FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS

K050826 · Cetro America · HGM · Apr 10, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K050826
• Device Name: FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
• Applicant: Cetro America
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.

Device Story

Replacement transducers for fetal monitors; includes ultrasound transducers and tocodynamometers. Ultrasound transducers utilize pulsed Doppler technology (approx. 33% duty cycle) to detect fetal heart rate via Doppler shift. Tocodynamometers utilize strain gauges to detect frequency and duration of uterine contractions. Devices are reusable; attach to patient abdomen via elastic belts. Connect to existing OEM fetal monitoring systems (Corometrics, HP, AMS/Spacelabs) via color-coded connectors. Output signals are processed by the host fetal monitor to display and chart clinical data. Used in clinical settings by healthcare providers to assess fetal well-being and labor progression.

Clinical Evidence

Bench testing only. Conformity to consensus performance standards for electrical, mechanical, and thermal safety and biocompatibility demonstrated.

Technological Characteristics

Ultrasound transducers: Pulsed Doppler mode, 33% duty cycle, center frequencies 0.9984 MHz to 1.536 MHz, acoustic output <20mW/cm2. Tocodynamometers: Strain gauge technology. Reusable, non-sterile, 8-foot cable, color-coded connectors. Compatible with specific OEM fetal monitor systems.

Indications for Use

Indicated for gravid patients, particularly during labor, to monitor and chart fetal heart rate and maternal uterine activity.

Regulatory Classification

Identification

A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• Corometrics 174 (U/S 5700 and TOCO 2260) (K891595)
• Corometrics 145 (K852076)
• HP 1356 (U/S 1356A and TOCO 1355A) (K900480)
• AMS IM-76 (U/S US91 and TOCO TD84) (K852518)
• AMS IM-77 (U/S US915 and TOCO TD84) (K940898)

Submission Summary (Full Text)

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K050826

## Appendix A Section E - 510 K Summary

# APR 1 0 2006

#### Applicant Information

Applicant Information: Cetro America, Inc. 925 Sherman Avenue Hamden, CT 06514 Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Establishment Registration Number: 3004167720

#### Contact Information:

Maya Cianciolo Cetro America 925 Sherman Avenue Hamden, CT 06514 Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date Prepared: March 14, 2005 Device Name Device Trade Name:

| Cetro America Replacement Device Trade<br>Name | OEM Equivalent Device Name |
|------------------------------------------------|------------------------------------------------------------------|
| TOCO Transducer Model 8032009-04 | HP Toco 1355A for 1350+ Series and more<br>recent model monitors |
| ULTRASONIC Transducer Model 8031012-02 | HP Ultrasound 1356 A for 1350 Series<br>Monitor |
| TOCO Transducer Model 8032010-04 | Corometrics Toco for all model monitors |
| TOCO Transducer Model 8032007-04 | AMS/Spacelabs TD84 for FM Model IM76<br>and AM 66 |
| ULTRASONIC Transducer Model 8031010-02 | AMS/Spacelabs US91 for FM Model 1M76<br>and AM 66 |
| TOCO Transducer Model 8032008-04 | AMS/Spacelabs TD84 for FM Model IM77<br>and AM 67 |
| ULTRASONIC Transducer Model 8031011-02 | AMS/Spacelabs US915 for FM Model IM77<br>and AM 67 |

#### Device Common Name: Transducers for Ultrasonic and Tocodynamometer fetal monitoring

Device Classification: Class II (performance standards) Regulation Description: Perinatal monitoring system and accessories.

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Regulation Numbers: 21 CFR 884.2740 Product Codes: 85 HGM Predicate Device

Predicate Device: These devices are equivalent to the following legally marketed devices:

- Corometrics 174 (U/S 5700 and TOCO 2260) K891595 .
- Corometrics 145 K852076 .
- HP 1356 (U/S 1356A and TOCO 1355A) K900480 .
- . AMS IM-76 (U/S US91 and TOCO TD84) K852518
- AMS IM-77 (U/S US915 and TOCO TD84) K940898 .

#### Device Description

Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.

#### Intended Use

These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity.

| Category | Cetro America | Coro<br>174 | Coro<br>145 | HP<br>1356 | AMS<br>IM-76 | AMS<br>IM-77 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|------------|--------------|--------------|
| Intended Use<br>(Ultrasound) | To detect, measure and record<br>fetal heart rate and the duration<br>and frequency of uterine<br>contractions during labor. | Same | Same | Same | Same | Same |
| Intended Use<br>(Toco) | To detect, measure and record<br>uterine pressure to determine<br>timing of contractions. | Same | Same | Same | Same | Same |
| Target<br>Patient<br>Population | Gravid patients, particularly during<br>labor. | Same | Same | Same | Same | Same |
| Anatomical<br>sites | The ultrasound transducer is<br>placed on the patient's abdomen<br>aimed at the fetal heartbeat. The<br>Toco is placed on the patient's<br>abdomen at the top of the uterus. | Same | Same | Same | Same | Same |
| FHR Range | As to monitor system specifications | Same | Same | Same | Same | Same |
| Uterine<br>Activity<br>Range | As to monitor system specifications | Same | Same | Same | Same | Same |
| Patient | Reusable | Same | Same | Same | Same | Same |

#### Predicate Comparison (Substantial Equivalence)

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| Use/Reuse | | | | | | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------|------|------|------|------|------|
| Sterility | Non-sterile | Same | Same | Same | Same | Same |
| Patient<br>Attachment | These devices attach to the<br>patient with elastic belts strapped<br>to the patient | Same | Same | Same | Same | Same |
| Cable Length | Eight feet | Same | Same | Same | Same | Same |
| Accessories | Transducer belts and Ultrasonic<br>Gel | Same | Same | Same | Same | Same |
| Connector<br>Design | Transducers are color coded and<br>designed to fit into the<br>appropriate monitoring system. | Same | Same | Same | Same | Same |
| Acoustic<br>Output<br>(Ultrasound<br>Transducer) | <20mW/cm2 average | Same | Same | Same | Same | Same |

| Category | Cetro America | Coro<br>174 | Coro<br>145 | HP<br>1356 | AMS<br>IM-76 | AMS<br>IM-77 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------|-------------|------------------|------------------|------------------|
| Operational<br>Characteristics | Cetro 8031010-02 - Pulsed Doppler<br>Cetro 8031011-02 - Pulsed Doppler<br>Cetro 8031012-02 - Pulsed Doppler | -- | -- | --<br>Same<br>-- | Same<br>--<br>-- | --<br>Same<br>-- |
| Specifications<br>(U/S Center<br>Frequency) | Cetro 8031010-02 - 1.536 MHz<br>Cetro 8031011-02 - 1.024 MHz<br>Cetro 8031012-02 - 0.9984 MHz | -- | -- | --<br>--<br>Same | Same<br>--<br>-- | --<br>Same<br>-- |

## Conclusion:

Bench testing demonstrates that the devices perform as intended.

The company declares conformity to consensus performance standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2006

Ms. Maya Cianciolo Official Correspondent Cetro America 9025 Sherman Avenue HAMDEN CT 06514

Re: K050826

Trade Name: Transducers for Ultrasonic and Tocodynamometer Fetal Monitor Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: March 22, 2006 Received: March 22, 2006

Dear Ms. Cianciolo:

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 Amendments, or to devices 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 requirements 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 Transducers for Ultrasonic & Tocodynamometer Fetal Monitoring, as described in your premarket notification:

### Transducer Model Number

TOCO Transducer Model 8032009-04 ULTRASONIC Transducer Model 8031012-02 TOCO Transducer Model 8032010-04 TOCO Transducer Model 8032007-04 ULTRASONIC Transducer Model 8031010-02 TOCO Transducer Model 8032008-04 ULTRASONIC Transducer Model 8031011-02

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#### Page 2 - Ms. Maya Cianciolo

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 (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 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 Ms. Michelle Byrne at [phone].

Sincerely yours.

Daniel le. Lyman

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

- Maps

, "-

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## Section D - Indications for Use

Device Name: Cetro America...

TOCO Transducer Model 8032009-04 ULTRASONIC Transducer Model 8031012-02 TOCO Transducer Model 8032010-04 TOCO Transducer Model 8032007-04 ULTRASONIC Transducer Model 8031010-02 TOCO Transducer Model 8032008-04 ULTRASONIC Transducer Model 8031011-02

Indications for Use: These devices are replacement accessories for the original inalCallons.for oso. These thansducers and are intended to obtain signals to manifor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor. Please refer to the chart below for appropriate replacement pairings:

| Cetro America Replacement Device Name | OEM Equivalent Device Name |
|----------------------------------------|---------------------------------------------------------------|
| TOCO Transducer Model 8032009-04 | HP Toco 1355A for 1350+ Series and more recent model monitors |
| ULTRASONIC Transducer Model 8031012-02 | HP Ultrasound 1356 A for 1350 Series Monitor |
| TOCO Transducer Model 8032010-04 | Corometrics Toco for all model monitors |
| TOCO Transducer Model 8032007-04 | AMS/Spacelabs TD84 for FM Model IM76<br>and AM 66 |
| ULTRASONIC Transducer Model 8031010-02 | AMS/Spacelabs US91 for FM Model IM76<br>and AM 66 |
| TOCO Transducer Model 8032008-04 | AMS/Spacelabs TD84 for FM Model IM77<br>and AM 67 |
| ULTRASONIC Transducer Model 8031011-02 | AMS/Spacelabs US915 for FM Model IM77<br>and AM 67 |

David de Segura

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

*Prescription Use*