TONOPORT V

K012647 · Par Medizintechnik GmbH · DXN · Nov 9, 2001 · Cardiovascular

Device Facts

• Record ID: K012647
• Device Name: TONOPORT V
• Applicant: Par Medizintechnik GmbH
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Tonoport V is intended to be used for measuring the systolic, diastolic, mean blood pressure and the heart rate of human beings for periods up to 30 hours. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 cm to 42 cm. Tonoport V is a prescription device in health care medicine. It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. Medically trained staff like a doctor or nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport. The patient does not operate with the Tonoport V by himself. A measurement with Tonoport V is combined with other measurements and medical examinations at the patient, so that a diagnosis about the patient's health condition depends not alone from the measurement of the Tonoport V. Tonoport V is not intended to be used in home care medicine or in intensive care medicine or for alarming of life-threatening conditions.

Device Story

Tonoport V is a patient-borne, non-invasive blood pressure (NIBP) Holter monitor. It uses an upper-arm cuff and internal electrical pump to perform oscillometric blood pressure measurements at predefined intervals for up to 30 hours. Powered by two AA batteries. Operated by medically trained staff (physicians/nurses) in clinical settings; patient does not self-operate. Data is stored internally and transmitted via RS-232 interface to an external printer (e.g., EPSON LX-300+) or medical device for evaluation/archiving. Output provides blood pressure and heart rate data to assist clinicians in diagnosis alongside other medical examinations. Benefits include ambulatory monitoring of blood pressure trends.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with voluntary and mandatory standards was verified through requirements specification review, software/hardware testing, safety testing, environmental testing, and final verification/validation.

Technological Characteristics

Oscillometric NIBP measurement system. Powered by two AA alkaline or NiMH batteries. Includes internal electrical pump and cuff for upper arm (17-42 cm). Connectivity via RS-232 serial interface for data transmission to external printers or medical devices. Compact, lightweight, patient-borne form factor. Software-controlled operation.

Indications for Use

Indicated for measuring systolic, diastolic, mean blood pressure and heart rate in adults and children (excluding neonates) with upper arm circumference 17-42 cm. Not for home care, intensive care, or life-threatening condition alarming.

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

• ABPM Mobil-o-Graph Blood Pressure Monitor, Model ABP Control (K964235)

Submission Summary (Full Text)

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PAR Medizintechnik GmbH

... ...

08/07/2001 Rev A01 510(k) Premarket Notification
Tonoport V

NOV 0 9 2001

K012647 p.1/2

#### 510(k) Summary 4

# 510(k) Summary of Safety and Effectiveness

| Date: | August 07, 2001 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | PAR Medizintechnik GmbH |
| | Einemstrasse 9 |
| | D-10787 Berlin |
| | Germany |
| Contact Person: | Lothar Engel |
| | Technical Manager |
| | PAR Medizintechnik GmbH |
| | Email: [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| Device: Trade Name: | Tonoport V |
| Common/Usual Name: | NIBP Holter System |
| Classification Names: | 21 CFR 870.1130 Non-Invasive Blood-Pressure Measurement System DXN |
| Predicate Device: | K964235 Device Name: ABPM Mobil-o-Graph Blood Pressure Monitor, Model ABP Control |
| Device Description: | The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method. The cuff is borne on the upper arm and an electrical pump inside the device generates the pressure in the cuff. The Tonoport V is powered from two AA size batteries (alkaline or rechargeable NiMH batteries). For periods of up to 30 hours it records the patient's blood pressure at predefined intervals and save the results. In order to assess the measurements, the stored data can be transmitted via a RS-232 interface to a 9-needle dot-matrix printer with serial interface (EPSON LX-300+) or to another medical device for further evaluation or archiving purposes. |
| Intended Use: | Tonoport V is intended to be used for measuring the systolic, diastolic, mean blood pressure and the heart rate of human beings for periods up to 30 hours. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 cm to 42 cm. Tonoport V is a prescription device in health care medicine. It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. Medically trained staff like a doctor or nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport. The patient does not operate with the |

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PAR Medizintechnik GmbH

08/07/2001 Rev A01

510(k) Premarket Notification Tonoport V

K012647 p.2/2

Tonoport V by himself. A measurement with Tonoport V is combined with other measurements and medical examinations at the patient, so that a diagnosis about the patient's health condition depends not alone from the measurement of the Tonoport V.

## Technology:

The Tonoport V employs the same functional technology as the predicate device.

## Test Summary:

The Tonoport V complies with the voluntary and mandatory standards as detailed in Section 12 of this submission. The following quality assurance measures were applied to the development of the Tonoport V:

- Requirements specification review .
- Software and hardware testing ●
- Safety testing .
- Environmental testing .
- Final verification and validation ●
- Compliance with performance standards ●

### Conclusion:

The results of these measurements demonstrated that the Tonoport V is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized depiction of three overlapping human figures, possibly representing individuals or families. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2001

Mr. Lothar Engel Technical Manager PAR Medizintechnik GmbH Einemstrasse 9 D-10787 Berlin GERMANY

Re: K012647 Trade Name: Tonoport V Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 7, 2001 Received: August 13, 2001

Dear Mr. Engel:

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.

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# Page 2 - Mr. Lothar Engel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a concentuations administered by other Federal agencies. You must or any I could statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607); fuocing (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (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) I mis letter wif anow you to oegin maing of substantial equivalence of your device to a legally prematicate 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 and 11 you desire specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Cr 11 at 3646. Additionally, for questions on the promotion and advertising of Compliance at [phone]. office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general miorination on your 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,

Katha Tiller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PAR Medizintechnik Umbi

510(k) Premarket Notification Tonoport V

SARE 24 - 12 - 12 - 12 - 12 - 12 - 12 -

NOV 0 9 2001

K012647

#### Statement of Indications for Use 3

PAR Medizintechnik GmbH Applicant: Einemstrasse 9 D-10787 Berlin Germany

unknown 510(k) Number (if known): _

Tonoport V Device Name:

The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NBP) holter I he Tonoport V is a compact, inguiff is borne on the upper arm and an electrical pump inside the using the oschlometre mediod. The curi is bothe on als apper answer from two AA size batteries (alkaline or rechargeable NiMH batteries).

(alkaline of rechargeable NiMIT battertes).
For periods of up to 30 hours it records the patient's blood pressure at predefined intervals and save the results.

the results.
In order to assess the measurements, the stored data can be transmitted via a RS-232 interface to a 9-needle dot-matrix printer with serial interface (EPSON LX-300+)

to a 9-needie dot maint printer evaluation or archiving purposes.

or to anouter intended to be used for measuring the systelic, diastolic, mean blood pressure and the Tonoport V is intended to be used for measuring the intended matient populations are adults and nearl rate of numall beings for perfous up to 50 nover arm in the range of 17 cm to 42 cm.

Tonoport V is a prescription device in health care medicine. It can be used if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. of the patient anows an actoriance, tron nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport V is sembined with other accommodation of the patients and the proparation and appris with Tonoport V is combined with other not operate with the Tonoport ▼ by million. It news a diagnosis about the patient's health mousurements not alone from the measurement of the Tonoport V.

Tonoport V is not intended to be used in home care medicine or in intensive care medicine or for alarming of life-threatening conditions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012647