(195 days)
Not Found. This document does not contain information related to image processing, AI, or machine learning devices. Thus, the information requested in the prompt is not available.
Not Found
No
The summary describes a mechanical elastomeric infusion pump and makes no mention of AI or ML.
No.
The provided text describes the device as similar to "other legally marketed elastomeric infusion pumps," and provides a predicate device K-number (K930404) which is an elastomeric infusion pump. While infusion pumps are used in therapy, the pump itself is a device that delivers medication or fluids, not a therapeutic device directly providing therapy.
No
The provided text describes the "DIB-RA Infusor" as an elastomeric infusion pump, which is used for delivering substances, not for diagnosing conditions.
No
The device description explicitly mentions physical components like a silicone shaft and balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as being similar to other elastomeric infusion pumps. Infusion pumps are used to deliver fluids (like medications) into a patient's body, which is an in vivo (within a living organism) process, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description focuses on the materials used in the pump's construction, which is relevant to a device that interacts with the body, not a diagnostic test that analyzes samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the DIB-RA Infusor, as described, is a medical device for delivering fluids, not an in vitro diagnostic device.
N/A
Not Found. This document does not contain information related to image processing, AI, or machine learning devices. Thus, the information requested in the prompt is not available.
§ 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).
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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-1X8 (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):
l ) 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)
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Management of Postoperative Pain Relief. Hioko Hirota. M.D.,et al. Department of Anesthesiology, Tokyo Toshima Hospital, Tokyo, Japan (attached)
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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)