(212 days)
Not Found
No
The device description details a purely mechanical and electrical system for measuring pressure changes. There is no mention of software analysis, algorithms, or learning capabilities.
No
The device is used for monitoring the progress of labor by measuring uterine contractions, not for treating a condition or disease.
Yes
The device is designed to measure the duration, frequency, and relative pressure of uterine contractions to monitor the progress of labor, which is a diagnostic purpose.
No
The device description clearly outlines multiple hardware components including a transducer, belt, adapter cable, and various materials like mylar, pressure-sensitive ink, silver traces, ceramic substrate, and an elastomeric button. It is a physical device that measures pressure.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disco™ Uterine Contraction Transducer System measures uterine contractions by being placed on the maternal abdomen. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is to monitor the progress of labor by measuring uterine contractions externally. This is a physiological measurement, not an in vitro diagnostic test.
The device is a medical device, but it falls under a different category than IVDs. It's a device used for physiological monitoring.
N/A
Intended Use / Indications for 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.
Product codes
85HFM
Device Description
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 achesive 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maternal abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed on the proposed product included clinical 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 exterral 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2720 External uterine contraction monitor and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
MAY 22 1996
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
Fredric I. Orkin, President Contact Person:
October 17, 1995 Date Prepared:
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 | Fetal Monitor Model 116 and Accessories | K831852 |
|---|---|---|
| Hewlett Packard | Physiological Pressure Transducer 1290C | |
| (Used with HP fetal Monitor HP8040) | 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 achesive 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 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 overed by this submission is substantially equivalent to other legally marketed uterine contraction transducers.
Copyright 1995, OCG Systems, Inc.
2
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, 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 exterral 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.