(43 days)
No
The summary describes a kit of standard medical components for performing a lumbar puncture and measuring CSF pressure. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is used for diagnostic purposes (sampling CSF, measuring CSF pressure) and for lowering intracranial pressure by CSF drainage, which are not considered therapeutic interventions by themselves. While lowering intracranial pressure may have a therapeutic effect, the device's primary listed functions are diagnostic or a procedural step rather than direct treatment of a disease or condition.
Yes
The device is indicated for obtaining CSF specimens for "diagnostic study when possible CNS infection is suspected" and for "measurement of intracranial pressure" which can result from various conditions like infection, tumor, hemorrhage, or edema. These uses directly relate to diagnosing medical conditions.
No
The device description explicitly states the kit includes physical components like tubing, a connector, a stopcock, and extension tubing, which are hardware.
Based on the provided text, the SIMS Lumbar Puncture (LP) Kit is not an In Vitro Diagnostic (IVD).
Here's why:
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Intended Use: The primary intended uses described are for:
- Sampling of Cerebrospinal Fluid (CSF): This is a procedure to obtain a biological sample, not to perform a diagnostic test on the sample itself.
- Measurement of CSF pressure: This is a physiological measurement taken in vivo (within the body), not a test performed in vitro (outside the body) on a sample.
- Lowering intracranial pressure: This is a therapeutic intervention, not a diagnostic test.
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Device Description: The components described (needles, manometer, stopcock, tubing) are used for the procedure of obtaining CSF and measuring pressure in vivo. The manometer measures pressure directly from the patient's CSF system.
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Lack of IVD Components: The description does not mention any reagents, test strips, or other components typically associated with performing a diagnostic test on a biological sample in vitro.
While the CSF sample obtained can be used for subsequent in vitro diagnostic testing (e.g., for infection), the SIMS LP Kit itself is the tool for obtaining the sample and performing a physiological measurement, not the diagnostic test itself.
N/A
Intended Use / 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
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.
Product codes
Not Found
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult or pediatric
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
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. There were no nonclinical or clinical tests performed with these kits.
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
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
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.
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
COMPANY INFORMATION
Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH 03431 (603) 352-3812 x457 (603) 357-5038 Timothy J. Talcott Manager of Regulatory Affairs
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
1
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.
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.
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.
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
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.
References:
ﻨﺘﻪ ﺑﻪ ﺗﺮﺟﻪ
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- Isselbacher KJ, Harrison's Principles of Internal Medicine, 10th Ed., McGraw-Hill, 1994; New York,
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- Adams RD, Victor M., Principles of Neurology, 5th Ed., McGraw-Hill, 1993; New York.
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- 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.
2
CONCLUSION OF NONCLINICAL AND CLINICAL TESTS
There were no nonclinical or clinical tests performed with these kits.
ﭘﯿﺮ ﭘﺮ
ADDITIONAL INFORMATION
None
)
Very truly yours,
Smiths Industries Medical Systems, Inc. dba Concord/Portex
Turathy R. Talcott
Timothy J. Calcott Manager of Regulatory Affairs