(39 days)
No
The description details standard oscillometric blood pressure measurement techniques and operational modes (Manual and Automatic) without mentioning any AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is described as a blood pressure monitor intended for measurement and does not state any therapeutic function.
Yes
The device measures systolic and diastolic blood pressure and pulse rate, which are used to assess a patient's health status and aid in the diagnosis of conditions like hypertension.
No
The device description explicitly states it is a "Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200)" that uses an "upper arm cuff" and "automatically inflates and deflates the cuff," indicating it is a hardware device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The BpTRU BPM-200 measures blood pressure and pulse rate directly from the patient's upper arm using a cuff and the oscillometric technique. This is a non-invasive measurement taken on the body, not a test performed on a specimen taken from the body.
The device description clearly indicates it's a non-invasive blood pressure monitor that interacts directly with the patient's body to obtain measurements. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BpTRU BPM-200:
- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
- Is intended for use in physicians' offices, nursing units, and patient care areas of . hospitals.
Product codes
DXN
Device Description
The BpTRU Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200) is a portable automated, non-invasive blood pressure monitor designed to measure the blood pressure and pulse rate of patients using an upper arm cuff. The device uses a standard blood pressure cuff to measure the blood pressure in the upper arm. The device automatically inflates and deflates the cuff, and uses the oscillometric technique to calculate systolic and diastolic blood pressure.
The BPM-200 has two blood pressure operational modes: Manual and Automatic. Manual Mode is designed to take a single blood pressure measurement. Automatic Mode takes six measurements, discards the first, and displays the average of the last five readings. The cycle time, or minutes between measurements (from the start of one measurement to the start of the next measurement), can be selected in Automatic Mode. Individual readings are stored and can be reviewed in both Manual and Automatic Modes.
The BPM-200 can be operated while mounted to a wall, attached to a roll-stand or self-standing on the tabletop. The new device includes an internal rechargeable battery and features USB connectivity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
3 years of age or older
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
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)
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
2.3. 510(K) Summary of Safety and Effectiveness
OCT 2 2 2002
Submitter:
VSM MedTech Ltd. 15th Floor, 675 West Hastings Street Vancouver, BC V6B 1N2 CANADA
Company Contact:
Daryl Wisdahl Director of Regulatory Affairs and Clinical Research Phone: (604) 738-8763 Fax: (604) 738-8762
Regulatory Identification:
| Device Name: | BpTRUTM Portable Automated Non-Invasive Blood Pressure Monitor |
|---|---|
| Model Name: | BPM-200 |
| Device Classification Name: | System, measurement, blood-pressure, non-invasive |
| Device Class: | II |
| Regulation Numbers: | CFR 870.1130 |
| Panel: | Circulatory System Device Panel (74) |
| Product Code: | DXN |
| Classification Advisory Committee: | Cardiovascular |
| Establishment Registration Number (Owner/Operator): | 9034609 |
Predicate Device Information:
VSM Technology BpTRU™ Automated Non-Invasive Blood Pressure Monitor (Model BPM-100) as cleared by K994423, K002046 and K012636.
September 12, 2002
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Device Description:
The BpTRU Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200) is a portable automated, non-invasive blood pressure monitor designed to measure the blood pressure and pulse rate of patients using an upper arm cuff. The device uses a standard blood pressure cuff to measure the blood pressure in the upper arm. The device automatically inflates and deflates the cuff, and uses the oscillometric technique to calculate systolic and diastolic blood pressure.
The BPM-200 has two blood pressure operational modes: Manual and Automatic. Manual Mode is designed to take a single blood pressure measurement. Automatic Mode takes six measurements, discards the first, and displays the average of the last five readings. The cycle time, or minutes between measurements (from the start of one measurement to the start of the next measurement), can be selected in Automatic Mode. Individual readings are stored and can be reviewed in both Manual and Automatic Modes.
The BPM-200 can be operated while mounted to a wall, attached to a roll-stand or self-standing on the tabletop. The new device includes an internal rechargeable battery and features USB connectivity.
Description of Modification:
The BPM-200 is an extension of the BpTRU family of NIBP devices, and as such the existing BPM-100 has been modified to create the BPM-200. The modifications include the addition of battery operation, USB connectivity, and provisions for polemounted and self-standing operation.
Indications for Use:
The BpTRU:
- . Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older
- Is intended for use in physicians' offices, nursing units, and patient care areas . of hospitals.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that suggest the shape of a head, body, and tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VSM MedTech Ltd. c/o Mr. Daryl Wisdahl Director of Regulatory Affairs and Clinical Research 15th Floor, 675 West Hastings Street Vancouver, BC V6B 1N2 CANADA
Re: K023055
Trade Name: BpTRU™ Portable Automated Non-Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 10, 2002 Received: October 11, 2002
Dear Mr. Wisdahl:
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.
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Page 2 -- Mr. Daryl Wisdahl
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,
Megan Magner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.2. Indications for Use Statement
| 510(k) Number: | K02-3055 |
|---|---|
| Device Name: | BpTRUTM Portable Automated Non-Invasive Blood Pressure Monitor |
| Model Name: | BPM-200 |
Indications For Use:
The BpTRU BPM-200:
- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
- Is 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 |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Utefane Mynul for BDZ
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K023655 |
|---|---|
| --------------- | --------- |
September 12, 2002