Search Results
Found 1 results
510(k) Data Aggregation
(43 days)
FOLEY CATHETERS WITH TEMPERATURE PROBE
Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244):
The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days.
The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to temperature probes usage. The device is indicated for use by qualified medical personnel only.
Disposable Foley catheters with temperature probe are used for drainage of the urinary bladder and simultaneous patient temperature measurement. These Foley catheters with temperature probe consist of the "Molex" plug connector on the adapter cable end, urine output flow path with a balloon and a thermistor inside the catheter. These probes are to be used with 400-series compatible temperature measurement systems only. The temperature probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These catheters have a skin and core contact with a patient. Catheters are shipped in sterile condition and there is a shelf life declared for each manufacturing batch. These Foley catheters with temperature probe can be used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175). Products are packed inside a cardboard box having 25 pcs of individually packed products (inside a plastic/ paper pouch) in sterile condition. The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution "Rx Only (USA). U.S. Federal law restricts this device to sale by or on the order of a physician." There is one instruction for use insert in the sales package of 25 probes.
The provided document is a 510(k) Premarket Notification for Foley catheters with temperature probes. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy for a diagnostic AI device.
Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type, training set sample size, how training ground truth was established) are not applicable or not provided in this type of submission.
This submission is for a physical medical device (catheter with a temperature sensor), not an AI/ML-driven diagnostic or prognostic device that would typically involve the detailed performance studies you're asking about. The "study" mentioned here refers to verification and validation activities against recognized standards to ensure the device performs as intended and is safe.
Here's what can be extracted and inferred from the document based on the context of a 510(k) submission for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific performance acceptance criteria (like diagnostic accuracy, sensitivity, specificity) with reported device performance for an AI/ML system. Instead, for this device, "acceptance criteria" are related to compliance with recognized standards and demonstrating substantial equivalence.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Conclusion |
|---|---|---|
| General Safety | IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (General requirements for safety) | "The devices have been thoroughly tested through validation and verification of specifications." |
| "No new questions of safety." | ||
| Patient Monitoring Safety | IEC 60601-2-49:2001 (Particular requirements for the safety of multifunction patient monitoring equipment) | "The devices have been thoroughly tested through validation and verification of specifications." |
| "No new questions of safety." | ||
| Material Biocompatibility | ISO 10993-x Biological evaluation of medical devices | Implied compliance through "thorough validation and verification." |
| "No new questions of safety." | ||
| Risk Management | ISO 14971:2000 Medical devices Application of risk management to medical devices | Implied compliance through "thorough validation and verification." |
| "No new questions of safety." | ||
| Sterility | 510(k) Sterility Review Guidance K90-1 | Devices are "shipped in sterile condition" and implied compliance through "thorough validation and verification." |
| Labeling | ISO 15223:2000, EN 980+A1+A2 (Symbols, Graphical symbols), 21 CFR Part 801 (Labeling) | Compliance with labeling standards is mentioned (e.g., "The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution 'Rx Only (USA). U.S. Federal law restricts this device to sale by or on the order of a physician.'"). Minor differences in "Labeling, artwork and a different wording of the instruction for use insert" compared to predicate are noted but determined not to affect substantial equivalence. |
| Accuracy (Temperature) | Implied by "400-series compatible temperature measurement systems" and comparison to predicate device. | The document states the thermistor is identical to the predicate device, implying similar performance. No specific temperature accuracy values are provided in this summary, but these would typically be tested against an internal specification during V&V. |
| Substantial Equivalence | Comparison to predicate device (DeRoyal disposable Foley catheters with temperature sensor (K041416)) | "Substantially equivalent in safety and effectiveness" to the predicate device. Identical features: "Thermistor, materials, cable surface, catheter and catheter material, plug interface and product dimensions." |
2. Sample size used for the test set and the data provenance
This document does not describe a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to verification and validation activities conducted on the physical device to ensure compliance with standards and specifications. Therefore, sample sizes and data provenance (country, retrospective/prospective) are not applicable in the AI/ML sense but would refer to engineering test samples and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to an AI/ML diagnostic device, not a physical temperature-sensing Foley catheter. The "ground truth" here would be established by reference temperature measurement standards and calibrated equipment during engineering verification.
4. Adjudication method for the test set
Not applicable. As above, this is for AI/ML diagnostic performance testing.
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. This device is a physical catheter with a temperature sensor, not an AI/ML system that directly assists human readers/diagnosticians.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical catheter, not an algorithm. Its "standalone" performance would be measured as part of its physical and electrical testing (e.g., temperature accuracy, material integrity).
7. The type of ground truth used
For the temperature sensing function, the "ground truth" for proving accuracy would be established using calibrated reference thermometers and temperature control baths. For the catheter's physical properties, the ground truth would be established through material specifications, mechanical testing standards, and biological compatibility testing protocols.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Ask a specific question about this device
Page 1 of 1