Who is the manufacturer of Myoject Luer Lock Needle Electrode?

Natus Manufacturing Limited filed the 510(k) submission for Myoject Luer Lock Needle Electrode (K161430).

What is the FDA product code for Myoject Luer Lock Needle Electrode?

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

What is the regulatory pathway for Myoject Luer Lock Needle Electrode?

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

What are the predicate devices for Myoject Luer Lock Needle Electrode?

Teca Myoject Disposable Needle Electrode (K973444).

Who can help prepare an FDA 510(k) submission like Myoject Luer Lock Needle Electrode?

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.

Myoject Luer Lock Needle Electrode

K161430 · Natus Manufacturing Limited · IKT · Mar 2, 2017 · Physical Medicine

Device Facts

Record ID	K161430
Device Name	Myoject Luer Lock Needle Electrode
Applicant	Natus Manufacturing Limited
Product Code	IKT · Physical Medicine
Decision Date	Mar 2, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1385
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

Device Story

Disposable hypodermic monopolar needle electrode; used in electromyography (EMG). Input: electrical signals from muscle tissue (motor unit action potentials); output: electrical stimulation to muscle and delivery of medication via open lumen. Operated by physicians in clinical settings. Device features Luer Lock/Slip hub for syringe attachment; stainless steel 304 needle with PTFE coating; single contact touch-proof DIN 42802 connector. Physician inserts needle to locate muscle, records potentials, stimulates muscle, and injects medication through lumen. Benefits include reduced patient discomfort via improved tip sharpness and secure drug delivery via Luer Lock mechanism.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included tensile testing, coating thickness, leak testing, tip geometry measurements, penetration testing, and Luer Lock design verification. Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity) confirmed compliance.

Technological Characteristics

Monopolar needle electrode; stainless steel 304; PTFE coating (Xylan 8820 G4075); Polypropylene hub (Escorene PP9074 MED); 10-16 degree conical grind angle; single contact touch-proof DIN 42802 connector. Sterilized via gamma irradiation. Dimensions: 0.30-0.71mm diameter; 25-75mm length. Standalone device.

Indications for Use

Indicated for patients requiring electromyography (EMG) procedures where muscle localization, motor unit action potential recording, muscle stimulation, and subsequent drug delivery into the muscle are necessary.

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

Teca Myoject Disposable Needle Electrode (K973444)

Related Devices

K173815 — Allergan Botox Needle Electrode · Natus Manufacturing Limited · Jun 29, 2018
K973444 — TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES · Medelec, Inc. D.B.A. Teca Corp. · Nov 20, 1997
K973442 — TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES · Medelec, Inc. D.B.A. Teca Corp. · Nov 20, 1997
K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED · Technomed Europe · Feb 16, 2007
K071185 — MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE · Ambu A/S · May 30, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 2, 2017 Natus Manufacturing Limited Michael Galvin Manager. Ouality and Regulatory Affairs IDA Business Park Gort, Co. Galway Ireland Re: K161430 Trade/Device Name: Myoject™ Luer Lock Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: February 9, 2017 Received: February 13, 2017 Dear Mr. Galvin: 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. 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, # Michael J. Hoffmann -S - Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161430 #### Device Name Myoject(TM) Luer Lock Needle Electrode #### Indications for Use (Describe) The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he'she injects a drug therein via the lumen of the needle. Type of Use (Select one or both, as applicable) | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 28 February 2017 Natus Manufacturing Limited Traditional 510(k) Myoject™ Luer Lock Needle Electrode Image /page/3/Picture/3 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are bold. There is a registered trademark symbol to the right of the "s". Natus Manufacturing Limited, IDA Business Park Gort, Co. Galway 353 091 630043 tel. 353 091 630050 fax. # Section 5: 510(k) Summary | Manufacturer's Name: | Natus Manufacturing Limited IDA Business Park Gort, County Galway Ireland | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Michael Galvin Manager, Quality and Regulatory Affairs Natus Manufacturing Limited IDA Business Park Gort, County Galway Ireland | | Telephone Number: | +353-(0)91-647451 | | Fax Number: | +353-(0)91-630050 | | Summary Date: | 17 May 2016 | | Trade Names: | Myoject™ Luer Lock Needle Electrode | | Common or Usual Name: | Electrode, Needle, Diagnostic Electromyograph | | Classification Name: | Diagnostic Electromyograph Needle Electrode | | Device Class: | Class II | | Product Code: | IKT | | Classification Regulation: | 21.CFR.890.1385 | {4}------------------------------------------------ 28 February 2017 Natus Manufacturing Limited Traditional 510(k) Myoject™ Luer Lock Needle Electrode | Classification Panel: | Neurology | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device: | K973444 Teca Myoject Disposable Needle Electrode | | Device Description: | The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode | | Intended Use: | The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle. | | Comparison: | The Myoject™ Luer Lock Needle Electrode employ the same technological characteristics as the predicate device. | | Nonclinical Tests: | Tensile testing Coating thickness Leak Testing Tip geometry measurements Penetration testing Luer Lock Design | | Substantial Equivalence: | The Myoject™ Luer Lock Needle Electrode is equivalent to the device cleared under K973444 | It has been shown in this 510(k) submission that the differences between the Myoject™ Luer Lock and the predicate device do not raise any questions regarding its safety and effectiveness. The Myoject™ Luer Lock Needle electrode device is substantially equivalent to the predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices. The Myoject™ Luer Lock Needle Electrode, as designed and manufactured is determined to be substantially equivalent to the referenced predicate devices. Substantial Equivalence Comparison Table. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and slightly rounded. A small registration mark is located to the right of the "s". | Table 5A: Substantial Equivalence Comparison Table | | | |----------------------------------------------------|--|--| | | | | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Natus Manufacturing Limited | TECA Corporation 3 Campus Drive Pleasantville New York 10570 | Minor changes to the labelling include change of legal manufacturer name, address and branding. In addition the new device labelling incorporates warnings and harmonized symbols. However, these changes do not raise questions of safety and effectiveness as they provide additional information to the user for the safe and effective use of the device. | | Trade Name | Myoject™ Luer Lock Needle Electrodes | Teca Myoject Disposable Needle Electrode | | | 510(k) number | K161430 | K973444 | | | Product Code | IKT | IKT | | | Labelling | Packaging Labels | Packaging Labels | | | Intended Use | The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a | The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to | | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | | | | | | | | Manufacturer | Natus Manufacturing Limited | TECA Corporation | | | 3 Campus Drive | | | | | Pleasantville | | | | | New York 10570 | | | | Trade Name | | | | | | Myoject™ Luer Lock Needle Electrodes | Teca Myoject Disposable Needle Electrode | | | 510(k) number | | | | | | K161430 | K973444 | | | Product Code | IKT | IKT | | | | probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle. | locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle. Note: TECA Corp. does not supply any drugs with needle electrodes nor does TECA Corp. offer for sale any form of drugs. | can be included in labeling. The needles are sold on their own as a medical device and are not specifically designated for use with a specific drug. Therefore, this statement is not appropriate for the IFU. | | Physical Characteristics | Monopolar Needle | Monopolar Needle | Same | | Connector | Single Contact Touch Proof DIN42 802 | Single Contact Touch Proof DIN42 802 | Same | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | | Manufacturer | Natus Manufacturing Limited | TECA Corporation 3 Campus Drive Pleasantville New York 10570 | | | Trade Name | Myoject™ Luer Lock Needle Electrodes | Teca Myoject Disposable Needle Electrode | | | 510(k) number | K161430 | K973444 | | | Product Code | IKT | IKT | | | Material of Needle | Stainless 304 | Stainless 304 | Same | | Needle Size (mm) | Needle Diameter: 0.30 0.41 0.46 0.51 0.71 | Needle Diameter: 0.30 0.41 0.46 0.51 0.71 | Same The dimensions relate to needle diameter | | Needle Coating material | PTFE (Xylan 8820 G4075) | PTFE (Ultralon R-605/T-5) | This change resulted from the Accessories development Department's request to reduce the initial penetration force and mitigate against the obsolescence of the Ultralon coating. This change does not raise questions of safety and effectiveness as the needle coating material remains as PTFE however just the | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | | Manufacturer | Natus Manufacturing Limited | TECA Corporation 3 Campus Drive Pleasantville New York 10570 | | | Trade Name | Myoject™ Luer Lock Needle Electrodes | Teca Myoject Disposable Needle Electrode | | | 510(k) number | K161430 | K973444 | | | Product Code | IKT | IKT | | | | | | formulation has changed to reduce the initial penetration force to aid easier insertion of the needle. As a result, this reduces patient discomfort when performing EMG examinations. | | Hub | Luer Lock/Slip | Luer Slip | This change originated from market place demand for the needles to fit a Luer Lock Syringe. The Luer Lock needle locks into place and as a result is more likely to be seepage free. Therefore, this reduces the risk of medication accidentally leaking from the syringe and possibly causing harm to the patient and user. This does not affect the safety | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | | Manufacturer | Natus Manufacturing Limited | TECA Corporation 3 Campus Drive Pleasantville New York 10570 | and effectiveness of the device as the overall function of the device remains unchanged, the Luer lock simply adds an additional safety mechanism to the device. | | Trade Name | MyojectTM Luer Lock Needle Electrodes | Teca Myoject Disposable Needle Electrode | | | 510(k) number | K161430 | K973444 | | | Product Code | IKT | IKT | | | Hub Material | Polypropylene (Exxonmobil) Escorene PP9074 MED | Polycarbonate | The material for this device has changed compared to the predicate device, however comparison with the predicate device demonstrates the material performance is equivalent and they are both variants of polymer materials. There is an insignificant | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | | Manufacturer | Natus Manufacturing Limited | TECA Corporation 3 Campus Drive Pleasantville New York 10570 | | | Trade Name | Myoject™ Luer Lock Needle Electrodes | Teca Myoject Disposable Needle Electrode | | | 510(k) number | K161430 | K973444 | | | Product Code | IKT | IKT | materials; as a result product performance, safety and effectiveness are not affected. In addition, Biocompatibility testing demonstrates there are no new concerns of safety or effectiveness. | | Needle grind angle | 10-16 degrees conical | 10-20 degrees conical | The grind angles have similar specifications; the slight change in the upper range of the grind angle is not a significant change and therefore does not raise new concerns of safety and effectiveness. The change does not alter the diagnostic effects of the device. | | Recording area (sqmm) | .19(mm≤) fine and then increases to .89(mm≤) depending on needle size | 0.25 | There are some differences in recording areas which vary depending on needle size | | Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences | | Manufacturer | Natus Manufacturing Limited | TECA Corporation 3 Campus Drive Pleasantville New York 10570…