(181 days)
Not Found
No
The description focuses on basic Doppler technology for detecting fetal heartbeats and does not mention any AI or ML capabilities.
No
The device is used for detecting fetal heartbeats, which is a diagnostic function, not a therapeutic one.
Yes
The device is explicitly described as being used for "detecting fetal heart beats," which is a diagnostic purpose to ascertain the presence and viability of the fetus. The predicate device is also a "Doppler Ultrasound System," reinforcing its diagnostic nature.
No
The device description explicitly states it is a "hand-held, battery powered audio Doppler device" and includes physical components like probes, buttons, a speaker, headphone jack, and LCD display, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Contect Pocket Fetal Doppler is a device that uses ultrasound to detect fetal heart beats in vivo (within the body). It directly interacts with the patient's body to obtain a signal.
The description clearly states its function is "detecting fetal heart beats" using "audio Doppler devices." This is a form of diagnostic ultrasound, which is not considered an in vitro diagnostic method.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
7
1
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:(303)423-7572 Fax:(303)431-5994
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
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:
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
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 | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | 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 | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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 | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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