PERIFIX CATHETER CONNECTOR

K022019 · B.Braun Medical, Inc. · BSO · Aug 1, 2002 · Anesthesiology

Device Facts

• Record ID: K022019
• Device Name: PERIFIX CATHETER CONNECTOR
• Applicant: B.Braun Medical, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 gauge Perifix catheters for continuous administration of anesthetic agents.

Device Story

Perifix Catheter Connector serves as interface between anesthesia conduction catheters (18/20 Ga) and luer-compatible fluid administration devices. Device features luer end, threading hole, catheter channel, and hinged clamp mechanism for catheter retention. Used in clinical settings (e.g., epidural/nerve block kits) by healthcare providers to facilitate continuous anesthetic delivery. Replaces previous twist-lock mechanisms with hinged clamp for improved catheter securement. Biocompatibility verified per ISO 10993.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

1.77-inch length; luer connector interface; hinged clamp mechanism for catheter retention. Materials biocompatibility tested per ISO 10993. Mechanical connection device; no energy source or software.

Indications for Use

Indicated for patients requiring continuous administration of anesthetic agents via 18 or 20 gauge Perifix catheters for epidural or nerve block procedures.

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

• Twist Lock Adapter Hub with Luer lock (K840287)
• Twist Lock Adapter Hub with Luer lock (K840179)

Submission Summary (Full Text)

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K022019

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AUG 01 2002

# 510(k) Summary

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2597<br>Contact: Amy S. Krall, RA Specialist |
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| DEVICE NAME: | Perifix® Catheter Connector |
| COMMON OR USUAL<br>NAME: | Anesthesia Catheter Connector |
| DEVICE<br>CLASSIFICATION: | Class II per Code of Federal Regulations, Title 21, §<br>868.5120 -Anesthesia Conduction Catheter, 868.5140 -<br>Anesthesia Conduction Catheter Kit |
| PREDICATE DEVICE: | B. Braun Medical Inc.; Twist Lock Adapter Hub with Luer<br>lock; K840287 (Accu-Bloc Brachial Plexus Anesthesia<br>Tray)<br>K840179 (Accu-Bloc Epidural Anesthesia Tray) |
| DESCRIPTION: | The Perifix Catheter Connector is a connecting device used<br>to connect an anesthesia conduction catheter (most<br>commonly an epidural or nerve block catheter) to a luer<br>device for the administration of anesthesia and/or<br>therapeutic fluids. Catheter connectors are commonly used<br>in epidural anesthesia kits and nerve block kits.<br><br>The Perifix Catheter Connector is approximately 1.77<br>inches long and can accept B. Braun Medical Inc. 18 and<br>20 Ga. Standard Perifix Catheters. The connector consists<br>of a luer device on one end for the attachment of a mating<br>luer device. The rest of the device consists of a threading<br>hole, catheter channel and hinged clamp mechanism. |
| INTENDED USE: | A connection device used to provide various anesthetic and<br>fluid administration devices with a single, common access<br>point to an 18 or 20 gauge Perifix catheter for delivery of<br>anesthetics. The connector is used in conjunction with 18<br>or 20 gauge Perifix catheters for continuous administration<br>of anesthetic agents. |

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## SUBSTANTIAL EQUIVALENCE:

The Perifix Catheter Connector is substantially equivalent to the B. Braun Medical Inc. Twist Lock Catherer Hub Adapter (K840179/K840287). The new catheter connector has similar indications for use as the predicate device. The design is different only in that there is a hinged clamp mechanism for the insertion and retention of the catheter, instead of a twisting screwing motion. There is also one new material in the connector. The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993. These minor changes do not raise any new safety of efficacy issues.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 01 2002

Ms. Amy S. Krall Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K022019

Trade/Device Name: Perfix® Catheter Connector Regulation Number: 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: June 19, 2002 Received: June 20, 2002

Dear Ms. Krall:

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.

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.

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Page 2 – Ms. Krall

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 and additionally 21 CFR Part 809.10 for in vitro 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski 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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Correspondence to Ms. Angela Smith Pending 510(k) K022019 . July 17, 2002Page 3 of 3

## Indications for Use Statement

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510(k) Number (if known): K022019

Device Name: Perifix® Catheter Connector

Indications For Use:

A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 gauge Perifix catheters for continuous administration of anesthetic agents.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _____________

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Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________