INTRAOP CATHETER

K991543 · I-Flow Corp. · MEB · Oct 25, 1999 · General Hospital

Device Facts

• Record ID: K991543
• Device Name: INTRAOP CATHETER
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intra Op Catheter is intended to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and nerve trunks outside of the epidural space. Routes of administration may be either, intraoperative, intramuscular, subcutaneous or percutaneous. The catheter is single patient use only.

Device Story

Intra Op Catheter is a single-patient-use anesthesia conduction catheter; designed for continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and nerve trunks. Device features a closed-end tip with lateral/radial side holes for fluid delivery. Configurations include a Touhy Borst connector or a bonded/insert-molded luer lock connector. Used by clinicians in surgical or clinical settings. Operates by delivering medication to target sites outside the epidural space; facilitates pain management. Benefits include targeted, prolonged (up to 30 days) delivery of anesthetic agents to surgical sites.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing performed in accordance with ISO 10993 Part 1 for external communicating devices with prolonged contact duration (24 hours to 30 days).

Technological Characteristics

Plastic catheter with closed-end tip and lateral/radial side holes. Fluid path materials conform to ISO 10993 Part 1. Available with Touhy Borst or luer lock connectors. Sterilized via ethylene oxide gas or radiation. External communicating device for tissue/bone/dentin contact.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and nerve trunks outside the epidural space via intraoperative, intramuscular, subcutaneous, or percutaneous routes.

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

• Teleflex Medical (TFX) Epidural Catheter (K840202)
• B. Braun Perifix Set (K813186)
• Epimed International FETH-R_KATH catheter

Submission Summary (Full Text)

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### OCT 2 5 1999

# SUMMARY OF SAFETY AND EFFECTIV

## Trade Name: Intra Op Catheter

Common Name: Anesthetic Catheter

Classification Name: Anesthesia Conduction Catheter

Classification Panel: Anesthesiology

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq., R.A.C. Kobort of Regulatory and Legal Affairs

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

Telephone: [phone] Fax: [phone]

#### GENERAL INFORMATION 1.0

#### Statement of Equivalence 1.1

- The Intra Op Catheter is substantially equivalent to the (1) Teleflex 1.1.1 The Intra Op Catheter (K840202, originally submitted by Medical (1177) Epidard. Grifix Set (K813186) and (3) the Epimed Internation FETH-R_KATH catheter.
- The Intra Op Catheter package may include components that are 1.1.2 The Mtra Op Oathetor Pre-amendment devices or devices that have legally murketed (Skring to market via premarket notification regulation).

#### PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.0

#### Description of the Intra Op Catheter 2.1

- The Intra Op Catheter is identical to the Teleflex Medical (TFX) 2.1.1 The Intra Op Catheter (K840202, originally submitted by Aries Medical) with Epludial Outholor (r & reading the inner diameter of the distal end of the catheter.
- Intra Op Catheter is manufactured by TFX using their 2.1.1.1 current plastic formulation.
- The catheter has a closed end tip with multiple holes 2.1.1.2 The catherer has along the lateral surface at the distal end of the device.

'SE = Substantially Equivalent

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- The catheter package may contain a "T" Peel catheter over needle or a 2.1.2 catheter connector (e.g. Touhy Borst) in addition to the catheter defined herein.
#### Product Configuration 2.2

- The Catheter 2.2.1
- The catheter is designed to be distributed in two basic 2.2.1.1 configurations.
- As shown in the catheter drawing (Dwg. No. 2.2.1.1.1 1120741 found in Appendix A), Detail G depicts the proximal end of the catheter with a catheter connector (Touhy Borst type) attached.
- An alternate configuration with a bonded or 2.2.1.1.2 insert molded luer lock catheter connector is also shown in the drawing.

#### OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

3.1

#### 4.0 BIOLOGICAL SPECIFICATIONS

- 4.1
- Biological testing is in conformance with ISO 10993 Part 1 for fluid path 4.2 components.
- The Intra Op Catheter is categorized as follows: 4.3
- Device Category: External Communicating Device. 4.3.1
- 4.3.2 Body Contact: Tissue/Bone/Dentin Communicating
- Contact Duration: Prolonged (24 hours to 30 days). 4.3.3

#### CHEMICAL AND DRUG SPECIFICATIONS . 5.0

- ર. 1 Compatibility
- There are no specific drugs referenced in the labeling for the Intra Op 5.1.1 Catheter.
- The Intra Op Catheter is intended for use with general local anesthetics 5.1.2 and narcotic medications.
- 5.2 Drug Stability
- There are no drugs included in the Intra Op Catheter. 5.2.1

#### 6.0 INTENDED USE

- 6.1 The Intra Op Catheter is intended to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and nerve trunks outside of the epidural space. Routes of administration may be either, intraoperative, intramuscular, subcutaneous or percutaneous.
- 6.2 The catheter is single patient use only.

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#### LABELS AND LABELING 7.0

- I-Flow Corporation believes the proposed labels and labeling, where appropriate, 7.1 meets the requirements of 21 CFR Part 801 as it relates to a determination of intended use and adequate directions for use.
#### STANDARDS 8.0

- There are currently no standards established for anesthesic catheters. 8.1
#### PACKAGING 9.0

- The catheter is packaged in either a Tyvek pouch or a form/fill/seal tray. 9.1
#### STERILIZATION INFORMATION 10.0

- The method of sterilization is Ethylene oxide gas or radiation 10.1
#### COMPARISON TO LEGALLY MARKETED DEVICES 11.0

- The Intra Op Catheter is substantially equivalent to the (1) Teleflex Medical 11.1 (TFX) Epidural Catheter (K840202, originally submitted by Aries) (2) the B. Braun Perifix Set (K813186) and (3) the Epimed Internation FETH-R_KATH catheter.
- Device Descriptions 11.2
- Comparisons 11.2.1
- The device under review and its predicates are closed end 11.2.1.1 with lateral/radial side holes.
- 11.2.2 Materials
- 11.2.2.1 The Intra Op Catheter's fluid path materials are in conformance with ISO 10993 Part 1.
- Based upon the data presented in this section, I-Flow Corporation has 11.2.3 determined that the Intra Op Catheter is substantially equivalent to the named predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines emanating from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 1999

Mr. Stanley E. Fry Vice President Regulatory Affairs/Quality Assurance I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630

K991543 Re: Intraop Catheter Trade Name: Regulatory Class: II Product Code: MEB September 3, 1999 Dated: Received: September 7, 1999

Dear Mr. Fry:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the markee is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been realour fied in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. प्र substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Fry

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo . Ulatow Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): i3991543 Device Name: Intra Op Catheter Indications for Use: ·

The Intra Op Catheter is intended to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and nerve trunks outside of the epidural space. Routes of administration may be either, intraoperative, intramuscular, subcutaneous or percutaneous.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sianwm m Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sig Division of De and General Ho 510(k) Number

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