(100 days)
Not Found
No
The device description and performance studies focus on standard oscillometric blood pressure measurement and do not mention any AI/ML components or algorithms. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is designed to measure blood pressure and pulse rate, which are diagnostic functions, not therapeutic. It does not provide any treatment or therapy.
Yes
The device measures systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and can aid in diagnosis.
No
The device description explicitly mentions hardware components such as an inflatable cuff, internal pump, internal exhaust valve, LCD, and Bluetooth wireless module, indicating it is not solely software.
Based on the provided information, the BP-BT Kiosk is not an In Vitro Diagnostic (IVD) device.
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 provide information about a person's health. These tests are performed outside of the body (in vitro).
- BP-BT Kiosk Function: The BP-BT Kiosk measures blood pressure and pulse rate directly from the patient's upper arm using an inflatable cuff and the oscillometric method. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
The device description clearly outlines a physical measurement process on the patient, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
BP-BT Kiosk is designed to measure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication: Prescription use in medical or clinic environment only.Rx only.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
BP-BT Kiosk has the same design as the predicated device with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is first adapted to the arm size and then, inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. BP-BT Kiosk will not inflate the cuff higher than 300 mmHg. BP-BT Kiosk will turn on an irregular heartbeat if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and transmitted via Bluetooth wireless module. The cuff is also deflated automatically to 0 mmHg at the same time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Prescription use in medical or clinic environment only.
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)
Clinical Test.: 267 sets of data were measured by the blood pressure monitor and Mercury Blood pressure monitor
- The average deviation of systolic pressure: 0.19mmHg .
- The standard deviation of systolic pressure: 1.56 mmHg
- The average deviation of diastolic pressure: 0.25mmHg ●
- The standard deviation of diastolic pressure: 1.65mmHg ●
- The error of pulse rate measured by blood pressure monitor was within ±5%.
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.
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors K151953
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
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May 15, 2020
LD Technology LLC Albert Maarek Quality Manager 100 N. Biscayne Blvd Suite 502 Miami, Florida 33132
Re: K200287
Trade/Device Name: BP-BT Kiosk Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 10, 2020 Received: April 14, 2020
Dear Albert Maarek:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200287
Device Name BP-BT Kiosk
Indications for Use (Describe)
BP-BT Kiosk is designed to measure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication: Prescription use in medical or clinic environment only.Rx only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for LD Technology. The logo consists of a circular emblem on the left and the text "LD Technology" on the right. The emblem features a green sphere with plant-like structures extending from the bottom, all enclosed within a white circle. The text "LD Technology" is in a light green color, with "LD" in a larger, bolder font and "Technology" in a smaller, italicized font.
510(k) Premarket Notification Number: date: January, 29,2020
510(k) Summary BP-BT Kiosk
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
- Submitter's Identification: Manufacturer: L.D TECHNOLOGY Address: 100 N. Biscayne Blvd, Suite 502 Miami, FL, 33132, USA Tel: 305-379-9900 E mail: albert.ldteck@gmail.com
2. Device Name / Classification
Trade name: Non-Invasive Blood Pressure measurement system Device Name and Model: BP-BT Kiosk Regulation number: 21CFR 870.1130 Product Codes: DXN Device Class: Class II Classification Name: Blood pressure monitor Classification Panel: Cardiology
3. Predicate legally marketed device
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors K151953. Applicant: A&D Engineering, Inc. Product Code: DXN
4. Device Description
BP-BT Kiosk has the same design as the predicated device with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is first adapted to the arm size and then, inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. BP-BT Kiosk will not inflate the cuff higher than 300 mmHg. BP-BT Kiosk will turn on an irregular heartbeat if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and transmitted via Bluetooth wireless module. The cuff is also deflated automatically to 0 mmHg at the same time. The detail of summary of substantial equivalence is listed below.
4
5. Intended use and indications for use
BP-BT Kiosk is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication : Prescription use in medical or clinic environment only. Rx only.
6. Performances, technical specifications and materials Performances
The main purpose of the device is to measure the subject blood pressure and Pulse rate.
Technical specifications i.e. table of comparison with the predicate device Patient contact materials:
The material in contact with the patient is the cuff. The Cuff material is nylon and latex free.
Image /page/4/Picture/7 description: The image shows a black warning symbol on a white background. The symbol is an equilateral triangle with a thick black border. Inside the triangle is a large black exclamation point, indicating a warning or caution. The exclamation point is centered within the triangle, with a small space between the point and the top of the triangle.
7. Contra-indications
- . Patients with any implanted electronic device (i.e. Pacemaker.).
- Patients with arterial catheters
- Patients with venous pulsations may cause erroneous reading in blood pressure (e.g. ● tricuspid valve regurgitation).
- Patients that have low blood perfusion. Using the blood pressure device may cause skin erosion and/or pressure necrosis.
- Patients that have double mastectomy procedure
8. Undesirable side effects:
No side effects or adverse reactions are known to date.
9. Substantial equivalence
Predicate legally marketed device:
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors K151953. Applicant: A&D Engineering, Inc. Product Code: DXN
Table of comparison
| Information | TM-2657 Family | BP-7000 Kiosk |
|---|---|---|
| Intended use | TM-2657, TM-2657P, TM-2657PBT, and | |
| TM-2657PRS are designed to measure blood | ||
| pressure (systolic and diastolic) and pulse rate | ||
| in adult patients with arm circumference range | ||
| between 7.1 inches (18.0 cm) to 13.8 inches | ||
| (35.0 cm). | BP-BT Kiosk is designed to measure blood | |
| pressure (systolic and diastolic) and pulse rate | ||
| in adult patients with arm circumference | ||
| range between 6.7 inches (17.0 cm) to 16.5 | ||
| inches (42.0 cm). | ||
| Power Supply | 100-240V AC 50/60Hz | AC 100-240V, 50-60Hz ; D.C.12V, 3.5A |
5
| Cuff design | Winding mechanism operated by
geared motor | Winding mechanism operated by
geared motor |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Type | Display by LED | Display by LED |
| Communication | Wired - RS232C standard (TM-2655
Family). Wireless - Bluetooth 2.1 Standard
(UA-767PBT) | Bluetooth serial port and USB interface. |
| Testing Bench | Type of protection against electric shock:
Class I. BF
Compliant with standards:
60601-1,
60601-1-2
80601-2-30.
Clinical Test | Type of protection against electric shock:
Class I. BF
Compliant with standards:
60601-1,
60601-1-2
60601-2-30
Clinical Test |
| Measurement types | Systolic and diastolic Blood pressure
Pulse rate
Method : oscillometric | Systolic and diastolic Blood pressure
Pulse Rate
Method: oscillometric |
| Operating and storage
environment | Operating: 10°C to 40°C with 15 % to 85%
RH
Storage: -20°C to 60°C with 10 -95% RH | Operating: 5°C to 40°C with15% to 80% RH
Storage: -20 °C to 55 °C with ≤93%RH |
| External dimensions and
weight | 241 (W) x 330 (H) x 390 (D) mm
Approx. 5.5 kg | 387.7mm (L) × 244.1mm (W) × 340.2mm (H)
Approx. 6 kg |
| Measurement ranges and
Accuracy | Pressure: 0- 299 mmHg
BP : +/- 3%, Pulse : +/- 5 % | Pressure: 0- 300 mmHg
BP: ± 2 mmHg Pulse rate: ± 5 % |
| Target population | Adult general public | Adult general public |
| Where used | Over the counter | Prescription use in medical or clinic
environment only. |
10. Performances and Effectiveness
Performances and effectiveness are demonstrated by:
- CRC (Cyclic redundancy check) Coding was performing to demonstrate the software performance to accurately capture, store, and analyze the data measured by the hardware's.
- IEC 80601-2-30: Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. 10/31/2010 Second Edition
- Testing comprises the Software verification and validation (SRS/SDS/STR). -
- Risk analysis and -
6
Clinical Test.: 267 sets of data were measured by the blood pressure monitor and Mercury Blood pressure monitor
- The average deviation of systolic pressure: 0.19mmHg .
- The standard deviation of systolic pressure: 1.56 mmHg
- The average deviation of diastolic pressure: 0.25mmHg ●
- The standard deviation of diastolic pressure: 1.65mmHg ●
- The error of pulse rate measured by blood pressure monitor was within ±5%. ●
The Following differences:
- The BP-BT Kiosk has a) a larger amplitude in arm circumference range and b) a D.C. converter 12V, 3.5A comparing to the predicate device.
Do not affect the performances and the effectiveness of the BP-BT s kiosk.
11. General Safety Concerns
The laboratory test reports, and clinical study of the BP-BT Kiosk have demonstrated the general safety of the device compared to the legally marketed predicate device.
12. Standards
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety > and essential performance. Third Edition December 2006
-
IEC60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. Fourth Edition 2014
-
IEC 80601-2-30: Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. 10/31/2010 Second Edition
-
Guidance for: Industry; FDA staff; and Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005
-
ISO 14971: Medical devices - Application of risk management to medical devices. March 01, 2007
Conclusion
BP-BT Kiosk is equivalent in performance, technology, safety and efficacy to the legally marketed predicate device.