STINGRAY EPIDURAL CATHETER CONNECTOR

K051171 · Epimed International, Inc. · CAZ · Aug 26, 2005 · Anesthesiology

Device Facts

• Record ID: K051171
• Device Name: STINGRAY EPIDURAL CATHETER CONNECTOR
• Applicant: Epimed International, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A connection device is used to provide various anesthetic and fluid administration to an access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.

Device Story

The Stingray Epidural Catheter Connector is a mechanical device consisting of two molded plastic body sections and a molded bushing. It functions via a twist-and-lock mechanism; the internal bushing compresses and grips an epidural catheter to secure the connection. It is used in clinical settings to provide a single access point for the continuous administration of anesthetic agents and fluids through an epidural catheter. The device is operated by healthcare professionals during anesthesia procedures. It facilitates the delivery of medication to the patient by ensuring a secure, leak-resistant connection between the catheter and the administration source.

Clinical Evidence

No clinical data provided; substantial equivalence is based on physical and technical comparison to the predicate device.

Technological Characteristics

Mechanical connector; molded plastic body sections with internal molded bushing; twist-and-lock mechanism; non-electronic; non-software; sterile.

Indications for Use

Indicated for use as a connection device to provide a single, common access point to an epidural catheter for the continuous administration of anesthetic agents and fluid solutions.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• B. Braun Medical Perifix® Catheter Connector (K032144)

Submission Summary (Full Text)

{0}------------------------------------------------

# KOSITY

AUG 2 6 2005

## Section II

# 510(K) Summary

#### Company Information:

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

#### Date Prepared:

May 4, 2005

#### Trade Name:

Stingray Epidural Catheter Connector

#### Common Name:

Anesthesia Conduction Catheter Kit

#### Product Class/Classification:

Class II - CAZ, 21 CFR 868.5140

#### Predicate Device(s):

B. Braun Medical Perifix® Catheter Connector (K032144)

#### Description:

The Stingray Epidural Catheter Connector consists of two molded plastic body The bungray Epitation in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.

{1}------------------------------------------------

#### Intended Use:

A connection device is used to provide various anesthetic and fluid administration A connection as not for to an access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.

### Comparison to Predicate:

The Stingray Epidural Catheter Connector has similar physical and technical The Stinglay Epidaran redicate device and a similar intended use to the predicate device.

#### Conclusion:

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

Epimed International, Inc.

Chall

Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

AUG 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Lake Manager of QA/RA Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095

Re: K051171

Trade/Device Name: Stingray Epidural Catheter Connector Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: August 16, 2005 Received: August 22, 2005

Dear Mr. Lake:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to reward young determined the device is substantially equivalent (for the icitications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichuments, or to do roos and time in the Act (Act) that do not require approval of a premarket the Federal F ood, Drag, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents 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 (1 Mr), it may be sacyeet to Jack of Federal Regulations, Title 21, Parts 800 to 898. In your device can or found in further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Lake

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease oc advisod that 1 DT o levice complies with other complies with other requirements mean that FDA has made a acessions administered by other Federal agencies. of the Act of ally I outstal buttors requirements, including, but not limited to: registration r ou must comply with and are are are any labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF R Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirencents as set form in the quasily is a 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) This letter will and w Jowell of Job finding of substantial equivalence of your device to a premiarket notification. The PDF 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 (71 CFR Part 801), If you desire specific at no for Joiance 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 may obtain 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/industry/support/index.html.

Sincerely yours,

Susan Runne

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K051171

Device Name: Stingray Epidural Catheter Connector

Indications For Use:

The Stingray Epidural Catheter Connector is intended to provide various The Stingray Epidoral Catherer tonnadevices with a single, common access andsthelic and fruid administration of anesthetics. The connector point to an epidural catheter for delivery of anesolutions.
is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Uuysvaorn,

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

510(k) Number.

Page 1 of ____________________________________________________________________________________________________________________________________________________________________