(86 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard vital sign monitoring.
No.
The device is intended for monitoring purposes (fetal and maternal vital signs) rather than for treating a condition, which is the primary function of a therapeutic device.
No
Explanation: The device is intended for "monitoring" fetal and maternal vital signs. Monitoring collects data but does not necessarily diagnose.
No
The device description and intended use clearly indicate a "Maternal/Fetal Monitor" which is a hardware device used to measure vital signs. The summary does not mention any software-only components or functionality.
Based on the provided information, the 120 Series Maternal/Fetal Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring fetal and maternal vital signs (heart rate, uterine activity, blood pressure, SpO2). This involves directly measuring physiological parameters from the patient.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. The 120 Series does not analyze such specimens.
- Device Description: The description aligns with a patient monitoring device, not a laboratory or diagnostic testing device.
The 120 Series is a patient monitoring device used for real-time assessment of physiological parameters in a clinical setting.
N/A
Intended Use / Indications for Use
The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.
Product codes
Not Found
Device Description
The proprietary name of the modified device to be introduced into interstate commerce is the 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM. As with the predicate Model 118, the 120 Series is a Class II device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/clinical environment
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
The 120 Series has been extensively tested to meet its requirements and design.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(k) SUMMARY: Corometrics 120 Series 9.0
FEB 2 1 1997
Prepared: 26 November 1996
[807.92(a)1] Contact Information
Maria Vitug Fouts Sr. Regulatory Compliance Specialist
Corometrics Medical Systems, Inc. Address: 61 Barnes Park Road North Wallingford, CT 06492
Phone: 203-949-2538 203-284-9465 Fax:
.
[807.92(a)2| Device Name and Classification
The proprietary name of the modified device to be introduced into interstate commerce is the 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM.
As with the predicate Model 118, the 120 Series is a Class II device.
[807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems).
| Predicate System | Manufacturer | k Number |
|---|---|---|
| Model 118 Maternal/ | ||
| Fetal Monitor | Corometrics Medical Systems, Inc. | |
| 61 Barnes Park Road North | ||
| Wallingford, CT 06492 | K934959, clearance | |
| date: 10/15/94 | ||
| Model 556 Critical | ||
| Care Monitor | K911310, clearance | |
| date: 6/10/91 |
[807.92(a)4 & 807.92(a)5] Device Description & Intended Use
The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.
[807.92(a)6] Predicate Device Comparison of Technological Characteristics
| Monitoring Mode | 120 Series | Model 118 | Model 556 |
|---|---|---|---|
| FHR/UA Monitoring | Yes | Yes | Not Applicable |
| Maternal Heart/Pulse Rate, | |||
| NBP, SpO2 Monitoring | Yes | Yes | |
| MECG Waveform | Yes | No | Yes |
1
K964770 D2/2
November 1996
[807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug and Cosmetic Act
To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration.
[807.92(d)] Additional Information
្នែក
The 120 Series has been extensively tested to meet its requirements and design.