(90 days)
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No
The summary describes a standard automated blood pressure monitor and contains no mention of AI, ML, or related concepts.
No
The device measures blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not provide treatment or alleviate symptoms.
No
The device measures vital signs (blood pressure and pulse rate), which are indicators of health status, but it does not diagnose a specific disease or condition. Diagnostic devices typically identify or confirm the presence of a disease.
No
The device description explicitly states "Automated Non-Invasive Blood Pressure Monitor, Model BPM-100," which strongly implies a hardware device designed to measure blood pressure. There is no mention of the device being solely software or running on a general-purpose computing platform.
No, 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. They are used to examine these samples outside of the body.
- BPM-100 Function: The BPM-100 measures blood pressure and pulse rate directly from the patient's body using non-invasive methods (likely a cuff). It does not analyze samples taken from the body.
The information provided clearly indicates the BPM-100 is a non-invasive medical device used for physiological measurements in vivo (within the living body), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The BPM-100: - Measures systolic and diastolic blood pressure and pulse rate in adults greater than ● 18 years of age. - ls intended for use in physicians' offices, nursing units, and patient care areas of . hospitals.
Product codes
74 DXN
Device Description
Automated Non-Invasive Blood Pressure Monitor Model BPM-100
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
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Indicated Patient Age Range
adults greater than 18 years of age.
Intended User / Care Setting
physicians' offices, nursing units, and patient care areas of hospitals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/10 description: The image shows a black and white logo. The logo features three curved lines stacked on top of each other, resembling a stylized bird in flight or waves. The lines are thick and bold, creating a sense of movement. Part of a circular shape with text is visible on the left side of the image.
MAR 2 8 200
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VSM Medtech Ltd. c/o Mr. Howard M. Holstein Hogan and Hartson, L.L.P. 555 13th Street NW Washington, DC 20004-1109
Re : K994423 Automated Non-Invasive Blood Pressure Monitor, Model BPM-100 Requlatory Class: II (two) Product Code: 74 DXN December 24, 1999 Dated: Received: December 29, 1999
Dear Mr. Holstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Howard M. Holstein
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
for James E. Dillard III
Director
Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VSM Technology Inc.
2.2. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K994423 |
|---|---|
| ---------------- | --------- |
Device Name: Automated Non-Invasive Blood Pressure Monitor
Model Name: BPM-100
Indications For Use:
The BPM-100:
- Measures systolic and diastolic blood pressure and pulse rate in adults greater than ● 18 years of age.
- ls intended for use in physicians' offices, nursing units, and patient care areas of . hospitals.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter USE
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
Aere L. Lamper Q
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K994423