(346 days)
Not Found
No
The description details standard oscillometric blood pressure measurement technology and basic signal analysis for irregular heartbeat detection, with no mention of AI or ML algorithms.
No.
The device is a monitor used to measure blood pressure and heartbeat rate, and it explicitly states it is "not intended to be a diagnostic device." It provides warning signals for irregular heartbeats and compares readings to hypertension guidelines, but it instructs users to "Contact your physician if hypertensive values are indicated," implying it does not provide therapy but rather information for a healthcare professional.
No
The "Intended Use / Indications for Use" section explicitly states: "Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device."
No
The device description explicitly details hardware components such as an inflatable cuff, pressure sensor, microprocessor, pump, valve, LCD, and battery power, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "measuring blood pressure and heartbeat rate in adult patient population". While it's a non-invasive measurement, the act of measuring physiological parameters from a patient's body for the purpose of providing information about their health status falls under the scope of IVDs.
- Device Description: The description details how the device measures blood pressure using an electronic pressure sensor and the oscillometric method, which is a technique used to obtain physiological data.
- Comparison to Guidelines: The device compares blood pressure results to the AHA hypertension guideline, which is a clinical guideline used in the diagnosis and management of hypertension. While the device itself is stated as "not intended to be a diagnostic device," the comparison to a diagnostic guideline and the warning signal for irregular heartbeats provide information that can be used in a diagnostic context by a physician.
While the device doesn't involve analyzing samples like blood or urine in a lab setting (which is a common understanding of "in vitro"), the regulatory definition of an IVD is broader and includes devices used to examine specimens, including those derived from the human body, to provide information for diagnostic purposes. In this case, the "specimen" is the physiological data obtained from the patient's arm.
The statement "Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device" is a crucial piece of information. It indicates that the device itself does not provide a definitive diagnosis. However, the data it provides (blood pressure readings, irregular heartbeat detection, comparison to guidelines) is used in the diagnostic process by a healthcare professional. This distinction is important in regulatory classification.
Therefore, while the device doesn't perform traditional "in vitro" laboratory testing, its function of measuring physiological parameters from a human body to provide information relevant to diagnosis and monitoring classifies it as an IVD under regulatory definitions.
N/A
Intended Use / Indications for Use
Transtek Blood Pressure Monitor, Models TMB 986, TMB987, and TMB995 are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
Transtek Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries or by a DC 6V 400mA adapter.
The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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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Section 5 - 510(k) Summary
Date of Summary Preparation: 11/09/2010
1. Submitter's Identifications
Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONIC CO., LTD. Address: Jinbiao Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Guo Zhiping Contact Email Address: gzp@transtek.cn Telephone: 086-760-88282982 ext. 231 Fax: 086-760-85339231
2. Correspondent's Identifications
Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China Contact Person: Leo Wang Contact Email Address: leo.w(@hibts.com Telephone: 086-28-86083300 Fax: 086-4006070050 ext. 8
3. Name of the Device
Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: Blood Pressure Monitor Trade Name: Transtek Models: TMB-986, TMB-987, TMB-995 Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications: None
4. The Predicate Devices
OMRON, Automatic Blood Pressure Monitor, Model HEM 780N3, K061822
5. Device Description
Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses
MAY 2 7 2011
1
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an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
Transtek Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries or by a DC 6V 400mA adapter. I
The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
6. Intended Use of Device
Transtek Blood Pressure Monitor, Models TMB 986, TMB987, and TMB995 are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
7. Summary of Substantial Equivalence
Table 1: The difference between Transtek Blood Pressure Monitor
| The Similarities and Difference among TMB-986, TMB-987 and TMB-995 | ||||||
|---|---|---|---|---|---|---|
| Feature | TMB-986 | TMB-987 | TMB-995 | Comparison | ||
| 1 | Power supply | Battery powered mode: | ||||
| 6VDC 4*AAA | ||||||
| alkaline batteries | 6VDC 4*AAA | |||||
| alkaline batteries | 6VDC 4*AA | |||||
| alkaline batteries | similar | |||||
| AC adaptor powered mode: | ||||||
| AC 100-240V, | ||||||
| 50-60Hz, 400mA | AC 100-240V, | |||||
| 50-60Hz, 400mA | AC 100-240V, | |||||
| 50-60Hz, 400mA | similar | |||||
| Feature | TMB-986 | TMB-987 | TMB-995 | Comparison | ||
| 2 | Display mode | Digital LCD | ||||
| V.A.128*50mm | Digital LCD | |||||
| V.A.150*34mm | Digital LCD | |||||
| V.A.128*50mm | TMB-986, and | |||||
| TMB-995: | ||||||
| 128*50mm | ||||||
| TMB-987: | ||||||
| 150*34mm | ||||||
| 3 | Measurement | |||||
| mode | Oscillographic | |||||
| testing mode | Oscillographic | |||||
| testing mode | Oscillographic | |||||
| testing mode | similar | |||||
| 4 | Accuracy | Pressure: | ||||
| $15℃~25℃$ : | ||||||
| within±0.4kpa / | ||||||
| 3mmHg | ||||||
| $10℃~40℃$ (out of | ||||||
| $15℃~25℃$ ): | ||||||
| Within ±0.65kpa / | ||||||
| 5mmHg | ||||||
| Heartbeat: | ||||||
| value:±5% | Pressure: | |||||
| $15℃~25℃$ : | ||||||
| within±0.4kpa / | ||||||
| 3mmHg | ||||||
| $10℃~40℃$ (out of | ||||||
| $15℃~25℃$ ): | ||||||
| Within ±0.65kpa / | ||||||
| 5mmHg | ||||||
| Heartbeat: | ||||||
| value:±5% | Pressure: | |||||
| $15℃~25℃$ : | ||||||
| within±0.4kpa / | ||||||
| 3mmHg | ||||||
| $10℃~40℃$ (out of | ||||||
| $15℃~25℃$ ): | ||||||
| Within ±0.65kpa / | ||||||
| 5mmHg | ||||||
| Heartbeat: | ||||||
| value:±5% | similar | |||||
| 5 | Normal | |||||
| working | ||||||
| condition | Temperature: $10℃$ | |||||
| $~40℃$ | ||||||
| Relative humidity | ||||||
| ≤80% | Temperature: $10℃$ | |||||
| $~40℃$ | ||||||
| Relative humidity | ||||||
| ≤80% | ||||||
| Barometric pressure: 105 | Temperature: $10℃$ | |||||
| $~40℃$ | ||||||
| Relative humidity | ||||||
| ≤80% | similar | |||||
| 6 | Storage & | |||||
| transportation | ||||||
| condition | Temperature: - $20℃~60℃$ | |||||
| Relative | ||||||
| humidity:10~93% | Relative | |||||
| humidity: 10~93% | Relative | |||||
| humidity:10~93% | similar | |||||
| 7 | Measurement | |||||
| perimeter | ||||||
| of upper arm | 22cm~42cm | 22cm~42cm | 22cm~42cm | similar | ||
| 8 | Weight | Approx.300g | ||||
| (Excluding the | ||||||
| batteries) | Approx.300g | |||||
| (Excluding the | ||||||
| batteries) | Approx.300g | |||||
| (Excluding the | ||||||
| batteries) | similar | |||||
| 9 | External | |||||
| dimensions | Approx. | |||||
| 18010039mm | Approx. | |||||
| 2006056mm | Approx. | |||||
| 18010039mm | TMB-986, | |||||
| and | ||||||
| TMB-995: | ||||||
| Approx. | ||||||
| 18010039mm | ||||||
| TMB-987: | ||||||
| Approx. | ||||||
| 2006056mm | ||||||
| 10 | Mode of | |||||
| operation | Continuous | |||||
| operation | Continuous | |||||
| operation | Continuous | |||||
| operation | similar |
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| Feature | TMB-986, TMB-987,
TMB-995 | Predicate: HEM 780N3 | Comparison |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device name | Blood Pressure Monitor | Automatic Blood Pressure
Monitor | Similar |
| Indication for use | Measure the blood pressure
and heartbeat rate.
Irregular heartbeat detection. | Measure the blood pressure
and heartbeat rate. | Add new
features |
| Components | Main Unit, Cuff, Adapter,
Instruction Manual, 4AAA
/4AA batteries, Storage
Case and Warranty Card | Main Unit, Cuff, Adapter,
Instruction Manual,
4"AA"batteries, Storage
Case and Warranty Card | Similar
components
and materials |
| Performance Tests | Biocompatibility
Electromagnetic
Compatibility and Electrical
Safety | Biocompatibility
Electromagnetic
Compatibility and Electrical
Safety | Similar |
| Labeling | Company name and address
Specification
Product description
Indication for use
Contraindications for use
Precautions
Warnings
Safety terms and conditions
Safety alert descriptions
Safety and performance
standards and so on | Company name and address
Specification
Product description
Indication for use
Contraindications for use
Precautions
Warnings
Safety terms and conditions
Safety alert descriptions
Safety and performance
standards and so on | Similar |
| Energy used | Battery (4AAA/4AA) or
AC adapter (DC 6V Output) | Battery (4*AA) or AC
adapter (DC 6V Output) | Similar |
| Display | Liquid crystal digital display | Liquid crystal digital display | Similar |
| Dimensions | TMB-986, TMB-995:
180(W)*100(D)*39(H)mm
TMB-987:
200(W)*60(D)*56(H)mm | 131(W)*155(D)*85(H)mm | Similar |
| Applicable cuff | Wrap around cuff | Wrap around cuff | Similar |
| Accuracy of
pressure indicator | Within ±3mmHg(1525℃)40°C(out of
Within ±5mmHg
(10°C
15℃25℃)) | Within ±3mmHg or 2% of42cm | 22cm~42cm | Similar |
reading | Similar |
| Accuracy of
heartbeat rate | Within ±5% of reading | Within ±5% of reading | Similar |
| Feature | TMB-986, TMB-987,
TMB-995 | Predicate: HEM 780N3 | Comparison |
| Cuff inflation | Automatic inflation with air
pump | Automatic inflation with air
pump | Similar |
| Deflation of
pressure | Automatic air release | Deflation rate is controlled by
an active electronic control
valve by 4 to 11 mmHg/s
depending on pulse rate | Similar |
| Operating voltage | DC 6V | DC 6V | Similar |
| Measurement
perimeter
of upper arm | 22cm
| Operation
environment | Temperature: 10℃40℃80 kPa
Relative humidity: ≤80%
Barometric pressure:
105
(790-600 mmHg) | Temperature: 10℃40℃80 kPa
Relative humidity: 30-80%
Barometric pressure:
105
(790-600 mmHg) | Similar |
| Transport and
storage environment | Temperature: -20℃60℃93% | Temperature: -20℃
Relative humidity:1060℃95% | Similar |
Relative humidity: 10
Table 2: The difference between Transtek Blood Pressure Monitor and Predicate HEM 780N3
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8. Conclusions
The subject devices have all features of the predicate device HEM 780N3 except the new features of irregular heartbeat detection, some specification of arm cuff and battery. These differences do not affect the safety and effectiveness of the subject devices.
Irregular heartbeat detection technology is same as what is used in Automatic Blood Pressure Monitor with Com Fit™ Cuff Model HEM-780. Thus, the subject devices are substantially equivalent to the predicate device.
--- End of this section --
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol with three curved lines forming the body and wings. Below the bird, there are wavy lines that represent water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zhongshan Transtek Electronic Co., Ltd. c/o Mr. Leo Wang A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District Chengdu City, Sichuan CHINA
MAY 2 7 2011
Re: K101681
Trade/Device Name: Transtek Blood Pressure Monitor Models TMB-986, TMB-987 and TMB-995
Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: May 13, 2011
Dear Mr. 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 10 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 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.
6
Page 2 – Mr. Leo Wang
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 device-related adverse events) (21 CFR 803); 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.
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.fdagov/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 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,
D. Zahariev, M.D.
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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Section 4 - Indications for Use
510(k) Number (if known): K101681
Device Name: Blood Pressure Monitor
Models: TMB-986, TMB-987, TMB-995
Indications for Use:
This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Prescription Use
AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) メ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number |
11/0168