(109 days)
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No
The description focuses on data recording, display, and basic analysis of pH and pressure data. There is no mention of AI, ML, or advanced analytical techniques that would typically involve these technologies.
No.
The device is used for recording, display, and analysis of physiological data to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides information that aids in the diagnosis and management of motility disorders." This indicates its role in identifying or characterizing a medical condition.
No
The device description explicitly states it is comprised of a "recorder" and "plug-in parameter modules" which are hardware components used for data collection. While it includes software for display and analysis, it is not solely software.
Based on the provided information, the FLEXILOG 3000 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The FLEXILOG 3000 system is used to record, display, and analyze data directly from the upper gastrointestinal tract in ambulant subjects. It is a device that interacts with the patient's body to collect physiological data.
- The intended use describes the device as aiding in the diagnosis and management of motility disorders. While this is a diagnostic purpose, it is achieved through the measurement of physiological parameters in vivo, not through the analysis of in vitro specimens like blood, urine, or tissue samples.
The FLEXILOG 3000 is a physiological monitoring and diagnostic device used for in vivo measurements.
N/A
Intended Use / Indications for Use
The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.
Product codes
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Device Description
The FLEXILOG 3000 system is a multi channel, multi parameter, ambulatory recording system with stationary capability. It is comprised of a recorder that supports data collection on up to 24 channels. The data collected is determined by up to 5 plug-in parameter modules. At present only pH (4 channel) and pressure (3 channel) modules are available. Multiple modules of the parameters can be installed to give the required number of channels. In ambulatory mode, data is saved onto a PCMCIA card and subsequently uploaded to the computer. In stationary mode, data is transferred via a patient isolated RS232 outlet to the computers serial port. The signals, recorded or online, are displayed on the computer VDU via a Microsoft Windows based program, FLEXISOFT III. FLEXISOFT III provides display, analysis and report generation options. The FLEXILOG 3000 is compatible with pressure and pH catheters currently approved for sale in the U.S.A. and manufactured and marketed by third parties.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper gastrointestinal tract
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
P102
Oakfield Instruments Limited, Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, WITNEY Oxfordshire, OX8 1JA, United Kingdom.
MAR - 4 1997
(+44) 1865 882532 TEL: (+44) 1865 883970 FAX:
John Giddings, Sales & Marketing Manager
28th October 1996
FLEXILOG 3000 Trade Name:
Multi Channel, Multi Parameter Recording System Common Name:
Classification Name:
Substantial equivalence is claimed to the following devices:
| Sandhill Medical Inc
8955 South Ridgeline Blvd #500
Highlands Ranch
| CO 80126, U.S.A. | Superlogger |
|---|---|
| Synectics Medical Inc | |
| 1425 Greenway Drive | |
| Irving | |
| TX 75038, U.S.A. | MicroDigitrapper |
Medical Measurement Systems PO Box 40178 7504 RD Enschede THE NETHERLANDS
UPS-2020
Description 1.
The FLEXILOG 3000 system is a multi channel, multi parameter, ambulatory recording It is comprised of a recorder that supports data system with stationary capability. collection on up to 24 channels. The data collected is determined by up to 5 plug-in parameter modules. At present only pH (4 channel) and pressure (3 channel) modules are available. Multiple modules of the parameters can be installed to give the required number of channels.
In ambulatory mode, data is saved onto a PCMCIA card and subsequently uploaded to the computer. In stationary mode, data is transferred via a patient isolated RS232 outlet to the computers serial port. The signals, recorded or online, are displayed on the computer VDU via a Microsoft Windows based program, FLEXISOFT III.
FLEXISOFT III provides display, analysis and report generation options.
The FLEXILOG 3000 is compatible with pressure and pH catheters currently approved for sale in the U.S.A. and manufactured and marketed by third parties.
트
1
510(k) SUMMARY
1964589 P2-12
2. Indications for use
The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.
Technology Characteristics 3.
The FLEXILOG 3000 is similar to the predicate devices having both ambulatory and stationary capability; being multi channel and recording both pH and pressure data. The system differs in that the parameter electronics are modular and data is saved to a PCMCIA memory card.
Control display and analysis software are Microsoft Windows based.
ing System
14589
17-4