Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard Doppler technology for detecting blood flow and fetal heart sounds, and explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No
The device is a diagnostic tool used to detect and display arterial and venous blood flow velocity, as well as fetal heart sounds and heart rates. It does not provide any therapeutic function.

Diagnostic

Yes

The device detects arterial and venous blood flow as well as fetal heart sounds, and displays velocity waveform, numerical data, and heart rates. It measures fetal heart rate to predict fetal well-being and checks vascular blood flow status by measuring pulse rate. These functions are indicative of diagnostics, as they assess physiological conditions to aid in diagnosis or monitoring.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "pocket size Ultrasound Doppler System" and includes "Ultrasound Doppler Probes," indicating it is a hardware device that utilizes ultrasound technology.

IVD (In Vitro Diagnostic)

Based on the provided information, the BT-200V Vascular Doppler is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The BT-200V uses ultrasound to directly interact with the patient's body (extremities for vascular flow, abdomen for fetal heart sounds) to detect signals. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
The intended use and device description clearly state that it detects blood flow and fetal heart sounds in vivo (within the living body).
The device description focuses on the physical interaction with the patient and the detection of Doppler signals from within the body.

Therefore, the BT-200V falls under the category of a diagnostic ultrasound device used for non-invasive examination of the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BT-200V Vascular Doppler ( Brand Hi-dop ) detects arterial and venous Hood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.

The BT-200V detects arterial and venous blood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.

Intended use: Diagnostic ultrasound imaging or measursing FHR, Pulse Doppler of the human body as follows:
Clinical Application: Fetal (PWD)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Pheperial (CWD)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Pheperial Vascular (PWD)

Product codes

DPW, ITX, HGM

Device Description

Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker, By measuring fetal heart rate (FHR), they are able to predict fetal well-being, BT-200V irradiates fetal 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.

4,5.8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate (PR) they are able to check vascular blood flow status.

BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient.

The following probes may be utilized with the BT-200V Vascular doppler:
2 MHz for fetal heart rate
4 MHz detections of arterial and venous blood flow velocity
5 MHz detections of arterial and venous blood flow velocity
8 MHz detections of arterial and venous blood flow velocity

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound Doppler

Anatomical Site

Extremities, Fetal, Pheperial, Vascular

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

BT-200V Vascular Doppler done various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff - Information for Manufacturers seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. All test report attached.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K050601 Smartdop 45 Vascular doppler Koven Technology Corp.

Reference Device(s)

K100885

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Bistos, Co., Ltd

. I

Summary of safety and effectiveness

AUG 2 2012

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. ( Reg Nr. 3006179052) 7th Fl. WooRim Lions Valley 5 cha 144-3 SangDaewon, JungWon Gu, SeoungNam, GyeongGi do, Republic of Korea Tel : 31 750 0340 Fax 31 750 0344

2. Contact person, Consultant

Mr. Young Chi / President BioMed USA Inc. ( Reg Nr. 2246683) 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-200V Vascular Doppler Hi-dop
Common or usual name	Vascular Doppler
Regulation number	870.2100
Regulation class	II
Product code	DPW
Subsequent Product Code	I T X
Classification panel	Cardiovascular, Radiology

4. Substantial Equivalence.

Smartdop 45 Vascular doppler Koven Technology Corp . model K050601

Bistos BT-200V Vascular Doppler is substantially equivalent in Intended use, Design, Function, Performing, direction to use, software, Technology/Principle of operation etc, but Bistos BT-200V has no Printing function.

1

5. Device Description

Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker, By measuring fetal heart rate (FHR), they are able to predict fetal well-being, BT-200V irradiates fetal 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.

4,5.8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate (PR) they are able to check vascular blood flow status.

BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient.

The following probes may be utilized with the BT-200V Vascular doppler:

2 MHz for fetal heart rate

4 MHz detections of arterial and venous blood flow velocity

5 MHz detections of arterial and venous blood flow velocity

8 MHz detections of arterial and venous blood flow velocity

6. Indications for use:

The BT-200V detects arterial and venous blood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.

7. Contra-indications:

None are known at this time.

8. Labeling

Back label, Market promoting leaflet designed by labeling requirement regulation i under (21CFR part 801) page 53, 54 of Technical Construction File

9.Biocompatibility test.

BT-200V used same material of patient contacted part as already cleared Biotos BT-200T under K100885 Fetal Doppler, and 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.

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2

10. Test Data

t

BT-200V Vascular Doppler done various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff - Information for Manufacturers seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. All test report attached

11, Conclusion.

BT-200V Vascular Doppler is substantially equivalent in Intended use Design, Function, Performing, direction to use, software, Technology/Principle of operation as already cleared predicate device K050601 SmartDop 45.

And used same material as already cleared and in marketing Bistos BT-200T under 510K 100885.

So BT-200V Vascular Doppler has no new issues in safety and effectiveness.

End of Summary

17

3

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is a stylized image of an abstract symbol that resembles a person embracing another person.

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

2 2012 AUG

Bistos CO., LTD % Mr. Young Chi President Bio-Med USA Inc. 111 Ellison Street PATERSON NJ 07505

Re: K121267

Trade/Device Name: BT-200V Vascular Doppler Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: April 23, 2012 Received: April 26, 2012

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 CFR Parts 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 (21 CFR Part 820). This letter 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 marketed 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 (301) 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/ReportaProblem/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-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. Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device · Evaluation and Safety Center for Devices and Radiological Health

Enclosure

5

め

Indication for use statement

510(K)number : 《121267

BT-200V Vascular Doppler Device name ..

The BT-200V Vascular Doppler ( Brand Hi-dop ) detects arterial and venous Indication for use : Hood flow in extremities as well as fetal heart sounds. and displays velocity waveform, numerical data and fetal heart rate with heart beat indicator. The BT-200V selection is 2, 4, 5 and 8 MHz.

or/and Over the Counter use Prescription use XX (Part 21CFR 801 Sub part C) (Part 21 CFR 801 Sub part D )

Please do not write below line-continued an another pages if needed

Concurrence of CDRH, office of (OVID)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and S

510K K1a1267

6

.

Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

2Mhz PW DOPPLER FETAL PROBE – MODEL: BT-200V

Intended use: Diagnostic ultrasound imaging or measursing FHR, Pulse Doppler of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal					P
Abdominal
Intraoperative (specify)
Intraoperative
Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Pheriperal
Vascular
Lapaloscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED currence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

F. L. I. C.

111

(Division Sign-Off) dIvision and Reproductive, Abdominal, And Radiological Devices 510(k) Number 12 1267

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-4 12's

7

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Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

4Mhz PW DOPPLER FETAL PROBE – MODEL: BT-200V

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical
Application | A | в | M | PWD Doppler | Amplitude
Doppler | Color
Velocity | Combined
(specify) | Other
(specify) |
|-------------------------|---|---|---| | | | | | | Ophthalmic | | | | | Fetal | | | | | Abdominal | | | | | Intraoperative | | | | | (specify) | | | | | Intraoperative | | | | | Neurological | | | | | Pediatric | | | | | Small Organ | | | | | (specify) | | | | | Neonatal Cephalic | | | | | Adult Cephalic | | | | | Cardiac | | | | | Transesophagea! | | | | | Transrectal | | | | | Transvaginal | | | | | Transurethral | | | | | Intravascular | | | | | Pheperial | | | | | Vascular | | | | | Lapaloscopic | | | | | Musculo-skeletal | | | | | Conventional | | | | | Musculo-skeletal | | | | | Superficial | | | | | Other (specify) | | | | | CWD | Color
-----|-----|------------------|----------------------|-------------------|-----------------------|--------------------|
| | | | Imaging | | |
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N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Michael D. O'Shea

(Division Sign-Off) Division and Reproductive, Abdominal, and Radiological Devices

510(k) Number K|21267

8

.

Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

5Mhz PW DOPPLER FETAL PROBE – MODEL: BT-200V

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical
Application | A | в | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|---------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(specify) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonata! Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Pheperial | | | | | N | | | | | |
| Vascular | | | | | | | | | | |
| Lapaloscopic | | | | | | | | | | |
| Musculo-skeleta! | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

.

Muthal D'Aher

(Division Sign-Off) Division and Reproductive, Abdominal, and Radiological Devices 510(k) Number_

ﭘ ﭘ : :

9

Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

8Mhz PW DOPPLER FETAL PROBE – MODEL: BT-200V .

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Pheperial Vascular				N
Lapaloscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Michael D O'Hara

(Division Sign-Off) Division and Reproductive, Abdominal, and Radiological Devices

510(k) Number K[2|26]

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