AVID-NIT NERVE STIMULATION NEEDLES

K014246 · Avid N.I.T., Inc. · CAZ · Jul 16, 2002 · Anesthesiology

Device Facts

• Record ID: K014246
• Device Name: AVID-NIT NERVE STIMULATION NEEDLES
• Applicant: Avid N.I.T., Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Jul 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug. These needles are to be used with battery powered periphera1 nerve locators only. These needles are specifically not intended for nerve stimulation for purposes other than nerve location. These needles are specifically not intended for neurolytic ablation.

Device Story

AVID-NIT Nerve Stimulation Needles are insulated hollow needles used by clinicians to locate peripheral nerves; device functions by delivering electrical stimulation from a battery-powered peripheral nerve locator; needle allows for simultaneous or subsequent single-shot administration of local anesthetic; device used in clinical settings; output is nerve location via stimulation response and anesthetic delivery; benefits include precise nerve identification for regional anesthesia; device is not for neurolytic ablation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Insulated hollow needle; electrical stimulation interface for battery-powered nerve locators; single-shot anesthetic delivery capability; sterile, single-use device.

Indications for Use

Indicated for locating peripheral nerves via electrical stimulation and single-shot local anesthetic administration. Contraindicated for nerve stimulation purposes other than nerve location and for neurolytic ablation.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Henderson Director, Engineering AVID-NIT, Incorporated 390 Scarlet Boulevard Oldsmar. Florida 34677

JUL 1 6 2002

Re: K014246

Trade/Device Name: AVID-NIT Nerve Stimulation Needles Regulation Number: 868.5140 / 882.1350 Regulation Name: Kit, Conduction Anesthetic / Electrode, Needle Regulatory Class: II Product Code: CAZ / GXZ Dated: April 22, 2002 Received: April 25, 2002

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 vour 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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## Page 2 - Mr. Scott Henderson

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 21 CFR Part 809.10 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Timothy A. Ulatowski

Tin Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)K014246_______________________________________________________________________________________________________________________________________________

Device Name: AVID-NIT Nerve Stimulation Needles

Indications For Use:

The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug.

These needles are to be used with battery powered periphera1 nerve locators only.

These needles are specifically not intended for nerve stimulation for purposes other than nerve location. These needles are specifically not intended for neurolytic ablation.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K014246 |

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use |
|----------------------|--------------------------------------------|----|--------------------------|
| (Per 21 CFR 801 109) | | | (Optional Format 1-2-96) |

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