(67 days)
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No
The summary describes a physical needle for administering anesthetic agents and contains no mention of AI, ML, image processing, or software components typically associated with AI/ML medical devices.
No.
Explanation: The device is used for the administration of anesthetic agents, which is a diagnostic/interventional procedure, not a therapeutic one. Therapeutic devices are typically used for treating diseases or conditions directly.
No
The Avid-NIT Lutz Needle is used for the administration of anesthetic agents, which is a therapeutic rather than a diagnostic function.
No
The intended use describes a physical needle, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Avid-NIT Lutz Needle is used for a percutaneous puncture (going through the skin) directly into the body (the epidural space) for the administration of anesthetic agents. This is an in vivo procedure (performed within the living body).
The intended use clearly describes a procedure performed directly on a patient, not the analysis of a sample outside the body.
N/A
Intended Use / 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 administration of anesthetic agents. This needle is not intended for use with an epidural catheter.
Product codes
73 BSP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
back, over the spine and into the epidural space
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
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.
1
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 (301) 594-4640. Thankshany, be are at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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.
(PLEASE DO NOT WRITE BELOW THUS LINE - CONTINUE ON ANOTHER PAGE IF NEBORD)
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)