(120 days)
Not Found
No
The summary describes a device that uses ultrasound technology to directly measure cervical dilation and fetal head station. There is no mention of AI/ML being used for image analysis, data interpretation, or prediction. The device appears to provide raw measurements and graphical displays based on these measurements.
No
The device is used for monitoring and measuring cervical dilation and fetal head station, providing information about the progress of labor rather than directly treating a disease or condition.
Yes
The device continuously measures cervical dilation and fetal head station, displaying these measurements numerically and graphically to show the progress of labor, which assists in monitoring and evaluating the physiological state of the patient.
No
The device description explicitly mentions "ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp" and "disposable sensors located on the maternal cervix and fetal head," indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- BirthTrack System Function: The BirthTrack System uses ultrasound technology to directly measure physical parameters (cervical dilation and fetal head station) within the body. It does not analyze samples taken from the body.
The BirthTrack System is a medical device used for monitoring physiological processes during labor, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Product codes
NPB
Device Description
Barnev's BirthTrack system uses ultrasound technology to provide Device Description: measurements of cervix dilatation and fetal head station. Signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
maternal abdomen, cervix, fetal scalp
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)
Based on bench studies and clinical evaluation, we believe that the Birthtrack System and their accessories are low risk devices. Moreover, the risks imposed by the Birthtrack system and its accessories are lower or equal to these imposed by the predicate devices and standards medical practice. The performance of the Birthtrack system is substantially equivalent to the performance of its predicate device cited above and to these of manual procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060028, K844608, K060028, K030691, K060028
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2800 Computerized Labor Monitoring System.
(a)
Identification. A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.(b)
Classification. Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.
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SPECIAL 510(K) SUMMARY
BIRTHTRACK SYSTEM
.
:
510(k) Number K080672
| Applicant's Name: | Barnev Ltd.
8 Hamelacha St.
Netanya 42504
Israel
Tel: +972-9-8923130
Fax: +972-9-8923131
e-mail:info@barnev.com
www.barnev.com |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ahava Stein, Regulatory Consultant
A. Stein - Regulatory Affairs Consulting
20 Hata'as St.
Kfar Saba 44425
Israel
Tel. + 972-9-7670002
Fax. +972-9-7668534
e-mail: ahava@asteinrac.com |
| Date Prepared: | March 2008 |
| Trade Name: | BirthTrack™ Continuous Labor Monitoring (CLM) System |
| Classification Name: | NPB |
| Classification: | Class II medical Device |
| Predicate Device: | The BirthTrack System is comparable to the following predicate
devices: |
| - CLM, Computerized Labor Monitoring system (K060028)
manufactured by Barnev. The BirthTrack is a name change of the
CLM system, and the changes from the approved CLM system
lies in its accessories, the Fetal Spiral Sensor and the Cervical
Sensor. | |
| - The Cervical Sensor is comparable to the Disposable FSE
(K844608) manufactured by Surgicraft Copeland, and to the
previous Cervical ITR (K060028) manufactured by Barnev. | |
I-3
1
-
The Fetal Spiral Sensor is comparable to the Disposable FSE (K030691) manufactured by Clinical Innovations, and to the previous Fetal ITR (K060028) manufactured by Barnev.
Barnev's BirthTrack system uses ultrasound technology to provide Device Description: measurements of cervix dilatation and fetal head station. Signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations. -
Intended Use / Indication for Use: The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Performance Standards: The BirthTrack System complies with:
U.S. Federal Performance Standard set forth in 21 CFR 898 for electrode lead wires and Patient Cables.
In addition, the device complies with the recognized standards: It also complies with ISO 11137, IEC-60601-1 and amendments, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37and AAMI/ANSI/ISO 10993-1.
Substantial Equivalence: Based on bench studies and clinical evaluation, we believe that the Birthtrack System and their accessories are low risk devices. Moreover, the risks imposed by the Birthtrack system and its accessories are lower or equal to these imposed by the predicate devices and standards medical practice. The performance of the Birthtrack system is substantially equivalent to the performance of its predicate device cited above and to these of manual procedures.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 8 2008
A.Stein Regulatory Affairs Consulting c/o Ms. Ahava Stein Barnev Ltd. 20 HATA'AS ST. KFAR SABA ISRAEL 44425
Re: K080672
Trade Name: BirthTrack™ Regulation Number: 21 CFR 884.2800 Regulation Name: Computerized Labor Monitoring System Regulatory Class: II Product Code: NPB Dated: June 13, 2008 Received: June 17, 2008
Dear Ms. Stein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Doctor Froger procharially equivalent (for the indications for relerenced aoove and nave acterimined arketed predicate devices marketed in interstate commerce use stated in the enclosure) to regarly many of the Medical Device Amendments, or to devices that prob to May 20, 1770, and onceanone auto 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 Controls provibions or also ing, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (soc above) filio entrols. Existing major regulations affecting your Approval), it thay be subject to such adultions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health.
3
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 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 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.
Sincerely vours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 1- INDICATION FOR USE
510(K) Number (if known): K080672
BirthTrack™ Device Name:
Indication for use: The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal These measurements are displayed numerically and scalp. graphically as a function of time to show the progress of labor.
Prescription Use 区 (Per 21 CFR 801.109) OR
Over the Counter Use
PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510(K) Number K080672
Hubert Lenoir
ion of Reproductive, Abdominal. nd Radiological Device
1-1
510(k) Number K880672