(115 days)
No
The summary mentions a "new algorithm" for "side inclination" correction, but there is no indication that this algorithm utilizes AI or ML techniques. The description focuses on ultrasound technology and signal analysis without mentioning any AI/ML specific terms or concepts.
No
The device is described as an ultrasound system used for monitoring cervical dilation and fetal head station during labor, providing diagnostic information rather than directly treating or mitigating a disease or condition.
Yes
Explanation: The device is intended for monitoring the active phase of labor and provides continuous measurements of cervical dilation and fetal head station. This information assists healthcare providers in assessing the progress of labor, which is a diagnostic function. While it doesn't diagnose a disease, it provides critical information to diagnose the stage and progress of a physiological process (labor).
No
The device description explicitly states it uses ultrasound transducers attached to the maternal abdomen, cervix, and fetal scalp, indicating 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 outside of the living body (in vitro).
- BirthTrack System Function: The BirthTrack System uses ultrasound technology to directly measure cervical dilation and fetal head station within the living body (in vivo). It is a monitoring device that provides real-time data about the progress of labor.
The device description and intended use clearly indicate that it is an ultrasound system used for in-vivo monitoring, not for testing samples in a laboratory setting.
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 measurements of cervix dilatation and fetal head station. The BirthTrack Workflow and measurements cycle have not changed with this version and 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. However signal analysis was enhanced with a new algorithm- a "side inclination" correction algorithm. The system's GUI was also enhanced introducing a graphic illustration of CD and HS as measured by the BirthTrack system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
maternal abdomen and cervix and to the 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 is a low risk device. Moreover, the risks imposed by the Birthtrack system are lower or equal to these imposed by the predicate devices and standard 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)
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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. 510(K) SUMMARY
JAN - 9 2009
BIRTHTRACK SYSTEM
510(k) Number K082704
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:
Trade Name:
BirthTrackTM Continuous Labor Monitoring (CLM) System
Classification Name: NPB
Class II medical Device Classification:
March 2008
Predicate Device:
The BirthTrack System is comparable to the following predicate devices:
- The system evaluated is software version 2 of the previously cleared BirthTrack (K080672) manufactured by Barnev. It is enhanced with a new User Interface and a new algorithm.
Device Description:
Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. The BirthTrack Workflow and measurements cycle have not changed with this version and 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. However signal
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analysis was enhanced with a new algorithm- a "side inclination" correction algorithm. The system's GUI was also enhanced introducing a graphic illustration of CD and HS as measured by the BirthTrack system
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:
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 is a low risk device. Moreover, the risks imposed by the Birthtrack system are lower or equal to these imposed by the predicate devices and standard 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/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2009
Barnev Ltd. c/o Ms. Ahava Stein A. Stein Regulatory Affairs Consulting Beit Hapa 'amon (Box 124) 20 Hata 'as St. 44425 Kfar Saba ISRAEL
Re: K082704
Trade/Device Name: BirthTrack™ Regulation Number: 21 CFR §884.2800 Regulation Name: Computerized labor monitoring system Regulatory Class: II Product Code: NPB Dated: December 24, 2008 Received: January 2, 2009
Dear Ms. Stein:
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 (OS) 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/cdrb/industry.suppor/index.html.
Sincerely yours,
Lawn B. Morris
anine M. Morris Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 1 - INDICATION FOR USE
510(K) Number (if known): K088704
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 scalp. These measurements are displayed numerically and 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_ K082204
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
1-1
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