(222 days)
Not Found
No
The summary describes a mechanical elastomeric infusion pump and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The 'Intended Use' states the device is an "elastomeric infusion pump," which are typically used for drug delivery, not for therapy itself.
No
The document describes an "Infusor," which is a device for delivering substances (like medication) into the body, not for diagnosing conditions.
No
The device description explicitly states it utilizes 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 legally marketed elastomeric infusion pumps." Elastomeric infusion pumps are devices used to deliver fluids (like medications) into a patient's body. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the materials used in the pump's construction (silicone shaft and balloon). This is consistent with a device that physically delivers substances.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens from the human body to provide information for diagnostic purposes. The description of the DIB Infusor clearly points to a device used for delivering substances into the body, not for analyzing substances from the body.
N/A
Intended Use / Indications for Use
The intended use of the DIB Infusor is similar to that of other legally marketed elastomeric infusion pumps.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The DIB Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
AUG = 5 1996
ATTACHMENT G
SUMMARY of SAFETY and EFFECTIVENESS for the DIB INFUSOR
I. Standards and Intended Use
The DIB Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon. The DIB Infusor will conform to the AMMI Draft Infusion Device Standard. The intended use of the DIB 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, 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):
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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)