← Product Code [FMJ](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ) · K970287 # LUMBAR PUNCTURE KIT (K970287) _B.Braun Medical, Inc. · FMJ · Apr 7, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K970287 ## Device Facts - **Applicant:** B.Braun Medical, Inc. - **Product Code:** [FMJ](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ.md) - **Decision Date:** Apr 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2500 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic, Pediatric ## Indications for 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. ## Regulatory 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](/device/K932569.md)) - Pharmaseal Clear Hub Spinal Needle ([K920305](/device/K920305.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 (610)691-5400 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. 5 {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K970287](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K970287) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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