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.
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 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.

AI/ML Overview

This 510(k) submission for the Bistos BT-200T Fetal Monitor is primarily based on substantial equivalence to a predicate device (Bistos BT-200, K052190). As such, the information provided focuses on demonstrating equivalence rather than detailed de novo efficacy studies with specific acceptance criteria and performance metrics typically found in submissions for novel devices.

However, Section 9 describes a "Voluntary performed Clinical safety test result attached (E) - *HR Accuracy Measuring Report (E-1)". This is the most relevant section for performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to an "HR Accuracy Measuring Report (E-1)" but does not present the specific acceptance criteria or the reported performance data within the text. For a full understanding, this report would need to be reviewed.

Based on the typical requirements for Fetal Heart Rate (FHR) monitors, the acceptance criteria would likely be related to accuracy and precision of FHR measurement compared to a gold standard. Without the actual report, the detailed criteria cannot be specified.

Hypothetical table (based on common FHR monitor standards and lack of specific data in the document):

Acceptance Criteria Category	Specific Metric (Hypothetical)	Acceptance Limit (Hypothetical)	Reported Device Performance (From E-1 report - Not in provided text)
FHR Accuracy	Mean Absolute Difference (MAD)	≤ 5 bpm	Not specified in provided document
FHR Accuracy	Bias (mean difference)	≤ 3 bpm	Not specified in provided document
FHR Accuracy	Standard Deviation	≤ 5 bpm	Not specified in provided document
FHR Detection Range	FHR Detection Range	50-240 bpm	Not specified in provided document
False Alarm Rate	False Alarm Rate	< X%	Not specified in provided document
Missed Beat Rate	Missed Beat Rate	< Y%	Not specified in provided document

Note: The above table uses hypothetical metrics and limits as the actual "HR Accuracy Measuring Report (E-1)" is not provided in the extracted text. The submission states the device's substantial equivalence to the predicate "in every angles" including "Performing," implying that its HR accuracy would meet similar standards to the cleared predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the "HR Accuracy Measuring Report (E-1)" or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For FHR accuracy, the "ground truth" would typically come from a highly reliable, simultaneously recorded FHR signal (e.g., direct fetal ECG in specific clinical settings, or a validated simulator). Clinical expert review is less common for establishing the ground truth of a numerical FHR value itself, though experts would interpret the overall fetal well-being.

4. Adjudication Method for the Test Set

Not applicable/not specified in the provided document. As ground truth for FHR would likely be a direct physiological measurement or simulation, an adjudication method amongst experts would not typically be required for the FHR value itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This type of study is typically related to diagnostic image interpretation where multiple readers assess cases with and without AI assistance. The BT-200T is a Fetal Monitor, which primarily measures and displays FHR, rather than an interpretative diagnostic imaging device.

6. Standalone (Algorithm Only) Performance Study

The "HR Accuracy Measuring Report (E-1)" represents a standalone performance evaluation of the device's ability to measure FHR. While the report itself is not included, its reference indicates a test of the device's intrinsic function.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "HR Accuracy Measuring Report (E-1)". For FHR devices, the ground truth is typically established by:

Simulated FHR signals: Using a phantom or simulator that can generate known FHR patterns.
Simultaneous direct FHR measurement: In some clinical scenarios, direct fetal ECG (such as during labor via a scalp electrode) can be used as a gold standard.
Simultaneous and independently validated ultrasound reference: Another highly accurate ultrasound system or a reference system known for its precise FHR measurement.

Given it's an "HR Accuracy Measuring Report," it strongly implies a comparison against a reliable, independent measurement of fetal heart rate.

8. Sample Size for the Training Set

The document does not mention a training set. Fetal monitors like the BT-200T are typically engineered using established signal processing algorithms to detect and calculate FHR from Doppler signals. While these algorithms are developed and refined, the concept of a "training set" as understood in modern machine learning is not explicitly discussed in this 2010 submission. The device's performance is demonstrated through its "HR Accuracy Measuring Report."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a distinct training set for an AI/ML algorithm is not explicitly described or implied in the provided document for this type of device. The FHR measurement principles are based on well-established Doppler physics and signal processing.

Summary

{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: 82 2 2108 4626 Fax : 82 2 2108 4629

2. Contact person

Mr. Young Chi / President Bio-Med USA Inc. 111 Ellison street, Paterson, NJ 07505. U.S.A. Tel: 973 278 5222 Fax:201 934 6030 E mail: biomedusa@msn.com

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

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 (01) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
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.(b)
Classification. Class II (performance standards).