EC6 PLETHYSMOGRAPH

K982707 · D. E. Hokanson, Inc. · JOM · Aug 26, 1998 · Cardiovascular

Device Facts

• Record ID: K982707
• Device Name: EC6 PLETHYSMOGRAPH
• Applicant: D. E. Hokanson, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Aug 26, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Indications for Use

A mercury strain gauge plethysmograph accurately measures volume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse volume waveforms and amplitudes, and blood flow into or out of limbs and digits. The instrument also contains an infrared photo plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes and measure blood pressure in the extremities in conjunction with blood pressure cuffs.

Device Story

EC6 Plethysmograph combines mercury strain gauge and infrared photo plethysmography; used in clinical settings by healthcare professionals. Mercury strain gauge measures limb/digit volume changes; infrared sensor acts as sensitive pulse detector. Operates with blood pressure cuffs to assess blood pressure, pulse waveforms, and blood flow. Provides visual output of waveforms and amplitudes for clinician evaluation; assists in vascular diagnostic decision-making. Benefits include non-invasive assessment of extremity blood flow and pressure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-modality plethysmograph: mercury strain gauge for calibrated volume measurement and infrared photo plethysmograph for pulse detection. Standalone instrument. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring measurement of blood pressure, pulse volume waveforms, pulse amplitudes, and blood flow in limbs or digits. Used in clinical settings for extremity vascular assessment.

Regulatory Classification

Identification

A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 1998

. " . " . " . "

Mr. D. Eugene Hokanson D.E. Hokanson, Inc. 12840 Northeast 21st Place Bellevue, WA 98005

Re: K982707 Trade Name: EC6 Plethysmograph Regulatory Class: II Product Code: JOM Dated: July 28, 1998 Received: August 3, 1998

Dear Mr. Hokanson:

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 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). 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 Regulations, 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 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 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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## Page 2 - Mr. D. Eugene Hokanson

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" (21CFR 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,
Thomas J. Callahon

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

Enclosure

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510(k) NUMBER (IF KNOWN) :

DEVICE NAME : _EC6 Plethysmograph

INDICATIONS FOR USE:

ه ۽ پي جي جو جو

The EC6 is two plethysmographs in one.

A mercury strain gauge plethysmograph accurately measures volume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse volume waveforms and amplitudes, and blood flow into or out of limbs and digits.

The instrument also contains an infrared photo plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes and measure blood pressure in the extremities in conjunction with blood pressure cuffs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lynne Reemer, 8/25/98

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)