AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L

K013231 · Avid N.I.T., Inc. · BSP · Dec 3, 2001 · Anesthesiology

Device Facts

• Record ID: K013231
• Device Name: AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
• Applicant: Avid N.I.T., Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Avid-NIT Lutz Needle is used for the percutaneous puncture of the back, over the spine and into the epidural space for the administration of anesthetic agents. This needle is not intended for use with an epidural catheter.

Device Story

The Avid-NIT Lutz Epidural Needle is a manual surgical instrument designed for percutaneous access to the epidural space. Available in plastic or metal hub configurations, the device is used by clinicians to facilitate the administration of anesthetic agents. It functions as a standard conduction needle for spinal procedures. The device is intended for prescription use only.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual anesthesia conduction needle; available in plastic or metal hub variants; intended for percutaneous puncture; Class II device (Product Code 73 BSP).

Indications for Use

Indicated for percutaneous puncture of the back, over the spine, into the epidural space for administration of anesthetic agents. Not for use with epidural catheters.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 3 2001

Mr. Scott Henderson AVID-NIT, Inc. 390 Scarlet Boulevard Oldsmar, FL 34677

Re: K013231

A VID-NIT Plastic Hub Lutz Epidural Needle A VID-NIT Metal Hub Lutz Epidural Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II (two) Product Code: 73 BSP Dated: September 26, 2001 Received: September 27, 2001

Dear Mr. Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Scott Henderson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DA s issuation of a basedianted on the requirements of the Act that FDA has made a decienment that your issues and agencies. You must of the said. or ally Federal Statutes and regulations adminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogin mailering of substantial equivalence of your device to a legally prematication. The PDF miding of casification 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 IT you desire specific acrice for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Far 007.10 101 m. The questions on the promotion and advertising of Compliance at [phone]. Thankshany, be are at [phone]. Also, please note the your device, product of marvand of by reference to premarket notification" (21CFR Part 807.97). I guiation chitteed, "Misorananing of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Donler Tiller

James E. Dillard I Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K01323i

#### 510(k) Number (if known):

Device Naunc: Avid-NIT. Lutz Epidura1 Needle

# Indications For Use:

The Avid-NIT Lutz Needle is used for the percutaneous puncture of the back, over the spine and into the epidural space for the of the back, over one bpannesthetic agents. This needle is not intended for use with an epidural catheter.

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### Coacureuce of CDRH, Offico of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K015231

Prescription Usc (Pcr 21 CFR 801.109)

OR

## Over-The-Counter Use

(Optional Formal 1-2-96)