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1. Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management.
2. Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump.
3. Freedom™is a single use only device.
4. Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment.
5. Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery.
6. Freedom™is not intended for use with chemotherapy drugs.
7. Freedom™is not intended for use with blood, blood products, or TPN.

The Freedom™ Infusion System pump will conform to the AMMI Draft Infusion Device Standard. The intended use of the Freedom™ Infusion System is identical to the legally marketed PainBuster system.

The provided document is a 510(k) premarket notification for the Freedom™ Infusion System. It indicates that the device is substantially equivalent to a legally marketed predicate device (PainBuster system). However, the document does not contain the detailed information requested to describe specific acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML powered device.

The document discusses:

• Standards and Intended Use: The device will conform to the AAMI Draft Infusion Device Standard, and its intended use is identical to the legally marketed PainBuster system.
• Manufacturing and Testing Procedures: Mentions Class 10,000 clean room manufacturing, 100% testing of silicone balloons to 110±5 mmHg (clinical operating pressure ~70 mmHg), and traceability.
• Prior In-Vitro Tests and Clinical Experience: References FDA file numbers (K930404, K941766, K955849) for burst testing, flow rate, flow profile, and accuracy bench tests. It also mentions clinical experience with DIB pumps for obstetrical analgesia, post-operative pain, chronic pain, and intravenous infusions in the USA.

Therefore, based on the provided text, I cannot complete the requested table and answer the specific numbered questions concerning acceptance criteria and a study proving the device meets those criteria, as the document does not contain the necessary information.

Here's why and what's missing:

• Acceptance Criteria Table: The document states conformity to an AAMI Draft Infusion Device Standard and internal pressure testing for balloons. However, it does not quantify specific performance metrics as acceptance criteria (e.g., accuracy +/- X%, error rate

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The intended use of the DIB Infusor is similar to that of other legally marketed elastomeric infusion pumps.

The DIB Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon.

It is not possible to extract the requested information from the provided text. The document "K955849" describes a medical device called the "DIB Infusor" and its intended use, manufacturing, and prior testing/clinical experience. However, it does not contain the specific details about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format requested.

The provided text discusses:

• Standards and Intended Use: States the DIB Infusor uses biocompatible materials and will conform to the AMMI Draft Infusion Device Standard. Its intended use is similar to other legally marketed elastomeric infusion pumps.
• Manufacturing and Testing Procedures: Mentions manufacturing in a clean room, GMP regulations, and 100% testing of silicone balloons to an internal pressure.
• Prior In-Vitro Tests and Clinical Experience: Lists several studies and clinical uses, but these documents are only referenced as "attached" and their content is not provided.

To answer your request, detailed study reports with acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications would be needed. This information is not present in the given "SUMMARY of SAFETY and EFFECTIVENESS" document.

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