(65 days)
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Not Found
No
The summary describes a constant voltage electrical stimulator and its intended use for cortical stimulation during intraoperative monitoring. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The device appears to be a hardware accessory for a monitoring system.
No
The device is described as being for "intraoperative diagnosis of acute dysfunction" and is an "electrical stimulator" used for "cortical stimulation" to identify conduction issues. This indicates a diagnostic rather than a therapeutic purpose.
Yes
The device is intended for "intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction." The term "diagnosis" directly indicates it's a diagnostic device.
No
The device is described as a "constant voltage electrical stimulator," which is a hardware component. It is also an accessory to a "Cadwell Cascade Intra-operative monitoring system," which is also a hardware system. The summary does not mention any software-only functionality.
Based on the provided information, the Cadwell TES-1 constant voltage electrical stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "cortical stimulation" and "intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction." This involves stimulating the patient's nervous system directly, which is an in vivo (within a living organism) procedure, not an in vitro (outside a living organism, typically in a lab) test.
- Anatomical Site: The anatomical site is "cortical," referring to the cerebral cortex of the brain, which is part of the living patient.
- Device Type: It's described as an "electrical stimulator," which is a device that applies electrical current to the body.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. The Cadwell TES-1 is directly interacting with the patient's body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.
Product codes
GWF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2004
Mr. Chris L. Bolkan Regulatory Specialist Cadwell Laboratories 909 N. Kellogg Street Kennewick, Washington 99336
Re: K042350
Trade/Device Name: TES-1 Constant Voltage Electrical Stimulator Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: October 22, 2004 Received: October 25, 2004
Dear Mr. Bolkan:
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 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.
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Page 2 - Mr. Chris L. Bolkan
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042350
Device Name: TES-1 Constant Voltage Electrical Stimulator
Indications for Use: The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.
Prescription Use X (Part 21 CFR 801 Subpart D)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
mindering n. hands and announcement in and result and and a view , 1994 , 1994 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 19
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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رام
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