HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO

• K Number: K020660
• Device Name: HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
• Manufacturer: I-FLOW CORP.
• Date Cleared: 2002-03-20 ( 19 days)
• Product Code: MEB
• Regulation Number: 880.5725
• Type: Special
• Panel: HO
• Reference & Predicate Devices: K932740 , K944692 , K984502 , K991513 , K992072 , K020251

Intended Use

1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intraarterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

Device Description

The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a new component that incorporates a variable flow rate mechanism.

AI/ML Overview

The provided document is a 510(k) summary for the I-Flow Variable Rate Elastomeric Pump. It establishes substantial equivalence to existing devices and approves the device for marketing. However, it does not contain any information about specific acceptance criteria, study data, or performance metrics that would be typically found in a clinical study report or a detailed validation summary.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data against acceptance criteria.

Regulation Number and Section

§ 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).