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K Number
K992015
Device Name
FREEDOM INFUSION SYSTEM
Manufacturer
NOVACON CORP.
Date Cleared
1999-09-10

(87 days)

Product Code
MEB
Regulation Number
880.5725
Type
Traditional
Panel
HO
Reference & Predicate Devices
K930404,K941766,K955849
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  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.
Device Description

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.

AI/ML Overview

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

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).