TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834

K040819 · American I.V. Products, Inc. · HGM · Aug 16, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040819
• Device Name: TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
• Applicant: American I.V. Products, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.

Device Story

Ultrasound and tocodynamometer transducers function as replacement accessories for Corometrics and Hewlett Packard fetal monitors. Ultrasound transducers utilize pulsed Doppler shift technology to detect fetal heart rate; tocodynamometer transducers measure uterine contractions. Devices attach to maternal abdomen via elastic straps. Operated by clinicians in clinical settings. Output is processed by the host fetal monitor to provide real-time fetal heart rate and uterine activity data, assisting clinicians in monitoring fetal well-being during labor.

Clinical Evidence

Bench testing only. Acoustic output testing confirmed power levels <20mW/cm2 average. Biocompatibility testing performed per consensus standards. No clinical data provided.

Technological Characteristics

Pulsed Doppler ultrasound transducers; center frequencies 1.0 MHz or 1.151 MHz. Acoustic output <20mW/cm2. Non-sterile. Reusable. Connectors are color-coded and keyed for specific fetal monitors. Materials conform to biocompatibility standards.

Indications for Use

Indicated for gravid patients, especially during labor, for fetal heart rate monitoring using ultrasound transducers.

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 Models 5700LAX (Ultrasound) (K982651)

Submission Summary (Full Text)

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AUG 1 6 2004

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K040819

Appendix C Page 1 of 2

510(k) Summary

### Submitter Information:

American IV Products, Inc. 7485 Shipley Avenue Hanover, MD 21076

### Contact:

Gregory Falk Engineering Manager Telephone: [phone] ext. 131 Fax:: [phone] e-mail: [e-mail]

#### Date Prepared:

March 26, 2004

#### Product Name:

Classification Name: Perinatal Monitoring System Accessories Common Name: Transducers for ultrasound fetal monitoring Proprietary Name: Transducers for ultrasound fetal monitoring

#### Predicate Device:

These AIV devices are equivalent to the following legally marketed devices: Corometrics Models 5700LAX (Ultrasound) K982651

#### Description:

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

The US transducers are used to detect the fetal heart rate using Doppier shift technology. These transducers are intended to be a direct replacement for the Corometrics transducers.

#### Intended Use:

These devices are intended to be used as replacement transducer accessories for Corometrics monitors, for use in measuring fetal heart rates.

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Kujira 10x

| | AIV | Corometrics |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended Use | Measure fetal heart rate and uterine<br>contractions in the gravid patient. | Same |
| Anatomical Sites | The ultrasound transducer is placed on<br>the maternal abdomen aimed at the fetal<br>heart; the TOCO transducer is placed on<br>the maternal abdomen over the fundal<br>area of the uterus. | Same |
| Target Patient<br>Population | Gravid patients, especially during labor. | Same |
| FHR Range | Dependent upon monitor specifications. | Same |
| Uterine Activity<br>Range | Dependent upon monitor specifications. | Same |
| Patient Use/Reuse | Reusable. | Same |
| Sterility | Non-sterile | Same |
| Description of<br>Patient Attachment | These devices attach to the gravid patient<br>with elastic straps around the waist. | Same |
| Cable Length | 10 feet | |
| Accessories | Transducer belts and ultrasonic gel | Same |
| Connector Design | Transducer cable connectors are color-<br>coded and keyed to fit the appropriate<br>fetal monitors. | Same |
| Acoustic Output | <20mW/cm2 average | Same |
| Operational<br>Characteristics | AIV FM10833 = Pulsed Doppler<br>AIV FM10834 = Pulsed Doppler<br>AIV FM10835 = Pulsed Doppler | 5700LAX =<br>Pulsed Doppler |
| Specifications<br>(Ultrasound Center<br>Frequency) | AIV FM10833 = 1.151 MHz<br>AIV FM10834 = 1.151 MHz<br>AIV FM10835 = 1.0 MHz | 5700LAX =<br>1.151 MHz |

## Comparison to Predicate Device:

## Performance Data and Conclusions:

- Acoustic output testing shows power is less than 20mW/cm² average. .
- AIV assembly design is equivalent to predicate device assembly design. .
- Al v assembly design is oquivalent to producted by devices perform as intended and are equivalent . to predicate device assemblies.
- to prodiouts do not accembility.
AIV plastics have conformed to consensus standards relating to Biocompatibility. .
- These devices do not raise new issues of safety and effectiveness, nor do they alter the . fundamental technology of the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/3 description: The image shows the date August 16, 2004. The text is in a simple, bold font. The date is written in the format of month, day, and year. The text is black and the background is white.

Mr. Gregory Falk Engineering Manager American IV Products, Inc. 7485 Shipley Avenue HANOVER MD 21076

Rc: K040819

Trade/Device Name: Transducers for Ultrasound Fetal Monitoring Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories

Regulatory Class: II Product Code: 85 HGM Dated: July 9, 2004 Received: July 12, 2004

Dear Mr. Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section - 10(t) production is substantially equivalent (for the indications ferenced above and nave decemblied the enclosed devices marketed in interstate for use stated in the encrosure) to tegars mannel date of the Medical Device Americal Developments, or to commerce prof to May 26, 1970, the cliaving with the provisions of the Federal Food, DNA devices that have been recalismed in accordance approval of a premarket approval application (PMA). and Cosmelle Act (Ret) that do not require approvince the general controls provisions of the Act. The Y ou may, therefore, market the device, backed requirements for annual registration, listing of general controls provisions of the received in the readulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (SCC above) into elthir elass regulations affecting your device can
may be subject to such additional controls. Existing major regulations of th may be subject to such additional ochironal ons. Little 21, Parts 800 to 898. In addition, FDA may be found in the Code of I outstal reg.
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 experience that FIFA has made a decermination that your as receed by other Federal agencies. You must comply of CEP Part of any regeral statutes and regulations and limited to: registration and listing (2) CFR Part with an the Act STEquirements, including, cartice requirements as set forth in the 807), labeling (21 C.FR Part 820), 5000, and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820), and if applicable, 1980, 1958, quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin manteang your device of your device to a legally premarket notification. The PDA instification 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 If you desire specific advice for your de tot to to to to to to to the regulation number at the top of the letter:

| 8xx.1xxx | | [phone] |
|----------------------------------|--|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | | [phone] |
| Other | | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions 01) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphanos at (21CFR Part 807.97) you may obtain. Other general of Yelector to premarked notified in the Act may be obtained from the Division of Small information on your responsibility of the many Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

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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# Indications for Use

K040819 510(k) Number (if known):

Transducers for Ultrasound Fetal Monitoring Device Name:

Indications For Use:

These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.

AIV Transducer Model Numbers: FM10833 and FM10834. These devices are direct replacements for the Corometric's 5700LAX.

Intended for use with Corometrics Fetal monitor models: 116,118,120 Series,150,151,155 and 340

Required information for the ultrasound transducers, relating to their indications for use, is attached.

Prescription Use (Part 21 CFR 801 Subpart D) ADDIOR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel h. Lyman

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

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