(283 days)
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.
The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode
Here's a breakdown of the acceptance criteria and the study information for the Natus Manufacturing Limited Myoject™ Luer Lock Needle Electrode, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Teca Myoject Disposable Needle Electrode K973444) through a comparison of characteristics and performance testing. There isn't a direct "acceptance criteria" table with specific pass/fail metrics explicitly stated alongside the new device's performance in a quantitative manner for most characteristics. Instead, the "Discussion of Differences" column in Table 5A (starting on page 5) serves as the primary mechanism for demonstrating equivalence and addressing performance.
However, for Biocompatibility and Bench Testing, the performance is reported against established ISO and ASTM standards.
| Characteristic / Test | Acceptance Criteria (Implicit from Predicate/Standards) | Myoject™ Luer Lock Needle Electrode Performance (Reported) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic (ISO 10993-5:2009) | Non-cytotoxic to L929 cells |
| Irritation (Intracutaneous) | Average reaction not greater than control (ISO 10993-10:2010) | Meets requirements; average reaction not greater than control for polar and non-polar extracts |
| Sensitization (Local Lymph Node Assay) | Non-sensitizer (ISO 10993-10:2010) | Polar and non-polar extracts considered non-sensitizers. Positive controls gave SI > 3 (as expected for positive control function). |
| Systemic Toxicity | PASS (ISO 10993-11:2006) | 0.9% sodium chloride solution extract: PASS; Cottonseed oil extract: PASS |
| Bench Testing | ||
| Tensile testing | Implied to meet design specifications | Conducted; meets performance and design specifications |
| Coating thickness | Implied to meet design specifications | Conducted; meets performance and design specifications |
| Leak Testing | Implied to meet design specifications | Conducted; meets performance and design specifications |
| Tip geometry grind measurements | Implied to meet design specifications | Conducted; meets performance and design specifications |
| Penetration testing | Reduced initial penetration force compared to predicate (discussed as an improvement) | Conducted; meets performance and design specifications. Implied improved penetration. |
| Luer Lock Design Verification | Secure Luer Lock connection (reduced seepage/leakage) | Conducted; meets performance and design specifications. Luer lock is described as adding an additional safety mechanism. |
| Other Comparisons (from Table 5A) | ||
| Labelling | Equivalent, with minor changes not affecting safety/effectiveness | Minor changes (manufacturer name, address, branding, warnings, harmonized symbols); do not raise questions of safety/effectiveness. |
| Intended Use | Same as predicate | Same as predicate; minor labeling nuance regarding drug supply does not affect safety/effectiveness. |
| Physical Characteristics | Monopolar Needle | Same |
| Connector | Single Contact Touch Proof DIN42 802 | Same |
| Material of Needle | Stainless 304 | Same |
| Needle Diameter (mm) | 0.30, 0.41, 0.46, 0.51, 0.71 | Same |
| Needle Coating Material | PTFE (different formulation) | PTFE (Xylan 8820 G4075); improved to reduce initial penetration force, similar safety/effectiveness. |
| Hub | Luer Slip (predicate) | Luer Lock/Slip; improved to reduce risk of medication leakage. Doesn't affect overall function/safety/effectiveness. |
| Hub Material | Polycarbonate (predicate) | Polypropylene (Exxonmobil) Escorene PP9074 MED; equivalent material performance, no new safety/effectiveness concerns. |
| Needle grind angle | 10-20 degrees conical (predicate) | 10-16 degrees conical; slight change in upper range, not significant, no new safety/effectiveness concerns, no altered diagnostic effects. |
| Recording area (sqmm) | 0.25 (predicate) | 0.19 (fine) to 0.89 (depending on size); differences vary, no effect on safety/effectiveness or diagnostic effects. |
| Length (mm) | 25, 37, 50, 75, 100 (predicate) | 25, 37, 50, 75; 100mm version obsolete. No new safety/effectiveness concerns. |
| Connecting lead | 14 or 26 inches, 2mm or touchproof plug (predicate) | 770±10mm, 'ST' moulded 1.5mm touch proof. Cable length "30" (76cm) to 1.5mm female touchproof connector; increased length, minor changes, no new safety/effectiveness concerns. |
| Sterilization | Supplied sterilized gamma irradiated | Same |
| Protective Sheath | Polyethylene (predicate) | Polypropylene Escorene PP9074 MED (Exxon Mobil); equivalent material performance, no new safety/effectiveness concerns. |
| Protective Pouch | Tyvek/Mylar | Same |
| Sterility Assurance Level (SAL) | 10 minus 6 (predicate) | 10 minus 6; improved needle tip sharpness. No new safety/effectiveness concerns. |
| Tip geometry | Lancet Point (predicate) | Trocar Point, 15 degree bevel; preferred for range of needles, improves tip sharpness, reduces patient discomfort. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state specific sample sizes for each of the performance tests (tensile, coating thickness, leak, tip geometry, penetration, Luer Lock verification). It refers to "Performance Testing" and "Bench Testing" being performed. For biocompatibility tests, details are provided on the methods (e.g., L929 cells for cytotoxicity, rabbit for intracutaneous reactivity, mouse for local lymph node assay), but the exact number of test items or animals used is not specified in this summary.
- Data Provenance: The studies were conducted by Natus Manufacturing Limited, which is based in Ireland. The nature of these tests (biocompatibility, bench testing) usually implies controlled laboratory settings rather than patient data. Therefore, the data Provenance is the manufacturer's internal testing. Not retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This is not applicable as the studies described are non-clinical performance tests (biocompatibility and bench testing) and technical comparisons to a predicate device. The "ground truth" is established by adherence to recognized international standards (ISO, ASTM) for materials, design, and manufacturing quality, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set:
- Not applicable, as this refers to non-clinical performance and design verification tests, not clinical studies with human assessors.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic electromyograph needle electrode, not an image-based diagnostic AI device that would typically involve an MRMC study. The comparison is primarily against a predicate device's design specifications and performance standards through bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a medical instrument (needle electrode), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating the device's acceptable performance and substantial equivalence is based on:
- Adherence to International Standards: ISO 10993 series (Biocompatibility), ISO 2859-1 (Sampling), ASTM F 1980 (Sterile Barrier).
- Predicate Device Specifications: The Teca Myoject Disposable Needle Electrode (K973444) serves as the primary benchmark for comparison of design and technological characteristics.
- Design and Performance Specifications: The device's own predetermined specifications for physical characteristics and functional performance (e.g., tensile strength, leak integrity, penetration force).
8. The Sample Size for the Training Set:
- Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.
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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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 LimitedIDA Business ParkGort, County GalwayIreland |
|---|---|
| Official Correspondent: | Michael GalvinManager, Quality and Regulatory AffairsNatus Manufacturing LimitedIDA Business ParkGort, County GalwayIreland |
| 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 |
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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 DisposableHypodermic Needle Electrode |
| Intended Use: | The disposable hypodermic monopolar needles are FOR SINGLEUSE ONLY in electromyography (EMG) in situations wherein it isdesired to insert an electrode, in the form of a probe, into a patientto locate a particular muscle and then inject a medication into thatmuscle. The hypodermic needle with an open lumen is designedfor muscle stimulation, motor unit action potential recording anddrug 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 sametechnological characteristics as the predicate device. |
| Nonclinical Tests: | Tensile testing Coating thickness Leak Testing Tip geometry measurements Penetration testing Luer Lock Design |
| SubstantialEquivalence: | 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.
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| Table 5A: Substantial Equivalence Comparison Table | ||
|---|---|---|
| Year | 2016 | 20 Nov 1997 (original submissiondate) | Discussion of Differences |
|---|---|---|---|
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew 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 NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 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 NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | ||
| 510(k) number | |||
| K161430 | K973444 | ||
| Product Code | IKT | IKT | |
| probe, into a patient to locate aparticular muscle and then inject amedication into that muscle. Thehypodermic needle with an openlumen is designed for musclestimulation, motor unit actionpotential recording and drugdelivery. Once the physician issatisfied with the location, he/sheinjects a drug therein via the lumenof the needle. | locate a particular muscle and theninject a medication into that muscle.The hypodermic needle with an openlumen is designed for musclestimulation, motor unit actionpotential recording and drug delivery.Once the physician is satisfied withthe location, he/she injects a drugtherein via the lumen of the needle.Note: TECA Corp. does not supplyany drugs with needle electrodes nordoes TECA Corp. offer for sale anyform of drugs. | can be included in labeling.The needles are sold on theirown as a medical device andare not specifically designatedfor use with a specific drug.Therefore, this statement isnot appropriate for the IFU. | |
| PhysicalCharacteristics | Monopolar Needle | Monopolar Needle | Same |
| Connector | Single Contact Touch Proof DIN42802 | Single Contact Touch Proof DIN42802 | Same |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Myoject™ Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| Material of Needle | Stainless 304 | Stainless 304 | Same |
| Needle Size (mm) | Needle Diameter:0.300.410.460.510.71 | Needle Diameter:0.300.410.460.510.71 | SameThe dimensions relate to needle diameter |
| Needle Coating material | PTFE (Xylan 8820 G4075) | PTFE (Ultralon R-605/T-5) | This change resulted from theAccessories developmentDepartment's request toreduce the initial penetrationforce and mitigate against theobsolescence of the Ultraloncoating. This change does notraise questions of safety andeffectiveness as the needlecoating material remains asPTFE however just the |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Myoject™ Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| formulation has changed toreduce the initial penetrationforce to aid easier insertion ofthe needle. As a result, thisreduces patient discomfortwhen performing EMGexaminations. | |||
| Hub | Luer Lock/Slip | Luer Slip | This change originated frommarket place demand for theneedles to fit a Luer LockSyringe. The Luer Lockneedle locks into place and asa result is more likely to beseepage free. Therefore, thisreduces the risk of medicationaccidentally leaking from thesyringe and possibly causingharm 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 Corporation3 Campus DrivePleasantvilleNew York 10570 | and effectiveness of thedevice as the overall functionof the device remainsunchanged, the Luer locksimply adds an additionalsafety mechanism to thedevice. |
| Trade Name | MyojectTM Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| Hub Material | Polypropylene (Exxonmobil)Escorene PP9074 MED | Polycarbonate | The material for this devicehas changed compared to thepredicate device, howevercomparison with the predicatedevice demonstrates thematerial performance isequivalent and they are bothvariants of polymer materials.There is an insignificant |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Myoject™ Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | materials; as a result productperformance, safety andeffectiveness are not affected.In addition, Biocompatibilitytesting demonstrates there areno new concerns of safety oreffectiveness. |
| Needle grind angle | 10-16 degrees conical | 10-20 degrees conical | The grind angles have similarspecifications; the slightchange in the upper range ofthe grind angle is not asignificant change andtherefore does not raise newconcerns of safety andeffectiveness. The changedoes not alter the diagnosticeffects 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 inrecording areas which varydepending on needle size |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Myoject™ Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| which does not affect thesafety and effectiveness of thedevice; as there are nochanges to the diagnosticeffects of the device. | |||
| Length (mm) | 25, 37, 50, 75 | 25, 37, 50, 75, 100 | The 100mm version of theTeca Myoject needle (MJT-10022) (22G) is no longeroffered. All other needle sizesare available. This does notraise new concerns of safetyand effectiveness as nochanges have been made tothe devices, the 100mmversion has just been madeobsolete. |
| Connecting lead | Myoject: 770±10mm, Form 'ST'moulded 1.5mm touch proof. CableLength "30" (76cm), terminating in | 14 or 26 inches terminated in a 2mmor touchproof plug | For this device the cable hasbeen increased in length to aidease of use when performingEMG examinations. The |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | MyojectTM Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| 1.5mm female touchproofconnector. | changes to the cable are minorand do not raise new issues ofsafety and effectiveness, thecable still serves the samefunction as the predicatedevice. In addition, thesechanges do not interfere withthe diagnostic functioning ofthe device. | ||
| Sterilization | Supplied sterilized gamma irradiated | Supplied sterilized gamma irradiated | Same |
| Protective Sheath | Polypropylene Escorene PP9074MED (Exxon Mobil) | Polyethylene | The function of the protectivesheath is to protect the sharpneedle tip in packaging andalso provide safety to userwhen handling the devicebefore and after use. Thematerial for this device has |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | MyojectTM Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | changed compared to thepredicate device, howevercomparison with the predicatedevice demonstrates thematerial performance isequivalent and they are bothvariants of polymer materials.There is an insignificantdifference between bothmaterials; as a result productperformance, safety andeffectiveness are not affected. |
| Protective Pouch | Tyvek/Mylar | Tyvek/Mylar | Same |
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| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
|---|---|---|---|
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | MyojectTM Luer Lock NeedleElectrodes | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
|---|---|---|---|
| Manufacturer | Natus Manufacturing Limited | TECA Corporation3 Campus DrivePleasantvilleNew York 10570 | |
| Trade Name | Myoject Luer Lock NeedleElectrode | Teca Myoject Disposable NeedleElectrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| Tip geometry | Trocar Point15 degree bevel | Lancet Point | Both Lancet and Trocargeometries are routinely used byneedle manufacturers in themedical device industry. Trocarpoint is the preferred geometry forthe range of needles to meet |
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| Sterility AssuranceLevel (SAL) | 10 minus 6 | 10 minus 6 | This change resulted frommodifications to the needle tipgeometry enabling improvementsto the needle tip sharpness. Thischange does not result in newissues related to safety andeffectiveness; as it increases tipsharpness which reduces theinitial penetration force whichreduces patient discomfort. This isan improved feature to the devicewhich ultimately functions thesame as the predicate device. Thediagnostic capabilities of thedevice are unaffected. |
|---|---|---|---|
| Same |
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Summary of Performance Testing-Biocompatibility
Myoject™ Luer Lock Needle Electrodes are Invasive Electrodes, classified per ISO 10993-1:2009 as external communicating devices in limited (≤ 24 hours) contact with tissue. Annex A defines that the following evaluation tests need to be considered cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation sensitivity (ISO 10993-10).
The Biocompatibility Evaluation testing summarized below was conducted on the Myoject™ Luer Lock Needle Electrodes to demonstrate compliance of these materials to the following standards:
- . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006 ● Biological evaluation of medical devices -- Part 11: Test for Systemic Toxicity
- . ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
International Standard BS EN ISO 10993-5: (2009) Biological Evaluation of Medical Devices- Part 5: Tests for in vitro Cytotoxicity
The extract of the test item was non-cytotoxic to L929 cells under the conditions of this test.
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization Section 6.4 Intracutaneous (Intradermal) Reactivity Test
Intracutaneous (Intradermal) Reactivity Test in the Rabbit
The average reaction to the polar test item extract was considered not to be greater than the average reaction for the corresponding control at any observation period.
The average reaction to the non-polar test item extract was considered not to be greater than the average reaction for the corresponding control at any observation period.
Polar and non-polar extracts of the test item meet the requirements of ISO 10993-10: 2010 Intracutaneous (Intradermal) Reactivity Test in the Rabbit.
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ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Local Lymph Node Assay in the Mouse - Polar and Non-Polar Extracts
A Polar extract of the test item was considered to be a non-sensitizer under the conditions of the test.
The non-polar extract of the test item was considered to be a non-sensitizer under the conditions of the test.
The polar positive control and non-polar positive control each gave a Stimulation Index of greater than 3.
ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Test for Systemic Toxicitv
The results are summarizes as follows: 0.9% sodium chloride solution test item extract: PASS Cottonseed oil test item extract: PASS The test item complies with ISO 10993-11: 2006, Systemic Toxicity Test in the Mouse.
Performance Testing-Bench Testing
Performance Testing was performed on device characteristics of the Myoject™ Luer Lock Needle Electrodes. This performance testing consisted of
- Tensile testing ●
- Coating thickness .
- Leak Testing ●
- Tip geometry grind measurements ●
- Penetration testing
- Luer Lock Design Verification ●
Conclusion
All performance testing and bench testing conducted as outlined above demonstrate that the device meets the performance and design specifications.
Verification results indicated that Myoject™ Luer Lock Needle Electrodes comply with their predetermined specification and with the applicable Standards detailed below:
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- . 21 CFR 820.75 Quality System Regulation - Process Validation
- ISO 2859-1:1999 Sampling Procedures For Inspection By Attributes Part 1: Sampling . Schemes Indexed By Acceptance Quality Limit (AQL) For Lot-By-Lot Inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
- . ISO 10993-1:2009 Biological Evaluation of medical devices Part 1: Evaluation and testing
- . ISO 10993-5:2009 Biological Evaluation of medical devices Part : Tests for in vitro cytotoxicity
- ASTM F 1980 07-2011 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices
Verification activities were conducted to establish the performance and safety characteristics of the Myoject 100 Luer Lock Needle Electrodes. The results of these activities demonstrate that the Myoject™ Luer Lock Needle Electrodes are safe and effective when used in accordance with the intended use, labelling and Instructions for Use.
Therefore, the Myoject™ Luer Lock Needle Electrodes are considered substantially equivalent to the predicate device Teca™ Myoject Disposable Needle Electrodes.
§ 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).