NEO-CARE LUMBER PUNCTURE KIT by KLEIN-BAKER MEDICAL, INC.

The provided document is a 510(k) clearance letter from the FDA for the Neo-Care Lumbar Puncture Kit. It is not a study report or a summary of a study that establishes acceptance criteria and reports device performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.

The letter explicitly states: "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..."

This indicates that the device's clearance is based on substantial equivalence to a predicate device, rather than a standalone study demonstrating performance against predefined acceptance criteria. The FDA reviews the provided information to ensure the new device is as safe and effective as a legally marketed predicate device.

Therefore, the following information cannot be provided based on the given text:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
Whether a standalone (algorithm only) performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The only piece of relevant information provided is the Indications for Use:

Indications for Use: A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

Summary

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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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Page 2 - Mr. Clyde N. Baker

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)

Over The Counter Use

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Regulation Number and Section

§ 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).