I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) 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 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. 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 I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.

AI/ML Overview

The provided text describes a Special 510(k) submission (K052117) for a modification to the I-Flow Elastomeric Pump. This submission focuses on a design change, specifically the addition of a multi-Y adapter to allow for 3 or more integrated administration lines, as an extension of an existing product line (K040337).

Crucially, the provided document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.

Instead, it's a declaration of substantial equivalence to a previously cleared device. The rationale is that the new multi-Y adapter utilizes the same technology as the existing unmodified design, and therefore, no new issues of safety or effectiveness are believed to arise from this change.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

Here's why and what information would typically be needed if a study were conducted:

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

Missing Information: The document does not define any specific acceptance criteria (e.g., flow rate accuracy, pressure stability, material compatibility, bacterial ingress prevention) for the new multi-Y adapter, nor does it report any performance data.

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

Missing Information: No test set is mentioned because no study was conducted for this specific submission to demonstrate performance against new criteria.

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)

Missing Information: Not applicable, as no study requiring ground truth establishment was conducted for this submission. This type of information is usually relevant for studies evaluating diagnostic or AI-driven devices, not a simple accessory modification like this.

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

Missing Information: Not applicable, as no study requiring adjudication was conducted.

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

Missing Information: Not applicable. This type of study is for evaluating AI performance in diagnostic imaging, which is completely unrelated to an elastomeric pump accessory.

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

Missing Information: Not applicable. This device does not involve any algorithms.

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

Missing Information: Not applicable, as no study requiring ground truth was conducted.

8. The sample size for the training set

Missing Information: Not applicable. This device does not involve a training set as there is no AI/ML component.

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

Missing Information: Not applicable, as there is no training set mentioned.

Conclusion from the provided text:

The submission K052117 is a "Special 510(k)" which indicates a modification to an already cleared device (K040337). The nature of the change (adding more "Y" splices to an existing administration line) is deemed minor enough by the submitter and the FDA to not require new performance studies. The core argument is based on technological equivalence to the predicate device, implying that the established safety and effectiveness of the original pump apply to this modified version. The FDA letter confirms the determination of "substantial equivalence" based on this premise, allowing the device to be marketed without new clinical or performance studies.

Summary

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SPECIAL 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

K052117

August 3, 2005

Submitter:

I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630

Contact:

Shane Noehre Director, Regulatory Affairs I-Flow Corporation

Trade Name: I-Flow Elastomeric Pump

Infusion Pump and Administration Set Common Name:

Classification Name: Pump, Infusion

Existing Device: I-Flow Elastomeric Pump (K040337)

Device Description: The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.

TechnologyComparison:	The multi-Y adapter utilizes the same technology forsplitting the administration line as the existingunmodified design.
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Conclusion: The new I-Flow Elastomeric Pump with a multi-Y adaptor model is simply an extension of the existing I-Flow Elastomeric Pump product line.

I-Flow Corporation believes that the new I-Flow Elastomeric Pump with a mulit-Y adaptor model is substantially equivalent to the existing (unmodified) I-Flow Elastomeric Pump and no new issues of safety or effectiveness arise from this design change.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three wings and two legs, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circle around the eagle.

SEP - 9 2005

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: K052117

Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 3, 2005 Received: August 11, 2005

Dear Mr. Noehre:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed your become mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devroos that have o Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppheansed (the Act. The general controls provisions of the Act include controls providents of the ristration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of subject to Bach adam Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Noehre

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); good manufacturing practice requirements as set 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 (240) 276-0115. 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 Division of 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/industry/support/index.html.

Sincerely yours.

Clus

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

510(k) Number (if known): K(152117

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 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of r no i row Esucturesthetics or narcotics) to surgical wound sites and/or close modiation (so nerves for preoperative, perioperative and postoperative regional anesthesia proxinity to norvos for processf 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 _ × (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)

Shula M. Minsky, MD for A. Wilson, GA DB 9/8/05

Division of Anesthesiology, General Hospit Infection Control, Dental Device

510(k) Number: Ka52117

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).