(216 days)
Not Found
No
The description mentions an "Automatic mode" where the device selects the most appropriate measurement mode "according to its own criteria," but this does not explicitly indicate the use of AI or ML. The document lacks any mention of AI, ML, training data, or performance metrics typically associated with such technologies.
No
The device is described as a non-invasive blood pressure recorder used for measurement, recording, and display. It explicitly states, "It makes no diagnoses," which indicates it is for diagnostic information gathering rather than direct therapy or treatment.
No
The device description explicitly states, "The system is only for measurement, recording and display. It makes no diagnoses."
No
The device description explicitly states that the DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module, indicating it is a hardware device with integrated software.
Based on the provided text, the Diasys Integra II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-invasive Ambulatory Blood Pressure (ABP) recorder." It measures physiological parameters (blood pressure and heart rate) directly from the patient's body.
- Device Description: The description reinforces that it's a "non invasive automatic ambulatory blood pressure recorder." It focuses on the physical measurements and recording of these parameters.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The Diasys Integra II does not interact with or analyze any such specimens.
- No Mention of Laboratory Use: The description focuses on patient use and data transfer to a computer or printer, not on laboratory procedures or analysis of biological samples.
Therefore, the Diasys Integra II falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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 .
Product codes
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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 | Oscillometric |
| Auscultatory | ||||
| ECG-gated auscultatory | ||||
| ● | Display result | Built-in LCD | ||
| display | ||||
| PC software | Built-in LCD display | |||
| Direct Print-out | Built-in LCD display | |||
| Direct Print-out | ||||
| PC software | ||||
| ● | Recording duration | 250 measurements, | ||
| 48 hours | 250 measurements or | |||
| 72 hours | 200 measurements or 48 hours | |||
| ● | Sampling periods | 3 time periods | 4 time periods | |
| (adjustable) | Up to 24 time periods | |||
| (adjustable) | ||||
| ● | Interval of | |||
| measurement | Adjustable from 2 to | |||
| 99 minutes | ● Adjustable from 2 to 99 minutes | |||
| ● Automatic adjustement to | ||||
| patient position | ||||
| ● | Maximal cuff | |||
| pressure inflation | Adjustable (max=270 mmHg) | |||
| ● | Additionnal | |||
| measurements | Additionnal | |||
| measurements | ||||
| triggered by the | ||||
| patient | ● Additionnal | |||
| measurements | ||||
| triggered by the | ||||
| patient | ||||
| ● Palliative | ||||
| measurements | Additionnal measurements | |||
| manually | ||||
| ● Triggered by the patient | ||||
| ● Trigger on pressure criteria | ||||
| ● Triggered on getting-up | ||||
| ● Palliative measurements |
2
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 | BP | |||
| HR | 25 – 260 mmHg | |||
| 40 – 200 bpm | 30 – 290 mmHg | |||
| 30 – 180 bpm | 30 – 260 mmHg | |||
| 30 – 240 bpm | ||||
| • BP precision | +/- 3 mmHg | +/- 3 mmHg | ||
| Interface | PC serial cable | NO | • PC serial cable | |
| • Modem cable | ||||
| PC Software | AccuWin Pro | |||
| software | NO | • DiasySoft software | ||
| • NovaModem software | ||||
| • NovaMail software | ||||
| • NovaDrive software | ||||
| Main components | • Two 1.5 AA | |||
| alkaline or | ||||
| rechargeable | ||||
| batteries. | ||||
| • Multiple cuff | ||||
| sizes | Six 1.5 AA batteries | |||
| 3 cuff sizes (large, | ||||
| standard, pediatric) | • 1 NiMH rechargeable | |||
| battery | ||||
| • 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.
3
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.
4
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
5
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)
Page 1 of /
| Division Sign-Off | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K082109 |
Bimmermo259