PAINBUSTER INFUSION SYSTEM

K980558 · I-Flow Corp. · MEB · May 28, 1998 · General Hospital

Device Facts

• Record ID: K980558
• Device Name: PAINBUSTER INFUSION SYSTEM
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PainBuster is intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management. The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter. The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery. The PainBuster is single use only. No testing has been conducted to determine the efficacv of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN. The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

Device Story

PainBuster Infusion System is a disposable, single-use elastomeric infusion pump kit; includes pump, catheter, and needle. Operates via strain energy of a natural latex bladder providing constant pressure to a fluid reservoir; flow rate regulated by integrated flow control tubing. Used in clinical or home settings for postoperative pain management; operated by clinicians or patients. Input: local anesthetic solution; Output: continuous percutaneous infusion into intraoperative sites. Healthcare providers use the device to manage postoperative pain by delivering medication directly to the surgical site. Benefits include ambulatory pain management and consistent drug delivery. Pump design is based on the Homepump C-Series; utilizes a single thicker natural latex bladder and soft PVC shell.

Clinical Evidence

Bench testing only. Performance evaluated at 31°C (skin temperature) with 0.9% NaCl. Flow rate accuracy tested for 65ml/0.5ml/hr and 125ml/2.0ml/hr models (n=27 and n=26), confirming performance within ±15% of nominal rates. Back pressure effects (16" HH, 42" HH, 3.1 psi) and drug viscosity effects (5% Dextrose) were assessed. Catheter/PICC line compatibility testing showed no significant impact on flow rate. Biological safety confirmed per ISO 10993 Part 1.

Technological Characteristics

Elastomeric infusion pump; natural latex bladder; soft PVC shell. Flow control via integrated tubing. Dimensions: 65ml or 125ml volumes. Flow rates: 0.5, 1.5, 2.0 ml/hr. Materials: Polyamide/nylon/FEP catheters; stainless steel needles. Sterilization: Gamma radiation or ETO gas. Single-use, disposable. No software or electronic components.

Indications for Use

Indicated for postoperative pain management in patients requiring continuous infusion of local anesthetic directly into intraoperative soft tissue or body cavity sites. Not for epidural, subcutaneous, or vascular delivery. Not for chemotherapy, blood, blood products, or TPN.

Regulatory Classification

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.

Predicate Devices

• Pain Control Infusion Pump (PCIP) (K896422)
• Homepump C-Series (K944692)
• Homepump Eclipse (K932740)

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 a logo with the text "I-FLOW" inside of a rounded box. The letters are outlined in black. There is a registered trademark symbol in the bottom right corner of the box.

I-FLOW CORPORATION 20202 Windrow Drive Lake Forest, CA 92630 [phone] [phone] Fax [phone]

K980558

# SUMMARY OF SAFETY AND EFFECTIVENESS MAY 2 8 1998

February 11, 1998

Trade Name: PainBuster Common Name: Elastomeric Infusion Pump Classification Name: Pump, Infusion, Elastomeric

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq., R.A.C. Vice President 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

#### Purpose of Submission 1.1

- This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market an intraoperative site infusion kit, the PainBuster™ Infusion System, that utilizes legally marketed components for a new intended use.
# Statement of Equivalence 1.2

- The PainBuster Infusion System is a kit which includes components that 1.2.1 are legally marketed (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation).
- The PainBuster Infusion System is substantially equivalent in intended 1.2.2 use to the Pain Control Infusion Pump (PCIP) (K896422) distributed by Sgarlato Laboratories, Inc.
- The Sgarlato PCIP kit contains an infusion pump produced 1.2.2.1 by Burron/B. Braun, B. Braun catheter and Jelco needle.
- The catheter and needle included in the PainBuster kit are 1.2.2.2 separately purchased pre-amendment or 510(k) devices similar to the devices in the Sgarlato PCIP kit.
- An example of the catheter included in the 1.2.2.2.1 PainBuster kit is the B. Braun Perifix® Epidural Catheter Set.
- 1.2.2.2.2 An example of the needle included in the PainBuster kit is the Jelco™ Catheter Introducer Needle.
- The PainBuster pump is substantially 1.2.2.2.3 equivalent to the Homepump C-Series (K944692) and Homepump Eclipse (K932740) marketed by I-Flow Corporation.
- 1.2.2.3 The PainBuster pump's design is nearly identical to the original Homepump C-Series, see section 2.1 below.

# PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.0

# 2.1 Description of Device

- 2.1.1 The PainBuster Infusion System is a kit that is comprised of an elastomeric infusion pump, a catheter and a needle.

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- The PainBuster pump is the Homepump C-Series with a new intended 2.1.2 use. The pump design is identical to the original Homepump C-Series except as follows:
- The PainBuster pump utilizes the same soft PVC shell that 2.1.2.1 the Homepump Eclipse uses.
- The two (2) outer natural latex bladders have been replaced 2.1.2.2 by a single thicker natural latex bladder.
- The PainBuster pump is intended to be used with a catheter 2.1.2.3 that is included with the kit.

# Product Configuration 2.2

- 2.2.1 Models
- 2.2.1.1 P065005: 65 ml volume, 0.5 ml/hr flow rate
- P125015: 125 ml volume, 1.5 ml/hr flow rate 2.2.1.2
- P125020: 125 ml volume, 2.0 ml/hr flow rate 2.2.1.3
- Each model consists of a kit with the following components: 2.2.2
- (1) PainBuster pump. 2.2.2.1
- 2.2.2.2 (1) Catheter
- 2.2.2.2.1 20 G catheter, 11 to 40 in. length, polyamide or nylon or FEP (fluorinated ethylene propylene) polymer.
- A catheter connector is included to connect the 2.2.2.2.2 catheter to the distal luer of the administration set.
- The B. Braun Perifix® Epidural Catheter Set is 2.2.2.2.3 an example of the type of catheter that may be used with the PainBuster Infusion System.
- 2.2.2.2.3.1 Product code: EC20-0
- 510(k) number: K813186 2.2.2.2.3.2

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- 2.2.2.3 (1) Needle: 14 to 18G, 1 ½ to 2 ¼ in. length, stainless 2.2.2.3.1 steel. The needle may be a catheter over needle as
- 2.2.2.3.2 in the Jelco™ example below.
- The Jelco™ Catheter Introducer Needle is an 2.2.2.3.3 example of the type of catheter introducer needle that may be used with the PainBuster Infusion System.

Product code: 4058 2.2.2.3.3.1

(1) Directions for Use (DFU) 2.2.2.4

#### 2.3 Components and Materials

All the components used in the PainBuster pump are identical to those used in the Homepump Eclipse or Homepump C-Series.

The PainBuster Infusion System is a disposable device intended for single use.

#### OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

#### 3.1 Standard Operating Conditions:

| Priming Volume: | less than 5.0 ml |
|------------------------|---------------------------------|
| Residual Volume: | less than 5.0 ml |
| Operating Temperature: | 31°C (skin temperature) |
| Test Solution: | 0.9% NaCl |
| Operating Pressure: | 9 to 14 psi |
| Head Height: | 16" |
| Accuracy: | ±15% at 95% confidence interval |

- Flow Rate Performance Data: Testing occurred at 31°C and at the nominal 3.2 head height of 16".

| | 65ml x<br>0.5ml/hr | 125ml x<br>2.0ml/hr |
|-------------------|--------------------|---------------------|
| Average Flow Rate | 0.48 ml/hr | 1.98 ml/hr |
| Std. Dev. | 0.02 | 0.05 |
| n | 27 | 26 |

65ml x 0.5ml/hr: A twenty seven (27) piece sample produced an average flow rate of 0.48 ml/hr. The resulting average is well within it's ±15% accuracy claim. The fastest infusion had an average flow rate of 0.53 ml/hr and the slowest infusion had an average flow rate of 0.41 ml/hr.

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125ml x 2.0ml/hr: A twenty six (26) piece sample produced an average flow rate of 1.98 ml/hr. The resulting average is well within it's ±15% 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 1.83 ml/hr.

- Back Pressure Comparison: Testing was performed on the Homepump 3.3 Eclipse 65ml x 0.5ml/hr and 100ml x 2.0ml/hr to determine the effects of back pressure on the flow rate. Testing occurred at the nominal head height of 16", at a head height of 42" and at 3.1 psi. Ten samples at each back pressure were tested. The test results for flow rate at each pressure for each product are summarized in the following table.

| | 65ml x 0.5ml/hr | | | 100ml x 2.0ml/hr | | |
|---------------------------|-----------------|--------|---------|------------------|--------|---------|
| Test Pressure | 16" HH | 42" HH | 3.1 psi | 16" HH | 42" HH | 3.1 psi |
| Average Flow Rate (ml/hr) | 0.51 | 0.49 | 0.45 | 1.96 | 1.77 | 1.79 |
| Std. Dev. | 0.03 | 0.02 | 0.03 | 0.09 | 0.08 | 0.08 |
| n | 15 | 10 | 10 | 15 | 15 | 15 |

The average decrease in flow rates produced by the increased back pressure is as expected.

- 3.4 Drug Delivery Comparison: The Homepump Eclipse 65ml x 0.5ml/hr has been tested to assess how a 5% Dextrose solution affects flow rate. The performance of the system is affected by the viscosity or density of a solution. The flow rate was measured at 31°C. The resulting data is presented below.
Note: Local anesthetics have densities similar to normal saline (e.g. 1.0035 for Bupivacaine).

| | Saline | 65ml x 0.5ml/hr |
|---------------------------|-------------|-----------------|
| | 5% Dextrose | |
| Average Flow Rate (ml/hr) | 0.49 | 0.46 |
| Std.Dev. | 0.02 | 0.02 |
| n | 30 | 15 |

65ml x 0.5ml/hr: The 5% Dextrose solution flow rate was 6% slower than the normal saline solution.

Product labeling includes a statement as to delivery times and the possible deviation from nominal.

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- Catheters and PICC Lines: The Homepump Eclipse 65ml x 0.5ml/hr has been 3.5 tested to assess how a 20 G x 60 cm PICC line and 23 G x 28 cm epidural catheter affects flow rate. The tests were performed at room temperature and 31°C at the nominal head height of 16". The results are summarized in the table below.

| | | Average<br>(ml/hr) | Std Dev. | Maximum<br>(ml/hr) | Minimum<br>(ml/hr) |
|----------------------|------------|--------------------|----------|--------------------|--------------------|
| PICC Line | Room Temp. | 0.41 | 0.02 | 0.44 | 0.39 |
| | 31°C | 0.51 | 0.03 | 0.58 | 0.48 |
| Epidural<br>Catheter | Room Temp. | 0.38 | 0.04 | 0.45 | 0.32 |
| | 31°C | 0.53 | 0.02 | 0.56 | 0.49 |

The PICC line and epidural catheter had no effect on flow.

# BIOLOGICAL SPECIFICATIONS 4.0

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

- 5.1 Compatibility
- There are no specific druqs referenced in the labeling for the PainBuster 5.1.1 Infusion System.
- 5.1.2 The PainBuster Infusion System is intended for use with general local anesthetics.

# 6.0 INTENDED USE

- The PainBuster is intended to provide continuous infusion of a local anesthetic 6.1 directly into the intraoperative site for postoperative pain management.
- 6.2 The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
- 6.3 The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
- 6.4 The PainBuster is single use only.
- 6.5 No testing has been conducted to determine the efficacv of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN.
- 6.6 The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

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# 7.0 PACKAGING

- The PainBuster kit components are packaged individually in either sterile Tyvek® 7.1 pouches or sterile Form/Fill/Seal trays. The components of the kit are packaged in a sealed tray.
- Packaging is suitable for either radiation or ETO sterilization. 7.1.1

# 8.0 STERILIZATION INFORMATION

Note: The catheter and needle components of the PainBuster Infusion System may be purchased non-sterile and packaged by I-Flow or sterile from the manufacture. The PainBuster pump and non-sterile purchased components shall be sterilized as follows:

- The methods of sterilization are gamma radiation (Cobalt 60) or ETO gas. 8.1

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# COMPARISON TO LEGALLY MARKETED DEVICE 9.0

Note: The following summarizes the similarities and differences of the PainBuster Infusion System versus its predicate devices.

| Homepump C-Series<br>(K944692) | SE¹ Homepump Eclipse<br>(K932740) | SE¹ PCIP (K896422) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Infusion use. | General infusion use. | To provide continuous infusion of<br>a local anesthetic directly into the<br>surgical wound site for<br>postoperative pain management. |
| I.V., intra-arterial,<br>or subcutaneous | Intravenous | Percutaneous |
| Pain management,<br>therapy, ambulatory, home | Primarily ambulatory, home<br>therapy. | Primarily pain management,<br>ambulatory, home therapy. |
| Not intended for blood, blood<br>or TPN. | Not intended for delivery of blood,<br>blood products or TPN. | Not intended for rapid infusions.<br>Not intended for intravenous<br>infusion. |
| Disposable, Single Use Only | Disposable, Single Use Only | Disposable, Single Use Only |
| Sold empty and capable of being<br>filled via a fill port. | Sold empty and capable of being<br>filled via a fill port. | Sold empty and capable of being<br>filled via a fill port. |
| 50 ml/hr | 50, 75, 100, 150 or 200 ml/hr | 0.5, 1.0 or 2.0 ml/hr |
| Elastomeric Pump | Elastomeric Pump | Spring Driven Syringe Pump |
| Constant pressure is applied to<br>reservoir. | None | None |
| Constant pressure is applied to<br>the fluid reservoir. | Constant pressure is applied to<br>the fluid reservoir. | |
| Strain energy of elastomeric<br>membranes | Strain energy of elastomeric<br>membranes | Compression spring |
| Thermoplastic (Krayton)<br>elastomeric membrane | Thermoplastic (Krayton)<br>elastomeric membrane | Polypropylene plastic syringe |
| Integrated, flow control tubing | Integrated, flow control tubing | Integrated, flow 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>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. |
| Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied with<br>a clamp to stop the infusion if<br>necessary. | Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied with<br>a clamp to stop the infusion if<br>necessary. | Fixed flow rate tubing prevents<br>fluid runaway conditions. Each<br>administration set is supplied with<br>a clamp to stop the infusion if<br>necessary. |

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1998

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

Re : K980558 PainBuster Infusion System Trade Name: Regulatory Class: II Product Code: MEB Dated: April 27, 1998 Received: April 28, 1998

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 legally marketed predicate 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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Bard

through 542 of the Act for devices under the Electronic chrough J42 OF the not 10 provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in your in your alence of your device to a legally marketed predicate device results in a classification for your marketed predicate actres 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 compreation 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"(21CFR 807.97). Other qeneral 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/dsma/dsmamain /html".

Sincerely yours

Timothy P. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/10/Picture/0 description: The image shows the logo for I-FLOW. The logo is in black and white and features the text "I-FLOW" in a stylized font. The letters are outlined and have a rounded appearance. The logo is enclosed in a rounded rectangle.

CORPORATION

20202 Windrow Drive Lake Forest, CA 92630 [phone] [phone] Fax [phone]

510(k) Number (if known): 17980558

Device Name: PainBuster™ Infusion System

# Indications for Use:

- 1. The PainBuster is intended to provide continuous infusion of a local anesthetic directly into the intraoperative (soft tissue / body cavity) site for postoperative pain management.
- 2. The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
- 3. The PainBuster is single use only.
- 4. The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
- 5. The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
- 6. The PainBuster is not intended for chemotherapy drugs.
- 7. No testing has been conducted to determine the efficacy of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUED ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use __

Patricio Vicente

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

(Optional Format 1-2-96)