(74 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on basic blood pressure and pulse rate measurement.
No
The device measures blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. Therapeutic devices are designed to treat or alleviate a medical condition.
No
The device measures blood pressure and pulse rate, which are vital signs, not typically considered diagnostic on their own but rather indicative of physiological state. Diagnostic devices generally identify the presence of a disease or condition.
No
The summary describes a device that measures blood pressure and pulse rate, which inherently requires hardware components (like a cuff and sensor) to interact with the patient's body. The lack of a device description doesn't negate the need for physical components to perform the stated function.
Based on the provided information, the BpTRU device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older." This is a direct physiological measurement taken from a living subject.
- 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. The BpTRU does not perform any analysis on such samples.
The BpTRU is a device that performs a physiological measurement on a living person, which falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
- age of officials' offices, nursing units, and patient care areas of hospitals.
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
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Indicated Patient Age Range
3 years of age or older
Intended User / Care Setting
officials' 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2001
Mr. Darvl Wisdahl Director of Regulatory Affairs and Clinical Research VSM MedTech Ltd. 15th Floor, 675 West Hastings Street Vancouver, BC Canada V6B 1N2
Re: K012636
Trade Name: BpTRU 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: August 10, 2001 Received: August 13, 2001
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.
1
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,
Della Tek
James E. Dillard III Director Division of Cardiovascular and Respiratory 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: | K012636 |
|---|---|
| Device Name: | BpTRU Automated Non-Invasive Blood Pressure Monitor |
| Model Name: | BPM-100 |
| Indications For Use: |
The BpTRU:
- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
- age of officials' offices, nursing units, and patient care areas of ● hospitals.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter USE
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K02636
August 10, 2001