(14 days)
Advanced Neuromodulation Systems, Trial Cable is indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Trial Cable is used as an accessory in the Multiprogram Trial Stimulator System (MTS ™). MTS ™ system is intended to be used with ANS Leads (percutaneous) to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.
Not Found
This document is a letter from the FDA regarding a 510(k) premarket notification for a device named "Trial Cable." It grants clearance for the device, stating it is substantially equivalent to legally marketed predicate devices.
The letter explicitly does not contain any information about:
- Acceptance criteria or reported device performance for the "Trial Cable."
- Any study conducted to prove the device meets acceptance criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any studies.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on regulatory approval and compliance requirements for the "Trial Cable."
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Penny Houston Regulatory Affairs Specialist Advanced Neuromodulation Systems 6901 Preston Road Plano, Texas 75024
APR 1 1 2007
Re: K070847
Trade/Device Name: Trial Cable Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: March 27, 2007 Received: March 28, 2007
Dear Ms. Houston:
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
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Page 2 – Ms. Penny Houston
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 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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications For Use: 2.2.
Device Name: Trial Cable
Indications For Use:
Advanced Neuromodulation Systems, Trial Cable is indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The Trial Cable is used as an accessory in the Multiprogram Trial Stimulator System (MTS ™). MTS ™ system is intended to be used with ANS Leads (percutaneous) to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.
Prescription Use X (Per 21 CFR 801.109) Or
Over-The-Gounter Use
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CO PAGE IF NEEDED)
510(k) Number
Concurrence of CDRH, office of Device Evaluation (ODE)
§ 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).