(576 days)
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Not Found
No
The summary describes nerve stimulation needles and kits, which are physical devices used in conjunction with a nerve stimulator, but there is no mention of AI or ML technology being incorporated into the needles or kits themselves.
No
The primary function of the device is to locate peripheral nerves and assist in the administration of anesthesia drugs, not to treat a condition.
No
The device is described as a nerve stimulator needle used for locating nerves and administering anesthesia drugs, not for diagnosing a condition.
No
The device description explicitly states "Nerve Stimulation Needles" and "Nerve Stimulation needle kits," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for regional anesthesia procedures, specifically for locating peripheral nerves and administering anesthesia drugs. This is a clinical procedure performed directly on a patient.
- Device Description: The device is a nerve stimulator needle/kit. This is a physical instrument used in a medical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a medical device used in vivo (within the body) for a therapeutic and diagnostic (nerve location) purpose during a medical procedure.
N/A
Intended Use / Indications for Use
The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves (when used with a nerve stimulator) and administration of anesthesia drugs.
Product codes
84 GXZ, 73 CAZ
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
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesiologists or other trained professionals, for the location of peripheral nerves
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)
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
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000
Te Me Na Sarl C/O Arthur Ward Regulatory and Marketing Services, Inc. 3234 Ella Lane New Pork Rickey, Fl 34655
K990100 Re: K990100
Polymedic UPA, UPC, Polyplex N, and Polyplex C Nerve Stimulation Needles Regulatory Class: II (two) Product Code: 84 GXZ, 73 CAZ Dated: May 18, 2000 Received: June 16, 2000
Dear Mr. Ward:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceion on (i) and determined the device is the device ferenced above and indications for use stated in the substantially equivalence (102 cordicate devices marketed in enclosure) to regally marked production the enactment date of the Incelstate Commerce pros, or to devices that have been reclassified Medical Device Amendales, of over of the Federal Food, Drug, and In accordance with the provinsy, therefore, market the device, subject to the general controls provisions of the Act. The general controls the general controls provibions of the annual registration, provisions of the not manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device 15 claboried (boo aboroval), it may be subject to such Controls, or class III (Freinan major regulations affecting your device auditional concertir. Eniosing and Regulations, Title 21, Parts 800 and in the ocus equivalent determination assumes compliance to 895. co oss. It babbeanound in ufacturing Practice requirements, as set with the Ourchio Sty System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS General regulation (2) on Drug Administration (FDA) will verify such Inspections, the rood and bray with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this eonecriing your actification submission does not affect any response to your premained inder sections 531 through 542 of the Act
1
Page 2 - Mr. Ward
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
for Mark N. Millikan
James E Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Device and Radiological Health
Enclosure
2
510(k) Number (if known): K990100
Polymedic Nerve Stimulator Needle Device Name:
Indications For Use:
The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves when used with a nerve stimulator) and administration of anesthesia drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark n Mulken
f Cardiovascular & Respiratory
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)