PC Software | | AccuWin Pro<br>software | NO | • DiasySoft software<br>• NovaModem software<br>• NovaMail software<br>• NovaDrive software |
| Main components | | • Two 1.5 AA<br>alkaline or<br>rechargeable<br>batteries.<br>• Multiple cuff<br>sizes | Six 1.5 AA batteries<br>3 cuff sizes (large,<br>standard, pediatric) | • 1 NiMH rechargeable<br>battery<br>• 3 cuff sizes (large,<br>standard, pediatric)<br>• ECG-Position cable<br>• ECG electrodes<br>• 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 [phone]. 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 [phone] or [phone] 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:

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 .

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 | <div style="text-align:left;"></div> |
|------------------------------------|--------------------------------------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K082109 |

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