(89 days)
a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births.
The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter's amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac.
The provided K961424 document, dated July 10, 1996, is a SMDA 510(k) Summary for a medical device. This type of document is a pre-market notification to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.
It's crucial to understand that this document does not describe a study involving algorithms, AI, or advanced statistical analysis as typically seen in modern device submissions for AI/ML-enabled devices. Instead, it's concerned with showing substantial equivalence to a previously cleared device for a relatively simple medical instrument. Therefore, many of the requested categories related to acceptance criteria, AI performance, and AI-specific study details are not applicable to this 1996 submission.
Here's an attempt to address the requested information based on the content of the document, highlighting where information is not present or not relevant to this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Intended Use | Monitoring frequency & duration of contractions during labor and delivery, visualization of fluid sample. | "A sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in "high risk" births. Intran-500 adds a molded clear plastic cylinder component which is attached to the catheter's amnio port, along with a plastic clip containing a color reference scale that fits over the plastic cylinder. The cylinder acts as a section in the liquid line that can be used by physicians for visualization of the color of a fluid sample drawn from the amniotic sac." |
| Functional Equivalence to Predicate | Must be "functionally identical" to Intran-400 (Intran Plus) regarding intrauterine pressure monitoring and amnio port function. | "Both the Intran-500 and predicate Intran-400 devices are functionally identical and both have Amnio Ports that allow direct communication into the amniotic sac." |
| Material Equivalence to Predicate | Materials contacting the patient must be identical to those in the predicate. | "Materials used in the Intran 500 that contact the patient are identical to materials used in the Intran-Plus." |
| Safety (Historical) | No product liability lawsuits from predicate's use. | "The safety of Intran Plus can be inferred directly from the fact that there have been no product liability lawsuits resulting from its use in an inherently risky procedure conducted by the most sued class of physicians in the U.S. in over 1.4 million uses since product introduction in 1991." |
| Biocompatibility & Sterilization | Information must be available. | "Biocompatibility and sterilization information is available from UMP upon request." (Implies meeting standards, not providing specific data in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for substantial equivalence of a physical medical device, not an AI/ML algorithm or a complex diagnostic test requiring a "test set" in the computational sense. The "safety" claim uses retrospective market data on the predicate device.
- Data Provenance: The safety claim refers to "over 1.4 million uses" of the predicate device since 1991, presumably in the U.S. market since it mentions "physicians in the U.S."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth needed for a "test set" in this context. The "safety" claim relies on the absence of product liability lawsuits during the real-world use of the predicate device, which isn't a "ground truth" establishment in the typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No "test set" or adjudication method described for this type of device submission.
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
- No. This device is a passive monitoring catheter; it does not involve "readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. There is no algorithm or AI component to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The primary "evidence" for substantial equivalence and safety relies on:
- Functional comparison to a predicate device itself (no "ground truth" beyond design specifications).
- Material comparison to a predicate device.
- Real-world outcomes data (absence of product liability lawsuits) for the predicate device, which serves as a proxy for safety validation rather than a formally established "ground truth" in clinical trials.
8. The sample size for the training set
- Not Applicable. No training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an AI/ML algorithm.
§ 884.2700 Intrauterine pressure monitor and accessories.
(a)
Identification. An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).