CONTEC POCKET FETAL DOPPLER

K082480 · Contec Medical System Co., Ltd. · KNG · Feb 25, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K082480
• Device Name: CONTEC POCKET FETAL DOPPLER
• Applicant: Contec Medical System Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Feb 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

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 Story

Hand-held, battery-powered audio Doppler device; detects fetal heart beats using ultrasonic transducers (2MHz or 3MHz). Input: ultrasonic signals from fetus; processing: Doppler shift analysis; output: audible heart sounds via speaker/headphone jack and visual heart rate/mode/battery status on LCD. Used in clinical or home settings by clinicians or patients. Healthcare providers use audible and visual outputs to monitor fetal status; facilitates assessment of fetal well-being. Models include Sonoline A/B (interchangeable probes) and Baby Sound A/B (integrated probe).

Clinical Evidence

Bench testing only. No clinical data provided. Validation included electrical safety and electromagnetic compatibility (EMC) testing to demonstrate compliance with consensus standards.

Technological Characteristics

Hand-held fetal Doppler; continuous wave (CW) ultrasound; 2MHz or 3MHz transducers; battery-powered; LCD display; audio output via speaker/headphone jack. Models: Sonoline A/B (interchangeable probes), Baby Sound A/B (integrated probe).

Indications for Use

Indicated for fetal heart beat detection in pregnant patients. Used for diagnostic ultrasound fluid flow analysis via continuous wave (CW) Doppler mode.

Regulatory Classification

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.

Predicate Devices

• LifeDop Doppler Ultrasound System (K024197)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

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

7

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# Intended Use:

Predicate Device

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 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:[phone] Fax:[phone]

# 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.

8

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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).

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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

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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 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 [phone]. 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 [phone] or [phone] 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 [phone].

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)

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# Exhibit D Indication for Use Form

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

## Indications for Use:

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.

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

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#### 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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(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