(64 days)
Not Found
None
No
The summary describes a simple, disposable lumbar puncture kit with no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is used for collection and sampling of spinal fluid, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is described as a "collection and sampling kit," which indicates it is used to gather information (spinal fluid) rather than to analyze it or make a medical diagnosis.
No
The device is described as a "lumbar puncture kit" which is a physical, disposable medical device used for collecting spinal fluid. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The intended use of this device is for the collection and sampling of spinal fluid. While the collected fluid may be used for IVD testing later, the device itself is the tool for obtaining the sample, not for performing the diagnostic test on the sample.
- The description focuses on the collection process. There is no mention of analyzing the spinal fluid or providing diagnostic information based on the fluid itself.
This device is a medical device used for a procedure (lumbar puncture) to obtain a biological sample. The subsequent testing of that sample would likely involve IVD devices.
N/A
Intended Use / Indications for Use
A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.
Product codes
MIA
Device Description
Not Found
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
Neonatal 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
MAY 2 2 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Clyde N. Baker Klein-Baker Medical, Inc. 12001 Network, Suite 110 San Antonio, Texas 78249
Re: K970997
Trade Name: Neo-Care Lumbar Puncture Kit Regulatory Class: II Product Code: MIA Dated: March 18, 1997 Received: March 19, 1997
Dear Mr. Baker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/trav. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration .....
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in
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the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains Povidone Iodine Swabsticks which are subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the
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Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K970997 510(k) NUMBER (if known):
NEO-CARE LUMBAR PUNCTURE KIT DEVICE NAME:
INDICATIONS FOR USE:
A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.
concurrence of cdrh, office of device evaluation
PRESCRIPTION USE (per 21 CFR 801.109)
OR
Over The Counter Use
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