PERIFIX CATHETER AND CONTIPLEX CATHETER

K042488 · B.Braun Medical, Inc. · BSO · Sep 30, 2004 · Anesthesiology

Device Facts

• Record ID: K042488
• Device Name: PERIFIX CATHETER AND CONTIPLEX CATHETER
• Applicant: B.Braun Medical, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Sep 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B. Braun Regional Anesthesia Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration include epidural and perineural (peripheral nerve block).

Device Story

Co-extruded anesthesia conduction catheter; inner polyamide layer; outer polyurethane layer. Available in 19/20 Ga diameters; 400–1010 mm lengths; open or closed tip configurations. Closed tip models feature six side ports for anesthetic/analgesic distribution. Includes depth markings (50.5–250 mm from tip) and three barium sulfate radiopaque stripes for radiographic visualization. Used by clinicians in clinical settings (OR, labor/delivery) for percutaneous administration of local anesthetics/analgesics. Provides continuous or intermittent infusion to manage pain or provide regional anesthesia. Benefits include targeted delivery of medication to epidural or perineural spaces.

Clinical Evidence

Bench testing only.

Technological Characteristics

Co-extruded catheter; inner layer polyamide, outer layer polyurethane. 19/20 Ga diameters; 400–1010 mm lengths. Open or closed tip; closed tip has six side ports. Three barium sulfate radiopaque stripes for visualization. Depth markings included. Sterilization method not specified.

Indications for Use

Indicated for patients requiring regional anesthesia or pain management via continuous or intermittent infusion of local anesthetics/analgesics in the epidural space or perineural (peripheral nerve block) sites during pre-operative, perioperative, and postoperative periods for general surgery, orthopedic surgery, or labor and delivery.

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

• Csen Ltd, Combined End-Multiple Lateral Hole Epidural Catheter (K951927)
• B. Braun Medical Inc., B. Braun Nerve Block Catheter (K030380)

Submission Summary (Full Text)

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SEP 3 0 2004

K042488

1. 3 510(k) Summary

| SUBMITTER: | B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 [phone], ext. 2597 Contact: Amy Smith, RAC |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun Regional Anesthesia Catheter Epidural Tradename - Perifix® Catheter Peripheral Nerve Block Tradename - Contiplex® Catheter |
| COMMON OR USUAL NAME: | Epidural / Nerve Block Catheter |
| DEVICE CLASSIFICATION: | Anesthesia Conduction Catheter 21 CFR Part 868.5120, Product Code BSO |
| PREDICATE DEVICE: | Csen Ltd, Combined End-Multiple Lateral Hole Epidural Catheter, K951927 B. Braun Medical Inc., B. Braun Nerve Block Catheter, K030380 |
| DESCRIPTION: | The B. Braun Regional Anesthesia Catheter is a co- extruded anesthesia conduction catheter consisting of an inner layer of polyamide and an outer layer of polyurethane. The catheter will range in length from 400 – 1010 millimeters and will be available in both 19 and 20 Ga. diameters. The catheter will be available in an open tip configuration as well as a closed tip configuration. The closed tip catheters will have a rounded closed tip with six side ports for distribution of anesthetics and analgesics. The catheter will also have depth markings beginning within 50.5 millimeters from the tip of the catheter and ending at approximately 250 millimeters from the tip. |
| INTENDED USE: | The B. Braun Regional Anesthesia Catheter is a device intended to provide, via percutaneous administration, continuous and/or inter.nittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the pre- operative, perioperative and postoperative periods |

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associated with general and orthopedic surgery as well as labor and delivery. Routes of administration include epidural and perineural (peripheral nerve block).

## SUBSTANTIAL EQUIVALENCE:

The new B. Braun Regional Anesthesia catheter is similar in size, application, performance and sterilization methods to the B. Braun Nerve Block Catheter (K030830). Both of these catheters are available in open and closed tip configurations and are provided in the same lengths. The new B. Braun Regional Anesthesia catheter is similar in application and characteristics to the Csen Ltd Combined End-Multiple Lateral Holes Epidural catheter (K951927). Both of these catheters contain multiple side ports to allow for distribution of anesthetics and analgesics. The indications for use for the subject device combines both the epidural and peripheral nerve block applications of the predicate devices.

The new B. Braun Regional Anesthesia catheter is different from the predicate devices in that it is a coextruded catheter with both polyamine and polyurethane. Additionally, to aid in locating the device radiographically, three barium sulfate radiopaque stripes are included instead of only one tungsten stripe. The subject device also has six side port holes while the predicate devices have either seven or three. The effect of these material and side port differences was evaluated by performance and functionality testing. The result of this testing does not raise any new issues of safety and effectiveness.

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2004

Ms. Amy Smith Senior Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K042488

Trade/Device Name: B. Braun Regional Anesthesia Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: September 10, 2004 Received: September 13, 2004

Dear Ms. Smith:

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 Eederal Register.

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Page 2 - Ms. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not I loase be advised that be a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the For ary I 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 and ilsuing (21 es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bectronic 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) I mis letter will are r Jearle FDA finding of substantial equivalence of your device to a promative nemily and 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), rl Jase 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 may overn 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,

Clus

Shu-Jen, Ph.D.

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

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## Indications for Use Statement 1.2

Page

| 510(k) Number (if known): | K042488 |
|---------------------------|---------|
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Device Name:

B. Braun Regional Anesthesia Catheter

Indications For Use:

The B. Braun Regional Anesthesia Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics perculancous administration, commac or near a nerve for regional anesthesia and pain management during the pre-operative and postoperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration include epidural and perineural (peripheral nerve block).

Prescription Use _ X (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042488