PERIFIX PEDIATRIC EPIDURAL KIT

K962696 · B.Braun Medical, Inc. · CAZ · Apr 3, 1997 · Anesthesiology

Device Facts

• Record ID: K962696
• Device Name: PERIFIX PEDIATRIC EPIDURAL KIT
• Applicant: B.Braun Medical, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Apr 3, 1997
• Decision: SEKD
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Perifix Pediatric Epidural Kit is designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.

Device Story

Kit provides regional anesthesia for pediatric surgical patients; used for procedures below T10 vertebrae. Components include Tuohy needle and catheter; facilitates epidural anesthesia administration. Used by clinicians in surgical settings. Device functions as standard conduction anesthesia kit; provides access for anesthetic delivery. Benefits include localized pain management during surgery.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination per Quality Control Test Procedure documents and GMP requirements.

Technological Characteristics

Conduction anesthesia kit containing Tuohy needle and catheter. Materials tested per Tripartite Guidance for Plastics. Standard physical testing and visual inspection protocols applied.

Indications for Use

Indicated for pediatric patients undergoing surgical procedures requiring regional anesthesia below the tenth thoracic vertebrae.

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 for Epidural Anesthesia (K813186)
• Lifecare Epidural Catheter (K893766)
• Spinal Anesthesia Tray (K953467)

Submission Summary (Full Text)

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K962696

II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

APR -3 1997

B. Braun Medical, Inc July 9, 1996
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Perifix Pediatric Epidural Kit

TRADE NAME: Conduction Anesthesia Kit

CLASSIFICATION NAME:

Anesthesiology
Class II, 73 CAZ, Conduction Anesthesia Kit
21 CFR 868.5140

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K813186 | Perifix Set for Epidural Anesthesia | Burron Medical |
| K893766 | Lifecare Epidural Catheter | Abbott |
| K953467 | Spinal Anesthesia Tray | Becton Dickinson |

DEVICE DESCRIPTION:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Perifix Pediatric Epidural Kit. The Perifix Pediatric Epidural Kit is designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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MATERIAL:

The Perifix Pediatric Epidural Kit is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

SUBSTANTIAL EQUIVALENCE:

The Perifix Pediatric Epidural Kit is equivalent in materials, form, and intended use to the Perifix Set for Epidural Anesthesia with Tuohy Needle and Catheter K813186 currently marketed by B. Braum Medical (formerly Burron Medical. It is also equivalent to Abbott's Epidural Catheter K893766 and Becton Dickinson's K953467 Spinal Anesthesia Tray. There are no new issues of safety or effectiveness raised by the Perifix Pediatric Epidural Kit.

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; 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.