(34 days)
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Not Found
No
The summary describes a standard automatic blood pressure monitor and does not mention any AI or ML capabilities.
No.
The device's stated intended use is to measure blood pressure and pulse rates, which is a diagnostic function, not a therapeutic one. It does not exert any physical or chemical action on the body to treat or alleviate a disease or condition.
Yes
The device is described as a "blood pressure monitor" used to "measure systolic, diastolic, and pulse rates." These measurements are used to assess a person's health status, which aligns with the definition of a diagnostic device.
No
The device description explicitly states "Rossmax Automatic Blood Pressure Monitor, model CardioCare 1000i," which is a physical hardware device used for measuring blood pressure. The summary does not mention any software component as the primary or sole medical device.
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 blood pressure and pulse rate. This is a physiological measurement taken directly from the body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: It's a blood pressure monitor, which is a device for measuring a vital sign directly.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information about a person's health status. This blood pressure monitor is a non-invasive device that measures a physiological parameter directly.
N/A
Intended Use / Indications for Use
The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7" to 12.6")
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Consumers / Over-the-counter use
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
§ 870.1130 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
d and Drug Administration 00 Corporate Boulevard Rockville MD 20850
MAY 2 2 2002
Mr. Michael Yeh Managing Director Rossmax International Ltd. 12F., No. 189, Kang Chien Road Taipei 114 TAIWAN
Re: K021225
Trade Name: Rossmax Automatic Blood Pressure Monitor, Model CardioCare 1000i Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 2, 2002 Received: May 6, 2002
Dear Mr. Yeh:
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. Michael Yeh
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 yours,
Dan V. Telleh
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT
| Indications for Use Statement | |
|---|---|
| 510(k) Number: | K021225 |
| Device Names: | Rossmax Automatic Blood Pressure Monitor, model |
| CardioCare 1000i | |
| Indications For Use: | The blood pressure monitor is used to measure systolic, |
| diastolic, and pulse rates in adult consumers with arm | |
| circumference between 22 cm to 32 cm (8.7" to 12.6") |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021225
Prescription Use______________________________________________________________________________________________________________________________________________________________
or
Over-the-counter use X