CONDUCTION CATHETER

K031600 · Micor, Inc. · FRN · Aug 13, 2003 · General Hospital

Device Facts

• Record ID: K031600
• Device Name: CONDUCTION CATHETER
• Applicant: Micor, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the subject device is for the administration of local anesthetics into intra-operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.

Device Story

Conduction catheter; closed-end design with multiple radial holes at distal end for anesthetic distribution; stainless steel coil reinforcement for flexibility and kink resistance; radiopaque. Used in clinical settings for post-operative pain management and regional anesthesia. Physician-operated; delivers anesthetic to surgical wound sites. Benefits patient via targeted local anesthetic delivery.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance characteristics compared to predicate devices.

Technological Characteristics

Polyamide co-polymer catheter body; stainless steel coil reinforcement; radiopaque; closed-end with multiple radial fenestrations; 19g and 20g sizes.

Indications for Use

Indicated for administration of local anesthetics into intra-operative sites for post-operative pain management and regional anesthesia outside the epidural space via intra-operative, 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

• MICOR EpiFlex Epidural Catheter (K991879)
• MICOR Epidural Conduction Catheter (K001717)
• MICOR Conduction Catheter (K003966)
• Pain Care Multi-Port Catheter (K003611)

Submission Summary (Full Text)

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K031600

# AUG 1 3 2003

## MICOR, INC CONFIDENTIAL

# Summary of Safety and Effectiveness 21 CFR 807.92(a)(6)

# Date of preparation of Summary: May 21, 2003

#### MICOR Contact:

- Susan Forgrave 1.
- MICOR, INC 2. 2855 Oxford Boulevard Allison Park, PA 15101
- Telephone: [phone]. Facsimile: 412-487-1747 E-mail: [e-mail]

#### Device Name:

- Common name Conduction Catheter 1.
- Trade name not applicable at this time 2.
- Classification Name: 3.
- Device name: Conduction catheter a.
- Speciality: Anesthesiology b.
- Product code: FRN C.
- Device class: 2 d.
- e. Regulation: 21 CFR 880.5725

#### Predicate Devices:

- K991879 MICOR EpiFlex Epidural Catheter 1.
- K001717 MICOR Epidural Conduction Catheter 2.
- K003966 MICOR Conduction Catheter 3.
- K003611 Pain Care Multi-Port Catheter 4.

## Product Description/Function:

- 1. Description:
- The subject device is available as a closed end with multiple holes, fenestrated area, a. located radially along the lateral surface at the distal end of the device.
- The subject device is radiopaque and is available in 19g and 20g sizes. b.
- 2. Function:
- The fenestrated area provides the distribution of anesthetic over the surgical wound 2. sites.
- The stainless steel coil increases the flexibility and kink resistance of the catheter. ს.

#### Technological Characteristics:

- Technological Characteristics of the subject device are substantially equivalent to the 】. predicate devices K991879 and K003966 manufactured by MICOR, INC.
#### Materials:

- The polyamide co-polymer, stainless steel coil and black ink used in the subject device is ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ substantially equivelent to the materials used in the predicate devices K991879 and K003966 manufactured by MICOR, INC.
Section 7 Page 1 of 2

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# \$()31600

# MICOR, INC CONFIDENTIAL

## Intended Use:

- The intended use of the subject device is for the administration of local anesthetics into intra-1. operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
- 2. The intended use of the subject device is equivalent to the predicates K003966 and K003611

# Safety and Effectiveness:

- No new issues of safety and effectiveness are raised by the design of the subject device. 』。
- The subject device is substantially equivalent in its performance to predicate K003966 and in 2. its intended use to predicates K003966 and K003611

# Conclusion:

- The design, performance, materials, intended use and safety and effectiveness of the subject 1. device is substantially equivalent to the cited predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

AUG 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Forgrave Quality Assurance & Regulatory Manager Micor Incorporated 2855 Oxford Boulevard Allison Park, Pennsylvania 15101

Re: K031600

Trade/Device Name: Conduction Catheter Regulation Number: 880. 5725 Regulation Name: Accessary to Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 20, 2003 Received: June 3, 2003

Dear Ms. Forgrave:

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 - Ms. Forgrave

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 Quarles

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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## MICOR, INC CONFIDENTIAL

# Indications For Use Statement 21 · I R 807.92(a)(5)

K031600 SIO(k) number(if known)

Device name: Conduction Catheter

Indications for use:

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> ·············································································································································································· percutaneous.

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Concurrence of CDRH Office, Office of Device Evaluation (ODE)

Prescription use

OR Over-the-Counter

Sultana Cucerant

(Division Sign-Off) Divisor of Anesthesiology Infection Control. Dent

510(k) Number: K051600

So. re: re: