BIRTHTRACK

K080672 · Barnev, Ltd. · NPB · Jul 8, 2008 · Ophthalmic

Device Facts

• Record ID: K080672
• Device Name: BIRTHTRACK
• Applicant: Barnev, Ltd.
• Product Code: NPB · Ophthalmic
• Decision Date: Jul 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2800
• Device Class: Class 2

Intended 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.

Device Story

BirthTrack is an ultrasound-based labor monitoring system. It utilizes disposable sensors attached to the maternal cervix and fetal scalp, alongside transducers on the maternal abdomen, to capture continuous data on cervical dilatation and fetal head station. This system replaces frequent manual vaginal examinations. Data is processed and displayed numerically and graphically over time, allowing clinicians to track labor progress. The device is intended for use in clinical settings during the active phase of labor. By providing objective, continuous measurements, it aims to reduce the need for invasive manual checks and assist healthcare providers in clinical decision-making regarding labor management.

Clinical Evidence

The submission relies on bench studies and clinical evaluation to support substantial equivalence. No specific clinical trial metrics (e.g., sensitivity, specificity, p-values) are provided in the summary document.

Technological Characteristics

Ultrasound-based measurement system. Components include disposable cervical and fetal scalp sensors and abdominal transducers. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4, IEC 60601-2-37 (ultrasound), and AAMI/ANSI/ISO 10993-1 (biocompatibility). Complies with 21 CFR 898 for electrode lead wires and patient cables. Sterilization method not specified.

Indications for Use

Indicated for women in active labor with term pregnancies, vertex presentation, and ruptured membranes, with cervical dilation between 3 cm and 7 cm.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CLM, Computerized Labor Monitoring system (K060028)
• Disposable FSE (K844608)
• Cervical ITR (K060028)
• Disposable FSE (K030691)
• Fetal ITR (K060028)

Submission Summary (Full Text)

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# SPECIAL 510(K) SUMMARY

## BIRTHTRACK SYSTEM

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## 510(k) Number K080672

| Applicant's Name: | Barnev Ltd.<br>8 Hamelacha St.<br>Netanya 42504<br>Israel<br>Tel: [phone]<br>Fax: [phone]<br>e-mail:[e-mail]<br>www.barnev.com |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ahava Stein, Regulatory Consultant<br>A. Stein - Regulatory Affairs Consulting<br>20 Hata'as St.<br>Kfar Saba 44425<br>Israel<br>Tel. + 972-9-7670002<br>Fax. [phone]<br>e-mail: [e-mail] |
| 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<br>devices: |
| - CLM, Computerized Labor Monitoring system (K060028)<br>manufactured by Barnev. The BirthTrack is a name change of the<br>CLM system, and the changes from the approved CLM system<br>lies in its accessories, the Fetal Spiral Sensor and the Cervical<br>Sensor. | |
| - The Cervical Sensor is comparable to the Disposable FSE<br>(K844608) manufactured by Surgicraft Copeland, and to the<br>previous Cervical ITR (K060028) manufactured by Barnev. | |

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- 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.

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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 (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 [phone] or [phone] 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

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510(k) Number K880672