SOFT TIP EPIDURAL CATHETER KIT

K971233 · B.Braun Medical, Inc. · CAZ · Oct 17, 1997 · Anesthesiology

Device Facts

• Record ID: K971233
• Device Name: SOFT TIP EPIDURAL CATHETER KIT
• Applicant: B.Braun Medical, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Oct 17, 1997
• Decision: SESD
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The soft tip epidural Catheters are intended for the repeated administration of anesthetic agents into the epidural space.

Device Story

Soft Tip Epidural Catheter Kit used for repeated administration of anesthetic agents into epidural space. Device features soft tip design to reduce trauma and incidence of catheter-induced paresthesias. Used in clinical settings by healthcare professionals. Kit components are identical to previously marketed Perifix sets. Device functions as a conduit for anesthetic delivery; no electronic or algorithmic components.

Clinical Evidence

No clinical data. Bench testing only, including sterility, pyrogenicity (LAL method), physical testing, and visual examination per GMP and quality control procedures.

Technological Characteristics

Epidural catheter with soft tip. Materials subject to biocompatibility testing per Tripartite Guidance. Device is a mechanical conduit for fluid delivery. No energy source, connectivity, or software.

Indications for Use

Indicated for the administration of anesthetic agents into the epidural space. Recommended for removal or replacement every 72 hours.

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

• Perifix Set (K813186)
• Positive Placement Continuous Epidural (K801912)

Submission Summary (Full Text)

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OCT 17 1997

# II 510(k) Summary

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

March 31, 1997
K971233

CONTACT: Mark S. Alsberge, Regulatory Affairs Director

PRODUCT NAME: Soft Tip Epidural Catheter Kit

TRADE NAME: Anesthetic Conduction Kit

CLASSIFICATION NAME:
Anesthesiology
Class II, 73 CAZ, Anesthetic Conduction Kit
21 CFR 868.5140

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K813186 | Perifix Set | B. Braun Medical, Inc. |
| K801912 | Positive Placement Continuous Epidural | Arrow International, Inc. |

# DEVICE DESCRIPTION:

B. Braun Medical Inc. intends to introduce into interstate commerce the Soft Tip Epidural Catheter Kit. These have the same design, components, and performance characteristics as the catheters currently marketed by B. Braun Medical and covered under K813186 for the Perifix Set. The intended use is for the repeated administration of anesthetic agents into the epidural space. The only difference is the soft tip of the catheter. Soft tip epidural catheters are less traumatic and reduce the incidence of catheter induced paresthesias. Arrow currently markets a Flex Tip Plus epidural catheter which we believe to be covered under K801912.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates

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to the fact that the product can be marketed without
premarket approval or reclassification. Such a
determination is not intended to be applicable to patent
infringement suits or any other patent matter related to
this product or the technology used to manufacture the
product.

## MATERIAL:

B. Braun Medical certifies that the biocompatibility tests
recommended in the Tripartite Guidance for this category of
contact duration will be completed for all the materials
used in the manufacture of the device.

## SUBSTANTIAL EQUIVALENCE:

The Soft Tip Epidural Catheters Kits are equivalent in
materials, form, and intended use to the Perifix Sets
currently marketed by B. Braun, Inc., covered under K813186.
They are also similar to Arrow’s Flex Tip Catheter which we
believed to be covered under K801912. The kit components
are identical to those items which were offered in the
Perifix Kit. There are no new issues of safety or
effectiveness raised by the Soft Tip Epidural Catheters.

## SAFETY AND EFFECTIVENESS:

All finished products are tested and must meet all required
release specifications before distribution. The array of
testing required for release include, but are not limited
to; sterility, pyrogenicity (endotoxin/ LAL Method),
physical testing, visual examination (in process and
finished product).

The physical testing is defined by Quality Control Test
Procedure documents. These tests are established testing
procedures and parameters which conform to the product
design specifications.

The testing instruction records for each of the individually
required procedures are approved, released, distributed and
revised in accordance with document control GMP’s.

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# III Proposed Labeling

a) Device and Package labels:

A draft sample label for the Soft tip epidural Catheter kit is included in Attachment 1.

b) Manuals and Package Insert:

No additional package insert is planned at this time. A manual is not applicable to this device.

c) Statement of Intended Use:

The soft tip epidural Catheters are intended for the repeated administration of anesthetic agents into the epidural space.

d) Advertisements or Promotional Materials:

No advertisements or promotional materials have been prepared at this time.

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HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR - 4 2008

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Mark S. Alsberge
B. Braun Medical Incorporated
824 Twelfth Avenue
P.O. Box 4027
Bethlehem, Pennsylvania 18018-0027

Re: K971233
Trade/Device Name: Soft Tip Epidural Catheter Kit
Regulation Number: 868.5140
Regulation Name: Anesthesia conduction kit
Regulatory Class: II
Product Code: CAZ
Dated: July 16, 1997
Received: July 21, 1997

Dear Mr. Alsberge:

This letter corrects our substantially equivalent letter of October 17, 1997.

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 (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 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 - Mr. Alsberge

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 continue 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,

Anette Y. Michiu

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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510(k) Number (if known): K971233

Device Name: Soft Tip Epidural Catheter Kit

## Indications For Use:

For the administration of anesthetic agents into the epidural space. B. Braun recommends that the epidural catheter be removed or replaced every 72 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division: Anesthesiology, General Hospital,

Infectious Disease

510(k) Number: K971233

OR

Over-The-Counter Use

Prescription Use ☑ (Per 21 CFR 801.109)

(Optional Format 1-2-96)