(65 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "TES-1 Constant Voltage Electrical Stimulator." It largely focuses on the regulatory approval for marketing the device based on its substantial equivalence to previously marketed devices.
Therefore, the requested information regarding acceptance criteria and performance studies for this specific device is not available within the provided text.
Here's why and what's missing:
- 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It doesn't typically include detailed clinical study reports or performance acceptance criteria in the clearance letter itself. These details would be submitted by the manufacturer to the FDA as part of their 510(k) submission, but they are not disclosed in this public-facing clearance letter.
- "Substantially Equivalent": The core of a 510(k) is proving substantial equivalence. This means the device has the same intended use as a predicate and similar technological characteristics, or, if there are differences, that they do not raise different questions of safety and effectiveness. The information to support this claim would be in the manufacturer's submission, not in this letter.
To answer your questions, one would need access to the full 510(k) submission document, which is not provided here.
However, I can tell you what is present in relation to the device:
- Device Name: TES-1 Constant Voltage Electrical Stimulator
- Intended Use: For cortical stimulation; intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
- Accessory Device: It is explicitly stated as an accessory to the Cadwell Cascade Intra-operative monitoring system only, not a stand-alone device, and not compatible with other systems.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.
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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)
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AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(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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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).