(22 days)
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, LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112 and TMB-1112-A 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%.
Here's a breakdown of the acceptance criteria and study information for the Transtek Blood Pressure Monitor, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria for the Transtek Blood Pressure Monitor models (LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A) are based on their accuracy for pressure and heartbeat rate, as well as the measurement range. The reported performance for all these models is identical.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Pressure): | |
| 15°C~25°C | Within ±3mmHg |
| 10°C~40°C (outside 15°C-25°C) | Within ±5mmHg |
| Accuracy (Heartbeat): | Within ±5% of reading |
| Measurement Range (Pressure): | 0~300mmHg |
| Measurement Range (Heartbeat): | 40~199 Pul/min |
Note: The document states that "These differences do not affect the safety and effectiveness of the subject devices," implying that the performance reported meets the necessary standards for substantial equivalence to the predicate device.
Study Information
The provided 510(k) summary is for a premarket notification submission for substantial equivalence. It primarily focuses on comparing the new devices to a legally marketed predicate device (Transtek Blood Pressure Monitor, Model TMB-986, K101681). This type of submission generally relies on comparison to a predicate device that has already established its safety and effectiveness through prior studies (which are not detailed in this document).
Therefore, many of the requested details about a specific clinical study (like sample size for test sets, ground truth establishment for a training set, MRMC studies) are not typically included in this type of 510(k) summary as they refer to a primary clinical validation study. The document does not describe an independent clinical study performed specifically for these new models to prove they meet the stated acceptance criteria beyond asserting their similarity in features and performance specifications to the predicate device.
However, based on the context of blood pressure monitor regulation, devices of this type are generally validated against established standards (e.g., ISO 81060-2 or AAMI standards) which often involve clinical studies. If such a study were conducted, these are the details that would usually be provided:
- Sample size used for the test set and the data provenance: Not explicitly stated for these specific models. For blood pressure monitor validation studies (e.g., following ISO 81060-2), a typical sample size would be around 85 subjects with specific demographic and blood pressure range distributions. Data provenance would likely be from a clinical setting, potentially in China (country of the manufacturer) or another region where the validation study was conducted, and it would be prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For blood pressure monitor validation, ground truth (reference blood pressure measurements) is typically established by trained clinical observers (e.g., physicians, nurses, or technicians) using a standardized auscultatory method, often with mercury sphygmomanometers, following strict protocols. Usually, at least two independent observers are involved for each measurement series.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. In blood pressure monitor validation studies, if multiple observers are used for ground truth, their readings are compared. Differences beyond a certain threshold often require a third observer or a predefined averaging/exclusion rule.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. These are standalone blood pressure monitors and do not involve human readers interpreting results with or without AI assistance in the way a diagnostic imaging AI would. They provide direct readings.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, indirectly. The performance specifications mentioned are for the device itself (algorithm and hardware combined) to measure blood pressure. The "oscillometric method" is an algorithmic approach. The comparison to the predicate device implies that the standalone performance is considered similar and acceptable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the ground truth for accuracy validation is typically expert consensus/clinical reference measurements obtained using a validated auscultatory method (e.g., using a mercury sphygmomanometer by trained observers).
- The sample size for the training set: Not applicable and not mentioned. These devices use the "oscillometric method," a well-established technique that generally doesn't involve a separate "training set" in the context of deep learning AI. The underlying algorithms are developed and refined based on engineering principles and physiological data, not typically machine learning training on a large dataset for each new model.
- How the ground truth for the training set was established: Not applicable, as no dedicated training set in the AI sense is described. The "ground truth" for the development of the oscillometric method itself would stem from extensive physiological studies and comparisons to direct arterial pressure measurements or established auscultatory methods.
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Section 5 - 510(k) Summary
Date of Summary Preparation: 12/21/2011
1. Submitter's Identifications
Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China
Contact Person: Lisa Li
Contact Email Address: lishal@transtek.cn
Telephone: 086-760-88282982 ext. 876
Fax: 086-760-85339231
2. Correspondent's Identifications
Correspondent's Name: A03 Lab of BTS
Address: No. I Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China
Contact Person: Leo Wang
Contact Email Address: leo.w@hibts.com
Telephone: 086-028-86083300
Fax: 086-4006070050 ext. 8
3. Name of the Device
Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive
Product Name: TRANSTEK Blood Pressure Monitor
Trade Name: TRANSTEK
Models: LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A
Classification Panel: Cardiovascular
Common/Usual Name: Automatic Blood Pressure Monitor
Product Code: DXN
Device Classification: Class II
Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device.
4. The Predicate Devices
TRANSTEK, Blood Pressure Monitor, Model TMB-986, K101681
Section 5 - 510(k) Summary
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5. Device Description
Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112 and TMB-1112-A 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%.
6. Intended Use of Device
Transtek Blood Pressure Monitor, Models LS-802, TMB-1018-A, TMB-1018-A, TMB-1112 and TMB-1112-A are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 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 tesults to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, LS-802, TMB-1018-A, TMB-1112 and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
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7. Summary of Substantial Equivalence
| Feature | LS-802 | TMB-1018 | TMB-1018-A | TMB-1112 | TMB-1112-A | Comparison | ||
|---|---|---|---|---|---|---|---|---|
| Power supply | Battery powered mode | Similar | ||||||
| 6VDC 4*AAalkalinebatteries | 6VDC 4*AAAalkalinebatteries | 6VDC 4*AAAalkalinebatteries | 6VDC 4*AAalkalinebatteries | 6VDC 4*AAalkalinebatteries | ||||
| Power supply | AC adaptor powered mode | Similar | ||||||
| AC 100~240V50-60 Hz400mA | AC 100~240V50-60 Hz400mA | AC 100~240V50-60 Hz400mA | AC 100~240V50-60 Hz400mA | AC 100~240V50-60 Hz400mA | ||||
| Display mode | Digital LCDV.A. 78*92mm | Digital LCDV.A. 140*36mm | Digital LCDV.A. 140*36mm | Digital LCDV.A. 61*93mm | Digital LCDV.A. 41*60mm | Similar | ||
| Measurementmode | Oscillographictesting mode | Oscillographictesting mode | Oscillographictesting mode | Oscillographictesting mode | Oscillographictesting mode | Similar | ||
| Accuracy | Pressure:15°C~25°C:within ±3mmHg | Pressure:15°C~25°C:within ±3mmHg | Pressure:15°C~25°C:within ±3mmHg | Pressure:15°C~25°C:within ±3mmHg | Pressure:15°C~25°C:within ±3mmHg | Similar | ||
| 10°C~40°C(outof 15°C-25°C): | 10°C~40°C(outof 15°C-25°C): | 10°C~40°C(outof 15°C-25°C): | 10°C~40°C(outof 15°C-25°C): | 10°C~40°C(outof 15°C-25°C): | ||||
| within ±5mmHgHeartbeat:within ±5% ofreading | within ±5mmHgHeartbeat:within ±5% ofreading | within ±5mmHgHeartbeat:within ±5% ofreading | within ±5mmHgHeartbeat:within ±5% ofreading | within ±5mmHgHeartbeat:within ±5% ofreading | ||||
| Measurementrange | Pressure: 0~300mmHgHeartbeat:40~199Pul/min | Pressure: 0~300mmHgHeartbeat:40~199Pul/min | Pressure: 0~300mmHgHeartbeat:40~199Pul/min | Pressure: 0~300mmHgHeartbeat:40~199Pul/min | Pressure: 0~300mmHgHeartbeat:40~199Pul/min | Similar | ||
| Measurementperimeter ofupper arm | 22cm~42cm | 22cm~42cm | 22cm~42cm | 22cm~42cm | 22cm~42cm | Similar | ||
| Net weight | Approx. 385g | Approx. 300g | Approx. 270g | Approx. 305g | Approx. 305g | Similar | ||
| Software | Ver. 1.0 | Ver. 1.0 | Ver. 1.0 | Ver. 1.0 | Ver. 1.0 | Similar | ||
| Feature | LS-802 | TMB-1018 | TMB-1018-A | TMB-1112 | TMB-1112-A | Comparison | ||
| Normalworkingcondition | Temperature:10℃~40℃ | Temperature:10℃~40℃ | Temperature:10℃~40℃ | Temperature:10℃~40℃ | Temperature:10℃~40℃ | Similar | ||
| Relativehumidity:15%~90% | Relativehumidity:15%~90% | Relativehumidity:15%~90% | Relativehumidity:15%~90% | Relativehumidity:15%~90% | ||||
| Barometricpressure:105~80kPa | Barometricpressure:105~80kPa | Barometricpressure:105~80kPa | Barometricpressure:105~80kPa | Barometricpressure:105~80kPa | ||||
| Storage &transportationcondition | Temperature:-20~60℃ | Temperature:-20~60℃ | Temperature:-20~60℃ | Temperature:-20~60℃ | Temperature:-20~60℃ | Similar | ||
| Relativehumidity:≤90% | Relativehumidity:≤90% | Relativehumidity:≤90% | Relativehumidity:≤90% | Relativehumidity:≤90% | ||||
| Externaldimensions | 12016069mm | 18010040mm | 18010040mm | 12014070mm | 12014070mm | Little different | ||
| Mode ofoperation | Continuousoperation | Continuousoperation | Continuousoperation | Continuousoperation | Continuousoperation | Similar |
Table 1: The difference between subjects Transtek Blood Pressure Monitor :
Section 5 - 510(k) Summary
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Table 2: The difference between subject Transtek Blood Pressure Monitor and the predicate device,
Transtek Blood Pressure Monitor, TMB-986
| Feature | LS-802, TMB-1018, TMB-1018-A,TMB-1112, TMB-1112-A | Predicate: TMB-986 | Comparison | |
|---|---|---|---|---|
| Device name | Blood Pressure Monitor | Blood Pressure Monitor | Similar | |
| Indication for use | Measure the blood pressure andheartbeat rate.Irregular heartbeat detection.These models are not intended to be adiagnostic device. | Measure the blood pressure andheartbeat rate.Irregular heartbeat detection.These models are not intended to be adiagnostic device. | Similar | |
| Components | Main Unit, Cuff, Adapter, InstructionManual, 4AAA/4AA batteries,Storage Case and Warranty Card | Main Unit, Cuff, Adapter, InstructionManual, 4*AAA batteries, StorageCase and Warranty Card | Similar | |
| Energy used | Battery (4AAA/4AA) or ACadapter (DC 6V Output) | Battery (4*AAA) or AC adapter (DC6V Output) | Similar | |
| Display | Liquid crystal digital display | Liquid crystal digital display | Similar | |
| Software | Ver. 1.0 | Ver. 1.0 | Similar |
Section 5 -- 510(k) Summary
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| Feature | LS-802, TMB-1018, TMB-1018-A,TMB-1112, TMB-1112-A | Predicate: TMB-986 | Comparison |
|---|---|---|---|
| External dimensions | LS-802: 12016069mmTMB-1018 & TMB-1018-A:18010040mmTMB-1112 & TMB-1112-A:12014070mm | 18010039mm | Similar |
| Applicable cuff | Wrap around cuff(Model numbers, 22/32, 22/42) | Wrap around cuff(Model numbers, 22/32, 22/42) | Similar |
| Accuracy of pressureindicator | Within±3mmHg (15℃~25℃)Within ±5mmHg (10℃~40℃ [out of15℃~25℃]) | Within±3mmHg (15℃~25℃)Within ±5mmHg (10℃~40℃ [out of15℃~25℃]) | Similar |
| Accuracy of heartbeatrate | Within ±5% of reading | Within ±5% of reading | Similar |
| Measurement range | Pressure: 0 | Pressure: 0 | Similar |
| Cult inflation | Automatic inflation with air pump | Automatic inflation with air pump | Similar |
| Dellation of pressure | Automatic air release | Automatic air release | Similar |
| Operating voltage | DC 6V | DC 6V | Similar |
| Measurementperimeter of upper arm | 22cm~42cm | 22cm~42cm | Similar |
| Operatingenvironment | Temperature: 10℃~40℃Relative humidity: 15% | Temperature: 10℃~40℃Relative humidity: 15% | Similar |
| Transport and storageenvironment | Temperature: -20~60℃Relative humidity: ≤90% | Temperature: -20~60℃Relative humidity: ≤90% | Similar |
8. Conclusions
The subject devices have all features of the predicate device TMB-986 except display and external dimensions. These differences do not affect the safety and effectiveness of the subject devices. Thus, the subject devices are substantially equivalent to the predicate device.
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Section 5 - 510(k) Summary
Page 5 ol 5
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 3 1 2012
Zhongshan Transtek Electronics Co., Ltd. c/o Mr. Leo Wang Consulting Manager A03 Lab of BTS No. 1 Fanghua Street Hi-Tech District Chengdu, CHINA 610041
K120058 Re:
K120036
Trade/Device Name: Transtek Blood Pressure Monitor Models: LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A
Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: January 7, 2012 Received: January 9, 2012
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersate for use stated in the encrosule) to regars mant date of the Medical Device Ameral Food Drug commerce prof to May 20, 1970, the enacified in accordance with the provisions of the Federation (DMA) devices that have been reclassified in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval organisms of and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Y ou may, therefore, market the devices, bayers to usements for annual registration, listing of the col general controls provisions of the Feet mends as a prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into existing major regulations affecting your device can be
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Page 2 -- Mr. Leo Wang
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 i lease be advised that I Drivedants over device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I edital statutes and regenments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CPN i art 607); adocing (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse overse) (2 regulation (7) CFR Part 820); and if applicable, the electronic forth in the quality bytellio (Ques (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 11 you desire specific acrisboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to intep://www.radiological Health's (CDRH's) Office of Compliance. Also, please the Center 101 Devices and note the regulation onlined, "Thisstanding 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 I ou may other built belief generational 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, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Renstek
Section 4 - Indications for Use
510(k) Number (if known):
Device Name:
Transtek Blood Pressure Monitor Models: LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A
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, LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . consider Devices 21200 S
Section 4 - Indications for Use
Page 1 of 1
§ 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).