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.

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.

AI/ML Overview

This is a 510(k) summary for a medical device called the I-Flow Elastomeric Pump, which is used for infusion of medications. The document describes the device, its intended use, and compares it to predicate devices. It also states that "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."

However, this document does not provide specific acceptance criteria or detailed study results. It only mentions that testing was conducted and met the acceptance criteria. It also mentions a simulated use study for human factors but doesn't provide details on its results in terms of concrete performance metrics.

Therefore,Based on the provided text, I cannot extract the detailed information requested regarding the acceptance criteria and study proving the device meets those criteria. The document states that testing was performed and met acceptance criteria, but it does not specify what those criteria are or present the results of the studies in a quantifiable manner.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states: "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," but it does not specify what those design requirements or acceptance criteria were (e.g., a specific percentage for flow rate accuracy). It also does not report the actual device performance numbers for these tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "non-clinical data and tests" and a "simulated use study of human factors," but it does not disclose the sample sizes for these tests or the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable / Cannot be provided. This device is an elastomeric infusion pump, not an AI/imaging device requiring expert ground truth for interpretation. The document does not mention any expert review or ground truth establishment in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Similar to point 3, this is not relevant for a physical medical device's performance testing described here.

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 an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI-assisted device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a physical device like an infusion pump, "ground truth" would relate to its physical performance metrics (e.g., actual flow rate against specified flow rate), not diagnostic interpretation. The document doesn't detail how these performance metrics were verified beyond stating they "met the design requirements and acceptance criteria."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary asserts that the device underwent various non-clinical tests (flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) and a human factors study, and that these met the design requirements and acceptance criteria. However, it does not provide the specific numerical acceptance criteria or the actual performance results from these tests. It acts as a summary rather than a detailed report of the testing.

Summary

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FEB - 3 2014

510(k) Summary

	5. 510(k) Summary
	Table 5-1 510(k) Summary Table
Submitter:	I-Flow, LLC43 Discovery, Suite 100Irvine, CA 92618
Contact:	Shelly HarrisRegulatory Affairs ManagerI-Flow, LLCTel: (949) 923-2400Fax: (949) 923-2401Email: shelly.harris@kcc.com
TradeNames:	ON-Q Pain Relief System, ON-Q PainBuster, ON-Q C-bloc, Homepump C-Series and Homepump Eclipse
CommonName:	Elastomeric Infusion Pump
Existing /PredicateDevices:	I-Flow Elastomeric PumpK063530 K052117
DeviceChanges:	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

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Table 5-1 510(k) Summary Table
DeviceDescription:	Trade Name	Target MarketPrimary Application	ON-Q Pain ReliefSystem/ON-Q PainBuster	ON-Q C bloc	Homepump Eclipse	HomepumpC-Series
		Regional analgesia and anesthesia	Surgical Siteor Nerve Block		Home infusion
					Antibiotics	Chemotherapy
	DeviceDescription	The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with anintegrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressuresource. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flowgenerated by the pressurized bladder. The pre-attached administration set may incorporate any of thefollowing 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. DeliverTimes		1 - 5 days		15 min - 5 hrs	8 days
Indicationfor Use:		The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and painmanagement. 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 orregional 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 localanesthetics 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

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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 bladderKraton Inner bladder (fluid contact)Di(2-ethylhexhyl) phthalate (DEHP)Plasticized Polyvinyl Chloride (PVC)DEHP plasticized PVC	Single bladder:Single layer siliconeTrioctyl Trimellitate(TOTM) plasticized PVCDi(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.

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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

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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

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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.

FOR FDA USE ONLY ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman Date: 2014.02.03 15:14:28 -05'00' PSC. Publishing Services : 301) 143-6740 Page 1 of 2 FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Regulation Number and Section

§ 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).