(73 days)
Not Found
No
The description focuses on the mechanical functions of a lumbar puncture kit and does not mention any computational or analytical capabilities that would suggest AI/ML.
No.
The primary uses of this device, as described, are for diagnostic purposes (collecting CSF, measuring ICP, detecting blood, injecting dyes for imaging) and for administering drugs or anesthesia, rather than directly treating a disease or condition.
Yes
The device is intended to "detect blood in CSF" and "measure intracranial pressure (ICP)" which are diagnostic functions.
No
The device description clearly outlines a physical kit designed for collecting CSF, measuring pressure, injecting substances, and administering drugs. These are all hardware-based functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in collecting CSF samples from a patient during a procedure, measuring pressure in the patient, injecting substances into the patient, and administering drugs to the patient. These are all procedures performed on or within the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are performed outside of the living body (in vitro).
- Device Description: The device description reinforces the intended use, focusing on the collection of CSF from a patient and other procedures performed on the patient.
The Lumbar Puncture Kit is a medical device used for a surgical/procedural intervention, not for analyzing samples in a laboratory setting.
N/A
Intended Use / 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.
Product codes
FMJ
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.
The Lumbar Puncture Kit contains components that have already been reviewed and cleared by the FDA for their intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The third and fourth lumbar vertebrae
Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2500 Spinal fluid manometer.
(a)
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.(b)
Classification. Class II (performance standards).
0
APR - 7 1997
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 EQUIVALENCE 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.
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.
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.
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