(24 days)
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The Axxess® Butterfly Anchor accessory is intended to be used with the ANS Axxess percutaneous permanent and trial leads to secure the leads to the interspinous ligament.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Axxess® Butterfly Anchor." It primarily addresses the device's substantial equivalence to previously marketed predicate devices and its intended use.
However, this document DOES NOT contain the type of acceptance criteria or details of a study (like an MRMC or standalone study) to prove device performance.
This letter is a regulatory approval document, not a detailed technical report of a performance study. It confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to existing legal predicate devices. This determination is based on the information provided in the original 510(k) submission (K052418), which is not fully included here.
Therefore, I cannot provide the requested information about acceptance criteria and study details from this document. The information you're asking for would typically be found in the manufacturer's original 510(k) submission, specifically in the sections outlining performance testing and clinical data (if any was required for this type of device).
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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
SEP 26 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steve Tamsett Sr. Regulatory Affairs Specialist Advanced Neuromodulation Systems 6901 Preston Road Plano, Texas 75024
Re: K052418
Trade/Device Name: Axxess® Butterfly Anchor Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: September 1, 2005 Received: September 8, 2005
Dear Mr. Tamsett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to may 2011 de nees may have been resuire approval of a premarket approval application (PMA). and Coometre For (110) that the device, subject to the general controls provisions of the Act. The r va may, mererere, mans 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 rr your de rise 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 t teast be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 – Mr. Steve Tamsett
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 Orth 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 radially wou to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated 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), please contact the Office of Compliance at (240) 276-_. 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,
Z
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Axxess® Butterfly Anchor accessory
Indications for Use:
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The Axxess® Butterfly Anchor accessory is intended to be used with the ANS Axxess percutaneous permanent and trial leads to secure the leads to the interspinous ligament.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use_
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052418
§ 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).