NEO-CARE LUMBER PUNCTURE KIT

K970997 · Klein-Baker Medical, Inc. · MIA · May 22, 1997 · Anesthesiology

Device Facts

• Record ID: K970997
• Device Name: NEO-CARE LUMBER PUNCTURE KIT
• Applicant: Klein-Baker Medical, Inc.
• Product Code: MIA · Anesthesiology
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Neo-Care Lumbar Puncture Kit is a single-use, disposable procedural tray designed for neonatal spinal fluid collection. Kit contains various medical components required to perform lumbar puncture. Used in clinical settings by healthcare professionals. Device facilitates fluid sampling; assists in diagnostic procedures for neonates. Benefits include convenience of pre-packaged, sterile components for specific neonatal patient population.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Kit containing multiple medical components for lumbar puncture. Components must be individually cleared or legally marketed. Sterilization required for kit assembly. No electronic or software components.

Indications for Use

Indicated for neonatal patients requiring lumbar puncture for spinal fluid collection and sampling.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 22 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/tray. 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
[phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia 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

510(k) NUMBER (if known): K970997

DEVICE NAME: NEO-CARE LUMBAR PUNCTURE KIT

## INDICATIONS FOR USE:

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

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION


PRESRIPTION USE ☑ (per 21 CFR 801.109)

OR

Over The Counter Use ☐

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