(266 days)
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.
The catheters will be packaged sterile in kits that will include components to facilitate insertion.
The provided text is a 510(k) summary for a medical device (Arrow® Pressure Injectable Midline Catheter) and does not describe acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets said criteria. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, and sterilization/packaging testing.
Therefore, most of the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.
However, I can extract the information that is present about the device's characteristics and the types of non-clinical tests performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria (e.g., "Pass if flow rate >= X mL/s") or specific reported performance values resulting from the tests. Instead, it indicates that "Non-clinical testing related to the device changes has been completed to support the substantial equivalence." This implies that the device met the internal and standard-based requirements for these tests to demonstrate equivalence, but the precise thresholds and results are not detailed.
| Test Category | Standard / Description | Implied Performance (Met) |
|---|---|---|
| Luer Hub Testing | BS EN ISO 80369-7: 2016 (Sub-atmospheric pressure air leakage, Stress Cracking/Fluid Leakage, Resistance to separation (axial load, unscrewing, overriding)) | Met requirements of standard |
| Labeling | BS EN ISO 10555-1: 2013 (Catheter Nominal Effective Length, Catheter outside diameter, Pressure Injection Gravity flow Rate, Visual Inspection, Surface Quality) | Met requirements of standard |
| Mechanical Testing | BS EN ISO 10555-1: 2013 (Force at Break – Juncture Hub & Catheter Body, Force at Break - Luer Hub & Extension Line, Catheter Body Elongation, Liquid Leakage under Pressure, Air Leakage during Aspiration, Priming Volume Pump Flow Rate, Pressure Injection Flow rate & Repeat Injection, Static Burst under Pressure Injection) | Met requirements of standard |
| Radiopacity | ASTM F640-20 | Met requirements of standard |
| Catheter Body Kink | BS EN ISO 13868: 2002 | Met requirements of standard |
| Collapse Resistance | Internal Test Method | Met internal requirements |
| Blood Draw | Internal Test Method | Met internal requirements |
| Extension Line Clamp Closure Efficacy | Internal Test Method | Met internal requirements |
| Clamp Force | Internal Test Method | Met internal requirements |
| Biocompatibility | BS EN ISO 10993-1: 2020 (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute/Subacute Systemic Toxicity, Hemocompatibility, Genotoxicity, Chemical Characterization) | Met requirements of standard |
| Sterilization Evaluation | ANSI/AAMI/ST72:2019 (Bacterial Endotoxin), BS EN ISO 10993-7: 2008 (Ethylene Oxide Residuals) | Met requirements of standard |
| Preconditioning | ISTA 3A, ASTM D4169 (Shipping, Distribution Simulation) | Met requirements of standard |
| Package Protection Testing | BS EN ISO 11607-1: 2020 | Met requirements of standard |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and biological performance testing, not AI/ML model testing with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here. The "ground truth" for these tests would be defined by the technical specifications of the standards (e.g., a specific pressure, flow rate, or biological response).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML device. For this device, the "ground truth" for testing is established by recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) and internal company test methods, which define acceptable parameters for physical and chemical properties, functionality, and biocompatibility.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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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.
September 2, 2022
Arrow International LLC Subsidiary of Teleflex Incorporated Kim Pennington Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K213855
Trade/Device Name: Arrow® Pressure Injectable Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: August 2, 2022 Received: August 3, 2022
Dear Kim Pennington:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K213855
Device Name Arrow® Pressure Injectable Midline
Indications for Use (Describe)
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
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 - K213855
1. Submitter Information
| Name: | Arrow International LLC, Subsidiary of Teleflex Incorporated |
|---|---|
| Address: | 3015 Carrington Mill BlvdMorrisville, NC 27560 |
| Telephone Number: | (610) 451-3095 |
| Contact Peron: | Kim PenningtonRegulatory Affairs Specialist |
| Email: | kim.pennington@teleflex.com |
| Date Prepared: | August 31, 2022 |
2. Device Name
| Device Trade Name: | Arrow® Pressure Injectable Midline Catheter |
|---|---|
| Common Name: | Midline Catheter |
| Classification Name: | Intravascular catheter |
| Regulation: | 21 CFR 880.5200 |
| Product Code: | PND |
| Class: | II |
3. Predicate Devices
K161313: Arrow Pressure Injectable Midline Catheter with ArrowG+ard Blue Advance Antimicrobial and Antithrombogenic Technology
4. Purpose
The purpose of this premarket notification is for the introduction to market of a sterile, single-use pressure injectable midline catheter without antimicrobial and antithrombogenic technology.
5. Device Description
The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4
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Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.
The catheters will be packaged sterile in kits that will include components to facilitate insertion.
6. Intended Use
The Pressure Injectable Midline Catheters are intended for short-term peripheral access to the venous system for intravenous therapy and blood sampling.
7. Indications for Use
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
8. Technological Characteristics and Substantial Equivalence
The subject device is substantially equivalent to the predicate device:
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| Features | Subject Device:Arrow PressureInjectable MidlineCatheterK213855 | Arrow Pressure InjectableMidline Catheter withArrowG+ard Blue AdvanceAntimicrobial andAntithrombogenicTechnology(K161313) | Assessment ofDeviceDifferences |
|---|---|---|---|
| ClassificationName | Intravascular catheter | Intravascular catheter | Same |
| Product Code | PND | PND | Same |
| RegulationNumber | 880.5200 | 880.5200 | Same |
| Class | II | II | Same |
| Indications forUse | The Arrow(R) PressureInjectable Midline Catheter isindicated for short-term (≤30 days) peripheral access tothe venous system forintravenous therapy, bloodsampling, infusion, andpressure injection of contrastmedia. The maximumpressure of pressure injectorequipment used with theArrow Pressure InjectableMidline Catheter may notexceed 300 psi (2068.4 kPa).The maximum pressureinjection flow rate for thespecific lumen being used forpressure injection is printedon the extension line hub. | The Arrow ® Pressure InjectableMidline Catheter with Chlorag+ard®Antimicrobial andAntithrombogenic Technology isindicated for short-term (<30 days)peripheral access to the venoussystem for intravenous therapy,blood sampling, infusion, andpressure injection of contrast media.The maximum pressure of pressureinjector equipment used with theArrow Antimicrobial andAntithrombogenic PressureInjecatable Midline Catheter may notexceed 300 psi (2068.4 kPa). Themaximum pressure injection flowrate for the specific lumen being usedfor pressure injection is printed onthe extension line hub.Chlorag+ard Technology treatmenton the external surface of the catheterbody as well as the entire fluidpathway of the catheter has beenshown to be effective in reducingmicrobial colonization and thrombusaccumulation on the cathetersurfaces. Antimicrobial andantithrombogenic effectiveness wasevaluated using in vitro and in vivotest methods and no correlationbetween these testing methods andclinical outcome has currently beenascertained. It is not intended to beused for the treatment of existinginfections or vein thrombosis. | DifferentThe subject deviceIFU is the same asthe predicate device.The predicate devicediffers in that thedevice is coated withan antimicrobial andantithrombogenictechnology on theinternal luminal andouter cathetersurface. The subjectdevice is non-coatings on or withinthe catheter. Thesubject device. |
| Single Use | Yes | Yes | Same |
| Population | Adult | Adult | Same |
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| Features | Subject Device:Arrow PressureInjectable MidlineCatheterK213855 | Arrow Pressure InjectableMidline Catheter withArrowG+ard Blue AdvanceAntimicrobial andAntithrombogenicTechnology(K161313) | Assessment ofDeviceDifferences |
|---|---|---|---|
| Device Design Feature | |||
| Lumens | Single and Double Lumen | Single and Double Lumen | Same |
| InternalLumenConfiguration | Round and Double D | Round and Double D | Same |
| PressureInjectionCapabilities | 5 mL/sec | 5 mL/sec | Same |
| Catheter BodyOD | 4 Fr - Single Lumen5 Fr - Double Lumen | 4.5 Fr - Single Lumen5.5 Fr - Double Lumen | DifferentJustification for noS&E impact: Thesmaller catheter bodyOD has no impact onthe use orfunctionality of thesubject pressureinjectable midlinecatheter per itsintended use asdemonstrated byappropriate testing incompliance with BSEN ISO 10555-1:2013, ASTM F640-20, BS EN ISO13868: 2002, andinternal test methodsfor collapseresistance and blooddraw which supportsthat there are no newsafety or efficacyconcerns. |
| CatheterUsable Length | 20 cm | 15 cm | DifferentJustification for noS&E impact: Thedifference in thecatheter usable lengthhas no impact on theuse or functionalityof the subject |
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| midline catheter perits intended use asdemonstrated byappropriate testing incompliance with BSEN ISO 10555-1:2013, ASTM F640-20, BS EN ISO13868: 2002, andinternal test methodsfor collapseresistance and blooddraw which supportsthat there are no newsafety or efficacyconcerns. | |||||||
|---|---|---|---|---|---|---|---|
| Catheter BodyMaterial | Clear Polyurethane withradiopacifier | Blue Polyurethane with radiopacifier | DifferentJustification for noS&E impact: Thedifference in thecatheter bodymaterial has noimpact on the use orfunctionality of thesubject pressureinjectable midlinecatheter per itsintended use asdemonstrated byappropriate testingin compliance withBS EN ISO 10555-1:2013, ASTM F640-20, BS EN ISO13868: 2002, BS ENISO 10993-1: 2020,and internal testmethods for collapseresistance and blooddraw which supportsthat there are no newsafety or efficacyconcerns. | ||||
| Radiopaque | Yes | Yes | Same | ||||
| Catheter BodyPrinting Ink | Black Ink | Black Ink | Same | ||||
| Catheter TipMaterial | No Tip | Blue Flex Tip | DifferentJustification for noS&E impact: Thedifference in thecatheter tip materialhas no impact on theuse or functionalityof the subject | of the subjectpressure injectablemidline catheter per | |||
| its intended use asdemonstrated byappropriate testing incompliance with BSEN ISO 10555-1:2013, BS EN ISO10993-1: 2020, andinternal test forcollapse resistanceand blood drawwhich supports thatthere are no newsafety or efficacyconcerns. | |||||||
| Juncture HubMaterial | polyether polyurethane | polyether polyurethane | Same | ||||
| Extension LineMaterial | natural polyurethane | natural polyurethane | Same | ||||
| Extension LineLength | Approximately 3/4" longer toaccommodate the largerpinch clamps | Shorter by approximately 3/4" | DifferentJustification for noS&E impact: Thedifference inextension line lengthhas no impact on theuse or functionalityof the subjectpressure injectablemidline catheter perits intended use asdemonstrated byappropriate testing incompliance with BSEN ISO 10555-1:2013 and internal testfor collapseresistance and blooddraw which supportsthat there are no newsafety or efficacyconcerns. | ||||
| Extension LineMarkings | "18 GA" | "Midline – Proximal""Midline - Distal" | DifferentJustification for noS&E impact: Thedifference in theextension linemarkings has noimpact on the use orfunctionality of thesubject pressureinjectable midlinecatheter per itsintended use as | intended use asdemonstrated byappropriate testing incompliance with BSEN ISO 10555-1: |
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| 2013 which supports | |||
|---|---|---|---|
| that there are no new | |||
| safety or efficacy | |||
| concerns. | |||
| Extension LineHub Material | Yellow and whitethermoplastic polyurethanes | Pink and white thermoplasticpolyurethanes | DifferentJustification for noS&E impact: Thedifference in theextension line hubmaterial has noimpact on the use orfunctionality of thesubject pressureinjectable midlinecatheter per itsintended use asdemonstrated byappropriate testing incompliance with BSEN ISO 80369-7:2016 and BS EN ISO10993-1: 2020 whichsupports that thereare no new safety orefficacy concerns. |
| Extension LineHub Markings | "Midline" and"Max PI 5 mL/sec" | "Distal" and "Proximal""Max 5 mL/sec" and "No CT" | DifferentJustification for noS&E impact: Thedifference inextension line hubmarkings has noimpact on the use orfunctionality of thesubject pressureinjectable midlinecatheter per itsintended use asdemonstrated byappropriate testing incompliance with BSEN ISO 10555-1:2013 which supportsthat there are no newsafety or efficacyconcerns. |
| Extension LineClamp | Pinch Clamp | Slide Clamp | DifferentJustification for noS&E impact: Thedifference in theextension line clamphas no impact on theuse or functionalityof the subjectpressure injectablemidline catheter perits intended use as |
| demonstrated byappropriate testing incompliance with BSEN ISO 10993-1:2020 and internal testmethods forextension line clampclosure efficacy andclamp force whichsupports that thereare no new safety or | |||
| efficacy concerns. | |||
| Shelf Life and Packaging | |||
| Packaging | PET/LDPE film mated withTyvek | PET/LDPE film mated with Tyvek | Same |
| Shelf Life | 2 years | 2 years | Same |
| Sterilization | |||
| Sterile | Yes | Yes | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
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9. Nonclinical Testing
Non-clinical testing related to the device changes has been completed to support the substantial equivalence of the of the subject devices to the predicate devices.
9.1 Performance Testing
| Testing | Standard |
|---|---|
| Luer Hub Testing | BS EN ISO 80369-7: 2016 |
| Material Sub-atmospheric pressure air leakage Stress Cracking/ Fluid Leakage Resistance to separation from axial load Resistance to separation from unscrewing Resistance to overriding | |
| Labeling | BS EN ISO 10555-1: 2013 |
| Catheter Nominal Effective Length Catheter outside diameter Pressure Injection Gravity flow Rate | |
| Visual Inspection | |
| Surface Quality | |
| Mechanical Testing | |
| Force at Break – Juncture Hub and Catheter Body Force at Break - Luer Hub and Extension Line Catheter Body Elongation Catheter Navigation Liquid Leakage under Pressure Air Leakage during Aspiration Priming Volume Pump Flow Rate |
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| Testing | Standard |
|---|---|
| Pressure InjectionFlow rate under Pressure Injection/ Repeat Pressure Injection Static Burst under Pressure Injection | |
| Radiopacity | ASTM F640-20 |
| Catheter Body Kink | BS EN ISO 13868: 2002 |
| Collapse Resistance | Internal Test Method |
| Blood Draw | Internal Test Method |
| Extension Line Clamp Closure Efficacy | Internal Test Method |
| Clamp Force | Internal Test Method |
9.2 Biocompatibility Testing
| Testing | Standard |
|---|---|
| Biocompatibility | BS EN ISO 10993-1: 2020 |
| • Cytotoxicity | |
| • Sensitization | |
| • Irritation | |
| • Material Mediated Pyrogenicity | |
| • Acute Systemic Toxicity | |
| • Subacute Systemic Toxicity | |
| • Hemocompatibility | |
| • Genotoxicity | |
| • Chemical Characterization |
9.3 Sterilization, Shipping, and Sterile Barrier Testing
| Testing | Standard |
|---|---|
| Sterilization Evaluation• Bacterial Endotoxin | ANSI/AAMI/ST72:2019 |
| Sterilization Evaluation• Ethylene Oxide Residuals | BS EN ISO 10993-7: 2008 |
| Preconditioning• Shipping• Distribution Simulation | ISTA 3AASTM D4169 |
| Package Protection Testing | BS EN ISO 11607-1: 2020 |
10. Conclusions
The subject Arrow Pressure Injectable Midline Catheter has the same intended use as the stated predicate device and similar indications for use and technological characteristics. Any differences in technological characteristics do not raise different questions of safety and effectiveness compared to those applicable to the predicate device and do not pose a significant safety or effectiveness concern for the subject device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).