(139 days)
Not Found
No
The document explicitly states that the devices do not alter the fundamental technology of the predicate devices and there is no mention of AI or ML in the description or performance studies.
No.
The device is used to measure fetal heart rate, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.
No
The devices are replacements for transducers that measure fetal heart rate. While these measurements can contribute to a diagnostic assessment, the devices themselves are described as measuring tools, not as providing a diagnosis or diagnostic information. They detect a physiological signal (fetal heart rate) using Doppler shift technology, which is a measurement function.
No
The device description explicitly states that the device is comprised of ultrasound and tocodynamometer transducers, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure fetal heart rate in a gravid patient using ultrasound and tocodynamometry. This is a direct physiological measurement taken from the patient's body.
- Device Description: The device is described as replacement transducers for fetal monitors. These transducers are applied externally to the patient's abdomen.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not process or analyze any biological specimens.
The device is a medical device used for physiological monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended to be used as replacement transducer accessories for Corometrics monitors, for use in measuring fetal heart rates.
Product codes
85 HGM
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
The ultrasound transducer is placed on the maternal abdomen aimed at the fetal heart; the TOCO transducer is placed on the maternal abdomen over the fundal area of the uterus.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
AUG 1 6 2004
Image /page/0/Picture/1 description: The image shows the logo for AIV, which is a company that supports clinical engineering worldwide. The logo consists of a star above the letters "aiv" in a stylized font. Below the logo is the text "Supporting Clinical Engineering Worldwide".
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: 410-787-1300 ext. 131 Fax:: 410-787-1337 e-mail: gfalk@aiv-inc.com
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.
1
Kujira 10x
| AIV | Corometrics | |
|---|---|---|
| Intended Use | Measure fetal heart rate and uterine | |
| contractions in the gravid patient. | Same | |
| Anatomical Sites | The ultrasound transducer is placed on | |
| the maternal abdomen aimed at the fetal | ||
| heart; the TOCO transducer is placed on | ||
| the maternal abdomen over the fundal | ||
| area of the uterus. | Same | |
| Target Patient | ||
| Population | Gravid patients, especially during labor. | Same |
| FHR Range | Dependent upon monitor specifications. | Same |
| Uterine Activity | ||
| Range | Dependent upon monitor specifications. | Same |
| Patient Use/Reuse | Reusable. | Same |
| Sterility | Non-sterile | Same |
| Description of | ||
| Patient Attachment | These devices attach to the gravid patient | |
| 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- | |
| coded and keyed to fit the appropriate | ||
| fetal monitors. | Same | |
| Acoustic Output |