(149 days)
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
The NerveGuard NRFit and NerveGuard LUER are single use sterile devices.
The NerveGuard NRFit and NerveGuard LUER are packed in a soft blister package.
The procedure requires connection to a needle intended for peripheral neve block and an injection device, typically a 10/20ml syringe (not subject to this 510(k)).
The NerveGuard is attached between the hub of the needle and the syringe via male and female connector.
Upon starting injection the pressure is monitored while the needle is inserted into the patients' skin. When exceeding the maximum pressure the NerveGuard limits the injection pressure. The user can slightly release force and proceed injection beyond the limitation value.
The NerveGuard pressure monitor is a disposable manometer for objective monitoring of injection pressure during administration of peripheral nerve blocks (PNB). Monitoring opening injection pressure with the NerveGuard helps identify unsafe injections before they start. When the NervGuard measures high opening injection pressure and limits this pressure down to a maximum of 18Psi. the needle can be repositioned and the injection resumed.
Usually the operator creates a force on the plunger (Fo) on the filled syringe which leads to normal flow of anesthetic through a valve in the NerveGuard. At this time, the resistance force of the locking mechanism Fs is higher when Fo. The locking mechanism closes the valve as soon as the force Fo overshoots Fs. The flow is stopped immediately. The NerveGuard will prevent a flow of anesthetic and fullfill it's protective function. Upon release of pressure Fo the valve reopens and the procedure can move on.
Here's a breakdown of the acceptance criteria and study information for the NerveGuard device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Detail | Standard / Protocol | Result (Reported Device Performance) |
|---|---|---|
| For Sterilization: | ||
| Sterilization Assurance Level (SAL) | ISO 11135 | 10^-6 (Pass) |
| Ethylene Oxide (EtO) Gas Type | ISO 11135 | Ethylene Oxide 99.99% |
| Exposure Time | ISO 11135 | 300 min. |
| Aeration Method | ISO 11135 | Evacuation, 2 airwashes |
| Aeration Period | ISO 11135 | Minimum 48h at 40°C (±5) |
| Residuals (EtO, ECH) | ISO 10993-7 | Pass (< 25ppm) |
| Pyroburden/Endotoxin | FDA Guideline, 1987 | Pass (< 0.06 EU/ml and 2.15 EU/device) |
| For Biocompatibility: | ||
| Biocompatibility | ISO 10993-1 | Pass |
| For Connector Integrity (LUER - ISO 80369-7): | ||
| Liquid Leakage | ISO 80369-7, 6.1 | Pass |
| Air Leakage | ISO 80369-7, 6.2 | Pass |
| Stress Cracking | ISO 80369-7, 6.3 | Pass |
| Axial Load | ISO 80369-7, 6.4 | Pass |
| Unscrewing Torque | ISO 80369-7, 6.5 | Pass |
| Overriding | ISO 80369-7, 6.6 | Pass |
| For Connector Integrity (NRFit - ISO 80369-6): | ||
| Liquid Leakage | ISO 80369-6, 6.1 | Pass |
| Air Leakage | ISO 80369-6, 6.2 | Pass |
| Stress Cracking | ISO 80369-6, 6.3 | Pass |
| Axial Load | ISO 80369-6, 6.4 | Pass |
| Unscrewing Torque | ISO 80369-6, 6.5 | Pass |
| Overriding | ISO 80369-6, 6.6 | Pass |
| Device Specific Performance: | ||
| Accuracy of Measuring | Internal protocol | Pass |
| Compatibility LUER | Internal Protocol | Pass |
| Compatibility NRFit | Internal Protocol | Pass |
| Pressure Limitation | (Implicit) Internal | Limits injection to <18psi (15psi tolerance +3) |
| Shelf Life | Internal (aging tests) | 5 years (no decrease in performance after 5 years) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for liquid leakage, air leakage, etc.). It generally states that "Sterility tests have been performed using worst case devices," and "Performance... has been tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years)."
The data provenance is from Germany (PAJUNK GmbH Medizintechnologie is located in Geisingen, Germany, and the contract sterilizer Sterigenics Germany GmbH is in Wiesbaden, Germany). The studies appear to be prospective in nature, as they involve testing the manufactured device against specific standards and internal protocols.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are primarily engineering and performance tests against established international standards (ISO) and an internal protocol, rather than clinical studies requiring expert ground truth in the medical sense.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The tests involve objective measurements against pass/fail criteria defined by standards or internal protocols, not subjective human adjudication of medical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device (NerveGuard) is a physical medical device (a disposable manometer/pressure limiter) and not an AI or imaging diagnostic tool that would typically undergo such a study. The comparison is against a predicate device's characteristics and performance, not human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The NerveGuard is a physical device used with human intervention for nerve blocks. It is not an algorithm or an AI system that operates in a standalone capacity.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is based on:
- International Standards: e.g., ISO 11135 for sterilization, ISO 10993-7 for residuals, ISO 10993-1 for biocompatibility, ISO 80369-7 and ISO 80369-6 for connector integrity tests.
- Internal Protocols: For "Accuracy of measuring," "Compatibility LUER," and "Compatibility NRFit," as well as the implicit pressure limitation function.
- Predicate Device Equivalence: The primary means of demonstrating substantial equivalence is by comparing the device's characteristics and intended use to a legally marketed predicate device (K031128 B-Smart).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for a training set.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
July 12, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PAJUNK GmbH Medizintechnologie Christian Quass Director Regulatory Affairs, Safety Officer Karl-Hall-Str. 1 78187 Geisingen, Germany
Re: K170435
Trade/Device Name: NerveGuard NRFit, NerveGuard LUER Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP, CAZ Dated: June 14, 2017 Received: June 16, 2017
Dear Christian Quass:
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,
Mark S. Fellman -S
for
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170435
Device Name NerveGuard NRFit NerveGuard LUER
Indications for Use (Describe)
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif and appears to be a custom typeface. A registered trademark symbol is located to the right of the letter "K".
Pioneering medical technology
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2017-07-12
Document Control Number: K170435
510(k) owner:
PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen, Baden-Wuerttemberg, Germany
Establishment Registration Number: 9611612
Submitter Information/ production site:
PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612
Contact:
Christian G. H. Quass Director Regulatory Affairs, Safety Officer Patricia Weisbrod Regulatory Affairs Manager Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com
USA Contact:
PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 140 Norcross, GA 30071 Phone +1 (888) 9PAJUNK (72-5865) Fax +1 (678) 514-3388
Establishment Registration Number: 3004076349
Contact
Marco Wohnig President PAJUNK® Medical Systems L.P. Phone: (770) 493-6832 Direct: (470) 448-4070 (770) 757-2449 Cell: Fax: (678) 514-3388 E-Mail: marco.wohnig@pajunk-usa.com
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Image /page/4/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and sans-serif. A registered trademark symbol is located to the right of the letter K.
K170435
Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | NerveGuard NRFitNerveGuard LUER |
| Sterilization method: | Ethylene Oxidedisposable device, supplied sterile to the enduser and non-sterile intended to be sterilizedprior to use to repackagers/ medical devicemanufacturers |
| Contract Sterilizer: | Sterigenics Germany GmbHKasteler straße 4565203 WiesbadenGermany, HessenEstablishment Registration Number:3002807090 |
| Document Control Number | K170435 |
| Classification Name: | Anesthetic conduction needle |
| Classification Reference: | 21 CFR 868.5150 |
| Product Codes: | BSP, CAZ |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Predicate Device by competitor | K031128B-Smart |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the NerveGuard with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7.
Substantial equivalence is based on a competitor´s device.
The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/ medical device manufacturers.
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Image /page/5/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and sans-serif. A small circle with an R inside is located to the right of the K, indicating that the word is a registered trademark.
Indications for use
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
Device Description/ Principle of operation
The NerveGuard NRFit and NerveGuard LUER are single use sterile devices.
The NerveGuard NRFit and NerveGuard LUER are packed in a soft blister package.
The procedure requires connection to a needle intended for peripheral neve block and an injection device, typically a 10/20ml syringe (not subject to this 510(k)).
The NerveGuard is attached between the hub of the needle and the syringe via male and female connector.
Upon starting injection the pressure is monitored while the needle is inserted into the patients' skin. When exceeding the maximum pressure the NerveGuard limits the injection pressure. The user can slightly release force and proceed injection beyond the limitation value.
The NerveGuard pressure monitor is a disposable manometer for objective monitoring of injection pressure during administration of peripheral nerve blocks (PNB). Monitoring opening injection pressure with the NerveGuard helps identify unsafe injections before they start. When the NervGuard measures high opening injection pressure and limits this pressure down to a maximum of 18Psi. the needle can be repositioned and the injection resumed.
Usually the operator creates a force on the plunger (Fo) on the filled syringe which leads to normal flow of anesthetic through a valve in the NerveGuard. At this time, the resistance force of the locking mechanism Fs is higher when Fo. The locking mechanism closes the valve as soon as the force Fo overshoots Fs. The flow is stopped immediately. The NerveGuard will prevent a flow of anesthetic and fullfill it's protective function. Upon release of pressure Fo the valve reopens and the procedure can move on.
Determination methods and results of Substantial Equivalence Determination:
| Intended Use | Result: Substantially Equivalent |
|---|---|
| Comparison of outer appearance and assemblies | Result: Substantially Equivalent |
| Accuracy test | Result: Substantially Equivalent |
| Stability of needle/ manometer connector | Result: Substantially Equivalent |
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Image /page/6/Picture/0 description: The image shows the word "PAJUNK" in white letters on a green background. The letters are bold and sans-serif. There is a registered trademark symbol after the K.
Equivalence in materials used and design
| Predicate device | Subject Device | Result ofcomparison, ifnecessary withrationale | |
|---|---|---|---|
| Characteristics | K031128 | NerveGuard | |
| B-SmartMACOSTA MEDICAL | Pajunk® GmbHMedizintechnologie | ||
| Biocompatibility | Both devices are external communicating. Therefore and based uponISO10993-1 biocompatibility applies. | Substantiallyequivalent | |
| Packaging | Individually packed and sterilized oras set component.Single sterile in medical paper bag(heat sealed) | Individually packed and sterilizedor as set component.Single sterile in Tyvek bag (heatsealed)As a set component packed in arigid tray, wrapped and packagedin a soft blister pack (heat sealed). | Same packagingThe PAJUNK®individual packagingwas selectedaccording to avalidated sterilizationand transportationprocess |
| Intended Use | The Macosta Medical B-SmartNerve Block Injection PressureManometer is a disposablemanometer for measuring injectionpressure during administration ofperipheral nerve blocks. | The NerveGuard Nerve BlockInjection Pressure Limiter is adisposable manometer formeasuring injection pressureduring administration of peripheralnerve blocks. | Substantiallyequivalent |
| Overall design: | Materials: plasticsNo direct patient contact | Materials: Polycarbonate, HDPENo direct patient contact | Both devices do nothave direct patientcontact and are madefrom plastic materials |
| Picture | Image: white pressure meter | Image: green pressure meter | Both systems alloweasy handling andconnecting |
| connectivity | Distal connector:maleProximal connector: female | Distal connector: maleProximal connector: female | Both systems dohave identicalconnectivity towardssyringe and needle |
| Capacity | Indicates pressure with a cylindricalhub | Indicates pressure and limitspressure to <18psi(15psi tolerance +3) | Both systems areequivalent in scale |
| increments | Indicates:<15psi white15psi – 20psi yellow>20psi red | Limits injection to <18psi(15psi tolerance +3) | Both systems areequivalent in scale |
| Characteristics | Predicate deviceK031128B-SmartMACOSTA MEDICAL | Subject DeviceNerveGuardPajunk® GmbHMedizintechnologie | Result ofcomparison, ifnecessary withrationale |
| Mechanism | Membrane pushing colouredindicator plunger | Sealing/ blocking mechanism | Predicate roughlyindicates pressure whilesubject device limitspressureSubject device protectspatient against highpressure while predicatedevice just gives anindication. Subjectdevice is substantiallyequivalent to thepredicate. |
| Connectivity | ISO 594-1 and ISO 594-2 (Luerconnectivity) | 80369-7 (Luer connectivity) ISO80369-6, -20 NRFit (connectorsfor neuroaxial applications) | standardizedconnectivities |
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Image /page/7/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are large and bold, and they appear to be slightly blurred. A registered trademark symbol is present to the right of the letter K. The overall impression is a clean and simple logo.
Each of the materials used either in the Predicate Devices or the Subject Device are established materials used for manufacturing medical devices.
Equivalence in the Indications for use
Subject Device:
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
Predicate Devices:
The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
Discussion
The indications for use as well as the intended use of the predicate device and of the subject device are equivalent.
Conclusion: Substantially Equivalent
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Image /page/8/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and slightly blurred, giving them a soft appearance. A small circle with an R inside is located to the right of the letter K, indicating a registered trademark.
Sterilization
The contract sterilizer and the sterilizing process are identical to the process and sterilizer used for all PAJUNK® - manufactured devices which are already cleared for market or exempt.
Sterilization parameters are
| SAL | 10-6 |
|---|---|
| Type of gas | Ethylene Oxide 99,99% |
| Exposure time | 300 min. |
| Aeration method | evacuation2 airwashes |
| Aeration period | residual EtO-gas is removed in circulatingair at 40° C (±5) for at least 48h |
Sterilization has been validated according to ISO 11135-1 Overkill Approach (1 sublethal cycle, 2 half cycle, 1 full cycle)
Residuals of EO and ECH are in compliance with ISO 10993-7.
Cleaning and Sterilization method, which ensures an SAL of 10° as well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtO-residuals as well as shelf life have been validated.
The limits listed below are met by each device:
Limits for Residuals: 25ppm = 25μg(g/device) of Ehyleneoxide (EO); 25ppm = 25μg/(g/device) Ethylene chlorhydrine
Limit for Pyroburden/ endotoxine: 0,06 EU/ml and 2,15 EU/ device acc. to FDA GUIDELINE ON VALIDATION OF LIMULUS AMEBOCYTE LYSATE TEST AS AN END-PRODUCT ENDOTOXIN TEST FOR HUMAN AND ANIMAL PARENTERAL DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL DEVICES - Issued 12/ 1987
Sterilization of devices purchased bulk by Repackagers/ Relabellers/ Kit Manufacturers:
The NerveGuard is also available in bulk non sterile. If appropriately packed and sterilized with Ethylene oxide according to the parameters above the technological parameters remain unchanged. However, final responsibility for sterilization remains with the customer of NerveGuard purchased bulk non-sterile.
Shelf Life
Efficacy of sterile product's lifecycle has been validated.
Sterility tests have been performed using worst case devices already cleared for market and being packed in identical packaging (material and dimensions).
Performance of the essential performance of the device (NRFit and LUER connection, stability of connections) has been tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years). There is no decrease in performance after 5 years.
Shelf-life is set to 5 years.
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Image /page/9/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and slightly blurred, giving them a soft appearance. A small registered trademark symbol is visible to the upper right of the letter "K".
Biocompatibility:
All products comply with ISO 10993-1, 2nd and 3rd edition.
The NerveGuard is an external communicating device with no direct patient contact. Therefore based upon ISO10993-1 biocompatibility is evaluated. Since biocompatibility of the materials used is proven with another device of the sponsor additional testing is obsolete and has not been carried out. Therefore and based upon sterilization and residuals validation the devices are considered to be biocompatible.
Technology Characteristics/ Performance Testing
The Subject Device has been tested to comply with the state-of-the-art standards listed below. For connector standards both, the male and female connector have been tested:
| Test Detail | Standard | FDA-Rec.-No. | Result |
|---|---|---|---|
| Sterilization | ISO 11135 | 14-452 | Pass |
| Residuals | ISO 10993-7 | 14-408 | Pass |
| Biocompatibility | ISO 10993-1 | 2-220 | Pass |
| Liquid Leakage | ISO 80369-7, 6.1 | 5-115 | Pass |
| Air Leakage | ISO 80369-7, 6.2 | 5-115 | Pass |
| Stress Cracking | ISO 80369-7, 6.3 | 5-115 | Pass |
| Axial Load | ISO 80369-7, 6.4 | 5-115 | Pass |
| Unscrewing torque | ISO 80369-7, 6.5 | 5-115 | Pass |
| Overriding | ISO 80369-7, 6.6 | 5-115 | Pass |
| Liquid Leakage | ISO 80369-6, 6.1 | 5-108 | Pass |
| Air Leakage | ISO 80369-6, 6.2 | 5-108 | Pass |
| Stress Cracking | ISO 80369-6, 6.3 | 5-108 | Pass |
| Axial Load | ISO 80369-6, 6.4 | 5-108 | Pass |
| Unscrewing torque | ISO 80369-6, 6.5 | 5-108 | Pass |
| Overriding | ISO 80369-6, 6.6 | 5-108 | Pass |
| Accuracy of measuring | Internal protocol | n.a. | Pass |
| Compatibility LUER | Internal Protocol | n.a. | Pass |
| Compatibility NRFit | Internal Protocol | n.a. | Pass |
Conclusion:
The comparison between the predicate devices and the subject device of this submission as well as the validated sterilization process and the results of the standard testing demonstrates that the subject device is substantially equivalent to the predicate device.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).