Arrow Pressure Injectable Midline Catheter

K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · PND · Sep 2, 2022 · General Hospital

Device Facts

• Record ID: K213855
• Device Name: Arrow Pressure Injectable Midline Catheter
• Applicant: Arrow International, LLC Subsidiary of Teleflex Incorporated
• Product Code: PND · General Hospital
• Decision Date: Sep 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Arrow Pressure Injectable Midline Catheter provides short-term peripheral venous access. Device consists of non-coated, radiopaque polyurethane catheter body (single or double lumen) with centimeter markings, integral pinch clamps, and extension lines. Used for IV therapy, blood sampling, and contrast media injection (max 5 mL/sec). Operated by clinicians in clinical settings. Device facilitates fluid delivery/sampling; contrast injection capability supports diagnostic imaging. Sterile, single-use kit includes insertion components.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included luer hub testing (BS EN ISO 80369-7), mechanical testing (force at break, collapse resistance, blood draw, clamp efficacy), radiopacity (ASTM F640-20), and biocompatibility (BS EN ISO 10993-1).

Technological Characteristics

Materials: medical-grade polyurethane, radiopacifier. Design: 4 Fr (single) or 5 Fr (double) lumen, 20 cm length. Connectivity: N/A. Sterilization: Ethylene Oxide. Standards: BS EN ISO 10555-1 (catheter performance), BS EN ISO 80369-7 (luer), BS EN ISO 10993-1 (biocompatibility), ASTM F640-20 (radiopacity), BS EN ISO 13868 (kink resistance).

Indications for Use

Indicated for adult patients requiring short-term (≤ 30 days) peripheral venous access for IV therapy, blood sampling, infusion, and contrast media pressure injection (max 300 psi).

Regulatory Classification

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.

Predicate Devices

• Arrow Pressure Injectable Midline Catheter with ArrowG+ard Blue Advance Antimicrobial and Antithrombogenic Technology (K161313)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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# 510(k) SUMMARY - K213855

## 1. Submitter Information

| Name: | Arrow International LLC, Subsidiary of Teleflex Incorporated |
|-------------------|--------------------------------------------------------------|
| Address: | 3015 Carrington Mill Blvd<br>Morrisville, NC 27560 |
| Telephone Number: | [phone] |
| Contact Peron: | Kim Pennington<br>Regulatory Affairs Specialist |
| Email: | [e-mail] |
| 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:<br>Arrow Pressure<br>Injectable Midline<br>Catheter<br>K213855 | Arrow Pressure Injectable<br>Midline Catheter with<br>ArrowG+ard Blue Advance<br>Antimicrobial and<br>Antithrombogenic<br>Technology<br>(K161313) | Assessment of<br>Device<br>Differences |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Intravascular catheter | Intravascular catheter | Same |
| Product Code | PND | PND | Same |
| Regulation<br>Number | 880.5200 | 880.5200 | Same |
| Class | II | II | Same |
| Indications for<br>Use | The Arrow(R) Pressure<br>Injectable Midline Catheter is<br>indicated for short-term (≤<br>30 days) peripheral access to<br>the venous system for<br>intravenous therapy, blood<br>sampling, infusion, and<br>pressure injection of contrast<br>media. The maximum<br>pressure of pressure injector<br>equipment used with the<br>Arrow Pressure Injectable<br>Midline Catheter may not<br>exceed 300 psi (2068.4 kPa).<br>The maximum pressure<br>injection flow rate for the<br>specific lumen being used for<br>pressure injection is printed<br>on the extension line hub. | The Arrow ® Pressure Injectable<br>Midline Catheter with Chlorag+ard®<br>Antimicrobial and<br>Antithrombogenic Technology is<br>indicated for short-term (<30 days)<br>peripheral access to the venous<br>system for intravenous therapy,<br>blood sampling, infusion, and<br>pressure injection of contrast media.<br>The maximum pressure of pressure<br>injector equipment used with the<br>Arrow Antimicrobial and<br>Antithrombogenic Pressure<br>Injecatable Midline Catheter may not<br>exceed 300 psi (2068.4 kPa). The<br>maximum pressure injection flow<br>rate for the specific lumen being used<br>for pressure injection is printed on<br>the extension line hub.<br>Chlorag+ard Technology treatment<br>on the external surface of the catheter<br>body as well as the entire fluid<br>pathway of the catheter has been<br>shown to be effective in reducing<br>microbial colonization and thrombus<br>accumulation on the catheter<br>surfaces. Antimicrobial and<br>antithrombogenic effectiveness was<br>evaluated using in vitro and in vivo<br>test methods and no correlation<br>between these testing methods and<br>clinical outcome has currently been<br>ascertained. It is not intended to be<br>used for the treatment of existing<br>infections or vein thrombosis. | Different<br>The subject device<br>IFU is the same as<br>the predicate device.<br>The predicate device<br>differs in that the<br>device is coated with<br>an antimicrobial and<br>antithrombogenic<br>technology on the<br>internal luminal and<br>outer catheter<br>surface. The subject<br>device is non-<br>coatings on or within<br>the catheter. The<br>subject device. |
| Single Use | Yes | Yes | Same |
| Population | Adult | Adult | Same |

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| Features | Subject Device:<br>Arrow Pressure<br>Injectable Midline<br>Catheter<br>K213855 | Arrow Pressure Injectable<br>Midline Catheter with<br>ArrowG+ard Blue Advance<br>Antimicrobial and<br>Antithrombogenic<br>Technology<br>(K161313) | Assessment of<br>Device<br>Differences |
|---------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Design Feature | | |
| Lumens | Single and Double Lumen | Single and Double Lumen | Same |
| Internal<br>Lumen<br>Configuration | Round and Double D | Round and Double D | Same |
| Pressure<br>Injection<br>Capabilities | 5 mL/sec | 5 mL/sec | Same |
| Catheter Body<br>OD | 4 Fr - Single Lumen<br>5 Fr - Double Lumen | 4.5 Fr - Single Lumen<br>5.5 Fr - Double Lumen | Different<br>Justification for no<br>S&E impact: The<br>smaller catheter body<br>OD has no impact on<br>the use or<br>functionality of the<br>subject pressure<br>injectable midline<br>catheter per its<br>intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10555-1:<br>2013, ASTM F640-<br>20, BS EN ISO<br>13868: 2002, and<br>internal test methods<br>for collapse<br>resistance and blood<br>draw which supports<br>that there are no new<br>safety or efficacy<br>concerns. |
| Catheter<br>Usable Length | 20 cm | 15 cm | Different<br>Justification for no<br>S&E impact: The<br>difference in the<br>catheter usable length<br>has no impact on the<br>use or functionality<br>of the subject |

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| | | | midline catheter per<br>its intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10555-1:<br>2013, ASTM F640-<br>20, BS EN ISO<br>13868: 2002, and<br>internal test methods<br>for collapse<br>resistance and blood<br>draw which supports<br>that there are no new<br>safety or efficacy<br>concerns. | | | | |
|-------------------------------|------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Catheter Body<br>Material | Clear Polyurethane with<br>radiopacifier | Blue Polyurethane with radiopacifier | Different<br>Justification for no<br>S&E impact: The<br>difference in the<br>catheter body<br>material has no<br>impact on the use or<br>functionality of the<br>subject pressure<br>injectable midline<br>catheter per its<br>intended use as<br>demonstrated by<br>appropriate testing<br>in compliance with<br>BS EN ISO 10555-1:<br>2013, ASTM F640-<br>20, BS EN ISO<br>13868: 2002, BS EN<br>ISO 10993-1: 2020,<br>and internal test<br>methods for collapse<br>resistance and blood<br>draw which supports<br>that there are no new<br>safety or efficacy<br>concerns. | | | | |
| Radiopaque | Yes | Yes | Same | | | | |
| Catheter Body<br>Printing Ink | Black Ink | Black Ink | Same | | | | |
| Catheter Tip<br>Material | | No Tip | | Blue Flex Tip | | Different<br>Justification for no<br>S&E impact: The<br>difference in the<br>catheter tip material<br>has no impact on the<br>use or functionality<br>of the subject | of the subject<br>pressure injectable<br>midline catheter per |
| | | | its intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10555-1:<br>2013, BS EN ISO<br>10993-1: 2020, and<br>internal test for<br>collapse resistance<br>and blood draw<br>which supports that<br>there are no new<br>safety or efficacy<br>concerns. | | | | |
| Juncture Hub<br>Material | polyether polyurethane | polyether polyurethane | Same | | | | |
| Extension Line<br>Material | natural polyurethane | natural polyurethane | Same | | | | |
| Extension Line<br>Length | Approximately 3/4" longer to<br>accommodate the larger<br>pinch clamps | Shorter by approximately 3/4" | Different<br>Justification for no<br>S&E impact: The<br>difference in<br>extension line length<br>has no impact on the<br>use or functionality<br>of the subject<br>pressure injectable<br>midline catheter per<br>its intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10555-1:<br>2013 and internal test<br>for collapse<br>resistance and blood<br>draw which supports<br>that there are no new<br>safety or efficacy<br>concerns. | | | | |
| Extension Line<br>Markings | | "18 GA" | | "Midline – Proximal"<br>"Midline - Distal" | | Different<br>Justification for no<br>S&E impact: The<br>difference in the<br>extension line<br>markings has no<br>impact on the use or<br>functionality of the<br>subject pressure<br>injectable midline<br>catheter per its<br>intended use as | intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10555-1: |

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| | | | 2013 which supports |
|--------------------------------|-------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | that there are no new |
| | | | safety or efficacy |
| | | | concerns. |
| Extension Line<br>Hub Material | Yellow and white<br>thermoplastic polyurethanes | Pink and white thermoplastic<br>polyurethanes | Different<br>Justification for no<br>S&E impact: The<br>difference in the<br>extension line hub<br>material has no<br>impact on the use or<br>functionality of the<br>subject pressure<br>injectable midline<br>catheter per its<br>intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 80369-7:<br>2016 and BS EN ISO<br>10993-1: 2020 which<br>supports that there<br>are no new safety or<br>efficacy concerns. |
| Extension Line<br>Hub Markings | "Midline" and<br>"Max PI 5 mL/sec" | "Distal" and "Proximal"<br>"Max 5 mL/sec" and "No CT" | Different<br>Justification for no<br>S&E impact: The<br>difference in<br>extension line hub<br>markings has no<br>impact on the use or<br>functionality of the<br>subject pressure<br>injectable midline<br>catheter per its<br>intended use as<br>demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10555-1:<br>2013 which supports<br>that there are no new<br>safety or efficacy<br>concerns. |
| Extension Line<br>Clamp | Pinch Clamp | Slide Clamp | Different<br>Justification for no<br>S&E impact: The<br>difference in the<br>extension line clamp<br>has no impact on the<br>use or functionality<br>of the subject<br>pressure injectable<br>midline catheter per<br>its intended use as |
| | | | demonstrated by<br>appropriate testing in<br>compliance with BS<br>EN ISO 10993-1:<br>2020 and internal test<br>methods for<br>extension line clamp<br>closure efficacy and<br>clamp force which<br>supports that there<br>are no new safety or |
| | | | efficacy concerns. |
| Shelf Life and Packaging | | | |
| Packaging | PET/LDPE film mated with<br>Tyvek | PET/LDPE film mated with Tyvek | Same |
| Shelf Life | 2 years | 2 years | Same |
| Sterilization | | | |
| Sterile | Yes | Yes | Same |
| Sterilization<br>Method | 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 Injection<br>Flow 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<br>• Bacterial Endotoxin | ANSI/AAMI/ST72:2019 |
| Sterilization Evaluation<br>• Ethylene Oxide Residuals | BS EN ISO 10993-7: 2008 |
| Preconditioning<br>• Shipping<br>• Distribution Simulation | ISTA 3A<br>ASTM 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.