CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER

K972899 · Cypress Medical Products, Ltd. · DXQ · Jul 7, 1998 · Cardiovascular

Device Facts

• Record ID: K972899
• Device Name: CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
• Applicant: Cypress Medical Products, Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jul 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.

Device Story

Aneroid sphygmomanometer; manual blood pressure measurement device. Inputs: manual inflation of cuff; mechanical pressure sensing via manometer analog gauge. Operation: clinician inflates cuff, listens for Korotkoff sounds via stethoscope (not included), observes analog gauge to determine systolic and diastolic pressure values. Used in clinical settings by healthcare professionals. Output: visual pressure reading on analog dial. Benefit: provides non-invasive blood pressure monitoring for clinical assessment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual aneroid sphygmomanometer. Components: inflatable cuff, manual inflation bulb, analog manometer gauge. Mechanical sensing principle. No electronic components, software, or energy source.

Indications for Use

Indicated for non-invasive measurement of systolic and diastolic blood pressure in patients requiring blood pressure monitoring. Prescription use only.

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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Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles facing right, stacked on top of each other.

## JUL 7 1998

Mr. Anthony L. Giaccio Director Quality Systems/Regulatory Affairs Cypress Medical Products 1202 South Route 31 McHenry, IL 60050

Re: K972899 Cypress Medical Products Aneroid Sphygmomanometer Regulatory Class: II (Two) Product Code: DXQ Dated: April 27, 1998 Received: April 28, 1998

Dear Mr. Giaccio:

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 leqally 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, Druq, 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 aqainst 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation may result in requlatory 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 requlations.

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## Page 2 - Mr. Anthony L. Giaccio

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 regulation (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/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callehan

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

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K 9 7 レ8 9 9

Device Name: Aneroid Sphygmomanometer

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972899 |

Prescription Use_V (Per 21 CFR 801.109) OR Over-The-Counter Use_

(Optional Format 1-2-96)