(108 days)
Not Found
No
The device description and performance studies focus on the physical characteristics of the needle and its echogenicity for use with ultrasound, with no mention of AI or ML for image processing or other functions.
No
The device is a needle indicated for the delivery of anesthesia or analgesia, which are therapeutic agents, but the needle itself is an accessory for delivery and not a therapeutic device.
No
This device is a needle used for delivering anesthesia for peripheral nerve blocks. Although it can be used with imaging devices to assist in placement, its primary function is therapeutic (delivery of a substance), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines physical components (cannula, hub, fluid extension tube) and mentions bench testing related to these physical properties (tensile strength, sharpness, leakage, stiffness, corrosion resistance). It is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Arrow UltraQuik Peripheral Nerve Block Needle is a device used within the body to deliver anesthesia or analgesia for peripheral nerve blocks. It is a surgical/procedural tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for "delivery of single-shot peripheral nerve block anesthesia or analgesia." This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description details the physical components of a needle used for injection, not a system for analyzing biological samples.
- Imaging Modality: While it uses ultrasound for guidance, the ultrasound is used to visualize the needle's position in vivo, not to analyze a biological sample.
Therefore, the Arrow UltraQuik Peripheral Nerve Block Needle falls under the category of a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
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.
- Cannula with sharp tip .
- Hub
- . Fluid extension line with female luer connector
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
medical imaging devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, sub-acute facilities, pain clinics, physician offices
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)
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 shelf-life. 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 Strength For regions not Inserted in body | Pass / fail criteria force to break is > 15 N Injection Tubing to needle hub - mean 27 N Injection Tubing to Luer Lock - mean 27 N |
| Tensile Strength Needle cannula to Hub joint | Pass / fail criteria force to break > 40 N All have a mean > 99 N |
| Needle Sharpness | Pass / fail criteria - none Penetration force - all have a mean >3.17 N |
| Injection leakage | Pass / fail criteria - no leak at 50 psi for 30 sec No leakage observed |
| Resistance to leakage | Pass / fail criteria - no internal leakage at - 25 mmHg for 120 sec No leakage observed |
| Corrosion Resistance | Pass / fail - no visible sign of corrosion No observed corrosion |
| Needle Stiffness | Pass / fail criteria - deflection |
§ 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).
0
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.
1
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.
2
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 Strength | |
| For regions not | |
| Inserted in body | Pass / fail criteria force to break is > 15 N |
| Injection Tubing to needle hub - mean 27 N | |
| Injection Tubing to Luer Lock - mean 27 N | |
| Tensile Strength | |
| Needle cannula to | |
| Hub joint | Pass / fail criteria force to break > 40 N |
| All have a mean > 99 N | |
| Needle Sharpness | Pass / fail criteria - none |
| Penetration force - all have a mean >3.17 N | |
| Injection leakage | Pass / fail criteria - no leak at 50 psi for 30 sec |
| No leakage observed | |
| Resistance to | |
| leakage | Pass / fail criteria - no internal leakage at - 25 mmHg for 120 sec |
| No leakage observed | |
| Corrosion | |
| Resistance | Pass / fail - no visible sign of corrosion |
| No observed corrosion |
3
510(k) Summary Page 4 of 6 29-Nov-12
| Needle Stiffness | Pass / fail criteria - deflection