BIG BEN SQUARE, BIG BEN ROUND

K972301 · Rudolf Riester GmbH & Co. KG · DXQ · Sep 17, 1997 · Cardiovascular

Device Facts

• Record ID: K972301
• Device Name: BIG BEN SQUARE, BIG BEN ROUND
• Applicant: Rudolf Riester GmbH & Co. KG
• Product Code: DXQ · Cardiovascular
• Decision Date: Sep 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.

Device Story

Big Ben Square and Big Ben Round are sphygmomanometers used to measure blood pressure. These devices are manual instruments operated by healthcare professionals in clinical settings. They function by measuring pressure in an inflatable cuff to determine systolic and diastolic blood pressure levels. The output is displayed on a mechanical gauge, which the clinician reads to assess the patient's cardiovascular status. This information assists in clinical decision-making regarding patient health and hypertension management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual sphygmomanometer consisting of an inflatable cuff, pressure gauge (round or square form factor), and inflation bulb. Mechanical measurement principle. No software, electronics, or energy source.

Indications for Use

Indicated for the measurement of blood pressure in patients.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Submission Summary (Full Text)

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## SEP 17 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Patricia Riester Freudenmann Rudolf Riester GmbH & Co. KG P.O. Box 35 Bruckstraße 31 D-72417 Jungingen GERMANY

Re: K972301 Big Ben Round and Big Ben Square Requlatory Class: II Product Code: DXQ Dated: September 17, 1997 Received: June 19, 1997

Dear Ms. Freudenmann:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | 870. 1120 |
|--|-----------|
| | Blood |
| | Pressure |
| | Co44 |

DXQ []

510(k) Number (if known):_ -・K972301

Big Ben Square, Big Ben Round Device Name:

Indications For Use:

Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bea V. Demperle
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number 972301

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Formal 1-2-96)