(90 days)
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
A diagnostic electromyography 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). The needle electrodes are for single patient only.
This 510(k) premarket notification is for a Disposable EMG Needle Electrode, a Class II medical device. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel performance against acceptance criteria through a clinical study. As such, the information typically found in acceptance criteria and efficacy studies is not present in this document.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or reported device performance in the way you might expect for a new, performance-based device. This 510(k) summary is for a device seeking substantial equivalence, meaning its safety and effectiveness are established by showing it is as safe and effective as a legally marketed predicate device. The focus is on demonstrating similar design, materials, packaging, and technological characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific test set, sample size, or data provenance because it is a 510(k) submission based on substantial equivalence. It does not present results from a clinical trial or performance study that would typically involve a test set.
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)
This information is not applicable and not provided. No "ground truth" was established for a test set as there was no study comparing the device's performance to a known truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There was no adjudication method as there was no performance study involving a test set and human readers.
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
An MRMC comparative effectiveness study was not performed and is not described in this document. The device is an electrode, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not performed and is not described. The device is a physical electrode, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided. No "ground truth" was used in a performance study.
8. The sample size for the training set
This information is not applicable and not provided. This document does not describe the development of an algorithm or AI model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There was no training set for which a ground truth needed to be established.
Summary of the K091410 Submission:
This 510(k) premarket notification by Spes Medica s.r.l. for their "Disposable EMG Needle Electrodes" is a Class II medical device submission seeking substantial equivalence. The core argument for safety and effectiveness is that the device is "similar in design, materials, packaging and other technological characteristics" to several legally marketed predicate devices (e.g., MEDICOTEST A/S Neuroline, AMBU A/S Neuroline, MEDELEC Disposable Needle Electrode, etc.).
The document describes the device's intended use: "Recording muscle activity for Electromyography (EMG) applications. For single patient use only." It also notes a specific use case for the hypodermic version: "injection of the Botulinum Toxin into a muscle, while recording electromyography activity."
The FDA's letter (AUG 11 2009) confirms that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means that, in the context of this 510(k), the device indirectly meets "acceptance criteria" by being deemed as safe and effective as existing products, without requiring independent performance studies with acceptance criteria or ground truth.
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510 (k) Summary of safety and effectiveness
AUG 11 2009
SUBMITTER INFORMATION
ﯿ
| A. | Company Name: | Spes Medica s.r.l. |
|---|---|---|
| B. | Company Address: | Via Europa - Zona IndustrialeBattipaglia SA, Italy 84091 |
| C. | Company Phone: | +39 0828 614191 |
| Company Fax: | +39 0828 341788 | |
| D. | Contact Person: | Alfredo SpadavecchiaQuality Assurance AssistantSpes Medica s.r.l.E-mail: a.spadavecchia@spesmedica.com |
| E. | Date Summary Prepared: | May 11, 2009 |
DEVICE IDENTIFICATION
| A. | Device name: | Disposable EMG Needle Electrodes |
|---|---|---|
| B. | Trade/Proprietary Name: | Disposable EMG Needle Electrodes, Myoline, Myobot |
| C. | Classification name: | Electrode, Needle, Diagnostic Electromyograph (21 CFR §890.1385) |
| D. | Product Code: | IKT |
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
- -MEDICOTEST A/S: Neuroline, Disposable Concentric Needle Electrodes, Neuroline, Disposable Monopolar Needle Electrodes, Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, K973529, K983597, K001869
- -AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Electrode, K071186, K071185
- MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle -Electrodes, Teca Myoject Disposable Needle Electrodes K961013, K973442, K973444
- DANTEC MEDICAL, INC .: Dantec Disposable Concentric Needle, K931966 ・
- -TECHNOMED EUROPE: Disposable Hypodermic EMG Needle Electrode K062437
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DESCRIPTION OF THE DEVICE
A diagnostic electromyography 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). The needle electrodes are for single patient only.
INTENDED USE
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for injection of the Botulinum Toxin into a muscle, while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
Spes Medica does not supply any drugs with the needle electrodes nor does Spes Medica offer for sale any form of drugs.
SUBSTANTIAL EQUIVALENCE
The Disposable EMG Needle Electrodes and the predicate devices are similar in design, materials, packaging and other technological characteristics to the predicate devices. In further support of a substantial equivalence determination, Section 6 provides a comparison chart of the Disposable EMG Needle Electrodes and the predicate devices.
Based on the available 510(k) summaries, the marketing literature and the information provided herein, we conclude that the Disposable EMG Needle Electrodes are substantially equivalent to the existing legally marketed devices under Federal Food. Drug and Cosmetic Act
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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 & Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Spes Medica S.r.l. c/o Alfredo Spadavecchia Quality Assurance Assistant Via Europa - Zona Industriale 84091 Battipaglia (SA) Italy
AUG 11 2009
Re: K091410
Trade/Device Name: Disposable EMG Needle Electrodes Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: II Product Code: IKT Dated: May 11, 2009 Received: May 13, 2009
Dear Mr. Spadavecchia:
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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Ratha m t
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KOGJ410
510(k) Number (if known):
Device Name: .
Disposable EMG Needle Electrodes
Indications for Use:
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Urths
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091410
§ 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).