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This accessory is used with a Koala Intrauterine Pressure System and is used in priming the catheter.

The pre-filled Syringe is 10 cc syringe filled with 0.9% isotonic saline and is an accessory to the Koala Intrauterine Pressure System used in priming the catheter. This product is a sterile, single-use device.

This submission is for a medical device (pre-filled syringe) and does not involve AI/ML. Acceptance criteria and study details as requested for AI/ML devices are not applicable.

Here's a summary of the information provided in the document:

Device: Pre-filled Syringe for Koala Intrauterine Pressure Catheter

Intended Use: To prime the catheter in an intrauterine pressure monitoring system.

Predicate Devices: Pre-filled syringes used with the Medex MX 4042 Series Intrauterine Pressure Catheter and the Quest (formerly Healthdyne Cardiovascular) ISOFLO Intrauterine Pressure Monitoring & Amnio.

Basis for Substantial Equivalence:

• Same intended uses: Priming catheters in intrauterine pressure monitoring.
• Same basic technological characteristics: A syringe pre-filled with saline.
• Same or similar materials: All materials are biocompatible and function well in the intended application.

Safety and Effectiveness Documentation:

• Safety and effectiveness are similar to existing devices as demonstrated in the laboratory.
• Biocompatibility testing shows that the materials used in the pre-filled syringe are safe for this application.
• Effectiveness is stated to be the same as the predicate devices.

Regulatory Classification: Class II, 21 CFR §884.2700, Product code: 85 HFN.

Note: The document is a 510(k) summary for a relatively simple medical device (a pre-filled syringe). It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and materials, rather than detailed performance metrics or clinical study data typically associated with more complex or AI-driven devices. Therefore, many of the specific questions regarding acceptance criteria and studies (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone performance for AI) are not applicable to this type of submission.

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