PARAGON INFUSION

K984146 · I-Flow Corp. · FPA · Feb 9, 1999 · General Hospital

Device Facts

• Record ID: K984146
• Device Name: PARAGON INFUSION
• Applicant: I-Flow Corp.
• Product Code: FPA · General Hospital
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Paragon Infusion Kit is a mechanical, non-electronic infusion system for continuous delivery of local anesthetics. System comprises a reusable mechanical pump and a disposable administration set. Pump utilizes two cylindrical shells with internal/external threads; internal pressure plate applies constant load to a pliable PVC drug bag via a spring-actuated scissors mechanism. Administration set includes fixed-diameter flow control tubing or glass orifice; flow rate determined by Poiseuille's equation based on orifice dimensions and fluid viscosity. Device is ambulatory; used in hospital, home, or alternative care sites. Operated by clinicians or patients. Output is a continuous, fixed-rate infusion of medication into surgical sites or via percutaneous/epidural routes. No alarms or electronic indicators; flow control is purely mechanical. Pinch clamp provided for manual infusion cessation. Benefits include portable, consistent postoperative pain management without external power requirements.

Clinical Evidence

Bench testing only. Flow rate performance evaluated for all models (0.5 to 10.0 ml/hr) using 0.9% NaCl at 31°C. Results demonstrated average flow rates within ±10% of nominal values at 95% confidence interval. Biological testing of fluid path components conducted in conformance with ISO 10993 Part 1.

Technological Characteristics

Mechanical spring-driven pump; no external power. Fluid path materials: PVC drug bag, polyamide/nylon/FEP/silicone/polyurethane/Teflon catheters, stainless steel needles. Flow control via fixed-diameter tubing or glass orifice. Sterilization: ETO or gamma radiation. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring continuous infusion of local anesthetics for postoperative pain management via intraoperative, percutaneous, subcutaneous, intramuscular, or epidural routes. Not intended for intravenous or intra-arterial delivery, or for delivery of blood, blood products, lipids, or fat emulsions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Paragon Infusion System (K923875)
• PainBuster Infusion Kit (K980558)
• PainBuster Infusion Kit (K982946)
• Sgarlato Pain Control Infusion Pump (PCIP) (K896422)
• Homepump C-Series (K944692)

Reference Devices

• B. Braun Perifix Epidural Catheter Set (K813186)

Submission Summary (Full Text)

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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 [phone]

K984146

# 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: [phone] Fax: [phone]

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# 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.

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#### 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

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- 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.

2.4.3.6.2.1 Product Code: 4973.

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- 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.

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# 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: | < 5 ml |
|--------------------------|---------------------------------|
| Operating Temperature: | 31°C skin temperature (90°F) |
| Test Solution: | 0.9% NaCl |
| Operating Pressure: | 6.0 psi pressure source |
| Head Height: | 0" |
| Accuracy: | ±10% at 95% confidence interval |

- Flow Rate Performance Data: Testing occurred at standard operating conditions. All 3.2 models produced an average flow rate within the ±10% accuracy claim.

| | 100 ml x 0.5<br>ml/hr | 100 ml x 1<br>ml/hr | 100 ml x 2<br>ml/hr | 100 ml x 4<br>ml/hr | 100 ml x 10<br>ml/hr |
|---------------------------|-----------------------|---------------------|---------------------|---------------------|----------------------|
| Average Flow Rate (ml/hr) | 0.53 | 0.99 | 1.99 | 4.14 | 10.30 |
| Std. Dev. | 0.01 | 0.03 | 0.07 | 0.10 | 0.38 |
| N | 5 | 5 | 5 | 5 | 10 |

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.

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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.

Back Pressure (Head Height) Comparison: Approximately 0.57 psi pressure difference results per 16" head height. Thus, a 10% flow rate change may occur for each 16" head height difference from nominal assuming a 6 psi pressure source.

- Drug Delivery Comparison: Local anesthetics have densities similar to normal saline 3.3 (e.g. 1.002 to 1.005 for Ropivacaine HCI vs. 1.0045 for normal saline) and should not affect flow rate. Product labeling includes a statement as to delivery times and the possible deviation from nominal due to drug viscosity.
## Safety / Alarm Functions 3.4

- The Paragon pump and administration set provide a continuous fixed flow 3.4.1 and as such is not subject to fluid runaway conditions similar to that of some electronic pumps.
- The Paragon pump will not be recommended for any application that exceeds 3.4.2 the minimum internal pressure of the system.
- If for any reason the patient needs to stop his or her infusions, each 3.4.3 administration set is supplied with a pinch clamp to stop the infusion.
- This device contains no alarms or indicators for flow other than visual. 3.4.4
- 3.4.5 This device contains no alarms or indicators to detect air in line or an occlusion: however, each set may include an integrated air-eliminating filter.

# BIOLOGICAL SPECIFICATIONS 4.0

- Biological testing is in conformance with ISO 10993 Part 1 for all fluid path 4.1 components of the Paragon administration set.
# CHEMICAL AND DRUG SPECIFICATIONS 5.0

- 5.1 Compatibility
- There are no specific drugs referenced in the labeling for the Paragon 5.1.1 Infusion Kit.
- 5.1.2 The Paragon Infusion Kit is intended for use with general local anesthetics and epidural medications.
- 5.2 Drug Stability
- 5.2.1 There are no drugs included in the Paragon Infusion Kit.

# 6.0 INTENDED USE

- The Paragon Infusion Kit is intended to provide continuous infusion a local anesthetic 6.1 directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management.
- 6.2 Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.
- 6.3 The Paragon pump is re-usable. The disposable Paragon administration set is single patient use only.

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- No testing has been conducted to determine the efficacy of the Paragon for the 6.4 delivery of blood, blood products, lipids or fat emulsions. The Paragon is not intended for the delivery of blood, blood products, lipids or fat emulsions.
- The Paragon is suitable for use as an ambulatory device and is intended for use in the 6.5 hospital, home environment or alternative care sites.

# PACKAGING 7.0

- The Paragon Kit consists of an inner pouch or tray with Tyvek lid stock surrounded by 7.1 a header bag with an ETO Tyvek strip.
- The Paragon administration set may be packaged in either a Tyvek pouch or 7.2 Form/Fill/Seal.
- The Paragon Kit components are placed in the inner tray or pouch. 7.3
- 7.4 Packaging is suitable for either radiation or ETO sterilization.

# STERILIZATION INFORMATION 8.0

Note: The kit components of the Paragon Infusion Kit may be purchased non-sterile and packaged by I-Flow or sterile from the manufacture. The Paragon administration set and non-sterile purchased components shall be sterilized as follows:

- The methods of sterilization are gamma radiation (Cobalt 60) or ETO gas. 8.1
### 9.0 COMPARISON TO LEGALLY MARKETED DEVICES

See Table 1 that follows this section for more specific information.

- 9.1 Intended Use
- 9.1.1 The Paragon Infusion Kit, the PainBuster Infusion Kit and the Sgarlato Pain Control Infusion Pump (PCIP) have the same intended use:
- 9.1.1.1 To provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management.
- 9.1.2 The predicate Paragon Infusion System and Homepump C-Series are intended for general infusion use, including chemotherapy and pain management.
- 9.2 Device Descriptions
- 9.2.1 The Paragon Infusion Kit
- 9.2.1.1 The Paragon Infusion Kit is identical to the predicate PainBuster Infusion Kit with the exception of the Paragon pump and administration set replacing the PainBuster pump.
- 9.2.1.2 The Paragon Infusion Kit uses the same mechanical, reusable Paragon pump as the predicate Paragon Infusion System.
- The Paragon Infusion Kit uses the same Paragon Administration 9.2.1.3 Set as the Paragon Infusion System.
- 9.2.2 The Paragon Infusion System
- 9.2.2.1 The Paragon Infusion Kit uses the same pump and administration sets as the Paragon Infusion System (K923875).

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- The Sgarlato Pain Control Infusion Pump (PCIP) 9.2.3
- The Sgarlato PCIP consists of a kit very similar to the Paragon 9.2.3.1 and PainBuster Infusion Kit. These kits consist of an infusion pump and administration set, catheter, needle, syringe, Y adapter, carry case, dressing, tape and gauze.
- The Sgarlato kit uses a disposable, spring driven syringe pump 9.2.3.2 with integrated administration set.
- The Homepump C-Series 9.2.4
- The Homepump C-Series consists of a disposable, elastomeric 9.2.4.1 infusion pump with integrated administration set.
- Specifications 9.2.5
- 9.2.5.1 The Paragon Infusion Kit, PainBuster Infusion Kit and Sgarlato PCIP have similar fill volumes and flow rates, see Table 1.
- Flow Control 9.2.6
- The Paragon Infusion Kit and all its predicate devices use either a 9.2.6.1 qlass orifice or PVC tubing to control the flow rate.
- 9.2.7 Materials
- 9.2.7.1 The Paragon Infusion Kit uses the same Paragon Administration Set as the Paragon Infusion Svstem. All fluid path materials of the Paragon Administration Set are in conformance with ISO 10993 Part 1.
- Based upon the data presented in this section 9.0 and Table 1, I-Flow 9.2.8 Corporation has determined that the Paragon Infusion Kit is substantially equivalent to the named predicate devices.

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| Comparison<br>Element | Paragon Infusion Kit<br>(subject device) | SE¹ Paragon Infusion System<br>(K923875) | SE¹ PainBuster Infusion Kit<br>(K980558, K982946) | SE¹ Sgarlato PCIP<br>(K896422) | SE¹ Homepump C-Series<br>(K944692) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To provide continuous infusion<br>of a local anesthetic directly<br>into the intraoperative site for<br>general surgery for<br>postoperative pain<br>management. | General infusion use, including<br>chemotherapy and pain<br>management. | To provide continuous infusion<br>of a local anesthetic directly<br>into the intraoperative site for<br>postoperative pain<br>management. | To provide continuous infusion<br>of a local anesthetic directly<br>into the surgical wound site for<br>postoperative pain<br>management. | General infusion use, including<br>chemotherapy and pain<br>management. |
| Routes of<br>Administration | Percutaneous, subcutaneous,<br>intramuscular and epidural | Intravenous | Percutaneous and<br>subcutaneous | Percutaneous, subcutaneous<br>and epidural | Intravenous, intra-arterial,<br>epidural or subcutaneous |
| Contraindications | Not intended for intravenous or<br>intra-arterial delivery. Not<br>intended for delivery of blood,<br>blood products, lipids or fat<br>emulsions. | Not intended for delivery of<br>blood, blood products, lipids or<br>fat emulsions. | Not intended for intravenous,<br>intra-arterial or epidural<br>delivery. Not intended for<br>delivery of blood, blood<br>products, lipids or fat<br>emulsions. | Not intended for rapid infusions<br>Not intended for intravenous<br>infusion. | Not intended for delivery of<br>blood, blood products, lipids or<br>fat emulsions. |
| Reuse<br>Capability | Re-usable pump, single patient<br>use disposable administration<br>set | Re-usable pump, single patient<br>use disposable administration<br>set | Disposable, single patient use | Disposable, single patient use | Disposable, single patient use |
| Description | Sold empty and capable of<br>being filled via a fill port. | Sold empty and capable of<br>being filled via a fill port. | Sold empty and capable of<br>being filled via a fill port. | Sold empty and capable of<br>being filled via a fill port. | Sold empty and capable of<br>being filled via a fill port. |
| Fill Volumes | 100 ml | 100 ml | 50 to 270 ml | 50 to 100 ml | 50 to 500 ml |
| Flow Rates | 0.5, 1.0, 2.0, 4.0 or 10.0 ml/hr | 0.5 to 200 ml/hr | 0.5, 1.0, 2.0, 5.0 or 10.0 ml/hr | 0.5, 1.0 or 2.0 ml/hr | 0.5 to 500 ml/hr |
| Pump Type | Mechanical spring | Mechanical spring | Elastomeric Pump | Spring driven syringe pump | Elastomeric Pump |
| Power<br>Requirements | None | None | None | None | None |
| Pump Mechanism | Constant pressure is applied to<br>the fluid reservoir. | Constant pressure is applied to<br>the fluid reservoir. | Constant pressure is applied to<br>the fluid reservoir. | Constant pressure is applied to<br>the fluid reservoir. | Constant pressure is applied to<br>the fluid reservoir. |
| Pressure Source | Mechanical spring energy | Mechanical spring energy | Strain energy of elastomeric<br>membranes | Mechanical spring energy | Strain energy of elastomeric<br>membranes |
| Fluid Reservoir | PVC drug bag | PVC drug bag | Thermoplastic (Krayton)<br>elastomeric membrane | Polypropylene plastic syringe | Thermoplastic (Krayton)<br>elastomeric membrane |
| Administration Set | | | | | |
| Flow Control | Consistent flow rate throughout<br>the entire course of therapy is<br>achieved by the combination of<br>constant pressure and flow<br>control tubing. | Consistent flow rate throughout<br>the entire course of therapy is<br>achieved by the combination of<br>constant pressure and flow<br>control tubing. | Consistent flow rate throughout<br>the entire course of therapy is<br>achieved by the combination of<br>constant pressure and flow<br>control tubing. | Consistent flow rate throughout<br>the entire course of therapy is<br>achieved by the combination of<br>constant pressure and flow<br>control tubing. | Consistent flow rate throughout<br>the entire course of therapy is<br>achieved by the combination of<br>constant pressure and flow<br>control tubing. |
| Safety / Alarm<br>Functions | Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied<br>with a clamp to stop the<br>infusion if necessary. | Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied<br>with a clamp to stop the<br>infusion if necessary. | Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied<br>with a clamp to stop the<br>infusion if necessary. | Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied<br>with a clamp to stop the<br>infusion if necessary. | Fixed flow rate tubing prevents<br>fluid runaway conditions.<br>Each administration set is supplied<br>with a clamp to stop the<br>infusion if necessary. |

# ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

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Image /page/10/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Robert J. Bard, Esq., R.A.C. Vice President Regulatory and Legal Affairs I-Flow Corporation 20202 Window Drive Lake Forest, California 92630

Re : K984146 Trade Name: Paragon Infusion Requlatory Class: II FPA Product Code: Dated: November 11, 1998 November 19, 1998 Received:

Dear Mr. Bard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bard

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K984146 Device Name: Paragon Infusion Kit Indications for Use:

> 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.

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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 _________________________________________________________________________________________________________________________________________________________

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