(377 days)
The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.
BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.
The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The provided text describes BIONEN Needle Electrodes (Disposable Concentric, Disposable Monopolar/Subdermal, and Disposable Monopolar Needle Electrodes) and summarizes the non-clinical tests performed to demonstrate their functionality and safety, asserting substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with quantifiable metrics for device performance (e.g., sensitivity, specificity, accuracy, or precision in signal recording) nor a study that directly proves the device meets such criteria through a clinical validation or comparative effectiveness study.
Instead, the document focuses on compliance with established standards for medical devices and material safety, and performance characteristics related to the physical integrity and electrical properties of the electrodes.
Therefore, many of the requested sections about acceptance criteria and study details cannot be fully extracted as they are not present in the provided text.
Here's a breakdown of what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria for device performance (e.g., signal-to-noise ratio, diagnostic accuracy) are not explicitly stated, nor are comparative performance values against the predicate devices for these aspects. The document focuses on performance related to physical attributes and safety.
| Acceptance Criteria Category | Specific Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Penetration and friction force (according to DIN 13097) (Concentric Needle) | "The result of testing indicates that the electrodes are as safe, as effective, and perform at least as safely and effectively as the legally marketed device." (Concentric Needle) |
| Sharpening, Bevel and burrs (visual examination with microscope camera) | "Needs meet criteria" (implied by "Quality control tests" and "Tests performed") | |
| Electrical Performance | Electrical continuity and insulation of poles (automated 100% control for Concentric; audible ohmmeter for Monopolar/Subdermal on 10%) | "Needs meet criteria" (implied by "Quality control tests" and "Tests performed") |
| Biocompatibility | Non-cytotoxicity (ISO 10993-5), Non-irritancy (ISO 10993-10), Non-sensitization (ISO 10993-10) | Cytotoxicity: Test article treated extract cells were 97% viable (NON-CYTOTOXIC) |
| Intracutaneous Reactivity: No erythema (Grade 0) or oedema (Grade 0) effects (NON-IRRITANT) | ||
| Sensitization: No hypersensitivity effects (Grade 0 erythema) (NON-SENSITIZING) | ||
| Sterility | Bioburden < 100UFC | Bioburden results consistently "extensively under this value" |
| Shelf-life / Aging | Functionality maintained during shelf life | "Ageing tests was performed to verify and ensure the functionality during the shelf life of the product." (Conclusion of successful maintenance implied) |
| Electrical Safety | "Touch-proof" safety connector prevents connection to AC power outlet and contact with hazardous voltage | Connector is "specifically designed" to meet this (implied successful design and function) |
| Mechanical Safety | Needle covered with a needle cover | "Packaged needle covered with a needle cover." (Implied compliance) |
| Compliance with Standards | IEC 60601-1, ISO 10993-1, ISO 10993-10, ISO 10993-5, ISO 11137, UNI EN 11607-1, UNI EN 868-5, DIN 13097, UNI EN 556-1, ASTM F1980-07, ASTM F2054-00, DIN 58953-6, ASTM F1929-98, ASTM F1886-98, ISO 11607-1 | "The following standards were applied during testing:" (Implied compliance) |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Concentric Needle Electrode: Not explicitly stated for each test, but "Quality control tests are performed on every lot" with "100% control" for needle continuity and pole isolation. Penetration and friction force testing, and aging tests are mentioned but sample sizes are not provided.
- Monopolar/Subdermal Needle Electrode: Tested on "10% of every lot" for sharpening, bevel/burrs, and needle continuity.
- Biocompatibility:
- Cytotoxicity: "Test article treated extract cells" - specific number not given.
- Intracutaneous Reactivity: "Test article treated extract" - specific number not given.
- Sensitization: Conducted "on guinea pig" - specific number not given, but refers to reports 408/10, 281/10, 1653 A-10 respectively.
- Bioburden: "Bioburden tests and Dose Audit are performed every 9 months by a third laboratory on a sample of the specific batch manufactured." - specific sample size not given.
- Data Provenance: The studies are non-clinical laboratory tests, likely conducted in Italy where BIONEN s.a.s. is based. The FDA 510(k) summary is a submission for marketing in the USA. The biocompatibility reports have numbers (e.g., 408/10) but no country of origin is explicitly stated for the lab that performed them. These are retrospective tests conducted on samples of the manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable / Not provided. The "ground truth" for these tests is based on objective measurements against established international and national standards (e.g., ISO, DIN, ASTM) and physical evaluations (visual, automated electrical checks). There is no indication of expert consensus for these technical performance parameters.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Since the studies are non-clinical technical and safety assessments against defined standards, an adjudication method for human interpretation is not relevant. Results are based on objective measurements or visual inspection against specified criteria.
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 document describes medical electrodes, not an AI or imaging device that would typically undergo an MRMC study. There is no mention of AI assistance or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This document describes a physical medical device (electrodes), not an algorithm.
7. The Type of Ground Truth Used
- Objective Technical Standards and Laboratory Measurements: The ground truth for the device's acceptable performance is established by compliance with international and national standards (e.g., ISO, IEC, DIN, ASTM) for electrical properties, mechanical properties, sterility, and biocompatibility. This includes laboratory test results like cell viability rates, skin irritation grades, and sensitization responses.
8. The Sample Size for the Training Set
- Not applicable / Not provided. This section discusses the performance characteristics of electrodes and does not involve a "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As there is no training set mentioned, the method for establishing its ground truth is also not relevant here.
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092973
Image /page/0/Picture/1 description: The image shows the logo for Bionen Medical Devices. The logo features a stylized letter "B" in a bold, sans-serif font, with a smaller, outlined "B" nested within the larger one. Below the "B" symbol, the word "BIONEN" is printed in a simple, sans-serif typeface, followed by the words "medical devices" in a smaller font size.
1 510(k) Summary or 510(k) Statement
Bionen s.a.s Via P. Petrocchi, 42/1 Florence, Italy 50127 P: 39 055 4265945 F: 39 055 412188
Contact: Allison Scott, RAC
Date: September 21, 2010
Trade Name: Disposable Concentric Needle Electrode Disposable Monopolar/Subdermal Needle Electrode Disposable Monopolar Needle Electrode
Common Name: Needle Electrodes
Classification Name: EMG Diagnostic Needle (21 CFR 890.1385, Product Code IKT) Needle Electrode (21 CFR 882.1350, Product Code GXZ)
Predicate Devices:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| Concentric Needle Electrode | ||
| K071186 | Neuroline, Disposable Concentric needleelectrode | Ambu A/S |
| K931966 | Needle electrode EMG | Alpine Biomed(ex Dantec) |
| Monopolar/Subdermal Needle Electrode | ||
| K050194 | Subdermal Needle Electrodes, Twisted Pair NeedleElectrodes, Corkscrew (spiral) Needle Electrode | Axon Systems, Inc. |
| Disposable Monopolar Needle Electrode | ||
| K091410 | Myobot Needles | Spes Medica |
| K062437 | Disposable Hypodermic Needle Electrode | Technomed Europe |
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Device Description:
The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.
BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.
The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
Indications for Use:
The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electroymyography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electroymyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.
Technological Characteristics:
BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor that can be of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant. The Electrode has a plastic (NYLON) ergonomic hub.
BIONEN Disposable Monopolar/Subdermal Needle Electrode consists of a formed stainless steel needle with a lead wire attached. The lead wire terminates in a safety connector that cannot be connected to an AC power outlet.
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BIONEN Disposable Monopolar Needle Electrode consists of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The lead wire terminates in a safety connector that cannot be connected in a AC power outlet.
Substantial Equivalence Discussion:
Compared to the predicate, the subject devices have intended use, similar physical and performance characteristics and are manufactured using similar processes.
| productcharacteristics | Needle electrodes | Neuroline, DisposableConcentric needleelectrode | DCN™ DisposableConcentric NeedleElectrodes |
|---|---|---|---|
| manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) |
| 510K number | K092973 | K071186 | K931966 |
| Device class | Class II | Class II | Class II |
| Product code | IKT | IKT | IKT |
| Device type | Needle electrode | Disposable Concentricneedleelectrode | Electrode, needle,diagnostic electromyograph |
| Regulationnumber | 882.1350890.1385 | 890.1385 | 890.1385 |
| indications foruse | The BIONEN DisposableConcentric Needleelectrodes are sterileelectrodes indicated forrecording muscle activityfor Electroymyography(EMG) applications. Theelectrodes are for singlepatient use only. | The Neuroline, DisposableConcentric needleelectrodes are made formuscle activity recordingfor Electromyography(EMG) applications. Theelectrodes are for singlepatient use only. | Alpine Biomed DisposableNeedle Electrodes cannotbe re-sterilized and are forsingle patient use only. Donot reuse but discard usedneedle electrodes in aproperly marked medicalbiohazard sharps container. |
| anatomical sites | subdermal, muscle or nervetissue | muscles | subdermal, muscle or nervetissue |
| where used(hospital, home,ambulance, etc) | Electrode preparation andapplication should besupervised by a qualifiedhealthcare professional | same | same |
| productcharacteristics | Needle electrodes | Neuroline, DisposableConcentric needleelectrode | DCN™ DisposableConcentric NeedleElectrodes |
| manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) |
| design | Ergonomic connector andgeometric sharper tip.Color-coded hub | Ergonomic and Color-codedhub | Pre-sterilized DCN™Electrodes have trueergonomic design and arealways sharp.Each needle has a matchingcolour-coded hub andpackage for easyidentification andreordering.The hub has a raised bevelindicator, so you alwaysknow the direction of therecording surface. Theneedle features a coaxialhub that allows you toeasily connect the needlesinto the HUSH™ electrodecables without orientation.A wiping contact is usedinside the hub to optimizethe connection throughoutthe life of the cable andreduce oxide build-up. Thecable can withstand a 50 lbspull test, so it is made tolast. |
| performance | Tested for penetrationand friction force andelectrical properties(according to DIN 13097).Ageing tests are performedto verify and ensure thefunctionality during theshelf life of the product. | Tested for penetrationand friction force andelectrical properties(according to DIN 13097).Ageing tests are performedto verify and ensure thefunctionality during theshelf life of the product. | Unknown |
| standards met | IEC 60601-1ISO 10993-1ISO 10993-10ISO 10993-5ISO 11137UNI EN 11607-1UNI EN 868-5 | unknown | Unknown |
| productcharacteristics | Needle electrodes | Neuroline, DisposableConcentric needleelectrode | DCN™ DisposableConcentric NeedleElectrodes |
| manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) |
| materials | Stainless Steel cannula,Platinum / Stainless Steelsensor,Polyethylene (PE) Hub,Epoxy Insulator,PELD Plastic protector,Stainless steel/gold platedconnection | Stainless steel cannula,Silver sensor,ABS Hub,Epoxy Insulator,Polyethylene (PE) Plasticprotector,brass/gold platedconnection | Stainless Steel cannula,Platinum sensor |
| Dimensions | Diameter = 0.45/0.35 mmL=25-30-35-40-45-50-65mm | Diameter = 0.45/0.35 mmL=25-30-38-50-75mm | Diameter = 0.30/0.46/0.64mmL=25-37-50-75mm |
| Recording area | $0,02 - 0,07mm^2$ | $0,02 - 0,07mm^2$ | $0.019 - 0.07mm^2$ |
| Connector cable | Din 5 poles | Din 5 poles | Din 5 poles |
| biocompatibility | selection of materials,which demonstrateappropriatelevels of biocompatibility.Tests on the basis of ISO10993-1 | selection of materials,which demonstrateappropriatelevels of biocompatibility.Tests on the basis of ISO10993-1 | Unknown |
| compatibilitywith theenvironmentand otherdevices | Compatibility is achievedthrough theconnecting cable toEMG/EEG machines orsimilar physiologicalrecording devices. | unknown | Unknown |
| sterility | Gamma irradiation | E-beam | E-Beam. |
| Shelf life | 60 months | 36 months | 36 months |
| electrical safety | The "touch-proof' safetyconnector is specificallydesigned so that it cannotbe plugged into AC poweroutlet and cannot get intouch with possiblehazardous voltage | unknown | Unknown |
| mechanicalsafety | Packaged needle coveredwith a needle cover. | Packaged needle coveredwith a needle cover. | Packaged needle coveredwith a needle cover. |
| chemical safety | Not applicable | Not applicable | Not applicable |
| thermal safety | Not applicable | Not applicable | Not applicable |
| radiation safety | Not applicable | Not applicable | Not applicable |
Concentric Needle Electrodes
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Monopolar/Subdermal Needle Electrodes
| product | Needle electrodes | Subdermial Needle Electrodes, |
|---|---|---|
| characteristics | Twisted Pair Needle Electrodes, | |
| Corkscrew (spiral) Needle Electrode | ||
| manufacturer | BIONEN s.a.s. | Axon Systems, Inc. |
| 510K number | K092973 | K050194 |
| Device class | Class II | Class II |
| Product code | GXZ | GXZ |
| Device type | Monopolar/Subdermal Needle electrode | Subdermal Needle electrode |
| Regulation number | 882.1350 | 882.1350 |
| indications for use | The BIONEN Disposable | Axon Systems' Subdermal Needle |
| Monopolar/Subdermal Needle electrodes | Electrodes are intended for use with | |
| are sterile electrodes indicated for | recording, monitoring and | |
| recording muscle activity for | stimulation/recording equipment for the | |
| Electroymyography (EMG) and/or | recording of biopotential signals including | |
| Electroencephalography (EEG) | electroencephalograph (EEG), | |
| applications. The electrodes are for | electromyograph (EMG) and nerve | |
| single patient use only. | potential signals and for stimulation | |
| during the intraoperative diagnosis of | ||
| acute dysfunction in corticospinal axonal | ||
| conduction. | ||
| anatomical sites | subdermal, muscle or nerve tissue | subdermal |
| where used | Electrode preparation and application | Use by a licensed physician or |
| (hospital, home, | should be supervised by a qualified | technologist under the supervision of a |
| ambulance, etc) | healthcare professional. | physician. |
| design | Ergonomic connector and geometric | Unknown |
| sharper tip. | ||
| Color-coded hub | ||
| performance | Sharpening; Camera visual | Unknown |
| examination with special | ||
| attention to bevel and burrs; Electrical | ||
| continuity and isolation of all | ||
| poles; | ||
| standards met | IEC 60601-1 | unknown |
| ISO 10993-1 | ||
| ISO 10993-10 | ||
| ISO 10993-5ISO 11137 | ||
| UNI EN 11607-1 | ||
| UNI EN 868-5 | ||
| materials | Stainless Steel / platinum needle | Stainless steel needle |
| Dimensions | Diameter=0,35mm | Diameter=0,4mm |
| L=15-20mm | ||
| biocompatibility | selection of materials, which | unknown |
| demonstrate appropriate | ||
| levels of biocompatibility. Tests on the | ||
| basis of ISO 10993-1 | ||
| compatibility with | Compatibility is achieved through the | unknown |
| the environment and | connecting cable to EMG/EEG machines | |
| other devices | or similar physiological recording devices. | |
| productcharacteristics | Needle electrodes | Subdermial Needle Electrodes,Twisted Pair Needle Electrodes,Corkscrew (spiral) Needle Electrode |
| manufacturer | BIONEN s.a.s. | Axon Systems, Inc. |
| Shelf life | 60 months | unknown |
| electrical safety | The "touch-proof' safety connector isspecifically designed so that it cannot beplugged into AC power outlet and cannotget in touch with possible hazardousvoltage | The DIN 42802 "touch-proof' safetyconnector is specifically designed so thatit cannot be plugged into AC power outlet |
| mechanical safety | Packaged needle covered with aneedle cover. | Packaged needle covered with aneedle cover. |
| chemical safety | Not applicable | Not applicable |
| thermal safety | Not applicable | Not applicable |
| radiation safety | Not applicable | Not applicable |
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Disposable Monopolar Needle electrode
| product | Disposable Monopolar | Myobot Needle | Disposable Hypodermic |
|---|---|---|---|
| characteristics | Needle electrode | Needle Electrode | |
| manufacturer | BIONEN s.a.s. | Spes Medica | Technomed Europe |
| 510K number | K092973 | K091410 | K062437 |
| Device class | Class II | Class II | Class II |
| Product code | IKT | IKT | IKT |
| Device type | Needle electrode | Needle electrode | Needle electrode |
| Regulation number | 890.1385 | 890.1385 | 890.1385 |
| indications for use | The BIONEN DisposableMonopolar Needleelectrodes are sterileelectrodes indicated forinjection of BotulinumToxin while recordingmuscle activity withElectromyography (EMG)applications. Theelectrodes are for singlepatient use only. | Recording muscle activityfor Electromyography(EMG) applications. Forsingle patient use only.The disposablehypodermic needle isintended to be used forinjection of the BotulinumToxin into a muscle, whilerecordingelectromyography activity.The electrode has an openlumen and is designed formuscle stimulation, motorunit action, potentialrecording and BotulinumToxin injection. | The disposablehypodermic EMG needleelectrode is used formuscle stimulation, motorunit action potentialrecording and drugdelivery. The motornerves are monitored bydetecting EMG activity inthe muscles theyinnervate. The drug usedshould be Botox BotulinumToxin type A.Note: Technomed Europedoes not supply any drugswith the Disposablehypodermic EMG needleelectrodes nor doesTechnomed Europe offerfor sale any form of drugs. |
| anatomical sites | muscle | muscle | muscle |
| productcharacteristics | Disposable MonopolarNeedle electrode | Myobot Needle | Disposable HypodermicNeedle Electrode |
| manufacturer | BIONEN s.a.s. | Spes Medica | Technomed Europe |
| where used(hospital, home,ambulance, etc) | Electrode preparation andapplication should besupervised by a qualifiedhealthcare professional.The specific Botox® type tobe injected must bechosen by the physician. | unknown | unknown |
| design | Ergonomic connector andgeometric sharper tip.The disposable MonopolarNeedle electrode consistsof a stainless steel cannulaelectrically insulated witha PTFE coating, except forthe lancet point and theinner surface of the tube.The coating is to ensureeasy skin penetration andto ensure electricalinsulation on the entirecannula, except for thepoint. A husk fittingtogether with a wire withconnection to anextension cable has beenattached to the cannula.This cable will enable theelectrical signal to betransferred to astimulating or recordingdevice | unknown | The disposablehypodermic EMG needleelectrode consists of astainless steel cannulaelectrically insulated witha PTFE coating, except forthe lancet point and theinner surface of the tube.The coating is to ensureeasy skin penetration andto ensure electricalinsulation on the entirecannula, except for thepoint. A husk fittingtogether with a wire withconnection to anextension cable has beenattached to the cannula.This cable will enable theelectrical signal to betransferred to astimulating or recordingdevice. |
| performance | Sharpening;Camera visualexamination with specialattention to bevel andburrs;Electrical continuity | unknown | unknown |
| standards met | IEC 60601-1ISO 10993-1ISO 10993-10ISO 10993-5ISO 11137UNI EN 11607-1UNI EN 868-5 | unknown | unknown |
| materials | Stainless Steel cannula,Polyethylene (PE) Hub,PELD Plastic protector,Stainless steel/gold plated | Stainless Steel cannula | Stainless steel cannula,PTFE coating, lead wire |
| productcharacteristics | Disposable MonopolarNeedle electrode | Myobot Needle | Disposable HypodermicNeedle Electrode |
| manufacturer | BIONEN s.a.s. | Spes Medica | Technomed Europe |
| Dimensions | Diameter=0,50mmL=20-30-40-50-60mm | Diameter=0,30-0,40-0,45-0,50-0,55-0,70mmL=25-37-50-75mm | Diameter=0,30-0,40-0,45-0,50mmL=25-37-50-75mm |
| biocompatibility | Tests on the basis of ISO10993-1 table 1 made onthe Concentric needleelectrode as the worsecase are considered validand extensible to this kindof device. | unknown | unknown |
| compatibility withthe environment andother devices | Compatibility is achievedthrough the connectingcable to EMG machines orsimilar physiologicalrecording devices. | unknown | unknown |
| sterility | Gamma irradiation | unknown | unknown |
| Shelf life | 60 months | unknown | unknown |
| electrical safety | The "touch-proof' safetyconnector is specificallydesigned so that it cannotbe plugged into AC poweroutlet and cannot get intouch with possiblehazardous voltage | unknown | unknown |
| mechanical safety | Packaged needle coveredwith a needle cover. | Packaged needle coveredwith a needle cover. | Packaged needle coveredwith a needle cover. |
| chemical safety | Not applicable | Not applicable | Not applicable |
| thermal safety | Not applicable | Not applicable | Not applicable |
| radiation safety | Not applicable | Not applicable | Not applicable |
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Discussion of Nonclinical Tests Submitted:
The non-clinical tests performed are laboratory tests to verify the functionality of the BIONEN Needle Electrodes. The following standards were applied during testing:
| IEC 60601-1:2005 | UNI EN 868-5:2002 |
|---|---|
| UNI EN ISO 10993-1 | UNI EN 556-1:200 |
| UNI EN ISO 10993-10 | ASTM F1980-07 |
| UNI EN ISO 10993-5 | ASTM F2054-00 |
| UNI EN ISO 11137-1 | DIN 58953-6 |
| UNI EN ISO 11137-2 | ASTM F1929-98 |
| UNI EN ISO 11137-3 | ASTM F1886-98 |
| DIN 13097:2009 | ISO 11607-1 |
The Concentric Needle Electrode is tested for penetration and friction force according to DIN 13097. The result of testing indicates that the electrodes are as safe, as effective, and perform at least as safely and effectively as the legally marketed device.
Ageing tests was performed to verify and ensure the functionality during the shelf life of the product.
Quality control tests are performed on every lot:
- Needle sharpening: visual examination with a microscope camera �
- . Bevel and burrs: visual examination with a microscope camera
- Needle continuity: automated process (100% control) .
- Needle pole isolation: automated process (100% control) �
The Monopolar/Subdermal needle electrode is tested on 10% of every lot:
- � Needle sharpening: visual examination under microscope
- Bevel and burrs: visual examination under microscope .
- Needle continuity: audible ohmmeter .
Bioburden tests and Dose Audit are performed every 9 months by a third laboratory to verify the microbic load on a sample of the specific batch manufactured.
BIONEN has determined its reference value at 100UFC and Bioburden results are always extensively under this value.
The biological safety of the BIONEN Concentric Needle Electrode has been assured through the selection of materials, which demonstrate appropriate levels of biocompatibility.
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Some tests were selected for the Biological evaluation of Medical Device on the basis of ISO 10993-10 and ISO 10993-5. The following tests were performed:
| Test | Reportnumber | Standard | Result | Conclusion |
|---|---|---|---|---|
| Cytotoxicity -Neutral Red Uptake | 408/10 &AddendumMay 3,2010 | ISO 10993-5:2009 | Test article treatedextract cells were foundto be 97% viable | Test sample extractis consideredNON-CYTOTOXIC |
| IntracutaneousReactivity | 281/10 | ISO 10993-10: 2009 | Test article treatedextract were found tohave no erythema(Grade 0) or oedema(Grade 0) effects | Test sample extractis consideredNON-IRRITANT |
| Sensitization teston guinea pig -Delayed contacthypersensitivity -Maximizationmethod | 1653 A-10 &AddendumSeptember30, 2010 | ISO 10993-10: 2009 | Test article treatedextract were found tohave nohypersensitivity effects(Grade 0 erythema) | Test sample extractis consideredNON- SENSITIZING |
From the tests' results, no adverse effects or sign of sensitization have been detected. The requirements of the test protocol were met.
From the results of the non clinical verification test and biocompatibility test, it has been concluded that BIONEN Needle Electrodes fulfill the products' specifications set for the design and are safe and effective needle electrodes comparable to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bionen SAS c/o Ms. Allison Scott Anson Group, LLC 11460 N. Meridian St., Ste 150 Carmel, IN 46032
DCT - 7 2010
Re: K092973
Trade/Device Name: Disposable Concentric Needle Electrode
Disposable Monopolar/Subdermal Needle Electrode Disposable Monopolar Needle Electrode
Regulation Number: 21 CFR 890.1385 Regulation Name: EMG Diagnostic Needle Regulatory Class: Class II Product Code: IKT, GXZ Dated: September 22, 2010 Received: September 24, 2010
Dear Ms. Scott:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Ms. Allison Scott
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 nut . 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.
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/ucm1118001/pp.flast 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Malvina B. Evdelman 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
510(k) Number (if known): H 09297 3
Device Name: BIONEN Needle Electrodes
Indications for Use:
The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Noll
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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510(k) Number K092973
§ 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).