(89 days)
Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment. The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet. Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.
The provided text describes a 510(k) premarket notification for Axon Systems' Subdermal Needle Electrodes. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device.
Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training) are not applicable to this type of submission as the core of a 510(k) is about demonstrating similarity to existing, legally marketed devices.
However, I can provide information based on what is available in the document:
1. Table of Acceptance Criteria and the Reported Device Performance:
- Acceptance Criteria: The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate devices, or that any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: The document states: "Axon Systems' Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This is the core performance claim in the context of a 510(k). Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as they are typically not required for this type of submission unless a significant new technological feature is being introduced that affects performance beyond that of the predicate.
2. Sample size used for the test set and the data provenance:
- Not Applicable: This was a 510(k) submission focused on substantial equivalence to predicate devices. There is no mention of a "test set" in the context of a performance study with human subjects or a dataset. The evaluation likely involved technical comparisons and analysis of the device's design, materials, and intended use against the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: See point 2.
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 device is a Subdermal Needle Electrode, which is an invasive medical device for recording and stimulating biopotential signals. It is not an AI-powered diagnostic imaging device or software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is hardware and is used by a licensed physician or technologist. It does not operate as a standalone algorithm in the way AI software would.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable: The concept of "ground truth" as used in performance studies (e.g., for diagnostic accuracy) is not relevant here. The "truth" in a 510(k) is established by successfully demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it shares their fundamental safety and effectiveness profile.
8. The sample size for the training set:
- Not Applicable: See point 2. There is no mention of a "training set" as this is not an AI/machine learning device requiring such a component.
9. How the ground truth for the training set was established:
- Not Applicable: See point 8.
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APR 2 6 2005
Appendix J Summary of Safety and Effectiveness
.
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11. Summary of Safety and Effectiveness
| Company Name: | Axon Systems, Inc.400-2200 Oser AveHauppauge, NY 11788 | ||
|---|---|---|---|
| Contact:Phone:Fax:Email: | Howard BailinVice President, C.O.O.631 436 5112631 436 5141hbailin@axonsystems.com | ||
| Summary Date | January 17, 2005 | ||
| Proprietary Name: | Subdermal Needle ElectrodesTwisted Pair Needle ElectrodesCorkscrew (spiral) Needle Electrode | ||
| Common Name: | Subdermal Needle Electrodes | ||
| Classification: | Class IINumber:Procodes: | (Performance Standards)882.1350GXZ | Needle Electrode |
| Predicate Devices | Manufacturer: Nicolet Biomedical | Trade Name: Sterile Subdermal Needle Electrodes | FDA number: K010019 |
| Manufacturer: TechnoMed Europe | Trade Name: Various Needle Electrodes | FDA number: K990015 | |
| Manufacturer: Agram Export-Import Company | Trade Name: Spiral Electrode | FDA number: K934779 |
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Page 2 of 2
Device Description
Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously.
The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.
The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet.
Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.
Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.
Intended Use
Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
Technological Characteristics
Axon Systems' Subdermal Needle Electrode consists of an insulated wire, of various lengths, electrically connected to a small gauge, stainless steel needle on one end, and a DIN 42802 "touch-proof" safety connector on the other end. The connector is specifically designed so that it cannot be plugged into AC power outlet. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices.
Conclusions
Axon Systems' Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard Bailin Vice President, Chief Operating Officer Axon Systems, Inc. 400-2200 Oser Avenue Hauppauge, New York 11788
Re: K050194
Trade/Device Name: Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: April 1, 2005 Received: April 5, 2005
Dear Mr. Bailin:
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. Howard Bailin
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/industry/support/index.html.
Sincerely vours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting 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 | K050194 |
|---|---|
| Device Name | Subdermal Needle Electrodes |
| Indications for Use | Axon Systems' Subdermal Needle Electrodes are intended for usewith recording, monitoring and stimulation/recording equipment forthe recording of biopotential signals includingelectroencephalograph (EEG), electromyograph (EMG) and nervepotential signals and for stimulation during the intraoperativediagnosis of acute dysfunction in corticospinal axonal conduction. |
Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1,Enive
cd Deve o
Page 1 of 1
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).