FETAL MONITOR, MODELS BT-300 AND BT-200

K052190 · Bistos Co., Ltd. · HGM · Oct 4, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K052190
• Device Name: FETAL MONITOR, MODELS BT-300 AND BT-200
• Applicant: Bistos Co., Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Oct 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BT-300 Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.

Device Story

BT-300 and BT-200 are fetal monitors; BT-300 is a stationary unit with thermal printer and remote transmission capability; BT-200 is a pocket-sized device. Both devices use pulsed Doppler ultrasound transducers to irradiate the maternal abdomen, detect reflected frequency signals from the fetal heart, and process these signals to calculate and display fetal heart rate (FHR). BT-300 additionally uses an external pressure (TOCO) transducer to measure uterine contractions. Outputs include numerical FHR/uterine activity values on LED/LCD screens, audible fetal heart sounds, and printed strip charts. Used in clinical settings by healthcare providers to assess fetal well-being and status. Data from BT-300 can be transmitted over telephone lines to remote receivers. Benefits include continuous monitoring of fetal status and uterine activity to assist in clinical decision-making during pregnancy and labor.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through bench testing, including electrical, mechanical, and environmental safety testing per EN/IEC 60601-1 and EMC testing per EN/IEC 60601-1-2. All test results were reported as satisfactory.

Technological Characteristics

Devices utilize pulsed Doppler ultrasound (1MHz for BT-300, 2MHz for BT-200) and external pressure (TOCO) transducers. BT-300 features a thermal printer, 7-segment LED display, and remote data transmission capability. BT-200 features an LCD display and built-in speaker. Power is provided via a 100-240VAC universal power adaptor. Systems are designed for perinatal monitoring (21 CFR 884.2740).

Indications for Use

Indicated for pregnant women requiring fetal heart rate monitoring and/or uterine contraction monitoring. BT-300 supports single or twin fetal heart rate monitoring via Doppler ultrasound and uterine activity via external TOCO transducer. BT-200 supports fetal heart rate monitoring via Doppler ultrasound.

Regulatory Classification

Identification

A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• IFM-500 Ultrasound Fetal Monitor (K994008)
• Sonotrax Ultrasonic Pocket Doppler (K040480)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence reads 'K05 2190'. The characters are written in a simple, clear style, making them easily readable. The background is plain, which helps to highlight the characters.

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: _Jun 10, 2005

1. Company and Correspondent making the submission:

Name – Bistos Co., Ltd. Address – 201, 2F, 239-15, Gasan-Dong, Geumcheon-Gu, Seoul, 153-801, Korea Telephone - [phone] Fax - [phone] Contact -- Mr. Seong Soo Hong Internet – http://www.bistos.co.kr

#### 2. Device :

| Trade/proprietary name | : BT-300, BT-200 Fetal Monitor |
|------------------------|---------------------------------|
| Common Name | : Fetal Monitor |
| Classification Name | : System, monitoring, perinatal |

## 3. Predicate Devices :

| Manufacturer | : BiOSYS Co., Ltd. |
|---------------|------------------------------------------|
| Device | : IFM-500 Ultrasound Fetal Monitor |
| 510(k) Number | : K994008(Decision Date - Sep. 29. 2000) |
| Manufacturer | : Edan instruments, Inc. |
| Device | : Sonotrax Ultrasonic Pocket Doppler |
| 510(k) Number | : K040480(Decision Date - May. 25. 2004) |

- 4. Classifications Names & Citations :
21CFR 884.2740, HGM, System, Monitoring, Perinatal, Class2

#### 5. Description :

- BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound

Bistos Co., Ltd.

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wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-300 analyzes this signal and displays the heart rate by LED. Also, BT-300 provides the sound from the heart of fetus.

BT-300 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values.

And BT-300 prints the heart rate of the fetus and the values of uterine contraction.

- BT-300 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer.
- BT-300 is capable of Twin Monitoring with two pulsed Ultrasound Transducers.
- BT-300 has a free voltage(100 240VAC input) power adaptor.
- BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. BT-200 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus.
- 6. Indication for use :
- The BT-300 is an Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.
- The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.
- 7. Comparison with predicate device :

Bistos Co., Ltd., believes that the BT-300 and the BT-200 Fetal Monitor are substantially equivalent to the IFM-500 of BiOSYS Co., Ltd. And Sonotrax of Edan Instruments, Inc..

- 8. Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to

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standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.

- 9. Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Bistos Co., Ltd. concludes that BT-300 and BT-200 are safe and effective and substantially equivalent to predicate devices as described herein.

- 10. Bistos Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes.

OCT 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bistos Co., Ltd. % Mr. Marc M. Mouser Officer Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

Re: K052190

Trade Name: BT-300, BT-200 Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Product Code: HGM Regulation Number: 21 CFR 884.2960 Regulation Name: Obstetric Ultrasonic Transducer Product Code: HGL Regulatory Class: II Dated: September 16, 2005 Received: September 19, 2005

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the BT-300, BT-200 Fetal Monitor, as described in your premarket notification:

Transducer Model Number

| BT-300 |
|--------|
| BT-200 |

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),

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it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Colin Pollard at [phone].

Sincerely yours,

David A. Lynn

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# Indications for Use

#### Kos 2190 510(k) Number(if known):

Device Name: BT-300, BT-200 Fetal Monitor

Indications for Use:

The BT-300 Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.

The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

David G. Lynn

Page 1 of 1

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## BT-200 Fetal Monitor 510(k) Submission

Appendix F

Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

## 2MHz PW DOPPLER FETAL PROBE – MODEL : BT-200

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | N | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Pheperial | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Lapaloscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

#### Additional Comments :

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Devic

Prescription Use(Per 21 CFR 801.109)

egam

Division Sogn-Off)
Division of Reproductive, Abdominal,
And Radiological Devices
510(k) Number K052190

00000045

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## BT-300 Fetal Monitor 510(k) Submission

Appendix F

## Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

## 1MHz PW DOPPLER FETAL PROBE - MODEL : BT-300

Intended use : Diagnostic uitrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | N | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Lapaloscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments :

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE

Prescription Use(Per 21 CFR 801.109)

(Division Sogn-Off)
Division of Reproductive, Abdominal,
And Radiological Devices
510(k) Number K052190