Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical and electrical properties of the catheter and does not mention any AI/ML components or functions.

Therapeutic

Yes.
The device is used for continuous nerve block anesthesia or analgesia techniques, which are therapeutic interventions aimed at pain management.

Diagnostic

No.
The device is a continuous nerve block catheter used for administering anesthesia or analgesia, not for diagnosing conditions. Its primary function is therapeutic/delivery, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as a stainless steel spring coil, polyurethane outer jacket, ribbon wire, plastic jacket, conductive resin tip, and a stylet. The performance studies also include tests related to the physical properties and interactions of these hardware components.

IVD (In Vitro Diagnostic)

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. This testing is done outside the body (in vitro).
Device Function: The Arrow UltraCath Continuous Nerve block Catheter is a device that is inserted into the body to deliver medication (anesthetics) for pain management. It is used in vivo (within the living body).
Intended Use: The intended use clearly states it's for "continuous nerve block anesthesia or analgesia techniques," which involves direct administration of substances into the body.
Device Description: The description details the physical components of a catheter designed for insertion and delivery of fluids.
Anatomical Site: The anatomical site is "Nerves and nerve plexuses," indicating direct interaction with the body's internal structures.

The device's function and intended use are entirely focused on delivering therapy within the body, not on analyzing samples taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Arrow UltraCath Continuous Nerve block Catheter is placed next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Product codes

BSO, CAZ

Device Description

Stimulating continuous nerve block catheters consist of a stainless steel spring coil encased in a polyurethane outer jacket. The inner spring coil contributes a kink-resistance nature to the catheter when bent through small radii, and in stimulating catheters provides electrical conductivity. A ribbon wire is welded to both the proximal and distal ends of the inside of the coil to prevent stretching. The coils of the main catheter body are tightly wound axially (small pitch), with zero space between adjacent coils. The catheter tip is visible under ultrasound.

The plastic jacket of the Conductive Resin Tip UltraCath Continuous Nerve Block Catheter is made of transparent resin and the catheter tip is made of black electrically conductive resin that covers the internal stainless steel spring coil and seals the system against undesired fluid or air ingress or egress. Anesthetics are distributed into the patient body through a single end hole located at the catheter distal end. The catheter distal tip is made of electrically conductive resin which provides an electrical contact point. The distal end of the catheter is printed with centimeter markings to aid in depth determination during catheter insertion. There is also printed distance indicator at proximal end in order to indicate proper catheter insertion inside the adaptor. A stylet placed inside the catheter's spring coil provides stiffness during the insertion procedure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

next to nerve plexuses, next to nerves and nerve plexuses

Indicated Patient Age Range

Adult Patients that require administration of local anesthetics

Intended User / Care Setting

Not Found

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)

Table 2 provides a summary of performance testing conducted, including:

Catheter Aspiration Test: Tests ability to aspirate fluid without signs of collapse by drawing water via syringe.
Body Column Strength Test: Tests ability of pushing catheter through the needle into the desired location.
Bolus Flow Rate Test: Tests the flow capability through the catheter when tested using de-ioneized water.
Catheter Removal Force from Needle Test: Tests the ability to insert and withdraw catheter through the needle tip without damage and force to remove catheter shall not exceed 3 Newtons.
Electrical Leakage Current: To test that the leakage current does not exceed 0.10 mA when a voltage of 110V AC at 50 Hz is applied for one minute.
Catheter Length: To measure the length of the catheter.
Catheter OD: To measure the outside diameter of the catheter.
Catheter-to-Snaplock Adapter Liquid Leak Test: Tests that no leakage from the catheter and between the catheter and detachable Luer fitting shall occur in the form of a drop of water in 30 seconds when tested under pressure.
Catheter-to-Snaplock Static Pull Test: Tests that the detachable Luer fitting does not become detached from the catheter.
Continuous Flow Rate Test: Tests the flow of de-ionized water through the catheter when tested less than 10 psi.
Corrosion Resistance: Tests metallic components for their resistance to corrosion.
Distance Markings/Ink Adhesion – Distal Ends: Tests to confirm ink adhesion and distance markings at the distal ends of the catheter and visible from all aspects.
Distance Markings/Ink Adhesion - Proximal Ends: Tests to confirm ink adhesion and distance markings at the proximal ends of the catheter and visible from all aspects.
Electrical Continuity Test: Tests the electrical continuity of the catheter from the electrical connector to the most distal tip of the catheter and measures the electrical resistance.
Flash Back Window Test – Length, Position, Transparency: Measures the length, position and transparency of the Flash Back Windows.
Kink Resistance Test: Tests the ability for flow through the catheter when looped around a 1.58 mm diameter pin.
Needle Stimulation by Catheter Test: Tests catheter's ability to stimulate the needle when being inserted inside the needle cannula.
Catheter Surface Inspection: Evaluates the condition of the surface of the catheter.
Catheter Tensile Strength Test: Tests the catheter tensile force at both the catheter tip and the main catheter body.
Tip Column Strength Test: Tests column strength of the catheter tip.
Catheter Tip Heat Emission Test: Tests the heat generated at the tip of the catheter when a current of 5mA is being delivered from simulator working on 100 volts or less.
Catheter Resistance to Leakage During Aspiration: Tests leakage at catheter joints (measured as pressure decay) when an internal pressure is applied at 25mmHg for 120 seconds.
L929 MEM Elution Test: Tests the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract.
Kligman Maximization Test: Evaluates the allergic potential or sensitizing capacity of the test article.
Intracutaneous Injection Test: Determines the potential irritation effects of the test article extra as a result of an intracutaneous injection in New Zealand white rabbits.
Systemic Injection Test: Determines the potential toxic effects of the test article extract as a result of a single-dose systemic injection in mice.
Material Mediated Rabbit Pyrogen: Determines the presence of chemical pyrogens in extracts of solid materials in order to limit to an acceptable level the risk of febrile reaction following administration of the product to the patient.
Abridged 28 Day Sub-acute Systemic Toxicity by Implant Test: Determines the toxicity potential of the test material administered by subcutaneous implantation in rates for 28 days.
Salmonella typhimurium and Escherichia coli Reverse Mutation Assay Test: Determines the potential mutagenicity of the test article or its extract on various strains of Salmonella typhimurium and Escherichia coli bacteria, via a change in their dependence for exogenous histidine or tryptophan.
Mouse Lymphoma Forward Mutation Assay: Determines the potential mutagenicity effect on mouse lymphoma cells (heterozygous thymidine kinase mutant TK+/- L5178Y) in response to the test article extract.
Mouse Blood Micronucleus Test: Determines the potential clastogenic effects of the test article extract on maturing erythrocytes in mice, via the detection of micronuclei in the circulating reticulocytes.
4 week Implantation Test: Evaluates the test article for local tissue responses and the potential to induce local toxic effects after implantation in the muscle tissue of albino rats.
Hemolysis - Rabbit Blood - Complete Method Test: Determines the potential hemolytic activity, via the induction of increased levels of free plasma hemoglobin in rabbit blood, in response to the test article and its extract.
Extractable and Leachable Study: Determines the extractable amount of chemical compounds present in and on the device.
Ethylene Oxide Residual Test: Determines the residual Ethylene Oxide on the device.
LAL Bacterial Endotoxin: Documents the bacterial endotoxin levels on the device.
Packaging Visual Test: Demonstrates no breach of package or seal.
Packaging Peel Strength: Demonstrates a peel strength greater than or equal to 0.57 lb/in.
Packaging Bubble Leak Test: Demonstrates no steady stream of bubbles emanating from the package seal area or other areas of the package.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030937

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).

Summary

0

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

Teleflex Medical, Inc. Kristen Bisanz Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K162522

Trade/Device Name: UltraCath Continuous Nerve Block Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO, CAZ Dated: January 10, 2017 Received: January 30, 2017

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.

1

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

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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) K162522

Device Name

UltraCath Continuous Nerve Block Catheter

Indications for Use (Describe)

The Arrow UltraCath Continuous Nerve block Catheter is placed next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

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)

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510(k) SUMMARY

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-433-2703 Fax: 919-433-4989

B. Contact Person

Kristen Bisanz Regulatory Affairs Specialist

C. Date Prepared

September 7, 2016

D. Device Name

Trade Name:	UltraCath Continuous Nerve Block Catheter
Classification Name:	Anesthesia Conduction Catheter
Product Code:	BSO and CAZ
Regulation Number:	868.5120
Classification:	II
Classification Panel:	Anesthesiology

E. Predicate Device

This submission demonstrates substantial equivalence to the catheter component of the predicate device, StimuCath Continuous Nerve block Set - K030937.

F. Device Description

Stimulating continuous nerve block catheters consist of a stainless steel spring coil encased in a polyurethane outer jacket. The inner spring coil contributes a kink-resistance nature to the catheter when bent through small radii, and in stimulating catheters provides electrical conductivity. A ribbon wire is welded to both the proximal and distal ends of the inside of the coil to prevent stretching. The coils of the main catheter body are tightly wound axially (small pitch), with zero space between adjacent coils. The catheter tip is visible under ultrasound.

4

The plastic jacket of the Conductive Resin Tip UltraCath Continuous Nerve Block Catheter is made of transparent resin and the catheter tip is made of black electrically conductive resin that covers the internal stainless steel spring coil and seals the system against undesired fluid or air ingress or egress. Anesthetics are distributed into the patient body through a single end hole located at the catheter distal end. The catheter distal tip is made of electrically conductive resin which provides an electrical contact point. The distal end of the catheter is printed with centimeter markings to aid in depth determination during catheter insertion. There is also printed distance indicator at proximal end in order to indicate proper catheter insertion inside the adaptor. A stylet placed inside the catheter's spring coil provides stiffness during the insertion procedure .

G. Indications for Use

The Arrow UltraCath Continuous Nerve block Catheter is placed next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

H. Technological Characteristics Comparison to the predicate

The proposed UltraCath Continuous Nerve Block Catheter is substantially equivalent to the predicate device with respect to indications for use, technology and construction. The differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. Table 1 provides a summary of the differences and similarities between the proposed and predicate devices.

| Comparative

Characteristic	Predicate Device:	Proposed Device:
	StimuCath® Continuous Nerve Block Set	UltraCath Continuous Nerve
Block Catheter
	K030937
Classification Name	Anesthesia Conduction Kit	Anesthesia Conduction Catheter
Product Code / CFR	CAZ, 868.5140	BSO, 868.5120
Intended Use/
Indications for Use	The Arrow StimuCath Continuous Nerve
block Set permits placement of catheters
next to nerves and nerve plexuses for
continuous nerve block anesthesia or
analgesia techniques for periods not
exceeding 72 hours.	The Arrow UltraCath
Continuous Nerve Block
Catheter is placed next to nerves
and nerve plexuses for
continuous nerve block
anesthesia or analgesia
techniques for periods not
exceeding 72 hours
Comparative
Characteristic	Predicate Device:
StimuCath® Continuous Nerve Block Set
K030937	Proposed Device:
UltraCath Continuous Nerve
Block Catheter
Patient Population	Adult Patients that require administration of
local anesthetics	Same
Catheter Design	Stimulating	Same
Catheter Gauge Size	19 Ga. And 20 Ga.	19 Ga.
Catheter Lengths	30cm, 60cm, 90cm	60cm
Catheter Outer Jacket	19 Ga., White 95A Tecothane, polyurethane

Table 1 - Differences/Similarities between the Proposed and Predicate Devices

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I. Performance Data

A brief summary of tests conducted to demonstrate substantial equivalence to the predicate can be found in Table 2 below.

Table 2 – Performance Testing Summary

| Test | Reference to Standard
(if applicable) | Principle of Test |
|-------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Catheter
Aspiration Test | Internal Requirement | Tests ability to aspirate fluid without signs of
collapse by drawing water via syringe |
| Body Column
Strength Test | Internal Requirement | Tests ability of pushing catheter through the
needle into the desired location |
| Bolus Flow Rate
Test | Internal Requirement | Tests the flow capability through the catheter
when tested using de-ioneized water |
| Catheter Removal
Force from
Needle Test | Internal Requirement | Tests the ability to insert and withdraw catheter
through the needle tip without damage and
force to remove catheter shall not exceed 3
Newtons. |
| Electrical Leakage
Current | Internal Requirement | To test that the leakage current does not exceed
0.10 mA when a voltage of 110V AC at 50 Hz
is applied for one minute. |
| Catheter Length | Internal Requirement | To measure the length of the catheter |
| Catheter OD | Internal Requirement | To measure the outside diameter of the catheter |
| Catheter-to-
Snaplock Adapter
Liquid Leak Test | BS EN 1707; BS EN 1618 | Tests that no leakage from the catheter and
between the catheter and detachable Luer
fitting shall occur in the form of a drop of water
in 30 seconds when tested under pressure. |
| Catheter-to-
Snaplock Static
Pull Test | BS 6196 | Tests that the detachable Luer fitting does not
become detached from the catheter. |
| Continuous Flow
Rate Test | Internal Requirement | Tests the flow of de-ionized water through the
catheter when tested less than 10 psi. |
| Corrosion
Resistance | BS EN 1618 | Tests metallic components for their resistance
to corrosion. |
| Distance
Markings/Ink
Adhesion – Distal
Ends | BS 6196 | Tests to confirm ink adhesion and distance
markings at the distal ends of the catheter and
visible from all aspects. |
| Distance
Markings/Ink
Adhesion -
Proximal Ends | BS 6196 | Tests to confirm ink adhesion and distance
markings at the proximal ends of the catheter
and visible from all aspects. |
| Electrical
Continuity Test | Internal Requirement | Tests the electrical continuity of the catheter
from the electrical connector to the most distal
tip of the catheter and measures the electrical |
| | | resistance. |
| Flash Back
Window Test –
Length, Position,
Transparency | Internal Requirement | Measures the length, position and transparency
of the Flash Back Windows |
| Kink Resistance
Test | Internal Requirement | Tests the ability for flow through the catheter
when looped around a 1.58 mm diameter pin |
| Needle
Stimulation by
Catheter Test | Internal Requirement | Tests catheter's ability to stimulate the needle
when being inserted inside the needle cannula. |
| Catheter Surface
Inspection | BS EN ISO 10555-1 | Evaluates the condition of the surface of the
catheter. |
| Catheter Tensile
Strength Test | BS EN 1618 | Tests the catheter tensile force at both the
catheter tip and the main catheter body. |
| Tip Column
Strength Test | Internal Requirement | Tests column strength of the catheter tip |
| Catheter Tip Heat
Emission Test | Internal Requirement | Tests the heat generated at the tip of the
catheter when a current of 5mA is being
delivered from simulator working on 100 volts
or less. |
| Catheter
Resistance to
Leakage During
Aspiration | BS EN 1618 | Tests leakage at catheter joints (measured as
pressure decay) when an internal pressure is
applied at 25mmHg for 120 seconds. |
| L929 MEM
Elution Test | ISO 10993-5 | Tests the potential biological reactivity of a
mammalian cell culture (L929) in response to
the test article extract. |
| Kligman
Maximization
Test | ISO 10993-10 | Evaluates the allergic potential or sensitizing
capacity of the test article. |
| Intracutaneous
Injection Test | ISO 10993-10 | Determines the potential irritation effects of the
test article extra as a result of an intracutaneous
injection in New Zealand white rabbits. |
| Systemic
Injection Test | ISO 10993-11 | Determines the potential toxic effects of the
test article extract as a result of a single-dose
systemic injection in mice. |
| Material Mediated | SO 10993-11 | Determines the presence of chemical pyrogens
in extracts of solid materials in order to limit to |
| Rabbit Pyrogen | | an acceptable level the risk of febrile reaction
following administration of the product to the
patient. |
| Abridged 28 Day
Sub-acute
Systemic Toxicity
by Implant Test | ISO 10993-11 | Determines the toxicity potential of the test
material administered by subcutaneous
implantation in rates for 28 days. |
| Salmonella
typhimurium and
Escherichia coli
Reverse Mutation
Assay Test | ISO 10993-3 | Determines the potential mutagenicity of the
test article or its extract on various strains of
Salmonella typhimurium and Escherichia coli
bacteria, via a change in their dependence for
exogenous histidine or tryptophan. |
| Mouse
Lymphoma
Forward Mutation
Assay | ISO 10993-3 | Determines the potential mutagenicity effect on
mouse lymphoma cells (heterozygous
thymidine kinase mutant TK+/- L5178Y) in
response to the test article extract. |
| Mouse Blood
Micronucleus
Test | ISO 10993-3 | Determines the potential clastogenic effects of
the test article extract on maturing erythrocytes
in mice, via the detection of micronuclei in the
circulating reticulocytes. |
| 4 week
Implantation Test | ISO 10993-6 | Evaluates the test article for local tissue
responses and the potential to induce local
toxic effects after implantation in the muscle
tissue of albino rats. |
| Hemolysis -
Rabbit Blood -
Complete Method
Test | ISO 10993-4 | Determines the potential hemolytic activity, via
the induction of increased levels of free plasma
hemoglobin in rabbit blood, in response to the
test article and its extract. |
| Extractable and
Leachable Study | ISO 10993-17 | Determines the extractable amount of chemical
compounds present in and on the device. |
| Ethylene Oxide
Residual Test | ISO 10993-7 | Determines the residual Ethylene Oxide on the
device |
| LAL Bacterial
Endotoxin | AAMI ST72 | Documents the bacterial endotoxin levels on
the device |
| Packaging Visual
Test | ASTM F1886:2009 | Demonstrates no breach of package or seal |
| Packaging Peel | ASTM F88:2009 | Demonstrates a peel strength greater than or |
| Strength | | equal to 0.57 lb/in |
| Packaging Bubble
Leak Test | ASTM F2096:2011 | Demonstrates no steady stream of bubbles
emanating from the package seal area or other
areas of the package. |

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J. Conclusion

The UltraCath Continuous Nerve Block Catheter has the same indications for use and similar technology of construction as the predicate device. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent.