COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER

K982651 · Corometrics Medical Systems, Inc. · HEL · Dec 11, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K982651
• Device Name: COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
• Applicant: Corometrics Medical Systems, Inc.
• Product Code: HEL · Obstetrics/Gynecology
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.

Device Story

Non-invasive transducers for fetal monitoring; Model 5700 detects fetal heart rate via pulsed Doppler ultrasound; Model 2264 detects uterine activity (Toco). Designed as watertight accessories for Corometrics Fetal/Maternal monitors. Used in clinical settings, including water-immersion labor environments. When used in water, transducers connect to telemetry systems to ensure electrical safety (avoiding direct connection to AC-powered monitors). Output signals are processed by the monitor to provide real-time fetal heart rate and uterine contraction data; assists clinicians in assessing fetal well-being during labor and delivery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Watertight transducers for fetal/maternal monitoring. Model 5700 uses pulsed Doppler ultrasound (9 crystals). Model 2264 uses Toco sensing for uterine activity. Designed for water and non-water environments. Connectivity: Direct connection to Fetal/Maternal monitors or telemetry systems.

Indications for Use

Indicated for fetal heart rate detection (Model 5700) and uterine activity detection (Model 2264) in pregnant patients. Intended for use in both water and non-water environments; when used in water, must be connected to telemetry systems, not AC-powered monitors.

Regulatory Classification

Identification

A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Predicate Devices

• Model 5700 US Transducer (k891595)
• M1356A US Watertight Transducer (K942887)
• Model 2260 Toco Transducer (k891595)
• M1355A Toco Watertight Transducer (k942887)

Submission Summary (Full Text)

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182651 510(k)

17

DEC 1 1 1998

## 510(k) SUMMARY: Corometrics Model 5700 and 2264 Watertight Transducer

Prepared: 7/29/98

#### [ 807.92(a)1 ] Contact Information

Richard J. Cehovsky Regulatory Affairs Manager

- Address: Corometrics Medical Systems 61 Barnes Park Road North Wallingford, CT 06492
Phone: [phone] Fax:

#### [ 807.92(a)2 ] Device Name and Classification

The proprietary names of the devices to be introduced into interstate commerce are the Corometrics Model 5700 & 2264 Series Watertight Transducers. Common name includes: Ultrasound and Tokodynamometer Transducer.

Current classifications that applies to these devices are: 21 CFR part 888.2720 -"External Uterine Contraction Monitor and Accessories," Class II; and 21 CFR part 888.2740 "Perinatal Monitoring System and Accessories," Class II.

## [ 807.92(a)3 ] Identification of Legally Marketed Equivalent Devices (Predicate Systems).

| Predicate System | Manufacturer | K Number | Class |
|---------------------------------------|--------------------------------------|----------|-------|
| Model 5700 US<br>Transducer | Corometrics Medical<br>Systems, Inc. | k891595 | II |
| M1356A US<br>Watertight<br>Transducer | Hewlett Packard | K942887 | II |

| Predicate System | Manufacturer | K Number | Class |
|-----------------------------------------|--------------------------------------|----------|-------|
| Model 2260 Toco<br>Transducer | Corometrics Medical<br>Systems, Inc. | k891595 | II |
| M1355A Toco<br>Watertight<br>Transducer | Hewlett Packard | k942887 | II |

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510(k)

#### 510(k) SUMMARY Continued:

#### | 807.92(a)4 & 807.92(a)5 ] Device Description & Intended Use

The Model 5700 and 2264 Series Non-Invasive Watertight Transducers are intended as accessories to Corometrics' Fetal and Fetal/Maternal Monitors. The Model 5700 Series Transducer provides for the detection of fetal heart rate and the Model 2264 Series Transducer provides for the detection of uterine activity.

#### [ 807.92(a)6 ] Predicate Device Comparison of Technological Characteristics

| Mode | Model 5700 US | Model 5700 Watertight US | HP M1356A Watertight US |
|--------------------------------------|---------------|--------------------------|-------------------------|
| Indications for Use | FHR | FHR | FHR |
| Watertight | No | Yes | Yes |
| Pulsed Doppler | Yes | Yes | Yes |
| No. of Crystals | 9 | 9 | 7 |
| Water Environment<br>Application Use | No | Yes | Yes |

FHR: Fetal Heart Rate

| Mode | Model 2260<br>Toco | Model 2264<br>Watertight<br>Toco | HP M1355A<br>Watertight<br>Toco |
|--------------------------------------|--------------------|----------------------------------|---------------------------------|
| Indications for Use | UA | UA | UA |
| Watertight | No | Yes | Yes |
| Water Environment<br>Application Use | No | Yes | Yes |

UA: Uterine Activity

# [ 807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug Cosmetic Act

To date, the Food and Drug Administration have promulgated no performance standards relating to accessories of this type.

## [ 807.92(d) ] Additional Information

The Corometrics Model 5700 and 2264 Series Watertight Transducers have been extensively tested to meet their requirements and design.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, with three overlapping faces suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.

DEC 1 1 1998

Richard Cehovsky Manager, Regulatory Affairs Corometrics Medical Systems, Inc. 61 Barnes Park Road North P.O. Box 333 Wallingford, CN 06492

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K982651 Corometrics Model 5700 and 2264 Watertight Transducer Dated: November 5, 1998 Received: November 6, 1998 Regulatory Class: II 21 CFR 884.2660/Procode: 85 HEL 21 CFR 884.2720/Procode: 85 HFM

Dear Mr. Cehovsky:

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 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 (OS) for Medical Devices: General regulation (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 Pat 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 your

Lillian Yin, Ph.D.
Director, Division of Reproductive

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 5700 & 2264 Series Watertight Transducer

Indications for Use:

Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.

* To be assigned by FDA upon receipt of 510(k) submission.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i OR Over the Counter Use (Per 21 CFR 801.19) Optional Format 1-2-96 (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 000022 510(k) Number.