(189 days)
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.
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.
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets them in the context of an AI/ML-based medical device. The document is a 510(k) summary for a physical medical device called the "UltraCath Continuous Nerve Block Catheter" and focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.
There is no mention of:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for test sets, data provenance, or use of experts and adjudication for ground truth related to an AI/ML algorithm.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
- Training set details for an AI/ML model.
The document lists various physical and chemical tests for the catheter, such as aspiration, column strength, flow rate, electrical leakage, and biocompatibility, but these are for the hardware itself, not an AI component.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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 (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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". Below the name, there is a "-s" written. The signature is a complex swirl of lines, and the name is written in a simple, clear font.
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) | |
|---|---|
| ☑ 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.
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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.
| ComparativeCharacteristic | Predicate Device: | Proposed Device: |
|---|---|---|
| StimuCath® Continuous Nerve Block Set | UltraCath Continuous NerveBlock 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 Nerveblock Set permits placement of cathetersnext to nerves and nerve plexuses forcontinuous nerve block anesthesia oranalgesia techniques for periods notexceeding 72 hours. | The Arrow UltraCathContinuous Nerve BlockCatheter is placed next to nervesand nerve plexuses forcontinuous nerve blockanesthesia or analgesiatechniques for periods notexceeding 72 hours |
| ComparativeCharacteristic | Predicate Device:StimuCath® Continuous Nerve Block SetK030937 | Proposed Device:UltraCath Continuous NerveBlock Catheter |
| Patient Population | Adult Patients that require administration oflocal 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, polyurethane20 Ga., Blue 95A Tecothane, polyurethane | 19 Ga., Clear 95A Tecothane,polyurethaneN/A |
| Exposed Length at DistalTip | 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 ElectricalConnection | Detachable electrical cable with clips (J-Snare connector) or integrated electricalcable with shrouded 2 mm femaleconnectors | Detachable electrical cable withclips (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(if applicable) | Principle of Test |
|---|---|---|
| CatheterAspiration Test | Internal Requirement | Tests ability to aspirate fluid without signs ofcollapse by drawing water via syringe |
| Body ColumnStrength Test | Internal Requirement | Tests ability of pushing catheter through theneedle into the desired location |
| Bolus Flow RateTest | Internal Requirement | Tests the flow capability through the catheterwhen tested using de-ioneized water |
| Catheter RemovalForce fromNeedle Test | Internal Requirement | Tests the ability to insert and withdraw catheterthrough the needle tip without damage andforce to remove catheter shall not exceed 3Newtons. |
| Electrical LeakageCurrent | Internal Requirement | To test that the leakage current does not exceed0.10 mA when a voltage of 110V AC at 50 Hzis 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 AdapterLiquid Leak Test | BS EN 1707; BS EN 1618 | Tests that no leakage from the catheter andbetween the catheter and detachable Luerfitting shall occur in the form of a drop of waterin 30 seconds when tested under pressure. |
| Catheter-to-Snaplock StaticPull Test | BS 6196 | Tests that the detachable Luer fitting does notbecome detached from the catheter. |
| Continuous FlowRate Test | Internal Requirement | Tests the flow of de-ionized water through thecatheter when tested less than 10 psi. |
| CorrosionResistance | BS EN 1618 | Tests metallic components for their resistanceto corrosion. |
| DistanceMarkings/InkAdhesion – DistalEnds | BS 6196 | Tests to confirm ink adhesion and distancemarkings at the distal ends of the catheter andvisible from all aspects. |
| DistanceMarkings/InkAdhesion -Proximal Ends | BS 6196 | Tests to confirm ink adhesion and distancemarkings at the proximal ends of the catheterand visible from all aspects. |
| ElectricalContinuity Test | Internal Requirement | Tests the electrical continuity of the catheterfrom the electrical connector to the most distaltip of the catheter and measures the electrical |
| resistance. | ||
| Flash BackWindow Test –Length, Position,Transparency | Internal Requirement | Measures the length, position and transparencyof the Flash Back Windows |
| Kink ResistanceTest | Internal Requirement | Tests the ability for flow through the catheterwhen looped around a 1.58 mm diameter pin |
| NeedleStimulation byCatheter Test | Internal Requirement | Tests catheter's ability to stimulate the needlewhen being inserted inside the needle cannula. |
| Catheter SurfaceInspection | BS EN ISO 10555-1 | Evaluates the condition of the surface of thecatheter. |
| Catheter TensileStrength Test | BS EN 1618 | Tests the catheter tensile force at both thecatheter tip and the main catheter body. |
| Tip ColumnStrength Test | Internal Requirement | Tests column strength of the catheter tip |
| Catheter Tip HeatEmission Test | Internal Requirement | Tests the heat generated at the tip of thecatheter when a current of 5mA is beingdelivered from simulator working on 100 voltsor less. |
| CatheterResistance toLeakage DuringAspiration | BS EN 1618 | Tests leakage at catheter joints (measured aspressure decay) when an internal pressure isapplied at 25mmHg for 120 seconds. |
| L929 MEMElution Test | ISO 10993-5 | Tests the potential biological reactivity of amammalian cell culture (L929) in response tothe test article extract. |
| KligmanMaximizationTest | ISO 10993-10 | Evaluates the allergic potential or sensitizingcapacity of the test article. |
| IntracutaneousInjection Test | ISO 10993-10 | Determines the potential irritation effects of thetest article extra as a result of an intracutaneousinjection in New Zealand white rabbits. |
| SystemicInjection Test | ISO 10993-11 | Determines the potential toxic effects of thetest article extract as a result of a single-dosesystemic injection in mice. |
| Material Mediated | SO 10993-11 | Determines the presence of chemical pyrogensin extracts of solid materials in order to limit to |
| Rabbit Pyrogen | an acceptable level the risk of febrile reactionfollowing administration of the product to thepatient. | |
| Abridged 28 DaySub-acuteSystemic Toxicityby Implant Test | ISO 10993-11 | Determines the toxicity potential of the testmaterial administered by subcutaneousimplantation in rates for 28 days. |
| Salmonellatyphimurium andEscherichia coliReverse MutationAssay Test | ISO 10993-3 | Determines the potential mutagenicity of thetest article or its extract on various strains ofSalmonella typhimurium and Escherichia colibacteria, via a change in their dependence forexogenous histidine or tryptophan. |
| MouseLymphomaForward MutationAssay | ISO 10993-3 | Determines the potential mutagenicity effect onmouse lymphoma cells (heterozygousthymidine kinase mutant TK+/- L5178Y) inresponse to the test article extract. |
| Mouse BloodMicronucleusTest | ISO 10993-3 | Determines the potential clastogenic effects ofthe test article extract on maturing erythrocytesin mice, via the detection of micronuclei in thecirculating reticulocytes. |
| 4 weekImplantation Test | ISO 10993-6 | Evaluates the test article for local tissueresponses and the potential to induce localtoxic effects after implantation in the muscletissue of albino rats. |
| Hemolysis -Rabbit Blood -Complete MethodTest | ISO 10993-4 | Determines the potential hemolytic activity, viathe induction of increased levels of free plasmahemoglobin in rabbit blood, in response to thetest article and its extract. |
| Extractable andLeachable Study | ISO 10993-17 | Determines the extractable amount of chemicalcompounds present in and on the device. |
| Ethylene OxideResidual Test | ISO 10993-7 | Determines the residual Ethylene Oxide on thedevice |
| LAL BacterialEndotoxin | AAMI ST72 | Documents the bacterial endotoxin levels onthe device |
| Packaging VisualTest | 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 BubbleLeak Test | ASTM F2096:2011 | Demonstrates no steady stream of bubblesemanating from the package seal area or otherareas 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.
§ 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).