(61 days)
Not Found
Not Found
No
The document describes a standard oscillometric blood pressure monitor and makes no mention of AI, ML, or related technologies. The focus is on standard performance testing and regulatory compliance.
No.
The device is purely for measurement and monitoring of blood pressure and pulse rate; it does not provide any therapy or treatment.
No
The device measures blood pressure and pulse rate, which are physiological parameters. While these measurements can be used by a healthcare professional as part of a diagnostic process, the device itself simply provides measurements and does not interpret them to identify a disease or condition. Its intended use is for measurement, not diagnosis.
No
The device description explicitly states it "measures systolic and diastolic blood pressures and pulse rate" using the "oscillometric method," which requires hardware components like a cuff and pressure sensor, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device "measures systolic and diastolic blood pressures and pulse rate." This is a direct measurement of physiological parameters from the body, not an analysis of a sample taken from the body.
- Method: The device uses the "oscillometric method," which is a non-invasive technique for measuring blood pressure using a cuff and pressure sensor. This does not involve analyzing a biological sample.
Therefore, the Reizen Talking Blood Pressure Monitor SF860T is a medical device, but it falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reizen Talking Blood Pressure Monitor SF860T measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in another outpatient setting.
Product codes
DXN
Device Description
The Reizen Talking Blood Pressure Monitor SF860T measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in another outpatient setting. It has the same technological characteristics as the predicate device.
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
adults (those 18 years of age and older)
Intended User / Care Setting
at home or in another outpatient setting.
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)
The device has been certified as meeting the standards of the ISO 9001/ISO 13485 Quality System Standard. Further, it has been certified as complying with the applicable requirements of the European Union Medical Devices Directive (93/42/EEC). The device also passed testing to show conformance with the ANSVAAMI SP10 Standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
A&D Medical LifeSource Talking Digital Blood Pressure Monitor, Model UA-7671'
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
AUG 3 1 2004
510(k) Summary
Sponsor Information:
Maxi-Aids 42 Executive Boulevard Farmingdale, NY 11735 Elliot Zaretsky Phone (631) 752-0521 Facsimile (631) 752-0689
Date Prepared:
June 25, 2004
Device Name:
Proprietary Name: Reizen Talking Blood Pressure Monitor, Model SF860T
Common/Usual Name: Blood pressure monitor
Classification Name: Noninvasive blood pressure measurement system (per 21 C.F.R. § 870.1130)
Device Description, Intended Use, and Technological Characteristics:
The Reizen Talking Blood Pressure Monitor SF860T measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in another outpatient setting. It has the same technological characteristics as the predicate device.
Predicate Device:
A&D Medical LifeSource Talking Digital Blood Pressure Monitor, Model UA-7671'
Performance Data:
The device has been certified as meeting the standards of the ISO 9001/ISO 13485 Quality System Standard. Further, it has been certified as complying with the applicable requirements of the European Union Medical Devices Directive (93/42/EEC). The device also passed testing to show conformance with the ANSVAAMI SP10 Standard.
1
Public Health Service
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Maxi Aids, Inc. c/o Mr. Wayne H. Matelski 1050 Connecticut Avenue Washington, DC 20036-5339
Re: K041778
K041778
Trade Name: Reitzen Talking Blood Pressure Monitor, Model SF860T Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: June 28, 2004 Received: July 1, 2004
Dear Mr. Matelski :
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) premained 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 encrosule) to regary manated povice Amendments, or to commerce prof to May 28, 1976, the encenture with the provisions of the Federal Food. Drug, devices that have been icclassified in acceraalso was a proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) that do not require approvinces in controls provisions of the Act. The Y ou may, merelore, market the devices, subject to annual registrator, listing of
general controls provisions of the Act include requirements for annual registration, disco. general controls provisions of the first 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 If your device is classifica (seculored in the exist is a major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroller Controller of the 898. In addition, FDA may be found in the Oous overning your device in the Federal Register.
2
Page 2 – Mr. Wayne H. Matelski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualice of a subcements with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a determination alat your as recess by other Federal agencies. You must a or any Federal statules and regulations daminities or registration and listing (21)
comply with all the Act's requirements, including, but not limited to: registration resear comply with all the Act s requirements, more of any cannon of the requirements as setting the closetter CFK Part 807); labeling (21 CFR Part 800); government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 am 1000 1 forin in the quality systems (QD) regalication (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors 597 - vice as described in your Section 510(k)
This letter will allow you to begin marketing your device to logics to 100) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket nother 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 if you desire specific advice for your ac 110 %. Also, please note the regulation entitled, contact the Office of Complians as (Set ) , (21CFR Part 807.97). You may obtain " Misoranding by reserved to premainter to be act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Goress http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R. Opler
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K041778
Device Name: Reizen Talking Blood Pressure Monitor, Model SF860T
Indications For Use:
The device measures systolic and diastolic blood pressures and pulse rate. It uses the i he device measures systems and diacters brose prosessor age and older) at home or in an outpatient setting.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
× Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden
| (Division Sign-Off)
| Division of Cardiovascular Devices |
|---|
| ----------------------------------------------------------- |
510(k) Number,
Page 1 of 1