(108 days)
The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices.
The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include:
- Gauge
- 20 Ga (Touhy only)
- 21 to 24 Ga
- Lengths
- 35 mm to 150 mm
- Point style
- Bevel tip
- Pencil point
- Touhy tip
- Cannula echogenicity
- The cannula is naturally echogenic but the addition of grooves on the cannula enhance the echogenicity
The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location.
Here's an analysis of the acceptance criteria and study information for the ARROW UltraQuik Peripheral Nerve Block Needle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength (Non-Inserted Regions) | > 15 N force to break | Injection Tubing to Needle Hub: mean 27 N |
| Injection Tubing to Luer Lock: mean 27 N | ||
| Tensile Strength (Needle Cannula to Hub joint) | > 40 N force to break | All have a mean > 99 N |
| Needle Sharpness (Penetration Force) | None (Pass/fail criteria not explicitly stated) | All have a mean > 3.17 N |
| Injection Leakage | No leak at 50 psi for 30 sec | No leakage observed |
| Resistance to Leakage (Aspiration/Vacuum) | No internal leakage at -25 mmHg for 120 sec | No leakage observed |
| Corrosion Resistance | No visible sign of corrosion | No observed corrosion |
| Needle Stiffness (Deflection) | < 0.5 mm deflection | All have a mean < 0.5 mm |
| Needle Markings | Permanent markings at 10 mm | Cannula are so marked |
| Component Capability (Usability Testing) | Usability testing favorable | Results were favorable |
| Imaging & Echogenic Properties | Deemed "easier to recognize" by clinicians (qualitative acceptance) | Comparative ultrasound images performed; clinical preference survey found echogenic design "easier to recognize." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for each test beyond "all" or generic descriptions. For the usability/clinical preference survey, the number of clinicians involved is not specified.
- Data Provenance: The study appears to be retrospective bench testing and a prospective (though informal) clinical preference survey. The geographic origin of the data (country) is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: For the Imaging and Echogenic property evaluation, a "clinical preference survey was done with clinicians." The specific number of clinicians is not stated.
- Qualifications of Experts: The term "clinicians" is used, implying medical professionals who use such devices. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: The document does not describe an adjudication method for the quantitative bench tests. For the clinical preference survey, it simply states "all found the echogenic design to be easier to recognize," suggesting a consensus or unanimous opinion among the surveyed clinicians, but no formal adjudication process (like 2+1 or 3+1) is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a medical instrument (needle) and involves bench testing and a clinical preference survey, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no mention of AI assistance or improvement in human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, a standalone performance test for an algorithm was not done. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- For the majority of the tests (tensile strength, sharpness, leakage, corrosion, stiffness, markings), the "ground truth" is defined by engineering specifications and measurable physical properties (e.g., force in Newtons, pressure in psi, deflection in mm).
- For "Component Capability (Usability Testing)" and "Imaging and Echogenic property evaluation," the ground truth involves subjective feedback and preference from clinicians based on their experience and visual assessment.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: This concept is not applicable here as this is a medical device approval that involved bench testing and a clinical preference survey, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: This is not applicable as there is no training set mentioned or implied for this device's approval process.
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510(k) Summary Page 1 of 6 29-Nov-12 . .
DEC 2 1 2012
Arrow International Inc. 2400 Bernville Road . Reading, PA 19605
Official Contact:
Paul Amudala Regulatory Affairs Specialist
Tel: 610-378-0131 Fax: 610-478-3179
Proprietary or Trade Name: ARROW UltraQuik Peripheral Nerve Block Needle
Common/Usual Name: Peripheral Nerve Block
Classification Name:
Product code - CAZ CFR 868-5140 - anesthetic conduction kit Class 2
Predicate Device:
A VID-NIT (Arrow) - StimuQuik™ PNB Needle - K014246
Device Description:
The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include:
- Gauge .
- 20 Ga (Touhy only) o
- 21 to 24 Ga 0
- . Lengths
- 35 mm to 150 mm 0
- Point style ●
- Bevel tip o
- Pencil point 0
- Touhy tip 0
- Cannula echogenicity
- The cannula is naturally echogenic but the addition of grooves on the cannula 0 enhance the echogenicity
The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location.
Basic Components for Peripheral Nerve Block needle
A typical basic Peripheral Nerve Block ("PNB") needle includes the following components.
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510(k) Summary Page 2 of 6 29-Nov-12
- Cannula with sharp tip .
- Hub
- . Fluid extension line with female luer connector
Indications for Use:
The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of singleshot peripheral nerve block anesthesia or analgesia using medical imaging devices.
Patient Population:
Patients requiring peripheral nerve block procedures.
Environment of Use:
The environment of use is - hospital, sub-acute facilities, pain clinics, physician offices
Contraindications:
Pre-existing nerve injury, neuritis or plexitis are relative contraindications for use of peripheral nerve blocks. These conditions should be considered prior to needle insertion. Skin sepsis in the area where the needle placement is planned and systemic sepsis are relative contraindications. Extreme care should be taken in patients with bleeding tendencies or patients receiving anticoagulants.
Comparison to Predicates
The UltraQuik PNB Needle for single shot non-stimulating nerve block procedures is viewed as substantially equivalent to the predicate device because:
Indications -
The intended uses are identical and the indications for use are identical except for the nonstimulating feature. Use of a non-stimulating PNB needle is common and not a new procedure. Equivalent to predicate - K014246 -- AVID-NIT StimuQuik PNB Needle.
Technology -
The components of the proposed UltraQuik PNB Needle are identical to the predicate K014246, A VID-NIT StimuQuik PNB Needle and there is no new technology or materials.
Materials -
The materials are identical to the predicate, K014246 - AVIV-NIT StimuQuik PNB Needle.
Environment of Use -
The proposed environments of use are identical to the predicate K014246 - AVID-NIT StimuQuik PNB Needle. They are - hospital, sub-acute facilities, pain clinics, and physician offices.
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510(k) Summary Page 3 of 6
29-Nov-12
Patient Population -
Patients requiring peripheral nerve block procedures. Identical to the predicate, K014246 -AVID-NIT StimuQuik PNB Needle.
Non-clinical Testing Summary -
The components of the proposed device are identical to the predicate K014246, except the addition of echogenic grooves. We have performed bench testing after 5 year accelerated shelflife. This testing included:
- Tensile strength for regions of the needle not intended for insertion into the body ●
- . Injection tubing to needle hub
- Injection tubing to Luer Lock connector
- Tensile strength for the needle cannula to needle hub .
- . Needle sharpness
- Injection tubing leakage
- Resistance to leakage during aspiration or vacuum .
- Corrosion resistance of metallic components .
- Needle Stiffness
- Luer Lock connector .
Summary of Test Results
| Description | Results |
|---|---|
| Tensile StrengthFor regions notInserted in body | Pass / fail criteria force to break is > 15 NInjection Tubing to needle hub - mean 27 NInjection Tubing to Luer Lock - mean 27 N |
| Tensile StrengthNeedle cannula toHub joint | Pass / fail criteria force to break > 40 NAll have a mean > 99 N |
| Needle Sharpness | Pass / fail criteria - nonePenetration force - all have a mean >3.17 N |
| Injection leakage | Pass / fail criteria - no leak at 50 psi for 30 secNo leakage observed |
| Resistance toleakage | Pass / fail criteria - no internal leakage at - 25 mmHg for 120 secNo leakage observed |
| CorrosionResistance | Pass / fail - no visible sign of corrosionNo observed corrosion |
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510(k) Summary Page 4 of 6 29-Nov-12
| Needle Stiffness | Pass / fail criteria - deflection < 0.5 mm ·Deflection - all have a mean < 0.5 mm |
|---|---|
| Needle Markings | Pass / fail - permanent markings at 10 mmCannula are so marked |
| ComponentCapability | Pass / fail - usability testingResults were favorable |
Imaging and Echogenic property evaluation:
Comparative ultrasound imagines were performed on the proposed design vs. the predicate. In addition a clinical preference survey was done with clinicians and all found the echogenic design to be easier to recognize.
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510(k) Summary
Predicate Comparative Table
.
| Features | ProposedUltraQuik PNB Needle | PredicatesK014246 – AVID-NIT – StimuQuik PNB Needle |
|---|---|---|
| Classification name | Anesthetic Conduction Kit | Anesthetic Conduction Kit |
| Product Code | CAZ868.5140 | CAZ868.5140 |
| Intended Use | Single Shot nerve block anesthetic administration | Single Shot nerve block anesthetic administration |
| Indications for use | The Arrow UltraQuik® Peripheral Nerve Block Needle isindicated for the delivery of single-shot peripheral nerve blockanesthesia or analgesia using medical imaging devices. | The AVID-NIT Nerve Stimulation Needles consist of aninsulated hollow needles intended for locating peripheralnerves by electrical stimulation, and for the single shotadministration of a local anesthetic drug. These needles areto be used with battery powered peripheral nerve locatorsonly. These needles' are specifically not intended for nervestimulation for purposes other than nerve location. Theseneedles are specifically not intended for neurolyticablation. |
| Environment of Use | Hospital, sub-acute facilities, pain clinics, physician offices | Hospital, sub-acute facilities, pain clinics, physician offices |
| Patient Population | Patients requiring peripheral nerve block procedures | Patients requiring peripheral nerve block procedures |
| Contraindications | Pre-existing nerve injury, neuritis or plexitis are relativecontraindications for use of peripheral nerve blocks. Theseconditions should be considered prior to needle insertion.Skin sepsis in the area where the needle placement isplanned and systemic sepsis are relative contraindications.Extreme care should be taken in patients with bleedingtendencies or patients receiving anticoagulants. | Pre-existing nerve injury, neuritis or plexitis are relativecontraindications for use of peripheral nerve blocks. Theseconditions should be considered prior to needle insertion.Skin sepsis in the area where the needle placement isplanned and systemic sepsis are relative contraindications.Extreme care should be taken in patients with bleedingtendencies or patients receiving anticoagulants. |
| Basic components | Non-insulated cannula with hubFluid extension tube with luer lock fitting | Insulated cannula with insulated coating and hubFluid extension tube with luer lock fittingLead wire for connection to a nerve stimulator |
| Features | ProposedUltraQuik PNB NeedleComponent Design and Specifications | PredicatesK014246 - AVID-NIT - StimuQuik PNB Needle |
| Cannula | ||
| Gauges / dimensions | 20 Ga for Touhy21 - 24 Ga | 21 - 24 Ga |
| Cannula length | 35 - 150 mm | 35 - 150 mm |
| Tip styles | BeveledPencil pointTouhy | BeveledPencil point |
| Cannula | SmoothGrooved | Smooth |
| Cannula insulated | No, not required | Yes |
| Cannula markings | Yes | Yes |
| Fluid Extension Tube | with female luer lock fitting | with female luer lock fitting |
| Lead wire | No, this is not a feature of the proposed device | Yes for connection to nerve stimulator |
| Echogenic Properties | Yes | Yes |
| Provided Sterile | Yes | Yes |
| Shelf-life | 5 years | 5 years |
Page 5 Page 5
K122690 Page 14 of 39
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510(k) Summary
Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predical
have been found to substantially
.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2012
Mr. Paul Amudala Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road READING PA 19605
Re: K122690
Trade/Device Name: UltraQuik Peripheral Nerve Block Needle Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: November 29, 2012 Received: December 3, 2012
Dear Mr. Amudala: · ·
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.
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Page 2 - Mr. Amudala
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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthong La m
Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement
Page 1 of 1
510(k) Number:
. K122690
Device Name:
UltraQuik Peripheral Nerve Block Needle
Indications for Use:
The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2012.12.20 1,2:32:25 -05'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: K122690
K122690 Page 9 of 39
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).