(162 days)
Not Found
No
The description focuses on standard signal processing and display of physiological parameters (fetal heart rate and uterine contractions) using ultrasound and pressure sensors. There is no mention of AI, ML, or any advanced analytical techniques that would typically involve these technologies.
No
The device is described as a "Prenatal Monitoring System" that measures maternal abdominal contractions and fetal heart rate to "aid in assessing the well being of the fetus." It is solely for monitoring and assessment, not for treating any condition.
Yes
The device is described as a "Prenatal Monitoring System" that non-invasively measures maternal abdominal contractions and fetal heart rate to "aid in assessing the well being of the fetus" during antenatal periods. This function falls under the definition of a diagnostic device as it gathers data to help medical personnel assess a patient's condition.
No
The device description explicitly details hardware components such as ultrasound transducers, pressure sensors, LCD/LED displays, a thermal printer, and a power adaptor, indicating it is a physical medical device, not software-only.
Based on the provided information, the BT-350 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- BT-350 Function: The BT-350 is a prenatal monitoring system that uses non-invasive methods (ultrasound and pressure sensors) to measure fetal heart rate and maternal contractions directly from the pregnant woman's abdomen. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate." This is a direct measurement from the patient, not an analysis of a specimen.
Therefore, the BT-350 falls under the category of a medical device used for monitoring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HGM, HGL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PW Doppler
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
-
- Device :
| Trade/proprietary name | : BT-350 Fetal Monitor |
|---|---|
| Common Name | : Fetal Monitor |
| Classification Name | : System, monitoring, perinatal |
-
- 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.
1
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.
-
- 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.
-
- 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.
-
- 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.
- Safety, EMC and Performance Data :
-
- 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.
- Conclusions :
-
- Bistos Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
-
END
2
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.
3
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)
4
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
5
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