FENESTRATED INFUSION CATHETER

K024190 · Promedic, Inc. · FRN · Mar 17, 2003 · General Hospital

Device Facts

• Record ID: K024190
• Device Name: FENESTRATED INFUSION CATHETER
• Applicant: Promedic, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Fenestrated Infusion Catheter is a 20-gauge, 30-inch small-bore tube with distal fenestrations (1.5", 3.0", or 5.0" lengths) for medication dispersion. Features standard Touhy Borst connector and shaft markings for clinician reference. Used in hospital or sub-acute settings for nerve blocks or wound site pain management. Operated by clinicians via intraoperative or percutaneous routes. Functions as accessory to infusion pumps or standalone; not for gravity feed. Delivers local anesthetics/medications to surgical sites or nerves to manage post-operative pain.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

20-gauge catheter, 30-inch length; PEBAXX 6333 material; UV-curable ink markings; Touhy Borst connector. Non-powered, mechanical infusion accessory. Provided sterile.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites or near nerves outside the epidural space for pain management. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• I-Flow - Soaker Catheter (K994374)
• Merit Medical Systems (K991619)

Submission Summary (Full Text)

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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 [phone]

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 [phone] Paul Dryden - President

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

#### 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.

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 pain<br>management. |
| | To provide continuous or intermittent delivery of<br>ocal anesthetics or other medications to surgical<br>wound sites and/or close proximity to nerves outside<br>he epidural space. Routes of administration may be<br>intraoperative or percutaneous. |
| | As an accessory to Sorenson medical infusion<br>pumps or as a standalone device, but not for use<br>with 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 at<br>proximal 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) cleared<br>devices | 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 [phone]. 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 [phone] or [phone] 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 pain<br>management. |
| | To provide continuous or intermittent delivery of<br>local 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)

or

Over-the-counter use