(78 days)
Not Found
K350
No
The summary describes a standard non-invasive blood pressure monitor and contains no mention of AI, ML, or related concepts.
No.
The device is a non-invasive blood pressure monitor that measures systolic/diastolic blood pressure and pulse rate, which are diagnostic measurements rather than therapeutic interventions.
Yes
The device is described as a non-invasive blood pressure monitor used for measuring systolic and diastolic blood pressure and pulse rate, which are key physiological parameters used in medical diagnosis.
No
The description explicitly states the device is a "non-invasive blood pressure monitor" and mentions a "cuff circumference," which are hardware components. There is no indication that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic, diastolic blood pressure, and pulse rate. These are physiological measurements taken directly from the body, not tests performed on samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: While the description is "Not Found," the intended use clearly points to a non-invasive measurement device.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This blood pressure monitor does not fit that description.
N/A
Intended Use / Indications for Use
S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic blood pressure and pulse rate from 8.5~22cm for adult individual in a home environment.
Product codes
DXN
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
Adult individual
Intended User / Care Setting
Home environment
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)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the border of the circle.
DEC 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rossmax International Ltd. c/o Mr. Tzu-Wei Li Manager Industrial Technology Research Institute Bldg. 16, 321 Kuang Fu Rd. Sec. 2 Hsinchu Taiwan 30042 R.O.C.
Re: K052727
K052727
Trade Name: Rossmax S380 and K350 Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 15, 2005 Received: November 17, 2005
Dear Mr. Li:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics from stantially equivalent (for the indications for referenced above and nave decimined the aconvents marketed in interstate comments, or to devices that use stated in the enclosure) to legally man color of the Medical Device Amendments, or to devices that prior to May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Pedication (PMA). You may have been reclassified in accordance with the provisition (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the general Act (Act) that do not require approval of a premainco sprovisions of the Act. The general therefore, market the device, subject to the general semannial registration, listing of devices, good
controls provisions of the Act include requirements for annual regulters controls provisions of the Act merade requirements assust 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 classified (see above) mo eliner regulations affecting your device can be may be subject to such adultional controls. Existing of the South and States of Financial of found in the Code of Feach in a and in the Federal Register.
1
Page 2 – Mr. Tzu-Wei Li
Please be advised that FDA's issuance of a substantial equivalence determination access of the At Please be advised that FDA 's Issualice of a substance of the requirements of the Act or that FDA has made a deletinination that your devices of agencies. You must comply with any Federal Statutes and regulations administered of by but not listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and lists i all the Act s requirements, menufacturing practice requirements as set forth in the quality [abeling (21 CFR 1 art 801), good manadiation production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod Systems (QB) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisious (Sections 551-942 or the 110), device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a loggios to loggi I his letter will anow you to begin maneting your avree quivalence of your everyte your doys premarket nothication. The PDA midning of sactainled of a lovice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your device of your access note the regulation entitled, contact the Office of Compilance at (210) 276 - 3279 Part 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may " Misoraliding of reference to promation in the Act from the Division of Small
general information on your responsibilities under the Act from the Division of Small general information on your responsionates and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the constitudes html Manufacturers, International and Consulter Assistance and Collectivindustry/support/index.html.
Sincerely yours,
Blumman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Rossamx S380, K350 Blood Pressure Monitors
Indications For Use:
S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, S380, K.350 are non-invasive blood prossure menters and .5~22cm for adult individual in a home environment.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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)
Blossom
510(k) Number
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