(187 days)
No
The device description and performance studies focus on the physical characteristics and electrical stimulation capabilities of the needle, with no mention of AI or ML.
No.
The primary purpose of this device is to locate nerves and facilitate the delivery of regional anesthesia, not to directly treat a disease or condition. While it aids in a medical procedure that can lead to pain relief (a therapeutic outcome), the needle itself is a diagnostic/locating tool for aiding in the administration of therapeutic agents.
No
This device is used to locate nerves and facilitate the delivery of regional anesthesia, not to diagnose a condition. Its primary function is therapeutic/interventional in nature (to assist in performing a nerve block), even though it uses stimulation and location.
No
The device is a physical needle with an insulated coating and electrical components, clearly indicating it is a hardware device, not software-only.
Based on the provided information, 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, or tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The Arrow StimuQuik and StimuQuik ECHO needles are used directly on the patient's body to locate nerves and deliver anesthesia. They are invasive devices used for a medical procedure, not for analyzing samples in a lab.
- Intended Use: The intended use clearly states "permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques." This is a procedural use, not a diagnostic test performed on a sample.
- Device Description: The description details a needle designed for insertion into the body, not for handling or analyzing biological specimens.
Therefore, the Arrow StimuQuik and StimuQuik ECHO needles fall under the category of medical devices used for procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Arrow StimuOuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
The StimuQuik peripheral nerve block needle is used to locate nerves or nerve plexuses and facilitate delivery of regional anesthesia to the desired location. The needles are constructed of a steel needle and insulated by a white, non-conductive siliconized polyester coating. A small area at the distal tip remains exposed to conduct the stimulating current to nerve tissue. The tip features a 30-degree bevel. and black centimeter markings are printed along the shaft of the needle. An electrical wire with a shrouded 2 mm female connector and an extension line with a Luer lock extend from the ergonomic plastic hub of the needle.
The StimuQuik ECHO peripheral nerve block needle is identical to the StimuQuik needle with the addition of 5 echogenic grooves on the needle tip. The five grooves are designed to help clinicians locate the tip of the StimuQuik ECHO needle under ultrasound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
nerves and nerve plexuses
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospitals, sub-acute facilities, pain clinics, and physician office
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 performance testing has been conducted to support that the proposed device performs as intended and conforms to user needs.
- Needle Markings: Visually inspect the needle markings. Results: Pass (Needles are permanently marked with black graduation at 10mm intervals starting from the tip. Visible markings are printed on the cannula per drawing.)
- Ink Adherence: Validate the adherence of ink to the needle. Results: Pass (Samples with initial rating of 4 or 5 have an adherence score after SCOTCH 610 tape test of 3 or greater. Samples with initial rating of 3 have an adherence rating score after SCOTCH 610 tape test of 3.)
- Continuity: Validate the continuity of electrical resistance. Results: Pass (Electrical resistance of all measured samples is
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 25, 2018
Teleflex Medical Kristen Bisanz Sr. Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560
Re: K173321
Trade/Device Name: StimuOuik Peripheral Nerve Block Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: March 20, 2018 Received: March 22, 2018
Dear Kristen Bisanz:
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 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);
1
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 mediation-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,
Geeta K. Pamidimukkala -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K173321 |
|---|---|
| -------------------------- | --------- |
Device Name
StimuQuik Peripheral Nerve Block Needle
Indications for Use (Describe)
The Arrow StimuQuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexus for single-shot nerve block anesthesia or analgesia techniques.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Sexvices (301) 443-6740
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510(k) SUMMARY StimuQuik® Peripheral Nerve Block Needle
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919.433.4932 Fax: 919.433.4996
Contact Person
Kristen Bisanz Senior Regulatory Affairs Specialist
Date Prepared
10 April 2018
Device Name
| Trade Name: | StimuQuik Peripheral Nerve Block Needle |
|---|---|
| Classification Name: | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Product Code: | BSP |
| Regulation Number: | 868.5150 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
Predicate Device
This submission demonstrates substantial equivalence to the predicate devices A VID-NIT Nerve Stimulation Needles (StimuQuik) cleared in submission K014246.
Device Description
The StimuQuik peripheral nerve block needle is used to locate nerves or nerve plexuses and facilitate delivery of regional anesthesia to the desired location. The needles are constructed of a steel needle and insulated by a white, non-conductive siliconized polyester coating. A small area at the distal tip remains exposed to conduct the stimulating current to nerve tissue. The tip features a 30-degree bevel. and black centimeter markings are printed along the shaft of the needle. An electrical wire with a shrouded 2 mm female connector and an extension line with a Luer lock extend from the ergonomic plastic hub of the needle.
The StimuQuik ECHO peripheral nerve block needle is identical to the StimuQuik needle with the addition of 5 echogenic grooves on the needle tip. The five grooves are designed to help clinicians locate the tip of the StimuQuik ECHO needle under ultrasound.
The StimuQuik Peripheral Nerve Block Needle product numbers and descriptions are below.
4
| Product Numbers | Product Description |
|---|---|
| AB-21090-SS | StimuQuik® 21G x 9cm (3.5") Peripheral Nerve Block |
| AB-21090-SSE | StimuQuik® Echo 21G x 9cm (3.5") Peripheral Nerve Block |
| AB-21150-SS | StimuQuik® 21G x 15cm (6") Peripheral Nerve Block |
| AB-21150-SSE | StimuQuik® Echo 21G x 15cm (6") Peripheral Nerve Block |
| AB-22025-SS | StimuQuik® 22G x 2.5cm (1") Peripheral Nerve Block |
| AB-22025-SSE | StimuQuik® Echo 22G x 2.5cm (1") Peripheral Nerve Block |
| AB-22050-SS | StimuQuik® 22G x 5cm (2") Peripheral Nerve Block Needle |
| AB-22050-SSE | StimuQuik® Echo 22G x 5cm (2") Peripheral Nerve Block |
Principle of Action and mechanism of action of the subject device
The StimuQuik Peripheral Nerve Block Needles include a cannula, hub, and fluid extension line with a female luer connector. The needles are used to deliver singleshot anesthesia in peripheral nerve block procedures. An insulated needle with stimulating tip allows for confirmation of needle guidance and placement using stimulation (StimuQuik) and/or ultrasound (StimuQuik Echo). As the needle is advancing in the patient, stimulations are delivered via a nerve stimulator until appropriate muscle twitches occur which demonstrates correct placement. The StimuQuik Echo needles contain 5 rings at the distal end of the needle cannula to help with identification under ultrasound.
Indications for Use
The Arrow StimuOuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.
Patient Population
The StimuQuik Peripheral Nerve Block Needles are intended for adult patients requiring peripheral nerve block procedures.
Environments of use
The environments of use are hospitals, sub-acute facilities, pain clinics, and 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.
Substantial Equivalence
The proposed device is substantially equivalent to the predicate listed below.
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| Predicate Device | 510(k) Number | Date Cleared |
|---|---|---|
| AVID-NIT Nerve Stimulation | ||
| Needles (StimuQuik) | K014246 | July 16, 2002 |
Comparison to Predicate Device
The proposed device has the same operating principles, patient population, sterilization and general design as the predicate device. Biocompatibility testing (Section 020) and Performance testing (Section 023) have been performed on the proposed device to establish substantial equivalence to the predicate device. The proposed changes discussed above do not raise different questions of safety or effectiveness of the StimuQuik Peripheral Nerve Block Needle. The subject device is therefore substantially equivalent to the predicate device identified within this submission.
| | Predicate
K014246 StimuQuik Peripheral
Nerve Block Needle | Proposed StimuQuik®
Peripheral Nerve Block Needle | Equivalence |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Classification
Name | Anesthesia Conduction Kit | Needle, Conduction, Anesthetic,
W/Wo Introducer | Equivalent |
| Product Code | 73CAZ | 73BSP | Equivalent |
| Classification | Class II | Class II | Identical |
| Regulation
Number | 868.5140 | 868.5150 | Equivalent |
| Intended Use | Single Shot nerve block anesthetic
administration | Single Shot nerve block anesthetic
administration | Identical |
| Indications
for Use | The AVID-NIT Nerve Stimulation
Needle consist of an insulated
hollow needle intended for locating
peripheral nerves by electrical
stimulation, and for the single shot
administration of a local anesthetic
drug. These needles are to be used
with battery powered peripheral
nerve locators only. These needles
are specifically not intended for
nerve stimulation for purposes other
than nerve location. These needles
are specifically not intended for
neurolytic ablation. | The Arrow StimuQuik Insulated
Peripheral Nerve Block Needle
permits the stimulation and location
of nerves and nerve plexuses for
single-shot nerve block anesthesia
or analgesia techniques. | Equivalent |
| Environment
of Use | Hospitals, Sub-acute facilities,
pain clinics, and physician office | Hospitals, Sub-acute facilities,
pain clinics, and physician office | Identical |
| Patient
Population | Patients requiring peripheral
nerve block procedures | Patients requiring peripheral
nerve block procedures | Identical |
| Contra-
indications | 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. | 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. | Identical |
| Biocompat-
ibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
| Basic
Components | Insulated cannula with insulated
coating and hub, fluid extension
tube with luer lock fitting, lead
wire for connection to a nerve
stimulator | Insulated cannula with insulated
coating and hub, fluid extension
tube with luer lock fitting, lead
wire for connection to a nerve
stimulator | Equivalent |
| Gauges/
Dimension | 21-24 Ga | 21 Ga | Identical |
| Cannula
Length | 35-150mm | 35-150mm | Identical |
| Tip Styles | Beveled
Pencil Point | Beveled
Pencil Point | Identical |
| Cannula | Smooth | Smooth | Identical |
| Cannula
Insulated | Yes | Yes | Identical |
| Cannula
Markings | Yes | Yes | Identical |
| Fluid
Extension
tube | Yes, with female luer lock fitting | Yes, with female luer lock fitting | Identical |
| Lead Wire | Yes, for connection to nerve
stimulator | Yes, for connection to nerve
stimulator | Identical |
| Echogenic
Properties | Yes | Yes | Identical |
| Sterilization | Sterile | Sterile | Identical |
| Prescription | Yes | Yes | Identical |
| Shelf Life | 5 years | 2 years | Equivalent |
6
7
Discussion
Classification Name/Product Code/Regulation Number: The product code of the predicate device is CAZ (anesthesia conduction kit/868.5150) The design and intended use of the predicate and proposed devices is identical. The product code BSP (anesthesia conduction needle/868.5140) was chosen for the proposed device in this submission because it more accurately reflects the intended use of the StimuQuik Peripheral Nerve Block Needle. While product code CAZ can encompass several components in a kit, product code BSP is specific for a device used in the same manner as the StimuQuik Peripheral Nerve Block Needle.
Indication for Use: The Indications for Use of the proposed device are identical to the Indications for Use cleared in K122690 for the UltraQuik Peripheral Nerve Block Needle. The UltraQuik Peripheral Nerve Block Needle in K122690 was deemed substantially equivalent to K014246, the predicate for this submission. The UltraQuik and StimuQuik needles differ only in the presence and absence of the insulating material on the needle. This does not raise any additional questions of safety and effectiveness. Therefore, the Indications for Use of the predicate and proposed devices are equivalent.
Basic Components: The proposed StimuOuik Peripheral Nerve Block Needle contains a different insulator material on the needle as compared to the predicate. Comprehensive functional testing has been successfully completed on the StimuQuik Peripheral Nerve Block Needle. The functional testing proves the proposed device meets the standard requirements and also performs as well as the predicate devices. The testing included: needle markings, ink adherence, continuity, needle current density, current leakage, resistance to leakage, tensile strength, kink resistance, and echogenicity. As demonstrated by the functional testing, the change in insulator material on the needle has no impact on the function or performance of the StimuOuik Peripheral Nerve Block Needle. Biocompatibility testing has been performed on the final finished proposed device. The following testing has been done: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, and Hemolysis. The materials tested all met the ISO 10993 requirements. As demonstrated by the biocompatibility testing, the change in insulator material on the needle has no impact on the performance or intended use of the StimuQuik Peripheral Nerve Block Needle.
8
Materials
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - | ||
| L929 MEM Elution | ||
| Assay | The test article will meet the requirements of the | |
| test if it obtains a Grade of 0,1, or 2 (not more | ||
| than 50% of the cells are round, devoid of | ||
| intracytoplasmic granules, and no extensive cell | ||
| lysis) | Acceptable | |
| Sensitization - | ||
| Kligman | ||
| Maximization Assay | The test article will be considered a non-irritant | |
| if the difference between the test article mean | ||
| score and the vehicle control mean score is 1.0 or | ||
| less. | Acceptable | |
| Irritation - | ||
| Intracutaneous | ||
| Injection Assay | The test article will meet the requirements of the | |
| test if it receives a Grade of 1, 0 or less using the | ||
| Kligman scoring system. | Acceptable | |
| Acute Systemic | ||
| Toxicity - | ||
| Systemic Injection | The test article will meet the requirements of the | |
| test if none of the animals injected with the test | ||
| article show a significantly greater biological | ||
| reaction than the animals treated with the control | ||
| article. | Acceptable | |
| Pyrogenicity - | ||
| Material Mediated | ||
| Rabbit Pyrogenicity | The test article will meet the requirements of the | |
| test if no rabbit shows an individual rise in | ||
| temperature of 0.5℃ or more above the baseline | ||
| temperature. | Acceptable | |
| Hemolysis – | ||
| Rabbit Blood | ||
| Hemolysis Complete | The test article will meet the requirements of the | |
| test and is not considered to have hemolytic | ||
| activity potential, if the hemolytic index above | ||
| the negative control article and negative control | ||
| article extract is Completed |
10
Conclusion
Based on the performance and comparative test results, the proposed StimuQuik Peripheral Nerve Block Needle is substantially equivalent to the predicate devices cleared to market in K014246. The modifications of the new insulator material do not introduce any different questions of safety and effectiveness.