(89 days)
No
The description focuses on a mechanical elastomeric infusion pump and kit components, with no mention of AI/ML capabilities or data processing for decision-making.
Yes
The device is intended to provide continuous infusion of a local anesthetic for postoperative pain management, which is a therapeutic purpose.
No
The device is an infusion pump designed to deliver local anesthetic for pain management, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is comprised of an elastomeric infusion pump and various kit components, which are hardware.
Based on the provided information, the PainBuster is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The PainBuster is intended to deliver a local anesthetic directly into a patient's body for pain management. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is an infusion pump and associated components designed to administer medication. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PainBuster's function falls outside of this definition.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
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. 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 for the Power Ring and clothing attachment clip. The original PainBuster Infusion System contained the pump, catheter and needle.
The PainBuster pump is intended to attach to the kit catheter at the 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. The PainBuster is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative (soft tissue / body cavity) site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, home environment or alternative care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Flow Rate Performance Data: Testing occurred at 31°C, at the nominal head 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 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.
- 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.
Key Results: All flow rates were within +/- 15% accuracy claim.
Back Pressure (Head Height) Comparison: Approximately 0.57 psi pressure 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ± 15% at 95% confidence interval
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 (800) 448-3569 : 714) 206-2700 Fax (714) 206-2600
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: 949.206.2700 Fax: 949.206.2600
1
GENERAL INFORMATION 1.0
1.1 Purpose of Submission
- This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market 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.
2
- 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.
3
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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): |