VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124

K023140 · Epimed International, Inc. · BSO · Aug 15, 2003 · Anesthesiology

Device Facts

• Record ID: K023140
• Device Name: VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
• Applicant: Epimed International, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Aug 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

Device Story

Versa-Kath Epidural Catheter is a sterile, single-use, disposable anesthesia conduction catheter. Device consists of a stainless steel spring lumen with a dual coating: inner polyester tube and outer fluorinated ethylene polypropylene (FEP) tube. Includes a stainless steel wire stylet with a molded plastic hub. Used in clinical settings for continuous epidural or caudal anesthesia delivery. Operates by providing a conduit for anesthetic agents into the epidural space. Intended for use by healthcare professionals. Benefits include providing sustained regional anesthesia for up to 72 hours.

Clinical Evidence

Bench testing only. No clinical data provided. Performance characteristics compared to the predicate device included tensile strength, flow, deflection (stiffness) per BS 6196, fluid pressure of the catheter/adapter connection, and luminal integrity.

Technological Characteristics

21-gauge catheter; stainless steel spring lumen; dual-layer construction (inner polyester, outer fluorinated ethylene polypropylene); includes stainless steel wire stylet with molded plastic hub. Sterile, single-use, disposable. Performance testing conducted per BS 6196.

Indications for Use

Indicated for patients requiring continuous epidural or caudal anesthesia via administration of anesthetic agents into the epidural space for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• Racz Epidural Catheter (K954584)

Submission Summary (Full Text)

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K023140

# Section II

## 510(K) Summary

### Company Information:

Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 [phone] Contact: Christopher B. Lake Manager of RA/QA

## Date Prepared:

September 16, 2002 (revised January 15, 2003)(revised May 16, 2003)

### Trade Name:

Versa-Kath Epidural Catheter

#### Common Name:

Anesthesia Conduction Catheter

#### Product Class/Classification:

Class II 73 BSO

## Predicate Device(s):

Racz Epidural Catheter (K954584)

### Description:

The Versa-Kath Epidural Catheter consists of a stainless steel spring lumen with a dual coating. The inner coating is Polyester tube and the outer coating is Fluorinated Ethylene Polypropylene tube. A stylet is also provided with the device which consists of a stainless steel wire and a molded plastic hub.

The Versa-Kath will be provided as a sterile, single use, disposable device. The Versa-Kath will be a 21 gauge catheter available in various lengths.

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### Intended Use:

For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

#### Comparison to Predicate:

The Versa-Kath Epidural Catheter has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device.

#### Non-Clinical Data:

Bench Testing performed on the Versa-Kath Epidural Catheter to compare performance characteristics to the predicate device confirmed that the performance of the Versa-Kath is similar to that of the device. The devices were tested with regard to Tensile strength, Flow, and Deflection(stiffness) Conformance to BS 6196. Fluid Pressure of the catheter/adapter connection, luminal integrity were also compared to the predicate.

#### Conclusion:

The testing performed and comparison to the predicate device demonstrates that the Versa-Kath Epidural Catheter is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

Epimed International, Inc.

Carl Ah

Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 15 2003

Mr. Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, NY 12095

Re: K023140

Trade/Device Name: Versa-Kath Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: May 16, 2003 Received: May 19, 2003

Dear Mr. Lake:

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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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 Eyaluation Center for Devices and Radiological Health

Enclosure Indications for Use statement

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of____________________________________________________________________________________________________________________________________________________________________________ Page 1

510(k) Number (if known): K023140

Device Name: Versa-Kath Epidural Catheter

Indications For Use:

For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sthunk

I Hospital.

(Optional Format 3-10-98)

510(k) Number: K123140

\Prescription DEVICE