(202 days)
Not Found
Not Found
No
The summary describes a simple nerve stimulation needle and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used for locating peripheral nerves by electrical stimulation and administering local anesthetic, not for treating a disease or condition. Its intended use explicitly states it is "not intended for nerve stimulation for purposes other than nerve location" and "not intended for neurolytic ablation."
Yes
The device aids in "locating peripheral nerves by electrical stimulation," which is a diagnostic function to determine the precise location of nerves for further medical intervention.
No
The device description explicitly states it consists of "insulated hollow needles," which are physical hardware components.
Based on the provided information, the AVID-NIT Nerve Stimulation Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AVID-NIT Function: The AVID-NIT Nerve Stimulation Needles are used in vivo (within the living body) for locating peripheral nerves by electrical stimulation and administering local anesthetic. They interact directly with the patient's body, not with specimens taken from the body.
Therefore, the AVID-NIT Nerve Stimulation Needles fall under the category of in vivo medical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
CAZ, GXZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
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
§ 868.5140 Anesthesia conduction kit.
(a)
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.(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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a human figure in profile, with three overlapping shapes representing the head, body, and legs.
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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 | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801 109) | (Optional Format 1-2-96) |
EYHIBIT 1