BT-350

K103545 · Bistos Co., Ltd. · HGM · May 13, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K103545
• Device Name: BT-350
• Applicant: Bistos Co., Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepatum periods(Non-Stress Test.) Therefore the Bt-350 is not used in delivery room. ,This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.

Device Story

BT-350 is a fetal monitor measuring fetal heart rate (FHR) and uterine contractions. Inputs: ultrasound waves directed at maternal abdomen; reflected Doppler frequency signals from fetal heart; pressure sensor data for uterine contractions. Device processes Doppler signals to calculate FHR; displays FHR and contraction values on LCD/LED screen; provides audible fetal heart sounds; prints data via thermal printer. Supports twin monitoring using two pulsed ultrasound transducers. Used in hospitals, clinics, doctor's offices, and patient homes by trained medical personnel. Output aids clinicians in assessing fetal well-being during antepartum periods (Non-Stress Test).

Clinical Evidence

No clinical data provided. Safety and effectiveness established via 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 satisfactory.

Technological Characteristics

System includes 1MHz PW Doppler fetal probe and pressure sensors. Features thermal printer, LCD/LED display, and 100-240VAC power adaptor. Supports twin monitoring. Complies with EN/IEC 60601-1 (safety) and EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for non-invasive prenatal monitoring of fetal heart rate and maternal abdominal contractions during antepartum periods (Non-Stress Test) in pregnant women. Not for use in delivery rooms. For use by trained medical personnel in hospitals, clinics, doctor's offices, and patient homes.

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)

Submission Summary (Full Text)

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K103545
pg. 1 of 2

510(k) Submission - BT-350

## 510(k) Summary

MAY 13 2011

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

Date: Dec. 1, 2009

1. Company and Correspondent making the submission:

Name - Bistos Co., Ltd.

Address - #106, Daeryung Techno Town 3-cha,

448, Gasan-dong, Geumcheon-gu, Seoul, 153-772, Rep. of KOREA

Telephone - [phone]

Fax - [phone]

Contact - Mr. Hyung-Ju Oh

E-mail : [e-mail]

Internet - http://www.bistos.co.kr

- 2. Device :

| Trade/proprietary name | : BT-350 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) |

4. Classifications Names & Citations :

21CFR 884.2740, HGM, System, Monitoring, Perinatal, Class2

5. Description :

- BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree. BT-350 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-350 analyzes this signal and displays the heart rate by LCD or LED(7-
Bistos Co., Ltd.

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K103545
pg. 2 of 2

510(k) Submission - BT-350

Segment). Also, BT-350 provides the sound from the heart of fetus.

BT-350 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values.

And BT-350 prints the heart rate of the fetus and the values of uterine contraction.

- BT-350 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-350 is capable of Twin Monitoring with two pulsed Ultrasound Transducers.
- BT-350 has a free voltage(100 240VAC input) power adaptor.
- 6. Indication for use :
- The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepatum periods(Non-Stress Test). Therefore the BT-350 is not used in delivery room. This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
- 7. Comparison with predicate device :

Bistos Co., Ltd., believes that the BT-350 Fetal Monitor are substantially equivalent to the IFM-500 of Biosys Co., Ltd.

- 8. Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to 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-350 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/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bistos Co., Ltd. c/o Mr. Steve Kohn Healthcheck Systems, Inc. 4802 Glenwood Road BROOKLYN NY 11234

MAY 1 3 2011

Re: K103545

> Trade Name: Model BT-350 Fetal Monitor Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM and HGL Dated: May 6, 2011 Received: May 6, 2011

Dear Mr. Kohn:

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-350 Fetal Monitor, as described in your premarket notification:

Transducer Model Number

## 1MHz PW Doppler Fetal Probe - Model BT-350

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Kathryn Daws-Kopp at [phone].

Sincerely yours.

hom M. Whay

C Herbert P. Lerner, MD, Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## Indications for Use

K103545 510(k) Number(if known) :

Device Name : BT-350 Fetal Monitor

Indications for Use :

The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepatum periods(Non-Stress Test.) Therefore the Bt-350 is not used in delivery room. ,This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.

Prescription Use ANDIOR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 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)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices K103545

Page 1 of 1

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## Diagnostic Ultrasound Indications For Use Form

Model BT-350 Fetal Monitor i System: Transducer: 1 MHz PW Doppler Fetal Probe - Model BT-3501

. .

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

| Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|------------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| General | Specific | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | P | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal.<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Hopi m. Why
(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number: K103545