(104 days)
- 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.
- The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
- The PainBuster is single use only.
- 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.
- The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
- The PainBuster is not intended for chemotherapy drugs.
- 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.
The PainBuster Infusion System is a kit that is comprised of an elastomeric infusion pump, a catheter and a needle. The PainBuster pump is the Homepump C-Series with a new intended 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 the Homepump Eclipse uses. The two (2) outer natural latex bladders have been replaced by a single thicker natural latex bladder. The PainBuster pump is intended to be used with a catheter that is included with the kit.
The provided document describes the I-Flow PainBuster Infusion System. This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel acceptance criteria.
The acceptance criteria primarily relate to the device's operational specifications, particularly its flow rate accuracy. The study demonstrating that the device meets these criteria is an engineering performance test rather than a clinical study involving human patients or ground truth established by experts.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Operational Specification) | Reported Device Performance (PainBuster Pump) |
|---|---|
| Accuracy: ±15% at 95% confidence interval (for flow rate) | 65ml x 0.5ml/hr model: Average flow rate 0.48 ml/hr (well within ±15% of 0.5 ml/hr nominal) |
| 125ml x 2.0ml/hr model: Average flow rate 1.98 ml/hr (well within ±15% of 2.0 ml/hr nominal) | |
| Priming Volume: less than 5.0 ml | (Not explicitly stated in performance data, but listed as standard operating condition) |
| Residual Volume: less than 5.0 ml | (Not explicitly stated in performance data, but listed as standard operating condition) |
| Operating Temperature: 31°C (skin temperature) | Testing occurred at 31°C |
| Test Solution: 0.9% NaCl | Testing occurred with 0.9% NaCl, and also compared against 5% Dextrose. |
| Operating Pressure: 9 to 14 psi | (Not explicitly tested for flow rate, but back pressure comparison tests were done on predicate device) |
| Head Height: 16" | Testing occurred at nominal head height of 16" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Flow Rate Performance Data (Test Set):
- 65ml x 0.5ml/hr model: 27 units
- 125ml x 2.0ml/hr model: 26 units
- Sample Size for Back Pressure Comparison (on Homepump Eclipse, a predicate device):
- 65ml x 0.5ml/hr model: 15 units at 16" HH, 10 units at 42" HH, 10 units at 3.1 psi
- 100ml x 2.0ml/hr model: 15 units at 16" HH, 15 units at 42" HH, 15 units at 3.1 psi
- Sample Size for Drug Delivery Comparison (on Homepump Eclipse, a predicate device):
- Saline: 30 units
- 5% Dextrose: 15 units
- Sample Size for Catheter/PICC Line Effects (on Homepump Eclipse, a predicate device):
- PICC Line (Room Temp): Not specified per test, but maximum/minimum/std dev suggest multiple runs/samples
- PICC Line (31°C): Not specified per test
- Epidural Catheter (Room Temp): Not specified per test
- Epidural Catheter (31°C): Not specified per test
- Data Provenance: The data appears to be from prospective in-vitro engineering performance tests conducted by I-Flow Corporation. There is no information about the country of origin of the data, but it can be inferred that it was likely conducted in the US, given the company's address and the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is the physical performance of the device (flow rate, residual volume, etc.) determined through engineering measurements, not expert assessment of a condition.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This concept pertains to expert review of clinical cases. The tests described are objective engineering measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a diagnostic device involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the device itself (the infusion pump), which is what the engineering tests described in "Flow Rate Performance Data" and "Operational Specifications" represent. The device's performance is measured and compared against its defined accuracy criteria. Therefore, the standalone performance data is available.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used is the objective physical measurement of the device's operational parameters (e.g., actual flow rate per hour, volume, pressure) against predetermined engineering specifications and industry standards.
8. The Sample Size for the Training Set
Not applicable. This is an elastomeric infusion pump, not an AI/ML algorithm that requires a training set. The device is designed based on engineering principles and tested for its inherent physical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 (800) 448-3569 (714) 206-2700 Fax (714) 206-2600
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: 714.206.2700 Fax: 714.206.2600
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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 x0.5ml/hr | 125ml x2.0ml/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(ml/hr) | Std Dev. | Maximum(ml/hr) | Minimum(ml/hr) | ||
|---|---|---|---|---|---|
| PICC Line | Room Temp. | 0.41 | 0.02 | 0.44 | 0.39 |
| 31°C | 0.51 | 0.03 | 0.58 | 0.48 | |
| EpiduralCatheter | 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(K944692) | SE¹ Homepump Eclipse(K932740) | SE¹ PCIP (K896422) |
|---|---|---|
| Infusion use. | General infusion use. | To provide continuous infusion ofa local anesthetic directly into thesurgical wound site forpostoperative pain management. |
| I.V., intra-arterial,or subcutaneous | Intravenous | Percutaneous |
| Pain management,therapy, ambulatory, home | Primarily ambulatory, hometherapy. | Primarily pain management,ambulatory, home therapy. |
| Not intended for blood, bloodor TPN. | Not intended for delivery of blood,blood products or TPN. | Not intended for rapid infusions.Not intended for intravenousinfusion. |
| Disposable, Single Use Only | Disposable, Single Use Only | Disposable, Single Use Only |
| Sold empty and capable of beingfilled via a fill port. | Sold empty and capable of beingfilled via a fill port. | Sold empty and capable of beingfilled 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 toreservoir. | None | None |
| Constant pressure is applied tothe fluid reservoir. | Constant pressure is applied tothe fluid reservoir. | |
| Strain energy of elastomericmembranes | Strain energy of elastomericmembranes | Compression spring |
| Thermoplastic (Krayton)elastomeric membrane | Thermoplastic (Krayton)elastomeric membrane | Polypropylene plastic syringe |
| Integrated, flow control tubing | Integrated, flow control tubing | Integrated, flow control tubing |
| Consistent flow rate throughoutthe entire course of therapy isachieved by the combination ofconstant pressure and flowtubing. | Consistent flow rate throughoutthe entire course of therapy isachieved by the combination ofconstant pressure and flowcontrol tubing. | Consistent flow rate throughoutthe entire course of therapy isachieved by the combination ofconstant pressure and flowcontrol tubing. |
| Fixed flow rate tubing preventsfluid runaway conditions. Eachadministration set is supplied witha clamp to stop the infusion ifnecessary. | Fixed flow rate tubing preventsfluid runaway conditions. Eachadministration set is supplied witha clamp to stop the infusion ifnecessary. | Fixed flow rate tubing preventsfluid runaway conditions. Eachadministration set is supplied witha clamp to stop the infusion ifnecessary. |
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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 (301) 594-4692. Additionally, for questions on compreation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 (800) 448-3569 (714) 206-2700 Fax (714) 206-2600
510(k) Number (if known): 17980558
Device Name: PainBuster™ Infusion System
Indications for Use:
-
- 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.
-
- The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
-
- The PainBuster is single use only.
-
- 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.
-
- The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
-
- The PainBuster is not intended for chemotherapy drugs.
-
- 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)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).