(82 days)
No
The device description and intended use focus on a mechanical, balloon-based infusion system with fixed flow rates and an optional patient-controlled bolus button. There is no mention of any computational or learning capabilities.
Yes
The device is intended for pain management and continuous/intermittent delivery of medication, which are therapeutic uses.
No
The device description and intended use clearly state that it is a system for delivering general infusion and medication (e.g., pain management) via various routes; it does not mention any function related to diagnosing a medical condition.
No
The device description explicitly states that the system consists of a "pump and an integrated administration set" and describes the pump as a "continuous silicone balloon type." This indicates the device is a physical hardware system for fluid delivery, not a software-only device.
Based on the provided information, the Accufuser and Accufuser Plus systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that the devices are for the infusion of medication into the body through various routes (intravenous, subcutaneous, etc.) for pain management and regional anesthesia. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a pump and administration set designed to deliver fluid (medication) to a patient. This aligns with a drug delivery system, not a device used to examine specimens from the body to diagnose conditions.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information. The Accufuser and Accufuser Plus systems are used in vivo (inside the body) to deliver medication.
N/A
Intended Use / Indications for Use
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative and postoperative and postoperative surgery.
The Accufuser and Accufuser Plus systems are 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.
The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Product codes
MEB
Device Description
The Accufuser/Accufuser Plus system consists of a pump and an integrated administration set. The pump is a continuous silicone balloon type. The pump provides continuous fluid delivery with an attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
The Accufuser/Accufuser Plus pump and administration set are intended for single patient use.
The Accufuser Plus is the Accufuser with the addition of a Patient Medication Control Module (PCM). The PCM allows the patient to administer a bolus of a fixed volume with a fixed lockout (re-fill) time. The PCM in integrated into the administration set with a bolus button that allows the patient controlled administration of medication as needed.
The Standard Procedure Kit is substantially equivalent to the predicate devices. The kit includes various kit components such as catheter, needle, syringe, y adapter, dressing, tape, gauze and carry case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-operative (soft tissue / body cavity) site, surgical wound sites and/or close proximity to nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, home environment or alternative care sites.
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)
K003915, K013928, K014091, K020862
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0J309f
Section D
Premarket Notification – 510(k) Summary of Safety and Effectiveness for Accufuser, Accufuser Plus and Standard Procedure Kit
DEC 0 9 2002
1
Premarket Notification - 510(k) Summary of Safety and Effectiveness for Accufuser, Accufuser Plus and Standard Procedure Kit
September 17, 2002 Date Prepared:
Trade Name: Accufuser; Accufuser Plus; Standard Procedure Kit
Common Name: Elastomeric Infusion Pump Kit
Classification Name: Pump, Infusion, Elastomeric
Classification Panel: General Hospital and Personal Use Device
Device Classification Regulation Number: 880.5725, Class II
Panel: 80
Procode: MEB
Existing Device Cleared 510(k): K003915, Accufuser and Accufuser Plus
Predicate devices demonstrating substantial equivalence include the following.
- K013928, Breg Corporation, Pain Care 3000 and 3200, and accessory Kit. .
- K014091, Stryker Pain Pump and Accessory Kit. .
- K020862, I-Flow, Infusion Pump and Administration Set. ●
Submitted by:
McKinley Infuser, LLC 631 Howard, #202 San Francisco, CA 94105 USA Phone: 415-543-2196 Contact for questions: John Chappell, RAC Establishment Registration Number: 3003468679 Owner/Operator Number: 9047569
This submission is intended to notify the Food and Drug Administration that McKinley Infuser, LLC intends to market a modification to an existing device (K003915) called the Accufuser/Accufuser Plus and Standard Procedure Kit. Modifications to the existing device include two new indications for use, expansion of the bolus delivery range, addition of two bolus lockout times, addition of one reservoir volume size through combining two reservoirs, addition of flow rates for bolus devices and addition of a standard procedure kit.
2
The Accufuser/Accufuser Plus system and its predicate device (K020862) are intended for use as follows.
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative and postoperative surgery.
The Accufuser and Accufuser Plus systems are 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.
The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital. home environment or alternative care sites.
Description of the Accufuser System
The Accufuser/Accufuser Plus system consists of a pump and an integrated administration set. The pump is a continuous silicone balloon type. The pump provides continuous fluid delivery with an attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
The Accufuser/Accufuser Plus pump and administration set are intended for single patient use.
The Accufuser Plus is the Accufuser with the addition of a Patient Medication Control Module (PCM). The PCM allows the patient to administer a bolus of a fixed volume with a fixed lockout (re-fill) time. The PCM in integrated into the administration set with a bolus button that allows the patient controlled administration of medication as needed.
The Standard Procedure Kit is substantially equivalent to the predicate devices. The kit includes various kit components such as catheter, needle, syringe, y adapter, dressing, tape, gauze and carry case.
Device Specifications and Safety Functions
The Accufuser/Accufuser Plus system has fill volumes and flow rates substantially equivalent to the pumps of the named predicate devices.
The Accufuser/Accufuser pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.
3
The Accufuser/Accufuser Plus provides a fixed flow and is not subject to fluid runaway conditions similar to that of some electronic pumps.
All fluid path materials of the Accufuser/Accufuser Plus system are in conformance with ISO 10993 Part 1.
There are currently no approved performance standards established for elastomeric infusion pumps under Section 514 of the Food, Drug and Cosmetic Act.
Packaging is suitable for ETO sterilization.
ETO is the validated sterilization method.
Product Configuration:
- o Reservoir volume range is from 60 ml to 550 ml.
- Flow rate range is 0.5 ml/hr to 10.0 ml/hr. o
- Bolus levels are 0.5 ml, 1.0 ml and 2.0 ml. o
- o Lockout times range from 6 minutes to 60 minutes and include increments of 6, 8, 15, 30 and 60 minutes.
| Materials: | PET-G, ABS, polypropylene, silicone, PVC, polycarbonate,
cellulose acetate, PTFE, and acrylic. DEHP-Free.
Plasticizer used is TOTM, Tri-Octyl Trimellitate. Latex-
Free. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Filter: | 1.2 Micron, air-eliminating, in-line filter |
| System Accuracy | Reservoir Volume | Accuracy |
|---|---|---|
| 60 ml | +/- 10% of nominal flow rate at 95% confidence interval | |
| 100 ml | +/- 10% of nominal flow rate at 95% confidence interval | |
| 275 ml | +/- 15% of nominal flow rate at 95% confidence interval | |
| 550 ml | +/- 15% of nominal flow rate at 95% confidence interval | |
| Operating Pressure | 5 to 6 psi | |
| System Residual Volume |