The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.

Device Description

This Doppler tests the fetal heart rate through non-invasive ultrasonic Doppler Effect. As is known, ultrasonic wave propagating at a given frequency will be reflected when encountering an obstacle. If it is still an obstacle, the back wave will share the same frequency with the transmitted wave. Once the obstacle moves, the frequency of the back wave will be changed. The higher rate the object moves at, the bigger frequency change will take place. This is the so-called Doppler Effect. With the apparatus, the ultrasonic probe is placed on the abdomen of the pregnant woman. The ultrasonic probe can perceive the fetal heartbeat. When the transmitted wave encounters the fetal heart, the back wave will develop offset frequency. With the offset frequency, the fetal heart rate and frequency can be worked out.

AI/ML Overview

The provided text from K082055 is a 510(k) summary for the PC-860 Fetal Doppler. It primarily focuses on demonstrating substantial equivalence to a predicate device and safety/performance based on standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for Fetal Heart Rate (FHR) detection accuracy. Instead, it broadly states that "Clinical testing was used to validate the effectiveness and accuracy of the device. Specific testing relating to Ultrasound equipment was use to verify performance to recognized standards. All test results were satisfactory."

Given this, the table below reflects what can be inferred or is directly stated:

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Effectiveness and Accuracy of FHR Detection	Clinical testing validated effectiveness and accuracy. Test results were satisfactory.
Safety (Electrical, Mechanical, Environmental)	Met standard EN/IEC 60601-1. Test results were satisfactory.
Performance to Recognized Ultrasound Standards	Performance verified to recognized standards. Test results were satisfactory.

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

The document states "Clinical testing was used to validate the effectiveness and accuracy of the device" but does not specify the sample size for this clinical testing.

The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results. The device appears to be a standalone Fetal Doppler, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance Study

The document states "Clinical testing was used to validate the effectiveness and accuracy of the device." This implies a standalone performance study was done to evaluate the device's ability to detect Fetal Heart Rate independently. However, specific performance metrics (e.g., sensitivity, specificity, accuracy against a reference) are not provided beyond the general statement of "satisfactory."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the clinical testing. Given it's a Fetal Doppler, the ground truth would typically be a reference method for FHR measurement (e.g., a cardiotocograph (CTG), a more advanced ultrasound, or expert auscultation with a stopwatch), but this is not detailed.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. Fetal Dopplers of this type typically do not involve machine learning models that require a distinct training set in the same way modern AI systems do. Their function is based on physical principles (Doppler effect) and signal processing.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not mentioned as part of the device's development or validation, there is no information on how its ground truth might have been established.

Summary of Missing Information:

This 510(k) summary is from 2009, a period before the widespread requirement for detailed AI/ML validation studies. As such, it lacks specific quantitative acceptance criteria, detailed clinical study methodologies (sample size, expert involvement, ground truth specifics), and any information relating to AI-specific study paradigms like MRMC or training sets. The submission focuses on substantial equivalence to a predicate device and adherence to general safety and performance standards for medical devices.

Summary

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K082055 page 1/3

FEB - 6 2009

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: May 14, 2008

Company and Correspondent making the submission:

Name - Shenzhen Creative Industry Co., Ltd.

Address - 2/F, Block 3, Nanyou Tian'an Industry Town, Shenzhen, China

Telephone - +86-755-2643 4955

Fax - +86-755-2643 5433

Contact - Jianbin Liu

Email - liujianbin@creative-sz.com

Device :

Trade/proprietary name: Fetal Doppler, Model PC-860 Common Name : Fetal Doppler Classification Name : Monitor, Ultrasonic, Fetal

Predicate Device: Edan Instruments, Inc., Ultrasonic Pocket Doppler Model: Sonotrax 510(K) number: K040480

Classifications Names & Citations : 21CFR 884.2660, KNG, Fetal Doppler, Class II

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4. Description

4.1 General

4.2 Directions

As discussed in the General description, the Shenzhen Creative Industry Co., Ltd Fetal Doppler, model PC-860 is relatively simple to use. The Doppler is placed on the abdomen of the patient by first feeling out the fetal contour with hand to find the approximate position of fetal heart. Generally, fetal heart is at a location 113 of the lower abdomen (below the navel) during short pregnant weeks, and along with the pregnant weeks increasing, it moves upwards and lean to right or lean to left. To scan the abdomen, the user must first daub the acoustics surface of Doppler probe uniformly with the appropriate ultrasonic gel, and then put the probe on pregnant woman's abdomen (a location near fetal heart). It is important to ensure that probe contacts surface completely.

5. Indication for use :

The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.

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6. Comparison with predicate device :

Shenzhen Creative Industry Co., Ltd., believes that the Fetal Doppler, Model PC-860 is substantially equivalent to the Edan Instruments, Inc., Ultrasonic Pocket Doppler, Model: Sonotrax, 510(K) number: K040480

1. Safety and Performance Data :
  Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Clinical testing was used to validate the effectiveness and accuracy of the device. Specific testing relating to Ultrasound equipment was use to verify performance to recognized standards. All test results were satisfactory.

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 Shenzhen Creative Industry, Inc., Ltd concludes that Fetal Doppler, Model PC-860 is safe and effective and substantially equivalent to predicate devices as described herein. ·

1. Shenzhen Creative Industry Co., Ltd. will update and include in a summary any other information deemed seasonably necessary by the FDA.
  END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH &" is vertically oriented on the left side of the logo, and the text "HUMAN SERVICES" is vertically oriented on the right side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2009

Shenzhen Creative Industry Co., Ltd. c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313

Re: K082055

Trade/Device Name: PC-860 Fetal Doppler Regulation Number: 21 CFR §884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: January 22, 2009 Received: January 23, 2009

Dear Mr. Job:

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 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 898. 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 Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter,

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K082055

Device Name: PC-860 Fetal Doppler

Indications For Use:

The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.

Prescription Use ... . AND/OR S (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

Aogn M. Whing

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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).