(273 days)
No
The description focuses on standard oscillometric blood pressure measurement and basic irregular heartbeat detection, with no mention of AI, ML, or related concepts like training/test sets for algorithmic learning.
No
The device is designed to measure blood pressure and pulse rate, which are diagnostic functions, not therapeutic ones.
Yes
The device is described as a "digital blood pressure monitor" designed to "measure blood pressure (systolic and diastolic) and pulse rate". These measurements are used to assess physiological states and can aid in the diagnosis of medical conditions, thus making it a diagnostic device.
No
The device description clearly outlines hardware components such as an inflatable cuff, internal pump, internal exhaust valve, LCD, internal printer, and potentially a Bluetooth module. This indicates it is a physical medical 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 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 living body (in vitro).
- Device Function: The description clearly states that this device measures blood pressure and pulse rate by wrapping a cuff around the patient's upper arm. This is a non-invasive measurement performed on the living body.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, based on the provided information, the TM-2657 Family of digital blood pressure monitors are not IVDs. They are devices used for direct physiological measurement on a living patient.
N/A
Intended Use / Indications for 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) and 13.8 inches (35.0 cm)
Product codes
DXN
Device Description
TM-2657 Family of digital blood pressure monitors have the same design as the predicated devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is 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 299 mmHg. TM-2657 Family of digital blood pressure monitors will not inflate the cuff higher than 299 mmHg. TM-2657 Family of digital blood pressure monitors will turn on an irregular heartbeat indicator 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 printed by the internal printer or transmitted via Bluetooth wireless module if it is installed. 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
Intended User / Care Setting
Not Found
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
Non-clinical Test Summary:
- Safety Tests: IEC 60601-1:2006
- EMC Tests: AAMI/ANSI/IEC 60601-1-2:2007
- Reliability Tests: IEC80601-2-30:2009+CI:2010 ●
- Risk Assessmetn: ISO 14971:2012 ●
- Bluetooth Tests: FCC 47 CFR Part 15.247 & EN 300 328 V1.8.1 (2012-06)
Clinical Test Summary based on BS EN 1060-4:2004 / ISO 141155-1 & -2:2003:
- Number of Subject: 85
- Number of Measurement: 3 times
- Observer: 2
- Observer Difference: +/- 4 mmHg less
- Gender: Male 43, Female 42
- Age: Older than 50 : 44
- Circumference of Arm: 18 – 35 cm : 49
- BP Range: SYS160mmHg at least 10% (24), DIA100mmHg at least 10% (29)
- Measurement Result: Average : SYS -0.99mmHg, DIA -1.09mmHg ; S.D. : SYS 7.62mmHg, DIA 5.87mmHg
Key Metrics
Accuracy: BP: +/- 3%, Pulse: +/- 5 %
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
A&D Company, Ltd Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, California 95131
Re: K151953
Trade/Device Name: A&D Medical TM-2657 Family of Digital Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 29, 2016 Received: March 3, 2016
Dear Jerry Wang:
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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Indications for Use | |
|---|---|
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K151953 |
| Device Name | A&D Medical TM-2657 Family Digital Pressure Monitors |
| Indications for Use (Describe) | 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) and 13.8 inches (35.0 cm) |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
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510(k) Summary
This summary of 510(k) safety and effective information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
Date Prepared 1.
Feburary 29, 2016
2. Submitter's Information
A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@andonline.com
3. Device Information
| Proprietary Name: | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors |
|---|---|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System 21 CFR 870.1130, Class II, DXN. |
4. Predicate Devices
- A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 ●
- A&D Model TM-2655 Family (TM-2655, TM-2655P and TM-2655PV) of Digital Blood . Pressure Monitors with 510(k) number K010828
Both predicate devices are designed and manufactured by the same company and facilities as the modified devices, TM-2657 Family of Digital Blood pressure Monitors.
ട്. Indications for 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).
6. Device Description – Technological and Operational Characteristics Comparison
TM-2657 Family of digital blood pressure monitors have the same design as the predicated devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is 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 299 mmHg. TM-2657 Family of digital blood pressure monitors will not inflate the cuff higher than 299 mmHg. TM-2657 Family of digital blood pressure monitors will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the
4
end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and printed by the internal printer or transmitted via Bluetooth wireless module if it is installed. The cuff is also deflated automatically to 0 mmHg at the same time. The detail of summary of substantial equivalence is listed below.
7. Summary of Substantial Equivalence
Modifications made from the predicate devices:
- . Change the plastic molds so the TM-2657 Family of Digital Blood Pressure Monitors have a new appearance.
- . Enable the same Bluetooth wireless communication capability of UA-767PBT to the new TM-2657 Family of digital blood pressure monitors.
- Reduce the arm size from 5.1 inches (13 cm) 17.7 inches (45 cm) to 7.1 inches (18 cm) . - 15.7 inches (40 cm).
- . Remove the voice/talking capability.
| Parameter | Predicate Devices
(TM-2655 Family & UA-767PBT | Modified Devices
(TM-2657 Family) |
|-----------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------|
| Power source | Transformer power supply
120V AC 60Hz | Switching power supply
100-240V AC 50/60Hz |
| Protection against
electrical shock | Class I, Type B | No change - the same |
| Measurement
Method | Oscillometric Method | No change - the same |
| Pressure display
range | 0-300mmHg | 0-299 mmHg |
| Minimum display
resolution | 1 mmHg | No change - the same |
| Pressure Sensor
design | Capacitance type pressure transducer | No change - the same |
| NIBP Clinical test | AASI/AAMI SP-10 :1992 | BS EN1060-4:2004, BHS:1993 |
| NIBP Measurement
range | Blood Pressure: 10-280mmHg
Pulse: 30-200bpm | SYS: 40-270 mmHg
DIA: 20-200 mmHg
Pulse: 30-240 bpm |
| Accuracy | BP: +/- 3%, Pulse: +/- 5 % | No change - the same |
| Pressurization Source | Automatic internal air pump | No change - the same |
| Cuff Design | Winding mechanism operated by
geared motor | No change - the same |
| Air Pressure Control
Method | Rubber valve with ceramic valve | Rubber valve with electrical
control valve |
| Exhaust Method | Automatic rapid exhaust by
electromagnetic valve | No change - the same |
| Display Type | 3-digit display by LED | No change - the same |
| Cuff Attachment
Method | By plastic hose connected to monitor | No change - the same |
| IHB (Irregular
Heartbeats Detection) | More than +/-25% to the mean
interval of all pulse intervals | No change - the same |
| Operating | 50°F (10°C) to 104°F (40°C) with | 50°F (10°C) to 104°F (40°C) |
Product Specification Comparison
5
| Environment | 85% RH or less , no condensing | with 15 %RH to 85% RH, no condensing |
|---|---|---|
| Storage Environment | 14°F (-20°C) to 140°F (60°C) with | |
| 95% RH or less, no condensing | 14°F (-20°C) to 140°F (60°C) with 10 -95% RH, no | |
| condensing | ||
| Arm Size | 5.1 inches (13 cm) to 17.7 inches (45 cm) | 7.1 inches (18 cm) to 15.7 inches (40 cm) |
| Printer function | Thermometer Printer | No change - the same |
| External dimensions | 245 (W) x 322 (H) x 390 (D) mm | 241 (W) x 330 (H) x 390 (D) mm |
| Weight | Approx. 9 kg | Approx. 5.5 kg |
| Connectivity | Wired - RS232C standard (TM-2655 Family) | |
| Wireless - Bluetooth 2.1 Standard (UA-767PBT) | No change - the same | |
| Voice/Talking | ||
| Capability | TM-2655V enabled | Disabled |
Key Features Comparison
| Parameter | Predicate Devices
(TM-2655 Family & UA-
767PBT | Modified Devices
(TM-2657 Family) |
|---------------------------|------------------------------------------------------|--------------------------------------|
| Field service | Not allowed | No Change - the same |
| Automatic zero at "START" | Yes | No Change - the same |
| Manual zero adjustment | Not allowed | No Change - the same |
| Calibration | Not allowed in the field | No Change - the same |
| Sterilization | Not needed | No Change - the same |
8. Discussion of standards used in the design verification and design validation
We conducted design verification and design validation activities based on the comparison of the TM-2657 Family of digital blood pressure monitors with the predicate devices. Based on the changes, we conducted the appropriated test methodology and pass/fail criteria. After the tests were conducted, the test records were collected in the design history file (DHF).
A&D Medical follows FDA regulation and international standards in our medical device development and manufacturing processes. The following standards were used to demonstrate compliance to FDA recognized consensus standards for the TM-2657 Family of digital blood pressure monitors devices.
- . ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment -- Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
- AAMI/ANSI 60601-1:2006 Medical electrical equipment. General requirements for . basic safety and essential performance
- . AAMI/ANSI/IEC 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- . AAMI/ANSI/ISO 14971:2012 Medical devices. Application of risk management to medical devices
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TM-2657 Family of digital blood pressure monitors met all applicable requirements of the standards. None of the test demonstrated that the TM-2657 Family of digital blood pressure monitors bring new issues of safety and effectiveness.
9. Evaluation Performance & Substantial Equivalence Conclusion:
TM-2657 family digital blood pressure monitors pass the clinical and non-clinical evaluation based on the followed table.
Non-clinical Test Summary:
- Safety Tests: IEC 60601-1:2006
- EMC Tests: AAMI/ANSI/IEC 60601-1-2:2007
- Reliability Tests: IEC80601-2-30:2009+CI:2010 ●
- Risk Assessmetn: ISO 14971:2012 ●
- Bluetooth Tests: FCC 47 CFR Part 15.247 & EN 300 328 V1.8.1 (2012-06)
| Item | Standard Requirements | Study Results | Pass/Fail |
|---|---|---|---|
| Number of Subject | 85 or more | 85 | Pass |
| Number of | |||
| Measurement | 3 times or more | 3 times | Pass |
| Observer | 2 | 2 | Pass |
| Observer Difference | +/- 4 mmHg or less | +/- 4 mmHg less | Pass |
| Gender | Male 40% or more | 43 | Pass |
| Female 40% or more | 42 | Pass | |
| Age | Older than 50 : 50-75% | 44 | Pass |
| Circumference of | |||
| Arm | 18 – 35 cm : 50-75% | 49 | Pass |
| BP Range | SYS160mmHg at least 10% | 24 | Pass |
| DIA100mmHg at least 10% | 29 | Pass | |
| Measurement Result | Average : +/-5mmHg or less | SYS -0.99mmHg | |
| DIA -1.09mmHg | Pass | ||
| S.D. : 8mmHg or less | SYS 7.62mmHg | ||
| DIA 5.87mmHg | Pass |
Clinical Test Summary based on BS EN 1060-4:2004 / ISO 141155-1 & -2:2003:
TM-2657 Family of digital blood pressure monitors Digital blood pressure monitors have the following similarities to the predicate devices, TM-2655 Family and UA-767PBT digital blood pressure monitors, which previously received the 510(k) clearance.
- Same intended use. ●
- Same oscillometric method to determine the blood pressure & pulse rate ●
- Same inflation method - automatic internal pump
- Same deflation method - standard exhaust valve
- Same materials, no new materials used
- Same manufacturing processes at the same facility
- Reduced Indication of Use in arm circumference range. ● Predicated Devices (TM-2655 Family) Modified Devices (TM-2657 Family)
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| The A&D Medical LifeSource TM-2655, | TM-2657, TM-2657P & TM-2657PRS |
|---|---|
| TM-2655P & TM-2655VP are designed to | & TM-2657PBT are designed to |
| measure blood pressure (diastolic and | measure blood pressure (diastolic and |
| systolic) and pulse rate in adult patients with | systolic) and pulse rate in adult patients |
| arm circumference range between 5.1 inches | with arm circumference range between |
| (13 cm) to 17.7 (45 cm) | 7.1 inches (18 cm) to 15.7 (40 cm) |
As a conclusion, TM-2657 Family of digital blood pressure monitors as described in its labeling and comparison analysis, have not changed as a result of the modifications. The fundamental scientific technology of the modified devices has not changed, either. There is no significant difference that affects the safety or effectiveness of the modified device as compared to the predicate devices.