For use in a kit for nerve blocks or wound site pain management. To provide continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutaneous. As an accessory to Sorenson medical infusion pumps or as a standalone device, but not for use with gravity feed. Single patient use only.

Device Description

The infusion catheter is a small bore, 20 gauge, tube with holes at the tip to permit dispersion of the modication into the site. The overall cather is 30" in length with various lengths of holes (fenestrations) of - 1.5", 3.0", and 5.0" with a standard Touly Borst connector. The catheter has markings on the shaft to provide a reference guide for the clinician. May be available in a kit. Provided stcrilc.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for a Fenestrated Infusion Catheter. It focuses on device description, intended use, and a declaration of substantial equivalence to predicate devices. Crucially, this document does not contain information about acceptance criteria or specific studies proving device performance against such criteria.

The 510(k) process primarily demonstrates substantial equivalence to a legally marketed predicate device rather than outright proof of meeting specific performance metrics through detailed studies. The absence of this information is typical for a 510(k) summary, which often relies on comparative claims rather than standalone performance studies with quantified acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the provided document.

To clarify, a 510(k) submission generally includes:

Device Description: What the device is and how it works.
Indications for Use: What the device is intended for.
Technological Characteristics Comparison: How the new device is similar to and different from predicate devices.
Performance Data (if applicable): Bench, animal, or clinical data may be submitted to support substantial equivalence, particularly if there are new technological characteristics or safety/effectiveness concerns. However, the summary provided here does not detail such studies or specific acceptance criteria.

The document's statement: "The data within the submission demonstrates that the proposed device is safe, effective, and substantially equivalent when compared to the predicate devices" indicates that such data was submitted to the FDA, but the specific details of that data, including acceptance criteria and study designs, are not included in this "Non-Confidential Summary."

Summary

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Fenestrated Infusion Catho

510(k) Summary of Safety and Effectiveness

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 March 13, 2003

Tel (317) 335-3780

MAR 1 7 2003

ProMedic, Inc. 6329 W. Watcrview Ct. McCordsville, IN 46055-9501

Official Contact: Proprictary or Trade Name: Common/Usual Name: Classification Name: Predicatc Devices:

Fax (317) 335-9270 Paul Dryden - President

Fenestrated Infusion catheter Infusion catheter Pump, infusion - accessory I-Flow - Soaker Catheter - K994374 Merit Medical Systems - K991619

Device Description:

Intended Use:

For use in a kit for nerve blocks or wound site pain management.

To provide continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutancous.

As an accessory to Sorenson medical infusion pumps or as a standalone device, but not for use with gravity feed.

Single patient use only

Environment of Use:

Hospital, Sub-acute Institutions

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..............................................................................................................................................................................

Non-Confidential Summary of Safety and Effectivencss Page 2 of 2 March 13, 2003

General Technical Characteristics

Attribute	Proposed device
Indications for use	For use in a kit for nerve blocks or wound site painmanagement.
	To provide continuous or intermittent delivery ofocal anesthetics or other medications to surgicalwound sites and/or close proximity to nerves outsidehe epidural space. Routes of administration may beintraoperative or percutaneous.
	As an accessory to Sorenson medical infusionpumps or as a standalone device, but not for usewith gravity feed.
Intended for single use	Yes
Prescription	Yes
Intended population	Not applicable
Intended Environment of Use	Hospital, Sub-acute Institutions
Design
20 gauge catheter of 30" length with holes atproximal end and standard Touhy Borst connector	Yes
Of various fenestration hole lengths	1.5", 3.0", 5.0"
Can be provided in a kit with 510(k) cleareddevices	Yes
Materials
Catheter - PEBAXX 6333 Clear	Yes
Ink –UV curable	Yes
Performance Standards
None under Section 514	Yes

Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed device is safe, effective, and substantially equivalent when compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its head, symbolizing health, human services, and prevention. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2003

Mr. Paul Dryden President ProMedics, Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K024190

Trade/Device Name: Fenestrated Infusion Catheter Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 18, 2002 Received: December 19, 2002

Dear Mr. Dryden:

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.

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 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.

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Page 2 – Mr. Dryden

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 (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 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/dsma/dsmamain.html

Sincerely yours.

Susan Runner, DDS, MA

Interim 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 Usc

Page 1 of 1

510(k) Number:	K024190 (To be assigned)
Device Name:	Fenestrated Infusion Catheter
Intended Use:	For use in a kit for nerve blocks or wound site painmanagement.
	To provide continuous or intermittent delivery oflocal anesthetics or other medications to surgical

nesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutaneous.

As an accessory to Sorcnson Medical infusion pumps or as a standalone device, but not for use with gravity feed.

Single patient use only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrice Crescent

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use _ (Per CFR 801.109)

Over-the-counter use

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).