(71 days)
Not Found
No
The document describes a mechanical infusion pump and administration set, with no mention of AI or ML capabilities. The performance data focuses on flow rate accuracy, which is a standard metric for such devices.
Yes
The device is intended to provide a continuous infusion of a local anesthetic for postoperative pain management, directly treating a medical condition.
No
The device is an infusion kit designed for continuous delivery of local anesthetics for pain management, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of a "SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- SideKick Infusion Kit Function: The SideKick Infusion Kit is designed to deliver a substance (local anesthetic) into the body for pain management. It is an infusion device, not a diagnostic test.
The description clearly states its purpose is for "continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site". This is a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.
Product codes
FRN
Device Description
The SideKick Infusion Kit is comprised of a SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The SideKick administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The SideKick administration set is a disposable device intended for single patient use. The SideKick pump is reusable. The SideKick is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites. The SideKick Infusion Kit models are available in 100 ml fill volumes with 1 or 2 ml/hr flow rates. Each model consists of a SideKick administration set with the following optional components/accessories: SideKick pump, catheter, needle, syringe, dressing, carry case, antiseptic skin swabs, tape, gauze and Y adapter. The SideKick pump is a mechanical pump that utilizes spring energy for power; no additional external power source is required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative (soft tissue / body cavity) site
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)
Flow Rate Performance Data: Testing occurred at standard operating conditions. All models produced an average flow rate within the ±15% accuracy claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±15% at 95% confidence interval
Predicate Device(s)
K984146, K923875, K980558, K982946, K896422, K944692, K982256
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
Image /page/0/Picture/0 description: The image shows the date 4/23/99 at the top left. Below the date is the I-FLOW logo, which is a stylized oval shape with the words "I-FLOW" inside. Underneath the logo, the words "I-FLOW CORPORATION" are printed in a simple, sans-serif font. The logo and text are centered.
20202 Windrow Drive Lake Forest. CA 92630 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600
1990425
SUMMARY OF SAFETY AND EFFECTIVENE
February 9, 1999
Trade Name: SideKick Infusion Kit
Common Name: Infusion Pump Kit
Classification Name: Pump, Infusion
All questions and/or comments concerning this document should be made to:
Robert J. Bard, Esq., R.A.C. Vice President of Regulatory and Legal Affairs
I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630
Telephone: 949.206.2700 Fax: 949.206.2600
1
1.0 GENERAL INFORMATION
1.1 Purpose of Submission
- This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market a new kit, the SideKick Infusion Kit.
- Trade Name: SideKick Infusion Kit 1.1.2
- 1.1.3 Common Name: Infusion Pump Kit
- 1.1.4 Classification Name: Pump, Infusion
- Classification Panel: General Hospital and Personal Use Device 1.1.5
1.2 Statement of Equivalence
- 1.2.1 The SideKick Infusion Kit includes components that are legally marketed (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation).
- 1.2.2 The SideKick Kit is substantially equivalent to the I-Flow Paragon Infusion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outbound Disposable Syringe Infuser (K982256).
2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS
2.1 Description of the SideKick Infusion Kit
- 2.1.1 The SideKick Infusion Kit is identical to the I-Flow Paragon Infusion Kit with the exception of the SideKick pump and administration set replacing the Paragon pump and administration set.
- 2.1.2 The kit is comprised of a SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case.
- 2.1.2.1 The Paragon Infusion Kit contains all the above components except for a Paragon pump and administration set instead of the SideKick pump and administration set.
- 2.1.3 The SideKick administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management.
- 2.1.4 The SideKick administration set is a disposable device intended for single patient use. The SideKick pump is reusable.
- 2.1.5 The SideKick is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
2.2 Product Configuration
- 2.2.1 The SideKick Infusion Kit models are available in 100 ml fill volumes with 1 or 2 ml/hr flow rates.
- 2.2.2 Each model consists of a SideKick administration set with the following optional components/accessories:
2
- SideKick pump, catheter, needle, syringe, dressing, carry case, 2.2.2.1 antiseptic skin swabs, tape, gauze and Y adapter.
2.3 Components and Materials
All fluid path components of the SideKick administration set are identical to the fluid path components of the Paragon administration set.
2.4 Power Requirements
- The SideKick pump is a mechanical pump that utilizes spring energy for 2.4.1 power. No additional external power source is required.
3.0 OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS
3.1 Standard Operating Conditions:
| Residual Volume: |