(152 days)
Alpha Omega's Sterile Disposable NeuroProbes for MER devices are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's sterile Disposable Cannulas for MER are intended for guiding the NeuroProbes in Neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's Sterile Disposable Recording Cables for MER are intended to be used in neurosurgery for connecting NeuroProbes to recording and stimulation device.
Alpha Omega's Sterile Disposable NeuroProbes, Cannulas and Recording Cables for MER are indicated for assisting Neurosurgeons, in the operation room during functional neurosurgery, to aid in placement of depth electrodes.
Sterile Disposables for MER
This appears to be a 510(k) clearance letter from the FDA for a medical device. This type of document typically does not contain the detailed study results, acceptance criteria, or performance metrics that you are requesting.
The letter confirms that the device, "Sterile Disposables for MER" from Alpha Omega Engineering, Ltd., has been found "substantially equivalent" to legally marketed predicate devices. This means it has similar technological characteristics and is intended for the same use as a device already on the market, implying that it is as safe and effective.
To provide the information you asked for, I would need access to the actual 510(k) submission, which is often much more detailed than the clearance letter itself and may contain the studies and data you're looking for.
Based on the provided text, I can only state that none of the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC study, standalone performance) is present.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alpha Omega Engineering, Ltd. c/o Mr. Ilan Sharon l Ha'rakefet St. P.O. Box 4262 Zichron Yaacov 30900 Israel
JUN 1 2 2012
Re: K120098
Trade/Device Name: Sterile Disposables for MER Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: March 7, 2012 Received: May 30, 2012
Dear Mr. Sharon:
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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Page 2 - Mr. Ilan Sharon
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 yours.
Hoang fore.
Malvina B. Evdelman, M.D. 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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Indications for Use
510(k) Number (if known): K120098
Device Name: Sterile Disposables for MER
Indications for Use:
Alpha Omega's Sterile Disposable NeuroProbes for MER devices are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's sterile Disposable Cannulas for MER are intended for guiding the NeuroProbes in Neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's Sterile Disposable Recording Cables for MER are intended to be used in neurosurgery for connecting NeuroProbes to recording and stimulation device.
Alpha Omega's Sterile Disposable NeuroProbes, Cannulas and Recording Cables for MER are indicated for assisting Neurosurgeons, in the operation room during functional neurosurgery, to aid in placement of depth electrodes.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR - - Over-The-Counter Ose_______________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
John Grimes, Ph.D.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K120098
Page 1 of 1
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).