(225 days)
The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.
The device is manufactured in the basic model variations listed below:
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High Resolution Gastrointestinal Catheter with up to 40 pressure sensors:
This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific site of interest. Pressure information is provided at multiple sensor sites. Pressures may be measured continuously, at rest, or dynamically. -
Gastrointestinal catheter, with pH sensors:
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except that this model variation includes up to 7 pH sensors. PH probes are added to allow measurements of pH in the stomach and/or esophagus. -
Gastrointestinal catheter, with sleeve:
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except one or more of the pressure sensor sites will include a sleeve. The sleeve is added to broaden the pressure sensitive one for the sensor site, and reduce positioning sensitivity. -
Gastrointestinal catheter, with impedance rings:
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes up to 14 conductive rings for impedance studies. -
Gastrointestinal catheter, with lumen
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes a lumen.
The Unisensor UniTip Gastrointestinal Pressure Sensor Catheter product line consists of multiple ultra-miniature solid-state pressure sensors, located at the distal end of a gastrointestinal catheter. pH sensors, silicon rubber sleeves, lumen, and conductive impedance rings, may also be included. There are scanning electronics for multiplexing the sensor signals, and an electrical connection located at the proximal end to carry the sensor element signals to an external gastrointestinal motility recording equipment. The UniTip GI catheters are produced in various lengths and catheter sizes.
This modification consists of increasing the maximum number of pressure sensor elements to 40. The closer proximity of the pressure sensor elements to each other allows for high-resolution mapping of pressures within the organs of the human gastrointestinal tract. This modification also increases the maximum number of pH sensors to 7, and the maximum number of impedence rings to 14.
This 510(k) summary explicitly states that no clinical studies were conducted or relied upon to establish substantial equivalence for the Unisensor UniTip High Resolution GI Catheter. Therefore, the device's acceptance criteria and the study proving it meets them cannot be described in terms of a clinical performance study.
Instead, substantial equivalence was established based on bench testing, design comparisons, and adherence to recognized standards, primarily in the areas of biocompatibility and risk management.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical performance study was conducted, direct acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) are not available from this document. The "acceptance criteria" here refer to the demonstration of safety and effectiveness through non-clinical means and similarity to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance/Evidence |
|---|---|
| Biocompatibility | Meets ISO 10993-1: The device's materials and design are evaluated to ensure biological compatibility, adhering to EN 30993-1/ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing." This implies that the device is not expected to cause adverse biological reactions when in contact with the human body. |
| Risk Management | Health hazards eliminated or mitigated: A rigorous risk management program was applied during design to eliminate or mitigate known health hazards associated with device use. This means potential risks (e.g., electrical, mechanical, material-related) were identified and addressed. |
| Functional Equivalence to Predicate Devices | Increased sensor capabilities: The primary modification (increase to 40 pressure sensors, 7 pH sensors, 14 impedance rings) enhances functionality while maintaining the same fundamental principles of operation as the predicate devices (Unisensor AG, UniTip Pressure Sensor Catheter K003580 and Sierra Scientific Instruments, Inc., Motility Visualization System K031169). This suggests the core pressure sensing technology remains equivalent. |
| Intended Use Consistency | Same intended use as predicates: The device's intended use remains consistent with the predicate devices – obtaining high-resolution mapping of peristaltic activity/pressure and pH/impedance within the GI tract. The increased sensor count provides "high-resolution mapping" which is an enhancement to the existing known functionality. |
| Adherence to General Controls & Regulatory Requirements | Compliance with 21 CFR 807.92: The submission is intended to comply with requirements for 510(k) summaries. The FDA's letter confirms substantial equivalence, allowing marketing subject to general controls (e.g., annual registration, GMP, labeling, advertising prohibitions). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical test set data was used or provided in the submission for performance evaluation.
- Data Provenance: Not applicable. No clinical data origin (country, retrospective/prospective) is relevant as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set and thus no ground truth derived from expert consensus were used to establish substantial equivalence.
4. Adjudication method for the test set
- Not applicable. No clinical test set was used for performance evaluation, so no adjudication method was employed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The device is a "Gastrointestinal motility monitoring system" with physical sensors and electronics. It is not an AI-powered diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a sensor catheter system, not a standalone algorithm. Its function is to collect data, which is then interpreted by medical personnel using external recording equipment.
7. The type of ground truth used
- Not applicable for a clinical performance evaluation. The "ground truth" for the device's efficacy is established through its physical function and robust engineering/bench testing validating its ability to accurately measure pressure, pH, and impedance, and its similarity to predicate devices that have established clinical utility. Biocompatibility standards serve as a "ground truth" for safety.
8. The sample size for the training set
- Not applicable. This is a physical sensor device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As no training set was used, no ground truth needed to be established for it.
§ 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).