(24 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is indicated for the management of chronic pain, which is a therapeutic purpose.
No
The device is indicated for the management of chronic pain, which is a treatment rather than a diagnostic purpose.
No
The device description is not found, but the intended use clearly describes physical leads (90 cm and 110 cm) which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of chronic pain of the trunk and/or limbs". This describes a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body.
- Device Description (Not Found): While the description is missing, the intended use strongly suggests a device that interacts with the nervous system for pain relief.
- No mention of biological samples: There is no indication that this device analyzes blood, urine, tissue, or any other biological sample.
- Anatomical Site: The anatomical site is the "trunk and/or limbs," which are parts of the body where a therapeutic device would be applied, not where a sample would be collected for in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and 3200 Series) Leads are indicated for the management of chronic pain of the trunk and limbs either as the sole mitigating agent, or as an adjunct to other modes of therapy such as a multidisciplinary approach and are intended for use with Advanced Neuromodulation Systems receivers, IPGs, transmitters, and/or antennae.
Product codes
GZB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trunk and limbs
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
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 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 symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
DEC 15 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Danielle Alarcon Regulatory Affairs Specialist Advanced Neuromodulation Systems 6901 Preston Road Plano, Texas 75024
Re: K053250
: K053250
Trade/Device Name: ANS 3100 and 3200 series leads: 90 and 110 cm lengths Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: November 18, 2005 Received: November 30, 2005
Dear Ms. Alarcon:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(x) premained is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the enactinent and other of the Federal Food. Drug, devices that have been reciassified in accondited approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessment of the Act The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general const You may, therefore, market the ucvice, subject to annual registration, listing of
general controls provisions of the Act include required withistras accing and general controls provisions of the Act mende requirement.
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 If your device is classified (see above) nito ennier caso if expecularies) affecting your device can
may be subject to such additional controls. Existing major regulations a may be subject to such additional controlist Existing major be found in the Code of I cacral regarations)
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 Please be advised that FDA s Issualitat of a substination with other requirements of the Act
that FDA has made a determination that your device after clongencies You must that I'DA has made a determination that your devies somplet Federal agencies. You must
1
Page 2 - Ms. Danielle Alarcron
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an this fier of 1 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. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter will and in your he FDA finding of substantial equivalence of your device to a legally premailed predicated 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
N
Mark N. Melkerson Acting Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): |