DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES

K954847 · Ocg Systems, Inc. · HFM · May 22, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K954847
• Device Name: DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
• Applicant: Ocg Systems, Inc.
• Product Code: HFM · Obstetrics/Gynecology
• Decision Date: May 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2720
• Device Class: Class 2

Intended Use

The Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.

Device Story

External uterine contraction transducer; strapped to maternal abdomen. Input: mechanical pressure from uterine contractions. Principle: pressure-sensitive ink silk-screened on mylar sheet; pressure changes alter electrical resistance; elastomeric button transfers force to transducer. Output: electrical signal transmitted via adapter cable to external fetal monitor (Corometrics or HP) for display/recording. Used in clinical labor/delivery settings; operated by clinicians. Benefits: single-patient use design reduces cross-contamination risk compared to reusable strain-gauge transducers; cost-effective.

Clinical Evidence

Clinical, bench, and electrical safety testing performed. Clinical testing compared Disco™ transducer against internal catheter, external HP transducer, and external Corometrics transducer. Bench testing included comparison against standard gauge and Corometrics transducer, plus linearity and hysteresis testing. Independent laboratory performed EMI and leakage current testing. Device met or exceeded functional requirements with performance virtually identical to marketed products.

Technological Characteristics

Non-sterile, single-patient use external transducer. Components: mylar sheet with silk-screened pressure-sensitive ink, rigid ceramic substrate with conductive silver traces, elastomeric button, insulated wire, RJ-11 connector. Output control switch adjusts signal level for compatibility with Corometrics or HP monitors. Sensing principle: piezoresistive (pressure-sensitive ink).

Indications for Use

Indicated for monitoring labor progress in pregnant patients by measuring uterine contraction duration, frequency, and relative pressure.

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 Fetal Monitor Model 116 (K831852)
• Hewlett Packard Physiological Pressure Transducer 1290C (K840121)

Submission Summary (Full Text)

{0}

K954847
MAY 22 1995

OCG Systems, Inc.
215 Prospect Avenue
Highland Park, Illinois 60035
(708)-266-0034, 0036 FAX

# 510(k) SUMMARY

## Disco™ Uterine Contraction Transducer and Accessories

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

OCG Systems, Inc.
215 Prospect Avenue
Highland Park, Illinois 60035
(708)-266-0034, 0036 FAX

Contact Person: Fredric I. Orkin, President
Date Prepared: October 17, 1995

Name of Device and Name/Address of Sponsor

Disco™ Uterine Contraction Transducer and Accessories
OCG Systems, Inc.
215 Prospect Avenue
Highland Park, Illinois 60035
(708)-266-0034, 0036 FAX

Common or Usual Name: Disco™

Classification Name: External uterine contraction transducer and accessories - 21 CFR 884.2720.
The product code for such devices is 85HFM.

Copyright 1995, OCG Systems, Inc.

{1}

OCG Systems, Inc.
215 Prospect Avenue
Highland Park, Illinois 60035
(708)-266-0034, 0036 FAX

## Predicate Devices:

| Corometrics Hewlett Packard | Fetal Monitor Model 116 and Accessories Physiological Pressure Transducer 1290C (Used with HP fetal Monitor HP8040) | K831852 K840121 |
| --- | --- | --- |

## Intended Use

The Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.

## Technological Characteristics and Substantial Equivalence

The Disco™ Uterine Contraction Transducer System is a non-sterile, single patient use external uterine contraction transducer and accessories. The system consists of a disposable belt with the transducer, an adapter cable with sensitivity switch for use with either Corometrics or Hewlett Packard patient monitor, and the package with appropriate label copy.

The Disco™ Uterine Contraction Transducer System uses a transducer that is placed in contact with the maternal abdomen and the output signal is displayed on a monitor and/or recording device. The transducer is composed of a mylar sheet with a pressure sensitive ink silk screened to its surface. This ink responds to changes in pressure from the foam pad by changing its electrical resistance. A series of conductive silver traces silk screened to a rigid ceramic substrate allow termination and measurement of this changing electrical resistance. A firm, yet flexible rounded elastomeric button is used to transfer the uterine contraction from the patient to the transducer. It is mounted in the center of the transducer and has an adhesive bond to the foam pad at its base. A thin, flexible, stranded, insulated wire is used to connect the transducer to the adapter cable. A two wire RJ-11 male telephone type connector is used as the electrical interface for the transducer. Because the pressure sensitive ink produces a stronger output signal than strain gauge type transducers, the Disco™ Uterine Contraction Transducer System has an output control switch to adjust the level of the output signal.

The Disco™ Uterine Contraction Transducer System covered by this submission is substantially equivalent to other legally marketed uterine contraction transducers.

Copyright 1995, OCG Systems, Inc.

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# OCG Systems, Inc.
215 Prospect Avenue
Highland Park, Illinois 60035
(708)-266-0034, 0036 FAX

Specifically, this Disco™ Uterine Contraction Transducer is substantially equivalent to the Corometrics and the HP uterine contraction transducers. The Disco™ Uterine Contraction Transducer System has the same general intended use, similar principals of operation, and similar technological characteristics as the previously cleared referenced predicate device. Although there are minor differences in the characteristics of the Disco™ Uterine Contraction Transducer System and the referenced predicate device, those differences do not raise new questions of safety or efficacy.

The Disco™ Uterine Contraction Transducer System uses pressure sensitive ink technology rather than strain gauge transducer technology used by the predicate devices. In contrast to the strain gauge type transducer, the pressure sensitive ink technology has no moving parts. Also the Disco™ Uterine Contraction Transducer is intended for a single patient use only, whereas predicate uterine contraction monitors use a significantly more expensive transducer system and are routinely used on multiple patients, posing a potential risk of cross-contamination if they are not cleaned properly. The minor differences between the Disco™ Uterine Contraction Transducer System and the referenced predicate devices, raise no new questions of safety and effectiveness and are simply provided for customer convenience and cost savings.

## Performance Data

Testing performed on the proposed product included clinical testing, bench testing, and electrical safety testing. In the clinical tests conducted the Disco™ transducer was compared to an internal catheter, to an external HP transducer, and to an external Corometrics transducer. In the bench tests conducted, the Disco™ Transducer was tested against a standard gauge, and against and external Corometrics transducer. A linearity and a hysteresis test was also performed. Finally, an independent laboratory tested the Disco™ transducer for EMI and leakage current. In all instances the proposed device met or exceeded all functional requirements and had virtually identical performance to marketed products.

Copyright 1995, OCG Systems, Inc.