(24 days)
Not Found.
K/DEN numbers: Not Found
No
The provided text describes a spinal cord stimulation lead and its compatible components, with no mention of AI or ML technology.
Yes
The device is described as aiding in the management of chronic pain, which is a therapeutic function.
No
The AXXESS™ Lead is described as a component of a spinal cord stimulation system used for chronic pain management, not for diagnosing conditions.
No
The device description explicitly states "Axxess Spinal Cord Stimulation Lead, Model 8000 Series," which is a physical component (a lead) used in a spinal cord stimulation system. This is hardware, not software only.
Based on the provided information, the AXXESS™ Lead is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "aid in the management of chronic pain of the trunk and/or extremities" as part of a spinal cord stimulation system. This is a therapeutic and pain management application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description refers to a "Spinal Cord Stimulation Lead," which is an implantable or percutaneous device used to deliver electrical stimulation to the spinal cord. This is a medical device used directly on or in the patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The AXXESS™ Lead is a device used to deliver therapy directly to the patient's spinal cord.
N/A
Intended Use / Indications for Use
The AXXESS™ Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities.
The AXXESS™ lead system is designed to be used with the following devices:
- Medtronic® Mattrix® Model 3272 RF system receiver and compatible transmitter, or .
- Medtronic® X-TREL® Model 3470 RF system receiver and compatible transmitter ● using the Medtronic® Model 7495 Quadripolar extension , and
- Medtronic® Model 3550-05 Percutaneous Extension with the Medtronic® Model 3550-. 03 Screener cable, and
- The Medtronic® Model 3628 DualScreen™ Screener using Axxess Screener Cable or ●
- The ANS TS-8 or MNT90T/TR-16 Test Stimulator using Axxess Screener Cable. ●
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
Spinal cord (implied by "Spinal Cord Stimulation Lead" and "chronic pain of the trunk and/or extremities")
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
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 graphic of an eagle or bird-like figure with three human profiles embedded within its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Drew Johnson Vice President Regulatory and Clinical Affairs Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024
Re: K030674
Trade/Device Name: Axxess Spinal Cord Stimulation Lead Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: February 21, 2003 Received: March 4, 2003
Dear Mr. Johnson:
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.
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. 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
1
Page 2 - Mr. Drew Johnson
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) 594-4659. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark A. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Page
510(k) Number (if known):
Device Name:
Axxess Spinal Cord Stimulation Lead, Model 8000 Series
Indications for Use: The AXXESS™ Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities.
The AXXESS™ lead system is designed to be used with the following devices:
- Medtronic® Mattrix® Model 3272 RF system receiver and compatible transmitter, or .
- Medtronic® X-TREL® Model 3470 RF system receiver and compatible transmitter ● using the Medtronic® Model 7495 Quadripolar extension , and
- Medtronic® Model 3550-05 Percutaneous Extension with the Medtronic® Model 3550-. 03 Screener cable, and
- The Medtronic® Model 3628 DualScreen™ Screener using Axxess Screener Cable or ●
- The ANS TS-8 or MNT90T/TR-16 Test Stimulator using Axxess Screener Cable. ●
Mark A. Milken
Division Sien-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) Or
Over-the-Counter Use -------