(118 days)
Not Found
Not Found
No
The summary describes a standard blood pressure cuff and lacks any mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is a blood pressure cuff, which is an accessory used with blood pressure monitors, not a therapeutic device itself.
No
Explanation: The device, a blood pressure cuff, is used in conjunction with blood pressure monitors to measure blood pressure. Its intended use is to facilitate measurement, not to diagnose a condition itself.
No
The device is described as a "blood pressure cuff," which is a physical hardware component used in blood pressure measurement systems. The description does not mention any software component.
Based on the provided information, the Zefon blood pressure cuff is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with non-invasive blood pressure measurement systems. This involves measuring a physiological parameter (blood pressure) directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The Zefon blood pressure cuff does not involve analyzing such samples.
- Lack of IVD-related information: The provided text lacks any mention of analyzing biological samples, laboratory procedures, or diagnostic testing.
Therefore, the Zefon blood pressure cuff is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zefon blood pressure cuff is a reusable device to be used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.
Product codes
DXO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Child, Small Adult, Adult, Large Adult and Thigh.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Zefon International c/o Mr. Scott Ryan, President 5350 SW 1st Lane Ocala, FL 34474
Re: K080366
Trade/Device Name: DuraCheck Blood Pressure Cuffs, ZDC4000 Series, with Sizes: Child, Small Adult, Adult, Large Adult and Thigh. Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXO Dated: May 7, 2008 Received: May 8, 2008
Dear Mr. Ryan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (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.
1
Page 2 - Mr. Scott Ryan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
page 1 of 1
Zefon
INTERNATIONAL
Air Sampling Equipment
Medical Products
Injection Molding
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Zefon DuraCheck Blood Pressure Cuff
Indications For Use:
The Zefon blood pressure cuff is a reusable device to be used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Division of Cardiovascular Devices | Concurrence of CDRH Qffice of Device Evaluation (ODE) | |
|---|---|---|
| 510(k) Number_K080366 | ||
| Prescription Use | ||
| (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use |
| (21 CFR 801 Subpart C) | ||
| Page 5 Rev |
Image /page/2/Picture/9 description: The image shows a BSI Registered logo. The logo is circular with the letters "BSI" at the top. Inside the circle is an inverted triangle shape. Below the circle, the text "ISO 9001:2000 FM 98629" is printed.
5350 SW 1st Lane Ocala, Florida 34474, USA • Phone: 352-854-8080 • Fax: 352-854-7480 • www.zefon.com