Contect Pocket Fetal Doppler (SONOLINE A, SONOLINE B, Baby Sound A and Baby Sound B) are hand-held, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. The user interface includes power button, mode button, volume control, single speaker, headphone jack and LCD display for heart rate, battery and working mode, probe type.

SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2MHz water proof probe,3MHz normal probe,3MHz water proof probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.

Device Description

Contect Pocket Fetal Doppler includes four models, SONOLINE A. SONOLINE B, Baby Sound A and Baby Sound B. They are handheld, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries.

SONOLINE A and SONOLINE B include four interchangeable probes (2MHz normal probe, 2MHz water proof probe, 3MHz normal probe and 3MHz proof resistance probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. Instead, it focuses on the device's substantial equivalence to a predicate device, intended use, and general compliance with standards.

Here's an analysis based on the available information, noting the missing elements:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification," and that "Results of these tests demonstrate compliance to the requirements of all consensus standards." However, it does not specify what those "design specifications" or "consensus standards" are, nor does it provide performance metrics.

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

Not available in the provided text.

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

Not available in the provided text.

4. Adjudication Method for the Test Set

Not available in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or mentioned in this document. The device in question is a fetal Doppler and does not involve AI for interpretation or assistance with human readers.

6. If a Standalone Study Was Done

A standalone performance study in the clinical sense (e.g., measuring diagnostic accuracy against a gold standard) is not explicitly detailed with specific metrics. The document mentions "Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification." This implies engineering and safety testing were performed standalone for the device, but not a clinical performance study as typically understood in the context of device accuracy.

7. The Type of Ground Truth Used

Based on the nature of the device (a fetal Doppler for detecting heartbeats) and the general regulatory context described, the "ground truth" for the device's primary function would likely be the actual presence or absence of a fetal heartbeat, potentially confirmed by other clinical methods or simultaneous observations. However, the document does not explicitly state how ground truth was established for any performance testing. For electrical safety and EMC, the ground truth would be compliance with established international standards.

8. The Sample Size for the Training Set

Not applicable. The device described is a hardware medical device (fetal Doppler) that detects fetal heartbeats. There is no indication that it utilizes a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set mentioned for this device.

Summary of what is available:

The provided documents primarily constitute a 510(k) summary for the Contec Pocket Fetal Doppler, aiming to demonstrate its substantial equivalence to an existing legally marketed predicate device (LifeDop Doppler Ultrasound System K-number: K024197). The primary evidence for meeting regulatory requirements lies in:

Comparison to a predicate device: The device shares similar intended use, technology, and operating principles with the LifeDop Doppler Ultrasound System.
Compliance with consensus standards: The manufacturer states that laboratory testing was conducted to ensure compliance with electrical safety, EMC, and other specifications, adhering to recognized consensus standards. However, the specific standards and test results are not detailed in this summary.

The document is a regulatory submission focused on proving equivalence and safety based on engineering tests and comparison to a predicate, rather than a detailed clinical performance study with specific acceptance criteria and ground truth derived from expert consensus or pathology.

Summary

{0}------------------------------------------------

KORZYSTN

Section III 510(k) Summary

FEB 2 5 2009

As Required by CFR 807.92

Sponsor:

Contec Medical Systems Co., LTD No.2-1 Hengshan Road, Economic and Technical Development Zone Qinhuangdao, Hebei, 066000, People's Republic of China

Mr. Li Xueyong Quality Manager Tel: Fax: Email:

Correspondent:

Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China

Ms. Diana Hong / Mr. Lee Fu Tel: 021-64264467 Fax: (760)466-5084 Email: diana.hong@mid-link.net

Proposed Device:

Device Trade/Proprietary Name: Contec Pocket Fetal Doppler Model: SONOLINE A/ SONOLINE B/Baby Sound A/Baby Sound B Device Common Name: Fetal ultrasonic monitor and accessories Device Classification Name: monitor, ultrasonic, fetal Product Code: KNG Regulation Number: 884.2660 Device Class: II

{1}------------------------------------------------

Intended Use:

Predicate Device

SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2MHz water proof probe,3MHz normal probe, 3MHz proof resistance probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.

LifeDop Doppler Ultrasound System K-number: K024197

Product Code: KNG

Intended Use:

The LifeDop is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and for blood flow detection in veins and arteries. the product includes four interchangeable probes(OB Late Term, OB Early Term, Vascular pencil probe, Vascular flat face probe) and user replaceable batteries. the user interface includes an on/off button, play/record button, volume control, single 2-1/4" speaker, headphone jack and LCD display for heart rate, battery and waveform information.

Manufactured by:

Summit Doppler Systerms, Inc. Add:5350 Vivian St. Suite A. Arvada, CO 80002-1957 Tel:(303)423-7572 Fax:(303)431-5994

Device Description

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

Testing Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards Substantially Equivalent

The proposed device, Contec Pocket Fetal Doppler, is substantially equivalent (SE) to the predicate device LifeDop Doppler Ultrasound System (K024197).

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the eagle. The eagle symbol is composed of three curved lines that suggest the shape of an eagle in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Contec Medical Systems Co., Ltd. % Ms. Diana Hong General Manager Shanghai Mid-Link Business Consultant Co., Ltd. Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road Shanghai, 200030 CHINA Re: K082480 Trade/Device Name: Contec Pocket Fetal Doppler

FEB 2 5 2009

Models: Sonoline A/B and Baby Sound A/B Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: February 17, 2009 Received: February 17, 2009

Dear Ms. Hong:

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 Intersule octimation of prices 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 the Evilual Connents 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 Contec Pocket Fetal Doppler - Models: Sonoline A/B and Baby Sound A/B, as described in your premarket notification:

Transducer Model Number

2MHz Normal Probe CMS-150-T0 2MHz CW Water Proof CMS-150-T1 3MHz CW Normal Probe CMS-150-T5 3MHz CW Water Proof Probe CMS-150-T2

{4}------------------------------------------------

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.

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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Lori McWhany

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

Enclosure(s)

{5}------------------------------------------------

Exhibit D Indication for Use Form

510(k) Number: K082480 Device Name: Contec Pocket Fetal Doppler

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arun Th Thang

(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number

Page 1 of 7

{6}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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

Device Name: SONOLINE A and SONOLINE B fetal Doppler

Main unit fetal system with either 2MHz CW or 3.0MHz CW

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(B/M)	Other(specify)
Ophthalmic
Fetal				N
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Comments:

The system consists of main unit with either 2MHz CW or 3,2 MHz CW for fetal applications. Only one transducer can be used with the main unit at one time

(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)

Page 2 of

Tony M. Whang

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082480

{7}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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

Device Name: 2MHz normal probe CMS-150-T0

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(B/M)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Comments:

The above is a 2.0MHz CW transducer for fetal heart detection

(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)

Page 3 of 7

Lomi M. Wz

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

{8}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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

Device Name: 2MHz CW water proof probe CMS-150-T1

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(B/M)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Comments:

The above is a 2.0MHz CW transducer for fetal heart detection.

(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)

Page 4 of

Vonghi M. Whang

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

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

Diagnostic Ultrasound Indications for Use Form

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

Device Name: 3MHz CW normal probe CMS-150-T5

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(B/M)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Comments:

The above is a 3.0MHz CW transducer for fetal heart detection.

(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)

Donna M. Whitten

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

Page 5 of 7

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

Diagnostic Ultrasound Indications for Use Form

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

Device Name: 3MHz CW water proof probe CMS-150-T2

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(B/M)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Comments:

The above is a 3.0MHz CW transducer for fetal heart detection

(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)

Page 6 of 7

Arguello Whan

(Division Sign-Off) Division of Reproductive, Abdominat and Radiological Devices 510(k) Number

{11}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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

Device Name: Baby Sound A and Baby Sound B

Main unit fetal system ingreted with 2MHz CW transducer

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(B/M)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Comments:

The system consists of main unit is integrated with 2MHz CW transducer for fetal applications.

(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)

Page

Tony M. Wang

(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 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).