LUMBAR PUNCTURE KIT

K970287 · B.Braun Medical, Inc. · FMJ · Apr 7, 1997 · General Hospital

Device Facts

• Record ID: K970287
• Device Name: LUMBAR PUNCTURE KIT
• Applicant: B.Braun Medical, Inc.
• Product Code: FMJ · General Hospital
• Decision Date: Apr 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

Device Story

Lumbar Puncture Kit; procedural tray for CSF collection, ICP measurement, and spinal injections. Used in clinical settings by healthcare professionals. Device facilitates sample collection, manometer attachment for pressure monitoring, and delivery of diagnostic/therapeutic agents between L3-L4 vertebrae. Kit components are previously cleared medical devices. No electronic or software components.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination per established Quality Control Test Procedures and GMP standards.

Technological Characteristics

Kit containing spinal needles and accessories. Components are previously FDA-cleared. No electronic, software, or energy-based components. Sterilization and material specifications conform to existing cleared product designs.

Indications for Use

Indicated for adult and pediatric patients undergoing lumbar puncture procedures for CSF collection, intracranial pressure measurement, radiologic studies via dye/gas injection, or administration of drugs/anesthesia.

Regulatory Classification

Identification

A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.

Predicate Devices

• Pencil Point Spinal Needle and Tray (K932569)
• Pharmaseal Clear Hub Spinal Needle (K920305)

Submission Summary (Full Text)

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APR - 7 1997
K970287

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

B. Braun Medical, Inc January 15, 1997
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Lumbar Puncture Kit

TRADE NAME: Lumbar Puncture Kit

CLASSIFICATION NAME: General Hospital
Class II, 80 FMJ, Spinal Fluid Manometer
21 CFR 880.2500

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K932569 | Pencil Point Spinal Needle and Tray | B. Braun of America |
| K920305 | Pharmaseal Clear Hub Spinal Needle | Baxter Healthcare Corporation |

## 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 Lumbar Puncture Kit. The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

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 Lumbar Puncture Kit contains components that have already been reviewed and cleared by the FDA for their intended use.

SUBSTANTIAL EQUIVALENCE:

The Lumbar Puncture Kit is equivalent in components and intended use to the Pencil Point Spinal Tray currently marketed by B. Braun Medical (formerly B. Braun of America). It is also equivalent to the Lumbar Puncture Kit manufactured by Baxter. There are no new issues of safety or effectiveness raised by the Lumbar Puncture 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.