(45 days)
Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body parts. In general, the width of a blood pressure cuff should be approximately 40% of the diameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.
Hokanson Blood Pressure Digit and Penile cuffs
I am sorry, but to answer your request with the specific details about acceptance criteria, device performance, and study information, I would need a clinical study report or a 510(k) summary that contains such data.
The provided document is an FDA 510(k) clearance letter for the "Hokanson Blood Pressure Digit and Penile Cuffs." This letter primarily:
- Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices.
- Specifies the regulation number and class: It classifies the device as a Class II blood pressure cuff.
- Lists the indications for use: It states that the cuffs are intended to measure blood pressure in small peripheral body parts.
However, this document does not contain:
- Acceptance criteria or reported device performance data.
- Details about any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, MRMC studies, or standalone performance).
- Information about the training set.
Typically, this kind of performance data and study design would be found in the 510(k) summary submitted by the manufacturer, which is often a separate document from the clearance letter itself.
Therefore, I cannot provide the requested table and detailed study information based solely on the text you provided.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
D.E Hokanson, Inc. c/o Mr. D. Eugene Hokanson President 12840 N E 21st Place Bellevue. WA 98005
Re: K041689
Trade Name: Hokanson Blood Pressure Digit and Penile Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: July 14, 2004 Received: July 19, 2004
Dear Mr. Hokanson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers formed your becament the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or 10 conninered proc to may 20, 1978, 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 r ou may, ifere, whiless 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. D. Eugene Hokanson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of devilode that i Drivination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or K in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in allow you to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. " " 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), please if you desire of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general michinal and Consumer 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 vours.
Neil R.P. Ogden
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041689
Device Name: Hokanson Blood Pressure Digit and Penile cuffs
Indications For Use:
Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body Proxamoon Digit and I characy, the width of a blood pressure cuff should be approximately parts of small adiameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Divisio
Division of Came devices
510(k) Number K041689
§ 870.1120 Blood pressure cuff.
(a)
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.(b)
Classification. Class II (performance standards).