The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks.

The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure intracranial pressure which can result from infection, tumor, hemorthage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

Device Description

The SIMS Lumbar Puncture (LP) Kit is available in adult or pediatric configurations. The kit includes the preparatory and procedural components to perform Lumbar Puncture. A manometer may be included with the kit, depending upon the kit selected.

The SIMS LP Kits with a manometer are used to measure cerebrospinal fluid pressure in centimeters of water (cm of H2O). The manometer consists of two calibrated sections of tubing with a connector welded to the upper portion of the tubing.

Lumbar puncture is performed with standard prep and procedural componentry, similar to those used in spinal anesthesia kits, with the addition of a two part manometer, a 3-way stopcock and 5 inches of small bore extension tubing for the measurement of intracranial CSF pressure.

AI/ML Overview

This document, a 510(k) summary for the SIMS Lumbar Puncture (LP) Kit, explicitly states:

"There were no nonclinical or clinical tests performed with these kits."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria.

Consequently, I cannot provide information for the following points as no such data is present in the document:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
Sample sized used for the test set and the data provenance: No test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth established from experts for a test set.
Adjudication method for the test set: No test set means no adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was performed, and this device is not an AI-based system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was done for an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth established.
The sample size for the training set: No training set was used.
How the ground truth for the training set was established: No training set means no ground truth establishment for it.

The document does offer a "SUMMARY OF PERFORMANCE DATA" for the manometer component stating: "Performance testing of the proposed kits show the SIMS manometer performed equal to or better than the predicate manometer from Abbott, both for the range in accuracy and for the average variance in accuracy." However, it does not detail the methodology, sample size, specific acceptance criteria, or raw performance data for this comparison. It only states a general outcome of comparison with a predicate device.

Summary

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SMITHS INDUSTRIES

Medical Systems

Image /page/0/Picture/1 description: The image shows a logo for SIMS. The logo is in black and white, and the letters are bold and blocky. There are horizontal lines above and below the letters.

K963570

SIMS Inc.

OCT 18 10

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

15 Kit Street Keene, NH 03431 Telephone: (603) 352-3812 Fax: (603) 352-3703

H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY

PREPARATION DATE OF SUMMARY

September 4, 1996

TRADE NAME

SIMS Adult (Pediatric) Lumbar Puncture Kit SIMS Adult (Pediatric) Lumbar Puncture Kit with Manometer

COMMON NAME

Adult (Pediatric) Lumbar Puncture Kit Adult (Pediatric) Lumbar Puncture Kit with Manometer

CLASSIFICATION NAME

Class II, 80 FMJ, 21 CFR 880.2500

PREDICATE DEVICE

American Pharmaseal® Company's Pediatric/Infant Lumbar Puncture Tray Abbott Laboratories' Lumbar Puncture, Child, 22-G x 3 1/2", Double-Decker Tray with Lidocaine Hydrochloride Abbott Laboratories' Lumbar Puncture, Adult, 20 -G x 3 1/2", Double-Decker Tray with Lidocaine Hydrochloride

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DESCRIPTION

The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure increased intracranial pressure which can result from infection, tumor, hemorrhage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

INDICATIONS FOR USE

The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks 123

References:

ﻨﺘﻪ ﺑﻪ ﺗﺮﺟﻪ

1. Isselbacher KJ, Harrison's Principles of Internal Medicine, 10th Ed., McGraw-Hill, 1994; New York,
1. Adams RD, Victor M., Principles of Neurology, 5th Ed., McGraw-Hill, 1993; New York.
1. Wyngaarden JB, Cecil, Textbook of Medicine, 19th Ed., W.B.Saunders, 1992; Philadelphia.

TECHNOLOGICAL CHARACTERISTICS

All components for the proposed LP kits, except the manometer and extension set, are legally marketed devices, marketed separately and/or contained in legally marketed devices for Pediatric Regional Anesthesia Systems, Spinal Anesthesia Systems, or Epidural Anesthesia Systems marketed under 510(k) K851134. The manometer is made of a biocompatible plastic used extensively in other medical devices. The extension set is made of materials used in our existing blood pressure monitoring tubing, K833171.

SUMMARY OF PERFORMANCE DATA

Performance testing of the proposed kits show the SIMS manometer performed equal to or better than the predicate manometer from Abbott, both for the range in accuracy and for the average variance in accuracy.

SUMMARY OF NONCLINICAL AND CLINICAL TESTS

There were no nonclinical or clinical tests performed with these kits.

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CONCLUSION OF NONCLINICAL AND CLINICAL TESTS

There were no nonclinical or clinical tests performed with these kits.

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ADDITIONAL INFORMATION

None

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Very truly yours,

Smiths Industries Medical Systems, Inc. dba Concord/Portex

Turathy R. Talcott

Timothy J. Calcott Manager of Regulatory Affairs

Regulation Number and Section

§ 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).