(24 days)
Not Found
No
The description focuses on the physical construction and cooling mechanism of magnetic stimulation coils, with no mention of AI or ML algorithms for data analysis, interpretation, or control.
No.
The device is solely intended for diagnostic purposes (stimulation of peripheral nerves for diagnostic purposes) and does not involve any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for stimulation of peripheral nerves for diagnostic purposes."
No
The device description explicitly details physical hardware components (coils, plastic housing, liquid cooling media, external Coil Cooler unit) that are essential to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stimulation of peripheral nerves for diagnostic purposes." This describes a procedure performed on the patient's body to elicit a response, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a magnetic stimulation coil used as an accessory to a magnetic stimulator. It transfers magnetic stimulation to tissue. This is a physical intervention, not a test on a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on sample analysis
In summary, the device is used for a diagnostic procedure involving direct interaction with the patient's body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The coils are intended for stimulation of peripheral nerves.
The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Product codes
GWF
Device Description
The coils MCF-B65, MCF-75, MCF-125 and Cool-B65 are used as an accessory together with a Magnetic stimulator used for magnetic stimulation. The coils transfer the magnetic stimulation to the tissue.
All four coils are constructed the same way. A coil winding element encapsulated in a plastic housing. The coil winding element is inside the housing surrounded by a liquid cooling media. The cooling media absorb the heat built up during use. The coil Cool-B65 is furthermore connected to an external Coil Cooler unit that generates an active circulation of the cooling media, which allows the coil to operate for an even longer period.
They are either circular or butterfly shaped. They are from 65 to 125 mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
510(k) special
510(k) Summary
07182
JUL 2 7 2007
the first for the first of the
Name of 510(k) owner:
Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum Denmark
Phone: Fax:
+45 4499 8444 +45 4499 1544
Contact:
Lise Terkelsen
Preparation date:
June 25, 2007
Trade name: Common name: Classification name: MCF-B65, MCF-75, MCF-125, Cool-B65 MCF-B65, MCF-75, MCF-125, Cool-B65 Evoked Response Electrical Stimulator
Identification of predicate devices:
K061645: MC-125, MC-B70, C-100, C-B60, MMC-140-II
Summary.doc
1
Device description
The coils MCF-B65, MCF-75, MCF-125 and Cool-B65 are used as an accessory together with a Magnetic stimulator used for magnetic stimulation. The coils transfer the magnetic stimulation to the tissue.
All four coils are constructed the same way. A coil winding element encapsulated in a plastic housing. The coil winding element is inside the housing surrounded by a liquid cooling media. The cooling media absorb the heat built up during use. The coil Cool-B65 is furthermore connected to an external Coil Cooler unit that generates an active circulation of the cooling media, which allows the coil to operate for an even longer period.
They are either circular or butterfly shaped. They are from 65 to 125 mm in diameter.
Intended Use:
The coils are intended for stimulation of peripheral nerves.
Substantial Equivalence:
The coils in this submission has the same characteristics as the predicate coils (K061645), Stimulation of peripheral nerves is the intended application which applies for the 5 cleared coils as well as the 4 modified coils. In size, shape and application they are all comparable.
All coils (both cleared and modified) have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the patient skin or operator.
The coil winding element of the predicate coils are surrounded by molding material. where as the modified coils are surrounded by a liquid cooling media. The magnetic field is not affected by the modification.
The coils are CE-marked and comply with the Medical Device Directive 93/42/EEC. The coils are developed and manufactured according to EN13485, "Medical devices -Quality management systems - Requirement for regulatory purposes". The coils comply with the standard for electrical safety standard, IEC 60601-1, and have been tested at a certified test center, UL Demko. The coils comply with the standard for EMC, IEC 60601-1-2.
Conclusion:
The MCF-B65, MCF-75, MCF-125 and Cool-B65 have the same intended use as the predicate coils and the same technological features. The modified coils do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate coils.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol composed of three curved lines that resemble a person embracing another person. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tonica Elektronik A/S % Ms. Lise Terkelsen Lucernemarken 15 DK-3520 Farum Denmark
JUL 2 7 2007
Re: K071821 Trade/Device Name: Coils, Models MCF-B65, MCF-75, MCF-125, Cool-B65 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: June 28, 2007 Received: July 3, 2007
Dear Ms. Terkelsen:
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 -- Ms. Tonica Elektronik
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A Millhess
Mark Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Coils: MCF-B65, MCF-75, MCF-125, Cool-B65
The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
Mule H. Millen
(Division Sign-Off) Division of General, Re-marative, and Neurological Devices
510(k) Number