(82 days)
No
The summary describes a mechanical infusion pump and associated disposable components for delivering local anesthetic. There is no mention of any computational or algorithmic features that would suggest the use of AI or ML. The performance data focuses on flow rate accuracy, which is a standard metric for infusion pumps.
Yes
The device is intended to provide continuous infusion of a local anesthetic for postoperative pain management, demonstrating a direct therapeutic effect.
No
The device is an infusion kit intended to deliver local anesthetic for pain management, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is comprised of a Paragon pump and administration set, along with various physical components like catheters, needles, and syringes, indicating it is a hardware device with associated disposables.
Based on the provided information, the Paragon Infusion Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver a local anesthetic directly into a patient's body for pain management. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a pump and administration set designed to infuse medication into a patient. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Paragon Infusion Kit's function is to administer medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
The Paragon Infusion Kit is intended to provide continuous infusion 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
FPA
Device Description
The Paragon Infusion Kit is identical to the I-Flow PainBuster Infusion Kit with the exception of the Paragon pump and administration set replacing the PainBuster pump. The kit is comprised of a Paragon pump and administration set (K923875) and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The PainBuster kit contains all the above components except for an elastomeric pump with integrated administration set instead of the Paragon pump and administration set. The Paragon 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 Paragon administration set is a disposable device intended for single patient use. The Paragon pump is reusable. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
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 ±10% accuracy claim.
100 ml x 0.5 ml/hr: A five (5) piece sample produced an average flow rate of 0.53 ml/hr. The resulting average is well within its ±10% accuracy claim. The fastest infusion had an average flow rate of 0.54 ml/hr and the slowest infusion had an average flow rate of 0.51 ml/hr.
100 ml x 1.0 ml/hr: A five (5) piece sample produced an average flow rate of 0.99 ml/hr. The resulting average is within its ±10% accuracy claim. The fastest infusion had an average flow rate of 1.04 ml/hr and the slowest infusion had an average flow rate of 0.96 ml/hr.
100 ml x 2.0 ml/hr: A five (5) piece sample produced an average flow rate of 1.99 ml/hr. The resulting average is within its ±10% accuracy claim. The fastest infusion had an average flow rate of 2.05 ml/hr and the slowest infusion had an average flow rate of 1.90 ml/hr.
100 ml x 4.0 ml/hr: A five (5) piece sample produced an average flow rate of 4.14 ml/hr. The resulting average is within its ±10% accuracy claim. The fastest infusion had an average flow rate of 4.24 ml/hr and the slowest infusion had an average flow rate of 3.99 ml/hr.
100 ml x 10.0 ml/hr: A ten (10) piece sample produced an average flow rate of 10.30 ml/hr. The resulting average is within its ±10% accuracy claim. The fastest infusion had an average flow rate of 10.80 ml/hr and the slowest infusion had an average flow rate of 9.65 ml/hr.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±10% at 95% confidence interval
Predicate Device(s)
K923875, K980558, K982946, K896422, K944692
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image shows the logo for I-Flow Corporation. The logo consists of the text "I-FLOW" in a stylized font inside of a rounded rectangle. Below the logo, the words "I-FLOW CORPORATION" are printed in a simple font.
20202 Windrow Drive Lake Forest. CA 92630 949) 206-2700 800) 448-3569 Fax (949) 206-2600
SUMMARY OF SAFETY AND EFFECTIVENESS
November 11, 1998
Trade Name: Paragon 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
GENERAL INFORMATION 1.0
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 intended use for the Paragon Infusion System (K923875), originally identified as the SideKick 50 Plus and SideKick 100 Plus. The Paragon will be marketed as a kit, the Paragon Infusion Kit, including labeling changes and additional components.
- 1.1.2 Trade Name: Paragon Infusion Kit
- Common Name: Infusion Pump Kit 1.1.3
- Classification Name: Pump, Infusion 1.1.4
- Classification Panel: General Hospital and Personal Use Device 1.1.5
1.2 Statement of Equivalence
- The Paragon Infusion Kit includes components that are legally marketed 1.2.1 (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation).
- 1.2.2 The Paragon pump and administration set are the same as used in K923875.
- The Paragon Kit is substantially equivalent to the I-Flow Paragon Infusion 1.2.3 System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422) and the I-Flow Homepump C-Series (K944692).
PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.0
2.1 Description of the Paragon Infusion Kit
- 2.1.1 The Paragon Infusion Kit is identical to the I-Flow PainBuster Infusion Kit with the exception of the Paragon pump and administration set replacing the PainBuster pump.
- 2.1.2 The kit is comprised of a Paragon pump and administration set (K923875) and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case.
- 2.1.2.1 The PainBuster kit contains all the above components except for an elastomeric pump with integrated administration set instead of the Paragon pump and administration set.
- 2.1.3 The Paragon 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 Paragon administration set is a disposable device intended for single patient use. The Paragon pump is reusable.
- 2.1.5 The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
2
2.2 Description of Paragon Pump
- 2.2.1 The Paragon pump consists of two cvlindrical shells. The top half of the pump has internal threads which mate to the external threads of the bottom half of the pump.
- The top incorporates a pressure plate which applies a load to the pliable drug 2.2.2 bag. The load is applied to the drug bag by way of two opposing springs which act upon a scissors mechanism. The spring/scissors mechanism creates a near constant pressure in the drug bag.
- The bottom half of the pump is slotted to allow for positioning of the 2.2.3 administration set.
- 2.2.4 When the top and bottom halves of the pump are fully threaded together, the pressure plate contacts the drug bag and acts as the pressurizing element.
- 2.2.5 This premarket notification proposes no changes to the Paragon pump.
Description of Paragon Administration Set 2.3
- The Paragon administration set consists of a PVC drug bag attached to the 2.3.1 administration line.
- 2.3.2 Each administration set consists of fixed diameter flow control tubing or glass orifice.
- 2.3.3 The flow control tubing or glass orifice is cut to a specific length L. When the PVC drug bag is pressured by the Paragon pump, the delivery times are defined by the inside diameter of the flow control orifice.
- 2.3.3.1 The delivery time characteristic is derived from the flow rate of the device which is in turn approximated by Poiseulle's equation:
$$\mathcal{Q} = \frac{\Delta\rho\pi D^4}{128,\mu L}$$
- 2.3.3.2 Where O is the flow rate. ¿ is the pressure drop across the orifice. D is the inside diameter of the flow controlling orifice, u is the dynamic viscosity of the fluid and L is the length of the orifice. The equation provides an approximation of the actual delivery time.
2.4 Product Configuration
- 2.4.1 The Paragon pump:
- PG100000P: 100 ml volume 2.4.1.1
- 2.4.2 The Paragon administration sets:
- 2.4.2.1 PG100005: 100 ml volume, 0.5 ml/hr flow rate
- 2.4.2.2 PG100010: 100 ml volume, 1.0 ml/hr flow rate
- 2.4.2.3 PG100020: 100 ml volume, 2.0 ml/hr flow rate
- 2.4.2.4 PG100040: 100 ml volume, 4.0 ml/hr flow rate
- 2.4.2.5 PG100100: 100 ml volume, 10.0 ml/hr flow rate
- 2.4.2.6 PG100020Y: 100 ml volume, 2.0 ml/hr flow rate, dual orifice, dual catheter with Y adapter
3
- The dual orifice set consists of a standard Paragon 2.4.2.6.1 set with dual orifice downstream from the Y adapter. Each orifice allows 2 ml/hr flow rate.
- Each model consists of a kit with the following components: 2.4.3
- 2.4.3.1 Paragon pump (optional).
- The reusable Paragon pump may be packaged and 2.4.3.1.1 sold separately from the disposable kit components.
- Paragon administration set. 2.4.3.2
- 2.4.3.3 Catheter:
- 18 to 22 G catheter, 11 to 40 in. length, polyamide, 2.4.3.3.1 nylon, FEP (fluorinated ethylene propylene) polymer, silicone, polyurethane or Teflon.
- A catheter connector is included to connect the 2.4.3.3.2 catheter to the distal luer of the administration set.
- The B. Braun Perifix® Epidural Catheter Set is an 2.4.3.3.3 example of the type of catheter that may be used with the Paragon Infusion Kit.
- 2.4.3.3.3.1 Product code: EC20-0.
- 510(k) number: K813186. 2.4.3.3.3.2
- 2.4.3.4 Needle:
- 14 to 18 G. 1 ½ to 3 ¼ in. length, stainless steel. 2.4.3.4.1
- 2.4.3.4.2 The needle may be a catheter over needle as in the Angiocath™ example below.
- 2.4.3.4.3 The Angiocath catheter introducer needle is an example of the type of catheter introducer needle that may be used with the Paragon Infusion Kit.
- 2.4.3.4.3.1 Product code: 382258.
- Syringe (optional): 2.4.3.5
- 2.4.3.5.1 60 cc plastic, luer lock syringe.
- The syringe is used to fill the Paragon drug bag with 2.4.3.5.2 medication.
- 2.4.3.5.3 The B-D 60 cc syringe is an example of the type of syringe that may be included in the Paragon Kit.
- 2.4.3.5.3.1 Product Code: 309663.
- 2.4.3.6 Dressing (optional):
- 2.4.3.6.1 The dressing is used to hold the catheter and/or flow restrictor in place.
- The OpSite™ is an example of the type of dressing 2.4.3.6.2 that may be used in the Paragon Kit.
- 2.4.3.1 Paragon pump (optional).
2.4.3.6.2.1 Product Code: 4973.
4
- Carry Case (optional): 2.4.3.7
- 2.4.3.7.1 The carry case is used to hold the Paragon pump while delivering medication.
I-Flow part numbers 1400749, 2.4.3.7.1.1 1400752 or 1400758.
- Antiseptic Skin Swabs (optional): 2.4.3.8
- 2.4.3.8.1 The antiseptic skin swabs are used to prep the skin area of the patient prior to inserting the catheter.
- The Alcohol Prep Pads or lodophor PVP Scrub 2.4.3.8.2 Swabsticks manufactured by Clinipad Corporation are examples of the type of antiseptic skin swabs that may be used in the Paragon Kit.
- 2.4.3.8.2.1 Model number: CL0110.
2.4.3.8.2.2 Model number: CL1244.
- Tape (optional): 2.4.3.9
- 2.4.3.9.1 The tape may be used to the secure catheter, flow control tubing or gauze.
- The Transpore™ Surgical Tape manufactured by 3M 2.4.3.9.2 is an example of the type of tape that may be used in the Paragon Kit.
2.4.3.9.2.1 Model number: 3M1527-1.
- Gauze (optional): 2.4.3.10
- 2.4.3.10.1 The gauze may be used to secure the catheter or flow control tubing.
- The Kling® Conforming Gauze manufactured by 2.4.3.10.2 Johnson and Johnson is an example of the type of gauze which may be used in the Paragon Kit.
2.4.3.10.2.1 Model number: JJ6923.
- 2.4.3.11 Y Adapter (optional)
- 2.4.3.11.1 The Y adapter is used for an additional catheter for a large wound or multiple wound sites.
- 2.4.3.11.2 The Flexible Y Fitting by Qosina is an example of the type of Y Adapter that may be used in the Paragon Kit.
2.4.3.11.2.1 Model number: 81120.
5
Components and Materials 2.5
The pump and administration sets used in the Paragon Infusion Kit are currently available models of the Paragon Infusion System (K923875). No changes will be made to the Paragon pump or administration sets.
All kit components other than the pump and administration set are identical to those used in the PainBuster infusion system submitted under K980558, K982946.
The Paragon administration set is a disposable device intended for single patient use. The Paragon pump is reusable.
Power Requirements 2.6
- The Paragon pump is a mechanical pump that utilizes spring energy for 2.6.1 power. No additional external power source is required.
OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0
3.1 Standard Operating Conditions:
| Priming/Residual Volume: | 1. The Paragon Infusion Kit is intended to provide continuous infusion 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUED ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) lective neprix
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
1984146 510(k) Number_
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)