DIB INFUSOR-RA

K960318 · Novacon Corp. · MEB · Aug 5, 1996 · General Hospital

Device Facts

• Record ID: K960318
• Device Name: DIB INFUSOR-RA
• Applicant: Novacon Corp.
• Product Code: MEB · General Hospital
• Decision Date: Aug 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

DIB-RA Infusor; elastomeric infusion pump; utilizes medical grade silicone shaft and silicone balloon. Device operates via internal pressure to deliver medication; balloon tested to 110±5 mmHg; clinical operating pressure ~70 mmHg. Used in clinical settings for pain management and IV infusions. Healthcare providers manage infusion; device provides continuous delivery to benefit patients requiring sustained medication administration.

Clinical Evidence

Evidence includes in-vitro flow studies and clinical literature. In-vitro testing conducted by University of Toronto and University of Utah. Clinical experience cited from international studies (Japan) covering continuous epidural block, postoperative pain relief, and cervical epidural anesthesia for Ramsey Hunt Syndrome.

Technological Characteristics

Materials: medical grade silicone shaft and balloon. Sensing/Actuation: elastomeric balloon pressure (110±5 mmHg test pressure; ~70 mmHg clinical operating pressure). Standards: AAMI Draft Infusion Device Standard. Manufacturing: Class 10,000 clean room, GMP compliant.

Indications for Use

Indicated for patients requiring continuous infusion of medications, including applications for obstetrical analgesia, post-operative pain management, chronic pain management, and intravenous infusions.

Regulatory Classification

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.

Reference Devices

• DIB Catheter (K930404)

Submission Summary (Full Text)

{0}

AUG - 5 1996
19603/8

# ATTACHMENT F

## SUMMARY of SAFETY and EFFECTIVENESS for the DIB-RA INFUSOR

### I. Standards and Intended Use

The DIB-RA Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon. The DIB-RA Infusor will conform to the AMMI Draft Infusion Device Standard. The intended use of the DIB-RA Infusor is similar to that of other legally marketed elastomeric infusion pumps.

### II. Manufacturing and Testing Procedures

All manufacturing operations are performed in a class 10,000 clean room in accordance with GMP regulations. The silicone balloons are 100% tested to an internal pressure of 110±5 mmhg. Normal clinical operating pressure has been measured at approximately 70 mmhg. Full traceability of production lots will be maintained.

### III. Prior In-Vitro Tests and Clinical Experience

A.) In-Vitro Tests: A Disposable Drug Infusion Balloon Catheter: A Laboratory Evaluation, Y. Susuki, M.D., et al, Department of Anesthesia, The Hospital for Sick Children and the University of Toronto, Toronto, Ontario, Canada M5G-IX8 (attached).
Dept of Biomedical Engineering, Univ of Utah, flow study on DIB model 10010

B) Clinical Experience: legally marketed DIB pumps have been used clinically in the USA for obstetrical analgesia, post operative pain, chronic pain and intravenous infusions.

Clinical Experience (outside the USA):
1) Continuous Epidural Block with a Micro-Infusion Balloon (DIB Catheter) and Patient Controlled Analgesia, Michihiro Murozono, M.D., et al, Department of Anesthesiology, Tokyo Medical School, Tokyo, Japan (attached)
2) Management of Postoperative Pain Relief, Hioko Hirota, M.D., et al, Department of Anesthesiology, Tokyo Toshima Hospital, Tokyo, Japan (attached)
3) Ramsey Hunt Syndrome (Hunt's Neuralgia) and Continuous Infusion of Cervical Epidural Anesthesia Haruma Ikebe, M.D., et al, Department of Anesthesiology, Ooita Medical College, Tokyo, Japan (attached)
(These publications are attached to the original Premarket Notification under FDA file K930404)