TRANSTEK BLOOD PRESSURE MONITOR

• K Number: K120058
• Device Name: TRANSTEK BLOOD PRESSURE MONITOR
• Manufacturer: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
• Date Cleared: 2012-01-31 ( 22 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended 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.

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%.

Predicate Devices

K101681

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard oscillometric blood pressure measurement technology and basic signal processing for irregular heartbeat detection, with no mention of AI or ML algorithms.

Therapeutic

No
The device is described as a monitor intended for measuring blood pressure and heartbeat rate, and specifically states it is "not intended to be a diagnostic device." It does not provide any treatment or therapy.

Diagnostic

No
The Intended Use / Indications for Use section explicitly states: "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."

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as an inflatable cuff, pressure sensor, pump, valve, LCD, and microprocessor, indicating it is a physical device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use explicitly states: "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."
• Device Description: The description details a non-invasive method of measuring blood pressure and heartbeat rate using a cuff and electronic sensor. This is a physiological measurement, not an in vitro test performed on samples taken from the body.
• Lack of IVD characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any reagents or kits typically associated with IVD devices.

Therefore, the device is a non-invasive blood pressure monitor, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DXN

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%.

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 patient population

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.

K101681

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

Regulation Number and Section

§ 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).

Summary

0

ittk

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: [e-mail]

Telephone: [phone] ext. 876

Fax: [phone]

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: [e-mail]

Telephone: [phone]

Fax: [phone] 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

1

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.

2

.

.

・・・

. .

.

.

:

··

RANSTEK

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*AA
alkaline
batteries	6VDC 4*AAA
alkaline
batteries	6VDC 4*AAA
alkaline
batteries	6VDC 4*AA
alkaline
batteries	6VDC 4*AA
alkaline
batteries
Power supply	AC adaptor powered mode					Similar
	AC 100~240V
50-60 Hz
400mA	AC 100~240V
50-60 Hz
400mA	AC 100~240V
50-60 Hz
400mA	AC 100~240V
50-60 Hz
400mA	AC 100~240V
50-60 Hz
400mA
Display mode	Digital LCD
V.A. 78*92mm	Digital LCD
V.A. 140*36mm	Digital LCD
V.A. 140*36mm	Digital LCD
V.A. 61*93mm	Digital LCD
V.A. 41*60mm	Similar
Measurement
mode	Oscillographic
testing mode	Oscillographic
testing mode	Oscillographic
testing mode	Oscillographic
testing mode	Oscillographic
testing 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(out
of 15°C-25°C):	10°C~40°C(out
of 15°C-25°C):	10°C~40°C(out
of 15°C-25°C):	10°C~40°C(out
of 15°C-25°C):	10°C~40°C(out
of 15°C-25°C):
	within ±5mmHg
Heartbeat:
within ±5% of
reading	within ±5mmHg
Heartbeat:
within ±5% of
reading	within ±5mmHg
Heartbeat:
within ±5% of
reading	within ±5mmHg
Heartbeat:
within ±5% of
reading	within ±5mmHg
Heartbeat:
within ±5% of
reading
Measurement
range	Pressure: 0~
300mmHg
Heartbeat:
40~199
Pul/min	Pressure: 0~
300mmHg
Heartbeat:
40~199
Pul/min	Pressure: 0~
300mmHg
Heartbeat:
40~199
Pul/min	Pressure: 0~
300mmHg
Heartbeat:
40~199
Pul/min	Pressure: 0~
300mmHg
Heartbeat:
40~199
Pul/min	Similar
	Measurement
perimeter of
upper 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
Normal
working
condition	Temperature:
10℃~40℃	Temperature:
10℃~40℃	Temperature:
10℃~40℃	Temperature:
10℃~40℃	Temperature:
10℃~40℃	Similar
	Relative
humidity:
15%~90%	Relative
humidity:
15%~90%	Relative
humidity:
15%~90%	Relative
humidity:
15%~90%	Relative
humidity:
15%~90%
	Barometric
pressure:
105~80kPa	Barometric
pressure:
105~80kPa	Barometric
pressure:
105~80kPa	Barometric
pressure:
105~80kPa	Barometric
pressure:
105~80kPa
Storage &
transportation
condition	Temperature:
-20~60℃	Temperature:
-20~60℃	Temperature:
-20~60℃	Temperature:
-20~60℃	Temperature:
-20~60℃	Similar
	Relative
humidity:
≤90%	Relative
humidity:
≤90%	Relative
humidity:
≤90%	Relative
humidity:
≤90%	Relative
humidity:
≤90%
	External
dimensions	12016069mm	18010040mm	18010040mm	12014070mm		12014070mm	Little different
Mode of
operation	Continuous
operation	Continuous
operation	Continuous
operation	Continuous
operation	Continuous
operation	Similar

Table 1: The difference between subjects Transtek Blood Pressure Monitor :

Section 5 - 510(k) Summary

・

.

. .

・

Page 3 of 5 -

3

, '

.

:

:

. " :

网站: ਦੇ ਦੇ ਦਿ

.

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 and
heartbeat rate.
Irregular heartbeat detection.
These models are not intended to be a
diagnostic device. | Measure the blood pressure and
heartbeat rate.
Irregular heartbeat detection.
These models are not intended to be a
diagnostic device. | Similar |
| | Components | Main Unit, Cuff, Adapter, Instruction
Manual, 4AAA/4AA batteries,
Storage Case and Warranty Card | Main Unit, Cuff, Adapter, Instruction
Manual, 4AAA batteries, Storage
Case and Warranty Card | Similar |
| | Energy used | Battery (4AAA/4AA) or AC
adapter (DC 6V Output) | Battery (4AAA) or AC adapter (DC
6V 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

. . . . . .

・

・

.

: : : : :

:

.

、

4

| Feature | LS-802, TMB-1018, TMB-1018-A,
TMB-1112, TMB-1112-A | Predicate: TMB-986 | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------|
| External dimensions | LS-802: 12016069mm
TMB-1018 & TMB-1018-A:
18010040mm
TMB-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 pressure
indicator | Within±3mmHg (15℃25℃)
Within ±5mmHg (10℃40℃ [out of
15℃25℃]) | Within±3mmHg (15℃25℃)
Within ±5mmHg (10℃40℃ [out of
15℃25℃]) | Similar |
| Accuracy of heartbeat
rate | Within ±5% of reading | Within ±5% of reading | Similar |
| Measurement range | Pressure: 0300mmHg
Heartbeat: 40199 Pul/min | Pressure: 0300mmHg
Heartbeat: 40199 Pul/min | 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 |
| Measurement
perimeter of upper arm | 22cm42cm | 22cm42cm | Similar |
| Operating
environment | Temperature: 10℃40℃
Relative humidity: 15%90%
Barometric pressure: 10580kPa | Temperature: 10℃40℃
Relative humidity: 15%90%
Barometric pressure: 10580kPa | Similar |
| Transport and storage
environment | Temperature: -2060℃
Relative humidity: ≤90% | Temperature: -2060℃
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.

--- End of this section ---

Section 5 - 510(k) Summary

Page 5 ol 5

5

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

6

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 [phone] or [phone] 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

7

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