(189 days)
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
The disposable hypodermic EMG needle electrode is designed for single use only. It consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point.
A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device.
The provided text describes a 510(k) premarket notification for a "Disposable hypodermic EMG needle electrode" (K062437) from Technomed Europe. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it outlines a regulatory submission for a medical device that has a long history of use and is compared to existing, legally marketed predicate devices.
Here's an attempt to answer the questions based on the available information, noting where data is absent:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study for a novel diagnostic algorithm would. The basis of this 510(k) submission is "substantial equivalence" to predicate devices, meaning the device performs similarly without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness substantially equivalent to predicate devices | "The Disposable hypodermic EMG needle electrode is safe and effective and is substantially equivalent to the predicate devices." (Conclusion) |
| Performance characteristics confirmed by bench testing | "Technomed Europe has been bench testing the Disposable hypodermic EMG needle electrode to confirm performance characteristics of this device." (Non-clinical data) |
| Design, materials, chemical composition, packaging, and technological characteristics equivalent to predicate devices | "The design, materials, chemical composition, packaging and other technological characteristics of the subject device is equivalent to those of the predicate devices." (Comparison to predicates) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on bench testing and comparison to predicate devices, not human or patient data in a "test set" as would be used for an AI or diagnostic algorithm.
- Data Provenance: Not applicable. The "non-clinical data" refers to "bench testing" performed by Technomed Europe (Netherlands).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of expert consensus or pathology is not relevant for this device's type of regulatory submission (a physical medical device establishing substantial equivalence). The determination of equivalence is made by the FDA based on the submitted information.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human-involved "test set" and thus no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical EMG needle electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of submission is essentially regulatory compliance and demonstrating that the device is as safe and effective as existing, legally marketed predicate devices. It relies on:
- Bench testing results to confirm performance characteristics.
- Comparison of design, materials, and technological characteristics to established predicate devices (K973444: Teca Myoject disposable needle electrode; K002992: Medtronic Disposable Hypodermic Needle Electrode).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an algorithm being developed or tested.
9. How the ground truth for the training set was established
Not applicable. There is no "training set."
Summary of what can be extracted from the document:
The document describes a 510(k) submission for a manual disposable hypodermic EMG needle electrode. The manufacturer, Technomed Europe, sought to demonstrate that their device is "substantially equivalent" to two existing predicate devices (Teca Myoject and Medtronic Disposable Hypodermic Needle Electrode).
The "study" in this context consisted of:
- Non-clinical bench testing to confirm performance characteristics. The specific tests and results are not detailed in this summary.
- Detailed comparison of the device's design, materials, chemical composition, packaging, and other technological characteristics to the predicate devices, concluding that they are equivalent.
The FDA's review of this information led to a determination of substantial equivalence, allowing the device to be marketed. The document does not describe a clinical trial, an AI algorithm, or patient data-driven performance metrics, which are often the focus of the requested information.
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| Attachment D: | 510(k) Summary | |
|---|---|---|
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands | |
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888 | |
| Contact person: | René RonckenManager Quality AssuranceE-mail: rroncken@technomed.nl | |
| Date: | December 22, 2006 | |
| Proprietary Name: | Diagnostic electromyography needle electrode | |
| Common/usual Name: | Disposable hypodermic EMG needle electrode | |
| Classification Name:890.1385) | Diagnostic electromyography needle electrode (21 CFR section | |
| Substantial Equivalence: | K973444: Teca Myoject disposable needle electrodeK002992: Medtronic Disposable Hypodermic NeedleElectrode | |
| Device description: | The disposable hypodermic EMG needle electrode is designedfor single use only. It consists of a stainless steel cannulaelectrically insulated with a PTFE coating, except for the lancetpoint and the inner surface of the tube. The coating is to ensureeasy skin penetration and to ensure electrical insulation on theentire cannula, except for the point.A husk fitting together with a wire with connection to anextension cable has been attached to the cannula. This cablewill enable the electrical signal to be transferred to a stimulatingor recording device. | |
| Intended Use: | The disposable hypodermic EMG needle electrode is used formuscle stimulation, motor unit action potential recording anddrug delivery.The motor nerves are monitored by detecting EMG activity inthe muscles they innervate.The drug used should be Botox Botilium Toxin type A.Note: Technomed Europe does not supply any drugs with theDisposable hypodermic EMG needle electrodes nor doesTechnomed Europe offer for sale any form of drugs | |
| Page 2:2 | ||
| Comparison to predicates: | The design, materials, chemical composition, packaging andother technological characteristics of the subject device isequivalent to those of the predicate devices. | |
| Non-clinical data: | Technomed Europe has been bench testing the Disposablehypodermic EMG needle electrode to confirm performancecharacteristics of this device. | |
| Conclusion: | The comparison to the predicate devices demonstrate that theDisposable hypodermic EMG needle electrode is safe andeffective and is substantially equivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Technomed Europe % Mr. Rene Roncken Manager Quality Assurance Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
FEB : 8 2007
Re: K062437
Trade/Device Name: Disposable Hypodermic EMG Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: January 22, 2007 Received: January 25, 2007
Dear Mr. Roncken:
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. Renee Roncken
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 levice 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.
Sincerely vours.
for D.J. Diaz
Mark N. Melkerson, M.S. 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): KO62437
Disposable hypodermic EMG needle electrode Device Name:
Indications For Use:
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorativegge 1 of _1 and Neurological Devices
510(k) N
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).