(156 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses on a surgical instrument for tissue/bone removal.
No
The device is used for tissue or bone removal, which is a surgical tool function, not a therapeutic one. It facilitates a treatment (surgery) but does not directly provide therapy (like drug delivery or rehabilitation). Its function is to remove tissue/bone, not to treat a condition.
No
The device description states its purpose is for the "removal of tissue or bone," which indicates a therapeutic or surgical function, not a diagnostic one.
No
The intended use describes a device for the removal of tissue or bone, which inherently requires a physical instrument (hardware) to perform this action. The summary does not mention any software-only function.
Based on the provided information, the PowerTREK Instrument is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "removal of tissue or bone in minimally invasive ENT and Orthopedic procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The PowerTREK Instrument does not perform this function.
- Lack of IVD-related information: The provided text lacks any mention of analyzing biological samples, laboratory settings (other than a surgical setting), or diagnostic purposes based on sample analysis.
Therefore, the PowerTREK Instrument is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The PowerTREK Instrument is indicated for use in the removal of tissue or bone in minimally invasive ENT and ,Orthopedic procedures. It is to be used within a surgical setting under sterile technique.
Product codes
77 ERL, 87 HRX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
surgical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
und Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dom L. Gatto President MedTREKTM Corporation 1204 Main Street, Suite 224 Branford, CT 06405
NOV - 5 1997
Re: K972057 PowerTREKTM Micro Debrider System Dated: September 11, 1997 Received: September 19, 1997 Regulatory Class: II 21 CFR 874.4250/Procode: 77 ERL 21 CFR 888.1100/Procode: 87 HRX
Dear Mr. Gatto:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.
If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regilation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h7liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indication for Use Statement:
K972057 510 (k) Number: PowerTREK Instrument Device Name:
Indications For Use:
The PowerTREK Instrument is indicated for use in the removal of tissue or bone in minimally invasive ENT and ,Orthopedic procedures. It is to be used within a surgical setting under sterile technique.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)