(148 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using a sensor to convert pressure changes to electrical signals for calculation, with no mention of AI or ML.
No
The device is used for measurement and monitoring of blood pressure, not for providing medical therapy.
Yes
This device measures physiological parameters (systolic, diastolic blood pressure, and pulse rate) to provide information about the patient's health status, which is a key characteristic of a diagnostic device. While it doesn't diagnose a specific disease, the act of measuring and providing health-related data for assessment falls under the umbrella of diagnostics.
No
The device description explicitly mentions an "inflatable cuff" and an "electronic semiconductor - sensor in the cuff," which are hardware components. The device uses the oscillometric method, which relies on physical measurements from the cuff and sensor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device function: The Compact Blood Pressure Monitor measures blood pressure and pulse rate by using a cuff wrapped around the upper arm. This is a non-invasive measurement taken on the body, not a test performed on a sample taken from the body.
The description clearly states it's a non-invasive technique using an inflatable cuff on the upper arm. This aligns with the definition of a non-IVD medical device used for physiological measurement.
N/A
Intended Use / Indications for Use
Model BD204 Compact Blood Pressure Monitor is intended for use by medical professionals in medical facilities or by patients for self- monitoring at home to monitor systolic, diastolic and pulse rates on a regular basis. This monitor is used in the same manner as the predicate model.
The Compact Blood Pressure Monitor is intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The device is reusable and intended for home use on adults.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Compact Blood Pressure Monitor, model BD204 is designed to measure systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Rather than using the ausculatory method, which employs either an aneroid gauge or mercury manometer with a stethoscope to determine systolic and diastolic pressure, the device uses the oscillometric method, wherein an electronic semiconductor - sensor in the cuff determines the measurements. The sensor converts minute alterations in cuff pressure to electrical signals, by analyzing the amplitude of those signals systolic and diastolic pressure and pulse rates are calculated. The device analyses the signals and displays the results immediately.
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
adult
Intended User / Care Setting
medical professionals in medical facilities or by patients for self- monitoring at home
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)
The accuracy of this monitor has been validated to the European Hypertension Society protocol.
The product has been tested and complies with the following standards: IEC/EN 60601-1: 2005. The AC/DC adapter was separately evaluated according to EN 60601-1/A2: 1995.
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.
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).
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FEB 8 2013
U.S. Food & Drug Administration – 510k Application
This application for 510k summarizes the safety and effectiveness information in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92.
K122810 The assigned 510(K) number is:
General Information A.
- Submitter's Name & Address : i.
Thermor Limited
16975 Leslie Street
Newmarket, Ontario
Canada
L3Y 9A1
- 800-387-8520 ii. Telephone 866-947-1034 iii. Facsimile Mark Beaton Contact Person iv. mbeaton@thermor-ins.com Contact Email v. September 10, 2012 Date Prepared vi.
General Information on Device B.
| i. | Name: | Digital Blood Pressure Monitor |
|---|---|---|
| ii. | Trade Name: | Compact Digital Blood Pressure Monitor, model BD204 |
| iii. | Common Name: | Blood Pressure Monitor |
| iv. | Classification Name: | System, measurement, blood pressure, non-invasive |
| V. | Product Code: | DXN |
| vi. | Class: | 2 |
| vii. | Regulation Number | 870.1130 |
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C. Identification of FDA Cleared Device (predicate)
- Digital blood pressure monitor, model LD 578 i. Name: K061279 ii. K Number: August 18, 2006 iii. Date Cleared:
D. Description of the Device
The Compact Blood Pressure Monitor, model BD204 is designed to measure systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Rather than using the ausculatory method, which employs either an aneroid gauge or mercury manometer with a stethoscope to determine systolic and diastolic pressure, the device uses the oscillometric method, wherein an electronic semiconductor - sensor in the cuff determines the measurements. The sensor converts minute alterations in cuff pressure to electrical signals, by analyzing the amplitude of those signals systolic and diastolic pressure and pulse rates are calculated. The device analyses the signals and displays the results immediately.
Oscillometric technology is well established and has been used for decades. The accuracy of this monitor has been validated to the European Hypertension Society protocol.
E. Intended Use Statement
Model BD204 Compact Blood Pressure Monitor is intended for use by medical professionals in medical facilities or by patients for self- monitoring at home to monitor systolic, diastolic and pulse rates on a regular basis. This monitor is used in the same manner as the predicate model.
F. Comparisons to the Predicate
The modified device (BD204) has the same intended use and identical fundamental technology as the predicate model LD 578. The device employs the same software to analyse the sensor readings using the oscillometric method, common to both monitors. It is identical in safety and effectiveness of the intended use to the 510(K) cleared device: LD 578.
The specific modifications from the original 510K cleared device are: different outer housing shape and size, addition of date and time to LCD readout, and minor modifications to the inflation and exhaust components.
Modifications made from Predicate:
-
- Shape and size of housing
- Date and Time on Display 2.
- Inflation and exhaust components 3.
-
- Packaging and wording in the Instruction manual
- Includes a UL approved AC/DC adaptor 5.
2
Tabulated comparisons demonstrating that the model BD204 is substantially equivalent to the predicate device with FDA 510K #K061279:
Technical Characteristics Comparison
| Intended Use | Identical |
|---|---|
| Fundamental Technology Employed | Identical |
| Target population | Identical |
| Use: by medical professional or patient | Identical |
| Safety and Effectiveness | Identical |
| Over the counter | Identical |
| Performance Specifications | Identical |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Electrical Safety | Identical |
| Standards Met | Identical |
| Energy Used or delivered | Identical |
| Environmental specifications | Identical |
| Ergonomics of patient user interface | Identical |
| Software | Identical |
| Packaging | similar |
| Dimensional Specification | Somewhat smaller out case |
| Inclusion of AC/DC Adaptor | Not included with predicate model |
Discussion of Similarities and Differences G.
The modified device is identical to the predicate in function and performance. The only differences are: Time & date on the display. The modifications to the original 510(k) cleared device are: the smaller outer housing, different packaging, slight change to inflation and exhaust components, inclusion of AC/DC UL approved adaptor.
The algorithm used to determine the blood pressure values and the software codes are unchanged from the predicate model. The Fundamental technology used by the modified device, is the same as the 510K cleared device.
None of the modifications will have any impact on the safety or effectiveness of the device for measuring blood pressure.
Performance Testing H.
The product has been tested and complies with the following standards:
3
IEC/EN 60601-1: 2005
The AC/DC adapter was separately evaluated according to EN 60601-1/A2: 1995
Conclusions l.
ﺮ ﺍﻟﻤﺴﺎﺣﺔ
Compact Digital Blood Pressure Monitor, Model BD204 is as safe and effective as the predicate device in it's intended use for blood pressure measurement based on electrical, mechanical and environmental testing results and the SP-10 standard requirements. Therefore, this device is essentially equivalent to the predicate device for blood pressure measurements.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol resembling an abstract caduceus, with three lines forming a shape reminiscent of a bird or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
FEB 8 2013
Thermor Ltd. c/o Mr. Mark Beaton Vice President of Marketing 16975 Leslie Street Newmarket, Ontario Canada L3Y 9A1
Re: K122810
Trade/Device Names: Compact Digital Blood Pressure Monitor, Model BD204 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: December 6, 2012
Dear Mr. Beaton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Mr. Mark Beaton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours. Bram D. Zuckerman
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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Indications for Use
510(k) Number (if known):
Device Name: Compact Digital Blood Pressure Monitor
Indications for Use: The Compact Blood Pressure Monitor is intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The device is reusable and intended for home use on adults.
Prescription Use _ (21 CFR 801 Subpart C) AND/OR
Over-The-Counter Use _ X (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) suces Division o ardiov STOR) Number
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