BT-350 by BISTOS CO., LTD. | FDA 510(k) Summary

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 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-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.

AI/ML Overview

The provided text describes the Bistos BT-350 Fetal Monitor and its 510(k) submission. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document outlines the device's function, its comparison to a predicate device, and compliance with general safety and EMC standards. It states, "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." This indicates that general safety and electromagnetic compatibility standards were met, but it doesn't provide specific performance acceptance criteria for the fetal heart rate measurement or uterine contraction measurement, nor does it detail a study proving such performance.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the limitations:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
Electrical, mechanical, environmental safety (EN/IEC 60601-1)	"All test results were satisfactory."
EMC compliance (EN/IEC 60601-1-2(2001))	"All test results were satisfactory."

No further detailed performance acceptance criteria (e.g., accuracy, precision for FHR or uterine contraction) or specific study results demonstrating those criteria were met are provided in the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "performance testing" but does not detail any clinical or performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical study or ground truth establishment process is described beyond general safety and EMC testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical study or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a fetal monitor, not an AI-powered diagnostic imaging device. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device for monitoring, not an algorithm being tested in a standalone fashion. The general safety and performance testing would refer to the device's integrated operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. For general safety and EMC testing, ground truth refers to compliance with the standards, verified by testing procedures outlined in those standards. No clinical "ground truth" for diagnostic accuracy is described.

8. The sample size for the training set

Not applicable. This device is not described as utilizing machine learning or requiring a training set in the context of its performance validation.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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

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 - +82-2-2-2108-4626

Fax - +82-2-2108-4629

Contact - Mr. Hyung-Ju Oh

E-mail : duckcy@bistos.co.kr

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

1. Device :

Trade/proprietary name	: BT-350 Fetal Monitor
Common Name	: Fetal Monitor
Classification Name	: System, monitoring, perinatal

1. Predicate Devices :

Manufacturer	: Biosys Co., Ltd.
Device	: IFM-500 Ultrasound Fetal Monitor
510(k) Number	: K994008(Decision Date - Sep. 29. 2000)

Classifications Names & Citations :

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

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.
1. 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.
1. 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.

1. 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.
1. 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.
1. 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 (301) 796-6535.

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 :

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& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal.(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

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).