(63 days)
Advanced Neuromodulation Systems Tripole 8C, Tripole 16C, and Exclaim 8 Lead Kits 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 used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.
Not Found
I apologize, but this document, which appears to be an FDA 510(k) clearance letter, does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for an AI/device study.
This document is a regulatory approval letter for a medical device called "Lamitrode Series Leads" (spinal cord stimulators). It confirms that the devices are substantially equivalent to previously marketed devices and can be marketed. It discusses regulatory requirements, classifications, and general controls.
The information you are requesting would typically be found in the summary of safety and effectiveness data or the clinical study report that would have been submitted as part of the 510(k) application, but those detailed study documents are not present in the provided text.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance metrics based on the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amy Clendening Regulatory Affairs Specialist Advanced Neuromodulation Systems 6901 Preston Road Plano, Texas 75024
Re: K063080
Trade/Device Name: Lamitrode Series Leads:
- Tripole 8C (model numbers 3209, 3210, 3211, and 3212),
- Tripole 16C (model numbers 3213, 3214, 3215, and 3217), and
- Exclaim 8 (model numbers 3223, 3224, 3225, and 3226)
Regulation Number: 21 CFR 882.5880
Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II
Product Code: GZB
Dated: November 20, 2006
Received: November 21, 2006
Dear Ms. Clendening:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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 devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
DEC 1 2 2006
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Page 2 - Amy Clendening
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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" (21 CFR 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
DEPUTY DIRECTOR
Pin
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): K 063 080
Device Name: ANS Tripole 8C, Tripole 16C, and Exclaim 8 Lamitrode Lead Kits
Indications For Use:
Advanced Neuromodulation Systems Tripole 8C, Tripole 16C, and Exclaim 8 Lead Kits 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 used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.
Prescription Use X (Per 21 CFR 801.109) Or Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
PloR
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Num'or K063080
§ 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).