(278 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of the pump, with no mention of AI or ML capabilities.
Yes
The device is intended for the infusion of medications for pain management, chemotherapy, and antibiotic delivery, which are therapeutic interventions. Its stated purpose to "significantly decrease narcotic use and pain" also directly points to a therapeutic effect.
No
Explanation: The device is an infusion pump designed for delivering medications, not for diagnosing medical conditions. Its purpose is therapeutic, not diagnostic.
No
The device description clearly outlines physical components like an elastomeric pressure source, administration set, tubing, filters, and connectors, indicating it is a hardware device.
Based on the provided information, the I-Flow Elastomeric Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the infusion of medications into the body via various routes (intravenous, subcutaneous, epidural, etc.). This is a therapeutic or drug delivery function.
- Device Description: The description details a mechanical pump that delivers fluid. It does not describe any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to diagnose, monitor, or screen for diseases or conditions by examining samples in vitro.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The I-Flow Elastomeric Pump's function is to deliver substances into the body, not to analyze substances from the body.
N/A
Intended Use / Indications for Use
The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain management. Routes of administration include intravenous, subcutaneous and epidural.
The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites (infiltration), percutaneous and epidural.
The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management.
The indications for use include hospital, alternate care, ambulatory and home environments.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow generated by the pressurized bladder. The pre-attached administration set may incorporate any of the following components:
• Y-tubing for multi-site delivery (single or dual)
• Air and particulate eliminating filter
• Flow Restrictor
• Luer Connector
The pump may be sold as a kit with additional devices or accessories such as the following: catheter, introducer needle, syringe, and E-clip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surgical Site or Nerve Block (for ON-Q Pain Relief System/ON-Q PainBuster)
perineural (nerve block), into intraoperative sites (infiltration), percutaneous and epidural (for infusion of medication for local or regional anesthesia and pain management)
surgical wound sites or close proximity to nerves (for delivery of local anesthetics)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, alternate care, ambulatory and home environments.
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)
Testing of the I-Flow Silicone/Non-DEHP Elastomeric Pump was conducted, including performance, biocompatibility, and chemical characterization testing. A Clinical Evaluation was determined not to be required; however, a simulated use study of human factors was conducted with intended users in the intended use environment that evaluated device performance, possible use error and user perception of difficulties with pump use. The study assessed the critical tasks or use scenarios where use related errors are most likely to occur.
A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing.
Results of design verification and validation testing demonstrated that the 1-Flow Silicon/Non-DEHP Elastomeric Pump functions as designed and can be operated by the user as intended through the user interface and instuctions provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
FEB - 3 2014
510(k) Summary
| 5. 510(k) Summary | |
|---|---|
| Table 5-1 510(k) Summary Table | |
| Submitter: | I-Flow, LLC |
| 43 Discovery, Suite 100 | |
| Irvine, CA 92618 | |
| Contact: | Shelly Harris |
| Regulatory Affairs Manager | |
| I-Flow, LLC |
Tel: (949) 923-2400
Fax: (949) 923-2401
Email: shelly.harris@kcc.com |
| Trade
Names: | ON-Q Pain Relief System, ON-Q PainBuster, ON-Q C-bloc, Homepump C-Series and Homepump Eclipse |
| Common
Name: | Elastomeric Infusion Pump |
| Existing /
Predicate
Devices: | I-Flow Elastomeric Pump
K063530
K052117 |
| Device
Changes: | This Traditional 510(k) submission proposes the following changes to incorporate:
Use a single Silicone bladder for the elastomeric pump. The predicate elastomeric pump consists of a dual Kraton (inner) and Latex (outer) bladder design configuration.
Components will not be manufactured or formulated with DEHP as a plasticizer.
For the low flow (i.e., 0.5 – 10 ml/hr) elastomeric pump models, the filter pore size was reduced from 1.2 micron to 0.22 micron to further enhance the elimination of particulate matter and air bubbles from the device. |
K131 249
Page 9 of 104
1
| Table 5-1 510(k) Summary Table | ||||||
|---|---|---|---|---|---|---|
| Device | ||||||
| Description: | Trade Name | Target Market | ||||
| Primary Application | ON-Q Pain Relief | |||||
| System/ON-Q PainBuster | ON-Q C bloc | Homepump Eclipse | Homepump | |||
| C-Series | ||||||
| Regional analgesia and anesthesia | Surgical Site | |||||
| or Nerve Block | Home infusion | |||||
| Antibiotics | Chemotherapy | |||||
| Device | ||||||
| Description | The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an | |||||
| integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure | ||||||
| source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow | ||||||
| generated by the pressurized bladder. The pre-attached administration set may incorporate any of the | ||||||
| following components: | ||||||
| • Y-tubing for multi-site delivery (single or dual) | ||||||
| • Air and particulate eliminating filter | ||||||
| • Flow Restrictor | ||||||
| • Luer Connector | ||||||
| The pump may be sold as a kit with additional devices or accessories such as the following: catheter, | ||||||
| introducer needle, syringe, and E-clip. | ||||||
| Approx. Deliver | ||||||
| Times | 1 - 5 days | 15 min - 5 hrs | 8 days | |||
| Indication | ||||||
| for Use: | The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain | |||||
| management. Routes of administration include intravenous, subcutaneous and epidural. | ||||||
| The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or | ||||||
| regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites | ||||||
| (infiltration), percutaneous and epidural. | ||||||
| The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local | ||||||
| anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management. | ||||||
| The indications for use include hospital, alternate care, ambulatory and home environments. |
Page 10 of 104
ge 10 of
.
2
| Table 5-1 | 510(k) Summary Table | ||
|---|---|---|---|
| Technology Comparison: | There is no change in fundamental scientific technology or principles of operation. The design remains the same as the predicate devices. | ||
| All the non-clinical data and tests (i.e., flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) performed, met the design requirements and acceptance criteria, thereby demonstrating substantial equivalence to the predicate devices. | |||
| Technology Characteristics | Drug reservoir material | Predicate Devices | New Pump |
| Administration set | Dual bladder: | ||
| Latex Outer bladder | |||
| Kraton Inner bladder (fluid contact) | |||
| Di(2-ethylhexhyl) phthalate (DEHP) | |||
| Plasticized Polyvinyl Chloride (PVC) | |||
| DEHP plasticized PVC | Single bladder: | ||
| Single layer silicone | |||
| Trioctyl Trimellitate | |||
| (TOTM) plasticized PVC | |||
| Di(2-ethylhexyl) terephthalate | |||
| (DEHT) plasticizer PVC | |||
| Bag, 100ml ON-Q, Radio Frequency (RF) | |||
| Seal w/Vent (non-fluid path) | |||
| Inline Filter | 1.2 micron size filter, air eliminating | 0.22 micron, | |
| air-eliminating filter | |||
| Performance Data | Testing of the I-Flow Silicone/Non-DEHP Elastomeric Pump was conducted, including performance, biocompatibility, and chemical characterization testing. A Clinical Evaluation was determined not to be required; however, a simulated use study of human factors was conducted with intended users in the intended use environment that evaluated device performance, possible use error and user perception of difficulties with pump use. The study assessed the critical tasks or use scenarios where use related errors are most likely to occur. |
A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing.
Results of design verification and validation testing demonstrated that the 1-Flow Silicon/Non-DEHP Elastomeric Pump functions as designed and can be operated by the user as intended through the user interface and instuctions provided. | | |
:
.
.
Page 11 of 104
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3
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2014
Shelly Harris Regulatory Affairs Manager I-Flow, LLC 20202 Windrow Drive Lake Forest, California 92630
Re: K131249
Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: December 31, 2013 Received: January 2, 2014
Dear Ms. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Harris
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
-s FDA
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
510(k) Number (if known) K131249
Device Name I-Flow Elastomeric Pump
Indications for Use (Describe)
The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, and pain management. Routes of administration include intravenous, subcutaneous, and epidural.
The I-Flow Elastomeric Pump is also infusion of medication (such as local anestheirs or narcotics) for tocal or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into interoperative sites (infiltration), percutaneous and epidural.
The I-Fiow Elastomeric Punp is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared to narcolic-only pain management.
The indications for use include hospital, alternate care, ambulatory and home environments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
7
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