Who can help prepare an FDA 510(k) submission like DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE

Q: Who is the manufacturer of DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE?

Bionen S.A.S. filed the 510(k) submission for DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE (K092973).

Q: What is the FDA product code for DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE?

IKT. It is classified under 21 CFR 890.1385 as a Class 2 device in the Physical Medicine panel.

Q: What is the regulatory pathway for DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE?

Neuroline, Disposable Concentric needle electrode (K071186); Needle electrode EMG (K931966); Subdermal Needle Electrodes, Twisted Pair Needle Electrodes, Corkscrew (spiral) Needle Electrode (K050194); Myobot Needles (K091410); Disposable Hypodermic Needle Electrode (K062437).

K092973 · Bionen S.A.S. · IKT · Oct 7, 2010 · Physical Medicine

Device Facts

Record ID	K092973
Device Name	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
Applicant	Bionen S.A.S.
Product Code	IKT · Physical Medicine
Decision Date	Oct 7, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1385
Device Class	Class 2

Intended 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.

Device Story

BIONEN needle electrodes (concentric, monopolar, subdermal) are sterile, single-use devices for recording biopotential signals (EMG/EEG) or facilitating Botulinum Toxin injection. Concentric needles feature a stainless steel cannula (reference) and an inner stainless steel or platinum conductor (active measure point) separated by insulation. Monopolar/subdermal needles consist of a formed stainless steel needle with an attached lead wire. Monopolar needles for injection feature an open lumen. All devices terminate in touch-proof safety connectors to prevent contact with hazardous voltage. Used in clinical settings by healthcare professionals, the electrodes connect to EMG/EEG recording equipment. The output is a biopotential signal used by clinicians for neuromuscular system examination or monitoring during drug delivery. Benefits include diagnostic utility for neuromuscular conditions and precise guidance for toxin injection.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility studies. Bench testing verified penetration force, friction force, electrical continuity, and isolation. Biocompatibility testing (ISO 10993-5, -10) confirmed non-cytotoxicity, non-irritation, and non-sensitization. Shelf-life and sterility (gamma irradiation) were validated.

Technological Characteristics

Stainless steel cannula; inner conductor (stainless steel or platinum); epoxy insulator; plastic (NYLON/PE) hub; PTFE coating (monopolar injection needles). Sensing: biopotential recording. Connectivity: touch-proof safety connector (DIN 42802 compatible). Sterilization: Gamma irradiation. Standards: IEC 60601-1, ISO 10993-1/5/10, ISO 11137, DIN 13097.

Indications for Use

Indicated for recording muscle activity for EMG and/or EEG applications, or for injection of Botulinum Toxin while recording muscle activity via EMG. For single patient use only.

Regulatory Classification

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).

Predicate Devices

Neuroline, Disposable Concentric needle electrode (K071186)
Needle electrode EMG (K931966)
Subdermal Needle Electrodes, Twisted Pair Needle Electrodes, Corkscrew (spiral) Needle Electrode (K050194)
Myobot Needles (K091410)
Disposable Hypodermic Needle Electrode (K062437)

Related Devices

K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, · Spes Medica Srl · Aug 11, 2009
K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes · Bio Protech, Inc. · Jun 3, 2016
K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED · Technomed Europe · Feb 16, 2007
K192603 — Spes Medica Subdermal Needle Electrodes · Spes Medica Srl · Nov 22, 2019
K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE · Ambu A/S · Jan 13, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ # 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 needle electrode | Ambu A/S | | K931966 | Needle electrode EMG | Alpine Biomed (ex Dantec) | | Monopolar/Subdermal Needle Electrode | | | | K050194 | Subdermal Needle Electrodes, Twisted Pair Needle Electrodes, Corkscrew (spiral) Needle Electrode | Axon Systems, Inc. | | Disposable Monopolar Needle Electrode | | | | K091410 | Myobot Needles | Spes Medica | | K062437 | Disposable Hypodermic Needle Electrode | Technomed Europe | {1}------------------------------------------------ #### 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. {2}------------------------------------------------ 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. | product characteristics | Needle electrodes | Neuroline, Disposable Concentric needle electrode | DCN™ Disposable Concentric Needle Electrodes | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 Concentric needle electrode | Electrode, needle, diagnostic electromyograph | | Regulation number | 882.1350 890.1385 | 890.1385 | 890.1385 | | 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 Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only. | Alpine Biomed Disposable Needle Electrodes cannot be re-sterilized and are for single patient use only. Do not reuse but discard used needle electrodes in a properly marked medical biohazard sharps container. | | anatomical sites | subdermal, muscle or nerve tissue | muscles | subdermal, muscle or nerve tissue | | where used (hospital, home, ambulance, etc) | Electrode preparation and application should be supervised by a qualified healthcare professional | same | same | | product characteristics | Needle electrodes | Neuroline, Disposable Concentric needle electrode | DCN™ Disposable Concentric Needle Electrodes | | manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) | | design | Ergonomic connector and geometric sharper tip. Color-coded hub | Ergonomic and Color-coded hub | Pre-sterilized DCN™ Electrodes have true ergonomic design and are always sharp. Each needle has a matching colour-coded hub and package for easy identification and reordering. The hub has a raised bevel indicator, so you always know the direction of the recording surface. The needle features a coaxial hub that allows you to easily connect the needles into the HUSH™ electrode cables without orientation. A wiping contact is used inside the hub to optimize the connection throughout the life of the cable and reduce oxide build-up. The cable can withstand a 50 lbs pull test, so it is made to last. | | performance | Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product. | Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product. | Unknown | | standards met | IEC 60601-1 ISO 10993-1 ISO 10993-10 ISO 10993-5 ISO 11137 UNI EN 11607-1 UNI EN 868-5 | unknown | Unknown | | | | | | | product characteristics | Needle electrodes | Neuroline, Disposable Concentric needle electrode | DCN™ Disposable Concentric Needle Electrodes | | manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) | | materials | Stainless Steel cannula, Platinum / Stainless Steel sensor, Polyethylene (PE) Hub, Epoxy Insulator, PELD Plastic protector, Stainless steel/gold plated connection | Stainless steel cannula, Silver sensor, ABS Hub, Epoxy Insulator, Polyethylene (PE) Plastic protector, brass/gold plated connection | Stainless Steel cannula, Platinum sensor | | Dimensions | Diameter = 0.45/0.35 mm L=25-30-35-40-45-50-65mm | Diameter = 0.45/0.35 mm L=25-30-38-50-75mm | Diameter = 0.30/0.46/0.64 mm L=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 demonstrate appropriate levels of biocompatibility. Tests on the basis of ISO 10993-1 | selection of materials, which demonstrate appropriate levels of biocompatibility. Tests on the basis of ISO 10993-1 | Unknown | | compatibility with the environment and other devices | Compatibility is achieved through the connecting cable to EMG/EEG machines or similar physiological recording devices. | unknown | Unknown | | sterility | Gamma irradiation | E-beam | E-Beam. | | Shelf life | 60 months | 36 months | 36 months | | electrical safety | The "touch-proof' safety connector is specifically designed so that it cannot be plugged into AC power outlet and cannot get in touch with possible hazardous voltage | unknown | Unknown | | mechanical safety | Packaged needle covered with a needle cover. | Packaged needle covered with a needle cover. | Packaged needle covered with 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 {3}------------------------------------------------ : ﮯ : . . . {4}------------------------------------------------ ・ : {5}------------------------------------------------ # 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 10993-5 ISO 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. | | | product characteristics | 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 is specifically designed so that it cannot be plugged into AC power outlet and cannot get in touch with possible hazardous voltage | The DIN 42802 "touch-proof' safety connector is specifically designed so that it cannot be plugged into AC power outlet | | mechanical safety | Packaged needle covered with a needle cover. | Packaged needle covered with a needle cover. | | chemical safety | Not applicable | Not applicable | | thermal safety | Not applicable | Not applicable | | radiation safety | Not applicable | Not applicable | . {6}------------------------------------------------ #### 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…