I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) by I-FLOW CORP.

The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Device Description

The current package labeling of the I-Flow Elastomeric Pump does not reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.

AI/ML Overview

This document, K040337, is a 510(k) premarket notification for a labeling change to the I-Flow Elastomeric Pump. It is not a study that proves the device meets acceptance criteria for a new device, but rather a notification to market an existing device with updated labeling based on a review of existing clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a new device evaluation is inherently not present in this type of submission.

Here's an analysis of what information can be extracted or inferred from the provided text, and where the requested information is absent due to the nature of the submission:

1. Table of acceptance criteria and the reported device performance

This information is not applicable/provided in this 510(k) submission. A 510(k) for a labeling change based on existing studies does not typically define new acceptance criteria for the device itself or report new performance data. The core of this submission is to demonstrate that the proposed labeling changes (referencing specific types of surgeries and benefits) are supported by already published clinical studies where the device was used according to its previously cleared indications.

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

This information is not applicable/provided for a new test set in this submission. The submission refers to "published clinical studies" that support the labeling changes. Details about the sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) of these individual published studies are not provided in this 510(k) summary. These details would be found within the referenced published studies themselves.

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)

This information is not applicable/provided for a new test set in this submission. Similar to point 2, the ground truth for the results of the referenced published studies would have been established within those studies. This 510(k) is a regulatory filing summarizing the existence and relevance of those studies, not establishing new ground truth for a new device test.

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

Not applicable/provided. As explained above, no new test set was established as part of this 510(k) filing.

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 submission is for an elastomeric infusion pump, not an AI-assisted diagnostic device or a system involving human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. This submission is for an elastomeric infusion pump, not an algorithm.

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

Not applicable/provided directly by this document for a new test set. The ground truth (e.g., pain relief, decreased narcotic use) for the results of the "published clinical studies" would be defined within those studies themselves. The submission states that the labeling changes are supported by "published clinical studies in widely known and esteemed journals," implying that the outcomes and conclusions of those studies serve as the "ground truth" to support the new claims. These outcomes likely pertained to patient-reported pain levels, narcotic consumption, or other clinical measures.

8. The sample size for the training set

Not applicable. This submission is not about an AI/ML device that requires a training set. The "training" for the device's claims comes from the clinical evidence generated in the "published clinical studies," which are not referred to as a "training set" in this context.

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

Not applicable. As explained in point 8, there is no "training set" in the context of this device and submission. The "ground truth" for the claims in the new labeling is established by the findings and conclusions of the referenced "published clinical studies."

Summary

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K640337

MAY 2 4 2004

Appendix E

Summary of Safety and Effectiveness

510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS

February 9, 2004

Submitter: I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630
Shane Noehre Contact: Director, Regulatory Affairs I-Flow Corporation

ON-Q, PainBuster, C-bloc, Eclipse, C-Series, Easypump, Homepump Trade Names:

Pump, Infusion, Elastomeric Classification Name:
Existing Device: I-Flow Elastomeric Pump
The current package labeling of the I-Flow Elastomeric Pump does not Device Description: reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.
The I-Flow Elastomeric Pump was used in the published clinical Conclusion: studies. The device was used according to FDA cleared indications for use (i.e. intraoperative or perineural local anesthetic delivery to relieve pain at the surgical site). I-Flow believes this change would not impact safety or efficacy and is supported by published clinical studies in widely known and esteemed journals.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.

Public Health Service

MAY 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630

Re: K040337

Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: May 18, 2004 Received: May 19, 2004

Dear Mr. Nochre:

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 cevices 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.

If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it may be subject to such 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 Eederal Register.

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Page 2 - Mr. Noehre

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease to acressed that 12 a determination that your device complies with other requirements mount that I Dr. may Federal statutes and regulations administered by other Federal agencies. or the riot of any a outh all the Act's requirements, including, but not limited to: registration 1 od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishlig (21 CF revis in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bettronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter mification. The FDA finding of substantial equivalence of your device to a premained formaticate 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj Sound Small Manufacturers, International and Consumer 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,

Susan Junre
C. Shih-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K040337 510(k) Number (if known):

Device Name:

I-Flow Elastomeric Pump

Indications For Use:

1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
1. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
1. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Irene Navesee for AW 3/21/04

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K040337

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).