(23 days)
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.
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.
I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a letter from the FDA regarding the substantial equivalence of the "EC6 Plethysmograph" to legally marketed predicate devices, and an "Indications for Use" statement. It does not contain details about performance studies, sample sizes, ground truth establishment, or expert qualifications.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
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.
{1}------------------------------------------------
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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)
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
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.(b)
Classification. Class II (performance standards).