TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

K992811 · Epic Medical Equipment Services, Inc. · HFM · Jan 18, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K992811
• Device Name: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
• Applicant: Epic Medical Equipment Services, Inc.
• Product Code: HFM · Obstetrics/Gynecology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.2720
• Device Class: Class 2

Intended Use

These devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rate and uterine contractions.

Device Story

Epic ultrasound and tocodynamometer transducers serve as replacement accessories for Corometrics and Hewlett Packard fetal monitors. Ultrasound transducers utilize Doppler shift technology (pulsed or continuous) to detect fetal heart rate; tocodynamometer transducers utilize strain gauge technology to detect uterine activity. Devices are placed on the maternal abdomen and secured with elastic straps. Output is transmitted to the host monitor for clinical evaluation of fetal status during labor. Intended for use in clinical settings by healthcare professionals. Benefits include providing compatible replacement hardware for existing monitoring systems to facilitate continuous fetal and uterine assessment.

Clinical Evidence

Bench testing only. Acoustic output testing confirmed levels < 20mW/cm2 average. Conformity to consensus standards for electrical, mechanical, and thermal safety and biocompatibility was declared.

Technological Characteristics

Ultrasound transducers use pulsed or continuous Doppler shift technology; tocodynamometer transducers use strain gauge technology. Center frequencies range from 1.0 MHz to 2.3 MHz depending on model. Devices are non-sterile, reusable, and connect via color-coded, keyed connectors to host monitors. Accessories include transducer belts and ultrasonic gel. Cable length is 8 feet.

Indications for Use

Indicated for use as replacement accessories for Corometrics and Hewlett Packard monitors to measure fetal heart rate and uterine contractions in gravid patients, especially during labor.

Regulatory Classification

Identification

An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

Predicate Devices

• Corometrics Models FM (US & TOCO) 115 (5600 & 2260) (K843385)
• Corometrics Models FM (US & TOCO) 116 (5700 & 2260) (K891595)
• Corometrics Models FM (US & TOCO) 118 (5700 & 2260) (K934959)
• Corometrics Models FM (US & TOCO) 120 (5700 & 2260) (K964770)
• Hewlett Packard Models 8040 (15245 & 15248) (510(k) unknown)
• Hewlett Packard Models 1350 (1356 & 1355) (K900480)

Submission Summary (Full Text)

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K992811. page 1/2

Providing Solutions Through Innovation and Creativity

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Appendix C Page 1 of 2

510(k) Summary

## Submitter Information:

Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074

#### Contact:

Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: [phone] Fax: [phone]

## Date Prepared:

August 17, 1999

#### Product Name:

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

#### Predicate Device:

These devices are equivalent to the following legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) - K843385 116 (5700 & 2260) - K891595 118 (5700 & 2260) - K934959 120 (5700 & 2260) - K964770

Hewlett Packard Models 8040 (15245 & 15248) - 510(k) unknown 1350 (1356 & 1355) - K900480

#### Description:

Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.

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2/2 sage 19928

> Appendix C Page 2 of 2

# Intended Use:

These devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rate and uterine contractions.

| | Epic | Corometrics | Hewlett Packard |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------|
| Intended use | Measure fetal heart rate and uterine<br>contractions in the gravid patient. | Same | Same |
| Anatomical<br>sites | The ultrasound transducer is placed on the<br>maternal abdomen aimed at the fetal heart and<br>the toco transducer is placed on the maternal<br>abdomen over the fundal area of the uterus. | Same | Same |
| Target patient<br>population | Gravid patients, especially during labor | Same | Same |
| FHR Range | Dependent upon monitor specifications | Same | Same |
| Uterine<br>Activity Range | Dependent upon monitor specifications | Same | Same |
| Patient<br>use/reuse | Reusable | Same | Same |
| Sterility | Non-Sterile | Same | Same |
| Description of<br>patient<br>attachment | These devices attach to the patient with elastic<br>straps around the mother. | Same | Same |
| Cable length | 8 feet | Same | Same |
| Accessories | Transducer Belts and Ultrasonic Gel | Same | Same |
| Connector<br>design | Transducer connectors are color- coded and<br>keyed to fit into the appropriate fetal monitors. | Same | Same |
| Acoustic output | < 20mW/cm2 ave. | Same | Same |
| Operational<br>Characteristics | EFU100-20 = Pulsed Doppler<br>EFU200-20 = Pulsed Doppler<br>EFU300-25 = Continuous<br>EFU400-25 = Pulsed Doppler | Coro 5600 =<br>Continuous<br>Coro 5700 =<br>Pulsed Doppler | HP 8040 = Pulsed<br>Doppler<br>HP 1356 = Pulsed<br>Doppler |
| Specifications<br>(Ultrasound<br>Center<br>Frequency) | Epic EFU100-20 = 1.0 MHz<br>Epic EFU200-20 = 1.0 MHz<br>Epic EFU300-25 = 2.3 MHz<br>Epic EFU400-25 = 1.151 MHz | Corometrics<br>5600 = 2.3 MHz<br>Corometrics<br>5700 = 1.151 MHz | HP 8040 = 1.024<br>MHz<br>HP 1356 = 0.9984<br>MHz |

## Comparison to Predicate Device:

# Performance Data & Conclusions:

- Acoustic output testing shows < 20mW/cm2 avg. ●
- Bench testing demonstrates that the devices perform as intended. ◆
- The company has declared conformity to consensus standards relating to ● Electrical/Mechanical/Thermal Safety and Biocompatibility.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

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JAN 1 8 2000

Ms. Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Epic Medical Equipment Services, Inc. 1800 10th Street, Suite 300 Plano, TX 75074

Re: K992811

Transducers for Ultrasound and Tocodynamometer Fetal Monitoring Dated: November 16, 1999 Received: November 29, 1999 Requiatory Class: II 21 CFR §884.2720/Procode: 85 HFM 21 CFR §884.2660/Procode: 85 HEL

Dear Ms. Oakes:

We have reviewed your Section 510(k) 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Indications For Use

0 7 510(k) # ਸੀ। Device Name: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

Indications for Use:

These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Required information relating to ultrasound transducer indications for use is attached.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

David h. Segerson

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