(69 days)
Not Found
No
The description focuses on standard Doppler ultrasound technology for measuring fetal heart rate and uterine contractions, with no mention of AI or ML algorithms for analysis or prediction beyond basic signal processing.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a diagnostic tool, used to monitor fetal heart rate to assess well-being, rather than administering any form of therapy.
Yes
The device is used to measure Fetal Heart Rate and uterine contractions, and aids in a comprehensive check for the well-being of a single fetus, which are diagnostic purposes.
No
The device description explicitly states it is a "pocket size Fetal Monitor" that "measures the fetal heart rate" using "Doppler ultrasound" and has a "built-in speaker" and "LCD screen," indicating it is a hardware device with integrated software.
Based on the provided information, the BT-200T is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- BT-200T Function: The BT-200T uses Doppler ultrasound to measure the fetal heart rate directly from the abdomen of a pregnant woman. This is an in vivo (within the body) measurement. It does not involve analyzing specimens taken from the body.
Therefore, the BT-200T falls under the category of a medical device, specifically a fetal monitor, but not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HGM
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
abdomen of a pregnant women
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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 (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
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