UltraCath Continuous Nerve block Catheter

K162522 · Teleflexmedical, Inc. · BSO · Mar 17, 2017 · Anesthesiology

Device Facts

• Record ID: K162522
• Device Name: UltraCath Continuous Nerve block Catheter
• Applicant: Teleflexmedical, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Mar 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The UltraCath Continuous Nerve Block Catheter is a medical device used for continuous nerve block anesthesia or analgesia. It consists of a stainless steel spring coil encased in a polyurethane outer jacket, with a black electrically conductive resin tip. A stylet is inserted into the spring coil to provide stiffness during placement. The device is placed next to nerve plexuses by a clinician. It functions by distributing anesthetics into the patient's body through a single end hole at the distal tip. The conductive tip allows for electrical stimulation to aid in placement. The device is intended for use in clinical settings for periods not exceeding 72 hours. By providing a continuous delivery path for anesthetics, it enables prolonged pain management or anesthesia, benefiting patients requiring extended nerve block procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included mechanical performance (aspiration, flow rate, tensile strength, kink resistance), electrical safety (leakage current, continuity, heat emission), and comprehensive biocompatibility testing per ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity, mutagenicity, implantation, hemolysis, and pyrogenicity).

Technological Characteristics

Catheter consists of a stainless steel spring coil encased in a 95A Tecothane polyurethane jacket. Distal tip is made of electrically conductive resin. Features include centimeter depth markings and a stylet for insertion stiffness. Sterilized via Ethylene Oxide. Single-use. Complies with BS EN 1707, BS EN 1618, BS 6196, and BS EN ISO 10555-1 standards.

Indications for Use

Indicated for adult patients requiring administration of local anesthetics via continuous nerve block anesthesia or analgesia techniques for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• StimuCath Continuous Nerve block Set (K030937)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) | |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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: [phone] Fax: [phone]

# 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.

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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<br>Characteristic | Predicate Device: | Proposed Device: |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | StimuCath® Continuous Nerve Block Set | UltraCath Continuous Nerve<br>Block Catheter |
| | K030937 | |
| Classification Name | Anesthesia Conduction Kit | Anesthesia Conduction Catheter |
| Product Code / CFR | CAZ, 868.5140 | BSO, 868.5120 |
| Intended Use/<br>Indications for Use | The Arrow StimuCath Continuous Nerve<br>block Set permits placement of catheters<br>next to nerves and nerve plexuses for<br>continuous nerve block anesthesia or<br>analgesia techniques for periods not<br>exceeding 72 hours. | The Arrow UltraCath<br>Continuous Nerve Block<br>Catheter is placed next to nerves<br>and nerve plexuses for<br>continuous nerve block<br>anesthesia or analgesia<br>techniques for periods not<br>exceeding 72 hours |
| Comparative<br>Characteristic | Predicate Device:<br>StimuCath® Continuous Nerve Block Set<br>K030937 | Proposed Device:<br>UltraCath Continuous Nerve<br>Block Catheter |
| Patient Population | Adult Patients that require administration of<br>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<br><br>20 Ga., Blue 95A Tecothane, polyurethane | 19 Ga., Clear 95A Tecothane,<br>polyurethane<br>N/A |
| Exposed Length at Distal<br>Tip | 5mm (19 Ga.) and 6mm (20 Ga.) | N/A, Tip not exposed |
| Exposed area at Distal Tip | 23.2 mm² | N/A, Tip not exposed |
| Catheter Current Density | 0.086 mA/mm² | 0.3 mA/mm² |
| Stylet Electrical<br>Connection | Detachable electrical cable with clips (J-<br>Snare connector) or integrated electrical<br>cable with shrouded 2 mm female<br>connectors | Detachable electrical cable with<br>clips (J-snare connector) |
| Shelf Life | 2 years | One Year |
| Method of Sterilization | Ethylene Oxide | Same |
| Single Use | Yes | Same |

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