(209 days)
None
No
The device description focuses on the physical characteristics of the needle and its use under ultrasound guidance, with no mention of AI or ML for image analysis, decision support, or any other function.
No
This device is a needle used for administering regional anesthetic blocks, which is a procedural tool rather than a therapeutic device that directly treats a disease or condition. Its purpose is for drug delivery.
No
The device is a needle used for administering regional anesthetic blocks, not for diagnosing conditions. Its primary function is therapeutic/interventional.
No
The device description clearly outlines physical components like a luer hub, stainless steel cannula, and polyethylene sheath, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The EchoGlo™ Peripheral Nerve Block Needle is a physical needle designed to be inserted into the body for the administration of regional anesthetic blocks. It is used in vivo.
- Intended Use: The intended use is for administering anesthetic blocks, which is a medical procedure performed directly on a patient.
The device is a surgical/procedural instrument, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous This device is intended for use in the administration of regional anesthetic blocks.
Intended population is adults.
Product codes
BSP
Device Description
The EchoGlo™ Peripheral Nerve Block (PNB) Needle consist of a polycarbonate luer hub, stainless steel cannula and a polyethylene sheath. The needle cannula will be supplied with a bevel tip or a Tuohy tip. The EchoGlo™ PNB Needle will be used for peripheral nerve block under ultrasound guidance. The distal end of the cannula has been engraved with two bands to increase ultrasound visibility by optimally reflecting ultrasound waves. These needles are provided as sterile, nonpyrogenic, single-use disposable devices. The needles may be used for single shot peripheral nerve block or for continuous infusion nerve block. The EchoGlo™ PNB Needle used for a single shot procedure will be supplied in a pouch along with a 24 inch extension set. The extension set will consist of polyvinyl chloride (PVC) tubing and have a Female luer at one end of the tubing and a Male luer at the opposite end of the tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guidance
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
prescribe by physician only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user.
ICU/OR
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Smiths Medical EchoGlo™ Peripheral Nerve Block Needle was evaluated via non-clinical performance testing to demonstrate the devices are substantially equivalent the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the EchoGlo™ Peripheral Nerve Block Needle performed as intended. A summary of the Non-Clinical performance testing is in Table 5-2. Biological and Bench testing was conducted to the Standards in Table 5-3.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
January 25, 2018
Smiths Medical ASD, Inc. Michael Johnson Sr. Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K171968
Trade/Device Name: EchoGlo Periphreal Nerve Block Needle: Single Shot and EchoGlo Periphreal Nerve Block Needle: Continuous Catheter Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: December 20, 2017 Received: December 22, 2017
Dear Michael Johnson:
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
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171968
Device Name
EchoGloTM Peripheral Nerve Block Needle: Single Shot EchoGlo™ Peripheral Nerve Block Needle: Continuous
Indications for Use (Describe)
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous This device is intended for use in the administration of regional anesthetic blocks.
Intended population is adults.
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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Confidential
3
1. ADMINISTRATIVE INFORMATION
| 510(k) | K171968 |
|---|---|
| Applicant's Name | |
| and Address | Smiths Medical ASD, Inc. |
| 6000 Nathan Lane North | |
| Minneapolis, MN 55442 USA | |
| Contact Person | Michael R. Johnson |
| Sr. Regulatory Affairs Specialist | |
| Phone: 763-383-3341 | |
| Fax: 763-383-3679 | |
| Email: mike.johnson@smiths-medical.com | |
| Date | December 14, 2017 |
| Regulation No. | 21 CFR § 868.5150 |
| Regulation Name | Anesthesia conduction needle |
| Primary Product | |
| Code | BSP |
| Trade Name | EchoGlo™ Peripheral Nerve Block Needle: Single Shot |
| EchoGlo™ Peripheral Nerve Block Needle: Continuous |
2. DEVICE INFORMATION
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | SONO Tap | |
| Tuohy Sono | EchoGlo™ Peripheral Nerve Block | |
| Needle: Single Shot | ||
| EchoGlo™ Peripheral Nerve Block | ||
| Needle: Continuous | ||
| Regulation No. | 21 CFR § 868.5150 | 21 CFR § 868.5150 |
| Regulation Name | Anesthesia conduction needle | Anesthesia conduction needle |
| Regulatory Class | II | II |
| Product Code | BSP | BSP |
| 510(k) | K113207 | K171968 |
3. DEVICE DESCRIPTION
The EchoGlo™ Peripheral Nerve Block (PNB) Needle consist of a polycarbonate luer hub, stainless steel cannula and a polyethylene sheath. The needle cannula will be supplied with a bevel tip or a Tuohy tip. The EchoGlo™ PNB Needle will be used for peripheral nerve block under ultrasound guidance. The distal end of the cannula has been engraved with two bands to increase ultrasound visibility by optimally reflecting ultrasound waves. These needles are provided as sterile, nonpyrogenic, single-use disposable devices. The needles may be used for single shot peripheral nerve block or for continuous infusion nerve block. The EchoGlo™ PNB Needle used for a single shot procedure will be supplied in a pouch along with a 24 inch extension set. The extension set will consist of polyvinyl chloride (PVC) tubing and have a Female luer at one end of the tubing and a Male luer at the opposite end of the tubing.
4
4. INDICATIONS FOR USE
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot
This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous
This device is intended for use in the administration of regional anesthetic blocks.
Intended population is adults.
5. SUBSTANTIAL EQUIVALENCE DISCUSSION
Indications for Use
The Echoglo indications for use is similar to the predicate devices include enhanced for ultrasound visibility, similar transient delivery and the option to facilitate placement of a catheter.
A. Both the subject and predicate devices are enhanced for ultrasound visibility. The EchoGlo™ needles are enhanced for ultrasound visibility via grooved echogenic feature. The EchoGlo™ needles also have visible bands which identify the needle length and needle insertion depth in 1cm increments after echogenic feature, visible to the eye without ultrasound imaging.
B. Both the subject and predicate devices offer similar transient use.
C. Both the subject and predicate devices offer the option to facilitate placement of a catheter. Testing demonstrating equivalency for placement.
Summary of Technology Characteristics
The Smiths Medical EchoGlo Peripheral Nerve Block Needles and predicate devices are both designed for enhanced ultrasound visibility, delivery of regional anesthesia, and to facilitate placement of a catheter. The Smiths Medical EchoGlo™ Peripheral Nerve Block Needles has similar technological characteristics as the predicate device. Both subject and predicate device incorporate 1cm incremented visible depth markings to monitor insertion depth through ultrasound imaging. The subject device and predicate devices are prescribe by physician only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user.
The difference between the predicate is the Smiths EchoGlo has echogenic visible bands with helical markers while the SonoTAP and Tuohy Sono include diamond shape markers. Additionally, the Echoglo offers a Bevel tip in 20G-22G, and a Tuohy tip in 18G.
| Table 5-1 | |||
|---|---|---|---|
| Characteristic | Predicate Device | ||
| K113207 | Subject Device | ||
| K171968 | Discussion | ||
| Company | Pajunk GMBH | Smiths Medical | NA |
| FDA Product Code | |||
| & CFE | BSP | ||
| 21 CFR 868.5150. | BSP | ||
| 21 CFR 868.5150. | Same | ||
| Trade Name | SONO Tap | ||
| Tuohy Sono | EchoGlo™ Peripheral | ||
| Nerve Block Needle: | NA | ||
| Characteristic | Predicate Device | ||
| K113207 | Subject Device | ||
| K171968 | Discussion | ||
| Single Shot | |||
| EchoGlo™ Peripheral | |||
| Nerve Block Needle: | |||
| Continuous | |||
| Product | Needle, Conduction, | ||
| Anesthetic (w/wo | |||
| introducer) | Single Shot and | ||
| Continuous Nerve Block | |||
| Needle | NA | ||
| Common / | |||
| Classification | |||
| Name | Anesthesia conduction | ||
| needle | Anesthesia conduction | ||
| needle | Same | ||
| Indications for Use | The cannulas/ needles | ||
| for anesthesia and | |||
| analgesia enhanced for | |||
| ultrasound visibility - | |||
| Tuohy Sono, Sono | |||
| TAP, Quincke Sono, | |||
| Chiba Sono, Sono and | |||
| Crawford Sono - are | |||
| intended for the | |||
| transient delivery of | |||
| anesthetics to provide | |||
| regional anesthesia | |||
| and analgesia or to | |||
| facilitate placement of | |||
| a catheter | The EchoGlo™ Peripheral | ||
| Nerve Block Needle: | |||
| Single Shot | |||
| This device is intended for | |||
| use in the administration | |||
| of regional anesthetic | |||
| blocks. | |||
| The EchoGlo™ Peripheral | |||
| Nerve Block Needle: | |||
| Continuous | |||
| This device is intended for | |||
| use in the administration | |||
| of regional anesthetic | |||
| blocks. | Similar. Both are | ||
| enhanced for | |||
| ultrasound | |||
| visibility. Also, | |||
| both are intended | |||
| for the delivery of | |||
| regional | |||
| anesthesia, or to | |||
| facilitate | |||
| placement of a | |||
| catheter. | |||
| Hospital Location | |||
| Use | ICU/OR | ICU/OR | Same |
| Visibility feature | Etched cannula/needle | ||
| to enhance ultrasound | |||
| visibility. The needle | |||
| cannula is equipped | |||
| with a specific | |||
| diamond shaped | |||
| reflector pattern that is | |||
| designed to reflect | |||
| ultrasound waves. | Etched cannula/needle to | ||
| enhance ultrasound | |||
| visibility. A special | |||
| helical-shaped groove | |||
| design is cut into the | |||
| needle cannula. The | |||
| grooves are designed to | |||
| optimally reflect | |||
| ultrasound waves to make | |||
| the needle more visible | |||
| under ultrasound. | Similar. Both are | ||
| etched needles that | |||
| are designed to | |||
| enhance visibility | |||
| under ultrasound. | |||
| Difference is the | |||
| etched pattern. | |||
| Proximal End | |||
| Connection | Luer, Per ISO 594-1, | ||
| and ISO 594-2 | Luer, Per ISO 594-1, and | ||
| ISO 594-2 | Same | ||
| Single Use | Yes | Yes | Same |
| Sterilization | |||
| Method | EtO | EtO | Same |
| Tip Design | Tuohy, Bevel | Tuohy, Bevel | Same |
| Needle Gauge | Tuohy SONO : 16G - | ||
| 26G | Bevel : 20G-22G | ||
| Tuohy: 18G | Similar. Subject | ||
| diameter is | |||
| Characteristic | Predicate Device | ||
| K113207 | Subject Device | ||
| K171968 | Discussion | ||
| Quincke SONO: 16G - | |||
| 26G | |||
| Sono TAP, Chiba | |||
| SONO: 16G - 26G | |||
| Crawford SONO: 16G |
- 26G | | between
predicate's gauge
range |
| Needle Length | Tuohy SONO: 20mm-
180mm
Sono TAP, Quincke
SONO: 20mm-180mm
Chiba SONO: 20mm-
180mm
Crawford SONO:
20mm-180mm | Single Shot: 35-150mm
Continuous: 50-150mm | Similar. Subject
length is within
predicate's length
range |
| Cannula Material | Stainless steel | Stainless steel | Same |
| Needle Hub
Material | Polycarbonate | Polycarbonate | Same |
| Sheath Material | Polyethylene | Polyethylene | Same |
| Extension Set
Tubing Material | Polyvinyl
chloride (PVC) | Polyvinyl
chloride (PVC) | Same |
| Extension Set Male
Luer Material | Polyacrylic | PVC | Similar |
| Extension Set
Female Luer
Material | PVC | PVC | Same |
A comparative analysis of the technological characteristics is provided in Table 5-1.
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smiths medical
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6. SUMMARY OF NON-CLINICAL TESTING
The Smiths Medical EchoGlo™ Peripheral Nerve Block Needle was evaluated via non-clinical performance testing to demonstrate the devices are substantially equivalent the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the EchoGlo™ Peripheral Nerve Block Needle performed as intended. A summary of the Non-Clinical performance testing is in Table 5-2. Biological and Bench testing was conducted to the Standards in Table 5-3.
| Category | Evaluation | Standards |
|---|---|---|
| Biocompatibility | Cytotoxicity | ISO 10993-7:2009: Biological |
| evaluation of medical devices— | ||
| Part 5: Tests for in vitro | ||
| cytotoxicity | ||
| Sensitization | ISO 10993-10:2010: Biological | |
| evaluation of medical devices— | ||
| Part 10: Tests for irritation and skin | ||
| sensitization | ||
| Acute systemic toxicity | ISO 10993-11:2006: Biological | |
| evaluation of medical devices— | ||
| Part 11: Tests for systemic toxicity | ||
| Material-Mediated Pyrogenicity | USPPyrogen Test | |
| Particulate Matter in Injections | USP:2012 Particulate Matter | |
| in Injections | ||
| Exaggerated Leachables | ISO 10993-17:2002: Biological | |
| evaluation of medical devices— | ||
| Part 17: Establishment of allowable | ||
| limits for leachable substances | ||
| Hemocompatibility | ISO 10993-4:2002/(R)2013 & | |
| A1:2006/(R)2013: Biological | ||
| evaluation of medical devices - Part | ||
| 4: Selection of tests for interaction | ||
| with blood | ||
| Packaging | Existing packaging material for currently | |
| marketed devices will be used for the | ||
| packaging of the EchoGlo™ Peripheral | ||
| Nerve Block Needle. Packaging integrity | ||
| test were performed to ensure packaging | ||
| meet specifications. For details reference | ||
| Section 14.3 | ASTM D4169:2016: Standard | |
| practice for performance testing of | ||
| shipping containers and systems. | ||
| ASTM F1886:2013: Determining | ||
| integrity of seals for flexible | ||
| packaging by visual inspection. | ||
| ASTM F2825:2015: Standard | ||
| practice of climatic stressing of | ||
| packaging systems for single parcel | ||
| delivery. | ||
| Category | Evaluation | Standards |
| test method for seal strength of | ||
| flexible barrier materials. | ||
| ASTM F2096:2011: Standard test | ||
| method for detecting gross leaks in | ||
| medical packaging by internal | ||
| pressurization. | ||
| ISO 11607-1:2006/(R):2010: | ||
| Packaging for terminally sterilized | ||
| medical devices Part 1: | ||
| Requirements for materials, sterile | ||
| barrier systems, and packaging | ||
| systems. | ||
| Device Performance | Gauging (T=0, T=6 months accelerated | |
| aging (AA)) | ||
| Leakage, Air (T=0, T=6 months AA) | ||
| Leakage, Liquid (T=0, T=6 months AA) | ||
| Ease of Assembly (T=0, T=6 months AA) | ||
| Separation Force (T=0, T=6 months AA) | ||
| Resistance to Overriding (T=0, T=6 months | ||
| AA) | ||
| Unscrewing Torque (T=0, T=6 months AA) | ||
| Stress Cracking (T=0, T=6 months AA) | ISO 594-1: Conical fittings with a | |
| 6% (luer) taper for syringes, | ||
| needles, and certain other medical | ||
| equipment - Part 1: General | ||
| Requirements | ||
| ISO 594-2 second ed. 1998-09-01: | ||
| Conical Fittings with a 6% taper | ||
| (luer) for syringes, needles, and | ||
| certain other medical equipment - | ||
| Part 2: Lock fittings | ||
| Needle Inspections | ||
| Bond - Needle and hub (T=0, T=6 months | ||
| AA) | ||
| Limits of Acidity/Alkalinity | ||
| Patency of Lumen | ||
| Limits for Extractable materials | ISO 7864 Fourth Edition: 2016-08- | |
| 01: Sterile hypodermic needles for | ||
| single use - Requirements and test | ||
| methods | ||
| Needle Inspections | ||
| Needle Stiffness | ||
| Resistance to Breakage | ||
| Resistance to Corrosion | ISO 9626 Second Edition 2016-08- | |
| 01: Stainless steel needle tubing for | ||
| the manufacture of medical devices |
- Requirements and test methods |
| | Bond Pull - Extension set (T=0, T=6
months AA)
Demonstration
Penetration Force
Ultrasound Visibility | N/A |
| Human Factors | Evaluate user interface | FDA guidance, Applying Human
Factors and Usability Engineering
to Medical Devices: Guidance for
Industry and Food and Drug
Administration Staff (3 February
-
|
Table 5-2 - Non-Clinical Performance Testing
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smiths medical
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| Recognition
| Number | Standard Number | Assessment |
|---|---|---|
| 14-452 | ISO 11135 2nd Edition 2014 | Sterilization Of Health-Care Products - |
| Ethylene Oxide - Requirements For The | ||
| Development, Validation And Routine | ||
| Recognition | ||
| Number | Standard Number | Assessment |
| 2-156 | ISO 10993-1:2009 R 2013 | Control Of A Sterilization Process For |
| Medical Devices. (Sterility) | ||
| 6-11 | ISO 594-1 | Biological Evaluation Of Medical |
| Devices - Part 1: Evaluation And Testing | ||
| Within A Risk Management Process | ||
| 6-129 | ISO 594-2 Second Ed. 1998-09-01 | Conical Fittings With A 6% (Luer) |
| Taper For Syringes, Needles And | ||
| Certain Other Medical Equipment - Part | ||
| 1: General Requirements | ||
| 14-457 | 11607-1:2006/(R)2010 | Conical Fittings With A 6% (Luer) |
| Taper For Syringes, Needles And | ||
| Certain Other Medical Equipment - Part | ||
| 2: Lock Fittings | ||
| 2-234 | ISO 10993-4:2002/(R)2013 & | |
| A1:2006/(R)2013 | Packaging For Terminally Sterilized | |
| Medical Devices - Part 1: Requirements | ||
| For Materials, Sterile Barrier Systems | ||
| And Packaging Systems [Including: | ||
| Amendment 1 (2014)] | ||
| 14-278 | 10993-7:2008(R)2012 | Biological evaluation of medical devices |
- Part 4: Selection of tests for interaction
with blood |
| 2-118 | AAMI ANSI ISO 10993-
11:2006/(R)2010 | Biological Evaluation Of Medical
Devices - Part 7: Ethylene Oxide
Sterilization Residuals |
| 14-227 | AAMI ANSI ISO 11737-1:2006
(R)2011 | Biological evaluation of medical devices
Part 11: Tests for systemic toxicity |
| 14-360 | ANSI/AAMI ST72:2011 | Sterilization Of Health Care Products -
Microbiological Methods - Part 1:
Determination Of The Population Of
Microorganisms On Product |
| 6-379 | ISO 7864 Fourth Edition 2016-08-01 | Bacterial Endotoxins - Test Methods,
Routine Monitoring, And Alternatives
To Batch Testing |
| 6-380 | ISO 9626 Second Edition 2016-08-01 | Sterile Hypodermic Needles For Single
Use - Requirements And Test Methods |
| 5-108 | ASTMD 4169-16 2014 | Stainless Steel Needle Tubing For The
Manufacture Of Medical Devices -
Requirements And Test Methods |
| N/A | USP | Standard Practice for Performance
Testing of Shipping Containers and
Systems |
| N/A | USP:2012 | Pyrogen Test |
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7. SUBSTANTIAL EQUIVALENCE CONCLUSION
The Smiths Medical EchoGlo™ Peripheral Nerve Block Needle is substantially equivalent to the
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Image /page/10/Picture/1 description: The image shows the logo for Smiths Medical. The logo consists of the words "smiths medical" in blue font. Below the logo is the tagline "bringing technology to life" in a smaller, lighter blue font.
predicate device based on comparisons of the device classifications, intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the subject devices for its intended uses. The results of biocompatibility testing and performance confirmed the substantial equivalence of the EchoGlo™ Peripheral Nerve Block Needle. The test results do not raise different safety or performance questions, and confirmed that the EchoGlo™ Peripheral Nerve Block Needle is substantially equivalent to the predicate devices.