Doppler fetal heartbeat rate detector uses Doppler principle of ultrasound signal to detect the fetal heart rate. Doppler fetal heartbeat rate detector uses a split D piezoelectric transducer. A high frequency oscillator supplies a continuous high frequency voltage to one half of the split D transmitter transducer. The high frequency voltage is converted to an ultrasound acoustic wave by the transducer and is transmitted to biophysical objects through an applied coupling water based medium and moves through biophysical objects. The acoustic ultrasound is reflected by body and moving objects such as the fetal heart. The reflected ultrasound is received by the second split D receiver transducer and is converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a loudspeaker. At the same time the fetal heart rate is displayed on a liquid crystal arithmometer display.

AI/ML Overview

The provided text details a 510(k) summary for a Doppler fetal heartbeat rate detector (K090570) manufactured by Shenzhen Bestman Instrument Co., Ltd. However, it does not contain specific acceptance criteria or an explicit study that quantitatively proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (K040480 SONOTRAX) rather than providing detailed performance metrics for the new device. The evaluation process in such submissions often relies on demonstrating that the new device performs "as well as" or "similarly to" the predicate, implying that if the predicate met certain performance standards, the new device will as well.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated quantitative acceptance criteria or detailed reported device performance metrics that can be presented in a table. The document broadly states:

"Doppler fetal heartbeat rate detector has been subjected to extensive safety, performance test and validations before release."
"Final test of the Doppler fetal heartbeat rate detector includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
"The conclusions drawn from the test of the Doppler fetal heartbeat rate detector demonstrates that the device is substantially equivalent to the predicate device."

This level of detail is typical for a 510(k) summary, which often summarizes testing without providing raw data or specific performance tables.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It simply states that "various performance tests" were conducted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for establishing ground truth for a test set.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. There is no mention of human readers or AI assistance, nor any effect size regarding improvement with AI. This is a standalone device without AI functionality for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device is described as a "Doppler fetal heartbeat rate detector" and an "Ultrasonic Fetal Monitor." Its function is to detect and display the average fetal heartbeat rate. The testing described (general performance and safety tests) would inherently be a standalone performance evaluation of the device itself, as it's a diagnostic tool that directly outputs a reading. While not explicitly termed "standalone performance" in the context of an AI algorithm, the device's function is standalone data acquisition and display.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used. Given the nature of a fetal heartbeat detector, the ground truth would typically be:

Physiological measurement from a reference standard: Comparison against a known, accurate method of measuring fetal heart rate. This could involve using a precise simulator or a direct physiological measurement from a live subject (animal or human) with a validated alternative method.
Clinical observation/expert consensus: In a clinical validation, comparison against the fetal heart rate determined by experienced clinicians using established methods.

However, the text does not explicitly state which method was used.

8. Sample Size for the Training Set

The device described is a hardware-based Doppler fetal monitor. It does not appear to be an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training set" concept is not applicable here as there is no learning algorithm involved.

9. How Ground Truth for the Training Set Was Established

As the device does not employ an AI/machine learning algorithm with a "training set," this question is not applicable.

Summary

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510(K) SUMMARY

This summary of 5 10(k) safety a nd ef fectiveness information is be ing submitted i n accordance with 21 CFD part 807.92.

The assigned 510(k) number is: K090570

APR 2 9 2010

Submitter's name, address, phone number, contact person and

preparation data:

Name: Shenzhen Bestman Instrument Co., Ltd.

Address: 4/F, Block 210, 2nd Industrial Area of Nanyou, Xiangnan Rd., Nanshan Dist., Shenzhen, P.R.China Phone: 86-755-26713783/26713784 Fax: 86-755-26495167/26713783 Contact Person: Bai Yong

Official correspondent:

Bai Yong General Manager Shenzhen Bestman Instrument Co., Ltd. Address: 4/F, Block 210, 2nd Industrial Area of Nanyou, Xiangnan Rd., Nanshan Dist., Shenzhen, P.R.China Tel: 86-755-26713783/26713784 Fax: 86-755-26495167/26713783 Email: bestm@public.szptt.net.cn

. Date of Preparation: April 27, 2010

2. Device:

. Proprietary Name: Doppler fetal heartbeat rate detector
Ultrasonic Fetal Monitor � Common Name:
Classification Name: Fetal Ultrasonic Monitor and Accessories ●

Product Code: KNG

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. Manufactured By: Shenzhen Bestman Instrument Co., Ltd., China
1. Predicate Device:

K040480 SONOTRAX

4. Classification Names:

Class II as per 21CFR 884-2660, Ultrasonic Fetal Monitor and accessories.

5. Description:

6. Indications for use:

This Doppler can be used for the detection of average fetal heartbeat rate. Models List Form: (Please see the attached "Diagnostic Ultrasound Indications For Use Format" forms for detail.)

Series	Models	Attached Transducers
1	BF-500B	CW20(fc=2.0MHz)
2	BF-500+BF-500++	CW25(fc=2.5MHz)

7. Contra-indications:

Not be discovered till now.

{2}------------------------------------------------

8. Comparison to Predicate Devices:

Doppler fetal heartbeat rate detector has the same device characteristics as the above predicate approved device.

9. Test Data:

Doppler fetal heartbeat rate detector has been subjected to extensive safety, performance test and validations before release. Final test of the Doppler fetal heartbeat rate detector includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the devices comply with applicable industry and safety standards. Doppler fetal heartbeat rate detector includes instructions for safe and effective use, warnings, cautions and guidance for use.

10. Literature Review:

A review of the literature pertaining to the safety of fetal Doppler has been conducted and appropriate safeguards h ave been incorporated in the design of the Doppler fetal heartbeat rate detector.

11. Conclusion:

The c onclusions drawn fr om the te st of the Doppler fetal hea rtbeat ra te det ector demonstrates that the device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Bestman Instrument Co., Ltd % Mr. Marc M. Mouser Manager/FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

APR 2 9 2010

Re: K090510

Trade/Device Name: Doppler fetal heartbeat detector Models: BF-500B, BF-500+, and BF500++ Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: April 2, 2010 Received: April 8, 2010

Dear Mr. Mouser:

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 Doppler fetal heartbeat detector - Models: BF-500+, and BF500++as described in your premarket notification:

Transducer Model Number

Model BF-500+ & BF-500++ CW25

Model BF-500B CW20

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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.

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/Safetv/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 Shahram Vaezy at (301) 796-6242.

Sincerely yours.

Robe RBeater J (fa)
Donald St. Pierre

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

Enclosure(s)

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Indications for Use

510(k) Number (if known): KO905 /0

Device Name: Doppler fetal heartbeat rate detector

Indications for Use:

This Doppler can be used for the detection of average fetal heartbeat rate.

Models List Form:

Series	Models	AttachedTransducers
1	BF-500B	CW20(fc=2.0MHz)
2	BF-500+	CW25(fc=2.5MHz)
	BF-500++

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert A. Zecker

(Division Sign, Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K090510

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X System: Transducer: __________________________________________________________________________________________________________________________________________________________________ BF-500B Model:

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal				N
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& 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)
PeripheralVessel	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

Koba
K090510

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System: ______________________________________________________________________________________________________________________________________________________________________ Transducer: __________________________________________________________________________________________________________________________________________________________________ Model: BF-500+

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)

Ophthalmic	Ophthalmic
	Fetal				N
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& 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 Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
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

Robert M. Becker
K090510

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X System: ___________________ Transducer:

Model: BF-500++

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal				N
FetalImaging& Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	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)
PeripheralVessel	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

8 .

Robert M. Bestery
K090510

{9}------------------------------------------------

System:

Transducer:

CW25(This probe applies to BF-500+ & BF-500++ Model) Model:

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal				N
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
FetalImaging& Other	Laparoscopic
	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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

Robert M. Beckerf
K090510

{10}------------------------------------------------

System:

Transducer:

CW20(This probe applies to BF-500B Model) Model:

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal				N
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	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)
PeripheralVessel	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

Tobe M. Beckey
K090510

Regulation Number and Section

§ 884.2660 Fetal ultrasonic monitor and accessories.

(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).