FETAL MONITOR MODEL: BT-200T

K100885 · Bistos Co., Ltd. · HGM · Jun 7, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100885
• Device Name: FETAL MONITOR MODEL: BT-200T
• Applicant: Bistos Co., Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jun 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

BT-200T is pocket size Fetal Monitor for measuring Fetal Heart rate, Pulse Doppler and uterine contraction of pregnant women. It is intended to aid a comprehensive check for the well being of single fetus.

Device Story

BT-200T is a pocket-sized fetal monitor; uses continuous Doppler ultrasound to measure fetal heart rate (FHR); irradiates ultrasound waves to maternal abdomen; detects Doppler frequency signals; analyzes signals to calculate FHR; displays heart rate on LCD screen; provides audible fetal heart sounds via built-in speaker; intended for use by clinicians to aid in assessing fetal well-being; provides real-time monitoring; assists in clinical decision-making regarding fetal health.

Clinical Evidence

Bench testing only. Includes HR accuracy measuring report, medical electrical equipment test report, and CB test certificate. Biocompatibility testing performed per ISO 10993 (parts 4, 5, 10) for surface-contacting skin devices.

Technological Characteristics

Pocket-sized fetal monitor; continuous Doppler ultrasound sensing; LCD display; built-in speaker; battery-operated; biocompatible skin-contacting materials tested per ISO 10993; surface device classification (limited contact <24 hrs).

Indications for Use

Indicated for pregnant women to monitor fetal heart rate and uterine contractions to assess the well-being of a single fetus.

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

• Bistos BT-200 (K052190)

Submission Summary (Full Text)

{0}------------------------------------------------

K100885

510(k) Submission - BT- 200T

## Summary of safety and effectiveness

# JUN - 7 2010

In accordance with section 513 (1) of the SMDA as defined in 21CFR part 807.92 This summary is submitted to obtain Pre market 510(K) notification

## 1. Submitter, manufacturer

Bistos Co., Ltd. #106, Daeryung Techno Town 3-cha 448 Gasan Dong Geumchen gu, Seoul,153-801, Rep of Korea Registration number:3006179052 Tel: [phone] Fax : [phone]

### 2. Contact person

Mr. Young Chi / President Bio-Med USA Inc. 111 Ellison street, Paterson, NJ 07505. U.S.A. Tel: [phone] Fax:[phone] E mail: [e-mail]

#### 3. Name of Device

| Trade name : | BT-200T Portable fetal monitor |
|------------------------|--------------------------------|
| Common or usual name : | Fetal monitor |
| Regulation number : | 884.2740 |
| Regulation class : | II |
| Product code : | HGM |
| Classification panel : | Obstetrics / Gynecology |

#### 4. Substantial Equivalence.

Bistos BT-200TFetal monitor is substantially equivalent in Intended use, Design Function, Performing and all used material, direction to use, labeling, software, producing process, Technology/Principle of operation and performance etc to already legally cleared Bistos' BT-200, under 510(K) 052190 on Oct 4, 2005

Comparison with predicate device attached. (A)

{1}------------------------------------------------

### 5. Device Description

Bistos' BT-200T is a pocket size Fetal Monitor that measures the fetal heart rate and out puts the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200T irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler Frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.

#### Operating mode

- . Pulsed Doppler
- Continuous Doppler ●
- Utērine Contraction .
- Fetal Movement .
- . Auto on off Switch

Detail, Engineering design. Performing features, Operating mode, attached (B)

#### 6. Device Intended use

BT-200T is pocket size Fetal Monitor for measuring Fetal Heart rate, Pulse Doppler and uterine contraction of pregnant women. It is intended to aid a comprehensive check for the well being of single fetus.

#### 7. Labeling

Back label, Market promoting leaflet designed by labeling requirement regulation under (21CFR part 801) attached (C)

Brochure C-1/2 Back label C-3

#### 8. Biocompatibility test.

All used material of patient contacted part was done Biocompatibility test by NAMSA ( North American Science ) by FDA guidance Blue Book Memo G95-1 use of ISO 10993 Biological Evaluation of Medical Device part 4, 5, 10.

Body contacting classification: Surface device, skin, limited less than 24 hrs.

The Skin contacting materials were found to be biocompatible.

Attached the Biocompatibility Certificate. (D)

Bistos Co., Ltd.

{2}------------------------------------------------

## 9. Voluntary performed Clinical safety test result attached (E)

- * HR Accuracy Measuring Report (E-1)
- * Medical Electrical Equipment test report (E-2)
- * CB Test Certificate (E-3)

# Conclusion

Bistos' BT-200T Pocket size Fetal monitor in this submission is substantially equivalent to the already cleared BT-200 under K052190 on Oct 2005 at Design, specification, intended use, used material, direction to use, software, Technology/principal operating and Performing etc in every angles.

The difference between the devices does not raise any new issues of safety or effectiveness

End of Summary

Bistos Co., Ltd.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Bistos Co., Ltd % Mr. Young Chi President BioMed USA, Inc. 111 Ellison Street . PATERSON NJ 07505

JUN - 7 2010

Re: K100885

Trade/Device Name: BT-200T Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: March 25, 2010 Received: March 30, 2010

Dear Mr. Chi:

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 to 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFR7Parts 801 and 809); medical"device reporting (reporting of

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 200). This etter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally vivarketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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 the free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Amlat. H.B

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

## Enclosure

{5}------------------------------------------------

# Indications for use

510(K) Number

K100885

Device Name

Fetal Monitor,

Indication for use .

.

The BT-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound.

Prescription use_

Over-the Counter use

(Please do not write below this line-continued on another pages if needed

and/or

Concurrence of CDRH, office of Device Evaluation (ODE) OLV.)

ರ

(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sa

Bistos Co., Ltd.

510K K100885