PAINBUSTER INFUSION KIT

K982946 · I-Flow Corp. · MEB · Nov 18, 1998 · General Hospital

Device Facts

• Record ID: K982946
• Device Name: PAINBUSTER INFUSION KIT
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: Nov 18, 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 an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous and subcutaneous infusion.

Device Story

PainBuster Infusion Kit is a single-patient-use, disposable elastomeric infusion pump system. It delivers local anesthetic continuously to surgical sites for postoperative pain management. The device consists of an elastomeric pump (K944692) and kit components (catheter, needle, syringe, dressing, tape, gauze, carry case, Y-adapter, Power Ring, and E-Clip). Operation relies on the strain energy of elastomeric membranes to provide constant pressure to the fluid reservoir, forcing fluid through flow-control tubing. It is used in hospital, home, or alternative care settings by clinicians or patients. The device lacks electronic components, alarms, or indicators; flow is regulated by fixed-rate tubing. Healthcare providers use the device to provide localized pain relief, potentially reducing systemic analgesic requirements. The kit is supplied sterile (gamma or ETO) or non-sterile for assembly.

Clinical Evidence

Bench testing only. Performance data for various models (50-270 ml volumes; 0.5-10 ml/hr flow rates) demonstrated average flow rates within ±15% accuracy at 31°C using 0.9% NaCl. Sample sizes ranged from n=6 to n=46 per model. No clinical trials were conducted.

Technological Characteristics

Elastomeric infusion pump; thermoplastic (Krayton) elastomeric membrane reservoir; flow-control tubing; non-electronic; no power source. Dimensions vary by model (50-270 ml). Sterilization via gamma radiation or ETO gas. Materials conform to ISO 10993-1.

Indications for Use

Indicated for postoperative pain management in patients undergoing general surgery. Provides continuous infusion of local anesthetic into intraoperative sites, percutaneously, or subcutaneously. Contraindicated for intravenous, intra-arterial, or epidural delivery; not for delivery of blood, blood products, lipids, or fat emulsions.

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

• PainBuster Infusion System (K980558)
• Pain Control Infusion Pump (PCIP) (K896422)
• Homepump C-Series (K944692)

Submission Summary (Full Text)

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K982946

Image /page/0/Picture/1 description: The image shows the date "NOV 1 8 1998". The month is November, the day is the 8th, and the year is 1998. The text is in a bold, sans-serif font. The text is black on a white background.

I·FLOW I-FLOW CORPORATION

20202 Windrow Drive Lake Forest. CA 92630 [phone] : 714) 206-2700 Fax [phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS

August 19, 1998

Trade Name: PainBuster Infusion Kit Common Name: Elastomeric Infusion Pump Kit 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

#### 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 an extension to the current PainBuster product line, including labeling changes and additional models and components.
- All models previously submitted under K980558 are included 1.1.1.1 under this premarket notification.
- Trade Name: PainBuster™ Infusion Kit 1.1.2
- 1.1.3 Common Name: Elastomeric Infusion Pump Kit
- Classification Name: Pump, Infusion, Elastomeric 1.1.4
- Classification Panel: General Hospital and Personal Use Device 1.1.5

#### 1.2 Statement of Equivalence

- The PainBuster Infusion Kit includes components that are legally 1.2.1 marketed (either pre-amendment devices or devices that have been aranted permission to market via premarket notification regulation).
- 1.2.2 The PainBuster pump is an additional model to the Homepump elastomeric infusion pumps marketed by I-Flow Corporation (C-Series -K944692 and Eclipse - K932740).
- 1.2.3 The PainBuster Kit is substantially equivalent to the PainBuster Infusion System (K980558) marketed by I-Flow Corporation and the Pain Control Infusion Pump (PCIP) (K896422) marketed by Sgarlato Laboratories, Inc.

#### 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS

#### 2.1 Description of Device

- 2.1.1 The PainBuster Infusion Kit is nearly identical to the PainBuster Infusion System (K980558) marketed by I-Flow Corporation except for some labeling changes and the addition of new models and optional components.
- 2.1.2 The kit is comprised of an elastomeric infusion pump (K944692) and various kit components such as catheter, needle, syringe, dressing, tape, gauze, carry case, Y Adapter, Power Ring and clothing attachment clip (E-Clip).
- The Sgarlato kit contains all the above components except 2.1.2.1 for the Power Ring and clothing attachment clip.
- 2.1.2.2 The original PainBuster Infusion System contained the pump, catheter and needle.

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- The PainBuster pump is intended to attach to the kit catheter at the 2.1.3 distal end of the administration set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management.
- The PainBuster is single patient use only. 2.1.4
- The PainBuster is suitable for use as an ambulatory device and is 2.1.5 intended for use in the hospital, home environment or alternative care sites.
- See Appendix A for drawings and Appendix B and C for labeling of the 2.1.6 PainBuster Infusion Kit.

#### 2.2 Product Configuration

See Appendix A for drawings and Appendix B and C for labeling.

- The following additional PainBuster models will be available: 2.2.1
- P060020: 50/65 ml volume, 2.0 ml/hr flow rate 2.2.1.1
- 2.2.1.2 P110005: 1|00/125 ml volume, 0.5 ml/hr flow rate
- P125050: 100/125 ml volume, 5.0 ml/hr flow rate 2.2.1.3
- P270010: 250/270 ml volume, 1.0 ml/hr flow rate 2.2.1.4
- P270020: 250/270 ml volume, 2.0 ml/hr flow rate 2.2.1.5
- P270050: 250/270 ml volume, 5.0 ml/hr flow rate 2.2.1.6
- P270100: 250/270 ml volume, 10.0 ml/hr flow rate 2.2.1.7
- P270050Y: 250/270 ml volume, 5.0 ml/hr flow rate, dual 2.2.1.8 catheter with Y adapter.
- 2.2.2 The following models were previously submitted under K980558.
- P065005: 50/65 ml volume, 0.5 ml/hr flow rate 2.2.2.1
- P125015: 100/125 ml volume, 1.5 ml/hr flow rate 2.2.2.2
- P125020: 1|00/125 ml volume, 2.0 ml/hr flow rate 2.2.2.3
- Each model above contains a variable fill volume designated by the 2.2.3 slash between the two numbers. For example, model P060020 may be marketed as a 60 ml volume, 2.0 ml/hr flow rate. Alternatively, I-Flow may market the device as a 50 ml volume or 65 ml volume in which case the model number would be P050020 or P065020 respectively.
- Models with flow rates from 0.5 ml/hr to 2 ml/hr are for small wound 2.2.4 sites while flow rates from 5 ml/hr to 10 ml/hr are for larger wounds.
- Each model consists of a kit with the following components: 2.2.5
- 2.2.5.1 PainBuster pump.

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- The Kling® Conforming Gauze manufactured 2.2.4.11.2 by Johnson and Johnson is an example of the type of gauze which may be used in the PainBuster Kit.
Model number: JJ6923 2.2.4.11.2.1

- Power Ring (optional): 2.2.4.12
- The Power Ring manufactured by I-Flow 2.2.4.12.1 Corporation is fitted over the syringe to ease filling the pump. See schematic in Appendix A.

#### 2.3 Components and Materials

All the pumps used in the PainBuster Kit are currently available models of the Homepump C-Series (K944692).

All the components used in the PainBuster pump are identical to those used in the original PainBuster submitted under K980558.

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

# OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

#### Standard Operating Conditions: 3.1

| Priming/Residual Volume (ml): | <= 9 270 ml Vol |
|-------------------------------|--------------------------------------|
| | <= 4 125 ml Vol |
| | <= 3 65 ml Vol |
| Operating Temperature | 31°C (skin temperature) |
| Test Solution: | 0.9% NaCl |
| Operating Pressure: | 9 to 14 psi |
| Head Height: | 16" |
| Accuracy: | $\pm$ 15% at 95% confidence interval |

- Flow Rate Performance Data: Testing occurred at 31°C, at the nominal head 3.2 height of 16", using normal saline (0.9% NaCl). Testing occurred at nominal fill volume for each models produced an average flow rate well within the ±15% accuracy claim.

| | 60 ml x 2<br>ml/hr | 110 ml x<br>0.5 ml/hr | 125 ml x 5<br>ml/hr | 270 ml x 1<br>ml/hr | 270 ml x 2<br>ml/hr | 270 ml x 5<br>ml/hr | 270 ml x<br>10 ml/hr |
|------------------------------|--------------------|-----------------------|---------------------|---------------------|---------------------|---------------------|----------------------|
| Average Flow<br>Rate (ml/hr) | 1.80 | 0.48 | 4.74 | 1.01 | 2.03 | 4.52 | 10.8 |
| Std. Dev. | 0.10 | 0.02 | 0.16 | 0.03 | 0.08 | 0.13 | 0.3 |
| n | 15 | 46 | 29 | 33 | 35 | 12 | 6 |

60 ml x 2 ml/hr: A fifteen (15) piece sample produced an average flow rate of 1.80 ml/hr. The fastest infusion had an average flow rate of 1.99 ml/hr and the slowest infusion had an average flow rate of 1.65 ml/hr.

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110 ml x 0.5 ml/hr: A forty six (46) piece sample produced an average flow rate of 0.48 ml/hr. The fastest infusion had an average flow rate of 0.53 ml/hr and the slowest infusion had an average flow rate of 0.45 ml/hr.

125 ml x 5 ml/hr: A twenty nine (29) piece sample produced an average flow rate of 4.74 ml/hr. The fastest infusion had an average flow rate of 5.16 ml/hr and the slowest infusion had an average flow rate of 4.37 ml/hr.

270 ml x 1 ml/hr: A thirty three (33) piece sample produced an average flow rate of 1.01 ml/hr. The fastest infusion had an average flow rate of 1.07 ml/hr and the slowest infusion had an average flow rate of 0.94 ml/hr.

270 ml x 2 ml/hr: A thirty five (35) piece sample produced an average flow rate of 2.03 ml/hr. The fastest infusion had an average flow rate of 2.17 ml/hr and the slowest infusion had an average flow rate of 1.84 ml/hr.

270 ml x 5 ml/hr: A twelve (12) piece sample produced an average flow rate of 4.52 ml/hr. The fastest infusion had an average flow rate of 4.8 ml/hr and the slowest infusion had an average flow rate of 4.3 ml/hr.

270 ml x 10 ml/hr: A six (6) piece sample produced an average flow rate of 10.8 ml/hr. The fastest infusion had an average flow rate of 11.3 ml/hr and the slowest infusion had an average flow rate of 10.5 ml/hr.

- Back Pressure (Head Height) Comparison: Approximately 0.57 psi pressure 3.3 difference results per 16" head height. Thus, a 5.7% flow rate change may occur for each 16" head height difference from nominal assuming a 10 psi average bladder pressure of the pump.
- 3.4 Drug Delivery Comparison: Local anesthetics have densities similar to normal saline (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.

## 3.5 Safety / Alarm Functions

- The PainBuster pump provides a continuous fixed flow and as such is 3.5.1 not subject to fluid runaway conditions similar to that of some electronic pumps.
- 3.5.2 The PainBuster pump will not be recommended for any application that exceeds the minimum internal pressure of the system.
- 3.5.3 If for any reason the patient needs to stop his or her infusions, each administration set is supplied with a pinch clamp to stop the infusion.
- 3.5.4 This device contains no alarms or indicators for flow other than visual.
- 3.5.5 This device contains no alarms or indicators to detect air in line or an occlusion.

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#### BIOLOGICAL SPECIFICATIONS 4.0

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

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

#### INTENDED USE 6.0

- The PainBuster is intended to provide continuous infusion of a local anesthetic 6.1 directly into the intraoperative site for general surgery for postoperative pain management.
- Additional routes of administration include percutaneous and subcutaneous 6.2 infusion.
- 6.3 The PainBuster is not intended for intravenous, intra-arterial or epidural drug delivery.
- 6.4 The PainBuster is single patient use only.
- No testing has been conducted to determine the efficacy of the PainBuster for 6.5 the delivery of blood, blood products, lipids or fat emulsions. The PainBuster is not intended for the delivery of blood, blood products, lipids or fat emulsions.
- The PainBuster is suitable for use as an ambulatory device and is intended for 6.6 use in the hospital, home environment or alternative care sites.

## 7.0 PACKAGING

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

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# STERILIZATION INFORMATION 8.0

Note: The kit components of the PainBuster Infusion Kit 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 Element | PainBuster Infusion Kit<br>(subject device) | SE1 PainBuster Infusion System<br>(K980558) | SE1 Sgarlato PCIP<br>(K896422) | SE1 Homepump C-Series<br>(K944692) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To provide continuous infusion of<br>a local anesthetic directly into the<br>intraoperative site for general<br>surgery for postoperative pain<br>management. | To provide continuous infusion of<br>a local anesthetic directly into the<br>intraoperative site for<br>postoperative pain management. | To provide continuous infusion of<br>a local anesthetic directly into the<br>surgical wound site for<br>postoperative pain management. | General infusion use. |
| Route of Administration | Percutaneous and subcutaneous | Percutaneous | Percutaneous, subcutaneous and<br>epidural | Intravenous, intra-arterial,<br>epidural or subcutaneous |
| Specific Use | Pain management | Pain management | Primarily pain management,<br>ambulatory, home therapy. | Primarily pain management,<br>chemotherapy, ambulatory, home<br>therapy. |
| Contraindications | Not intended for intravenous,<br>intra-arterial or epidural drug<br>delivery. Not intended for delivery<br>of blood, blood products, lipids or<br>fat emulsions. | Not intended for vascular or<br>epidural drug delivery. Not<br>intended for delivery of blood,<br>blood products or TPN. | Not intended for rapid infusions.<br>Not intended for intravenous<br>infusion. | Not intended for blood, blood<br>products or TPN. |
| Reuse Capability | Disposable, Single Patient Use<br>Only | Disposable, Single Use Only | Disposable, Single Use Only | Disposable, Single Use Only |
| Description | 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. | Sold empty and capable of being<br>filled via a fill port. |
| Fill Volumes | 50 to 270 ml | 50 to 125 ml | 50 to 100 ml | 50 to 500 ml |
| Flow Rates | 0.5, 1.0, 1.5, 2.0, 5.0 or 10.0 ml/hr | 0.5, 1.5 or 2.0 ml/hr | 0.5, 1.0 or 2.0 ml/hr | 0.5 to 500 ml/hr |
| Pump Type | Elastomeric Pump | Elastomeric Pump | Spring Driven Syringe Pump | Elastomeric Pump |
| Power Requirements | 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. |
| Pressure Source | Strain energy of elastomeric<br>membranes | Strain energy of elastomeric<br>membranes | Compression spring | Strain energy of elastomeric<br>membranes |
| Fluid Reservoir | Thermoplastic (Krayton)<br>elastomeric membrane | Thermoplastic (Krayton)<br>elastomeric membrane | Polypropylene plastic syringe | Thermoplastic (Krayton)<br>elastomeric membrane |
| Administration Set | Integrated, flow control tubing | Integrated, flow control tubing | Integrated, flow control tubing | Integrated, flow control tubing |
| 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. |
| Safety / Alarm Functions | 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. | 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. |

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and the consideration of

:

'SE = Substantially Equivalent

-----

and to 27 apped

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Image /page/8/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with three human profiles embedded within the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

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

Re : K982946 PainBuster Infusion Kit Trade Name: Unclassified Requlatory Class: Product Code: MEB August 20, 1998 Dated: Auqust 21, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory action. In addition, FDA may publish further announcements 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 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 leqally 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 requlation (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

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

Enclosure

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K982946

Revised Indications for Use (Nov. 9, 1998)

510(k) Number (if known): ___K982946

Device Name: _ PainBuster™ Infusion Kit

# Indications for Use:

1. The PainBuster 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 and subcutaneous infusion.

(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
Patricia Gro

Over-The-Counter Use

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

(Optional Format 1-2-96)

510(k) Number 1982946