(113 days)
The Epiducer system is an accessory to the leads component of St. Jude Medical Neuromodulation Division neurostimulation systems, which are indicated for spinal cord stimulation (SCS) in 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 multi-disciplinary approach.
The Epiducer™ lead delivery system is intended to introduce Lamitrode S-Series paddle leads and/or St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below the L1 vertebra.
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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Epiducer™ Lead Delivery System," indicating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and includes an "Indication For Use Statement."
Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical Neuromodulation c/o Ms. Rasnmi Moza Senior Regulatory Affairs Specialist 6901 Preston Road Plano, TX 75024
JUN 2 4 2011
Re: K110609
Trade/Device Name: Epiducer™ Lead Delivery System Regulation Number: 21 CFR 882.5880 Regulation Name: Spinal Epidural Electrode Regulatory Class: Class II Product Code: LHG, GZB Dated: March 2, 2011 Received: March 3, 2011
Dear Ms. Moza:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Melvin R. Felder, M.D.
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication For Use Statement
510(k) Number K110609
Device Name: Epiducer™ Lead Delivery System
Indications For Use:
The Epiducer system is an accessory to the leads component of St. Jude Medical Neuromodulation Division neurostimulation systems, which are indicated for spinal cord stimulation (SCS) in 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 multi-disciplinary approach.
The Epiducer™ lead delivery system is intended to introduce Lamitrode S-Series paddle leads and/or St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below the L1 vertebra.
Prescription User- X (Part 21 CFR 801 Subpart D) : ﻧ ંતું
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Over-The-Counter Use __ (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,
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Nose and Throat Devices
KI10609 510(k) Number_
§ 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).