ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

K161313 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · PND · Aug 24, 2016 · General Hospital

Device Facts

• Record ID: K161313
• Device Name: ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
• Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
• Product Code: PND · General Hospital
• Decision Date: Aug 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (< 30 days) peripheral access to the venous therapy, blood sampling. infusion, and pressure injection of contrast media. The maximum pressure injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

Device Story

Single-use, radiopaque polyurethane midline catheter; provides short-term (<30 days) peripheral venous access. Features Chlorag+ard antimicrobial/antithrombogenic coating on external surface and internal fluid path. Available in 4.5 Fr (single lumen) and 5.5 Fr (double lumen) configurations; 15 cm length. Includes Blue FlexTip for atraumatic insertion. Used for IV therapy, blood sampling, and contrast media injection (max 300 psi). Operated by clinicians in clinical settings. Output is venous access; healthcare providers use device to deliver fluids/medications or extract blood. Benefits include reduced microbial colonization and thrombus accumulation on catheter surfaces, potentially lowering catheter-related complications.

Clinical Evidence

Bench testing only. Performance evaluated via priming volume, gravity flow rate, pumped flow rate, pressure injection, static burst, mechanical hemolysis, and tensile testing. Antimicrobial/antithrombogenic efficacy evaluated via in vitro and in vivo methods; no clinical outcome correlation established.

Technological Characteristics

Polyurethane catheter body with 30% Bismuth Oxychloride; Blue FlexTip; Chlorhexidine-based coating. 4.5 Fr (single lumen) and 5.5 Fr (double lumen). Pressure injection up to 300 psi. Standards: ISO 10555-1, ISO 10555-3, ISO 10993-7, ISO 11135, ASTM F756-08.

Indications for Use

Indicated for short-term (< 30 days) peripheral venous access for IV therapy, blood sampling, infusion, and contrast media pressure injection in patients requiring peripheral venous access. Contraindicated for treatment of existing infections or vein thrombosis.

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 Peripherally Inserted Midline Catheter (K963257)

Reference Devices

• ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896)

Submission Summary (Full Text)

{0}------------------------------------------------

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 stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted with simple, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

August 24, 2016

Arrow International, Inc. (subsidiary of Teleflex Inc.) Ms. Julie Lawson Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605

Re: K161313

Trade/Device Name: Arrow Pressure Injectable Midline Catheter with Chlorag+arde Antimicrobial and Antithrombogenic Technology Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: July 22, 2016 Received: July 25, 2016

Dear Ms. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 yours,

Tina Kiang

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

### 510(k) Number (if known) K161313

#### Device Name

- ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

#### Indications for Use (Describe)

The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (< 30 days) peripheral access to the venous therapy, blood sampling. infusion, and pressure injection of contrast media. The maximum pressure injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 510(k) SUMMARY

### ARROW PRESSURE INJECTABLE MIDLINE CATHETER WITH CHLORAG ARD ANTIMICROBIAL AND ANTITHROMBOGENIC TECHNOLOGY

### 1. Submitter Information

| Name: | Arrow International, Inc. (subsidiary of Teleflex Inc.) |
|-------------------|---------------------------------------------------------|
| Address: | 2400 Bernville Road<br>Reading, PA 19605-9607 |
| Telephone Number: | [phone] |
| Contact Person: | Julie Lawson<br>Regulatory Affairs Specialist |
| Telephone Number: | [phone] Extension 603256 |
| Fax Number: | [phone] |
| Email: | [e-mail] |

Date Prepared: May 9, 2016

### 2. Device Name

| Device Trade Name: | Arrow® Pressure Injectable Midline Catheter<br>with Chlorag+ard® Antimicrobial and Antithrombogenic<br>Technology |
|--------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | Midline Catheter |
| Regulation Number: | 21 CFR: 880.5200 |
| Regulation Name: | Intravascular Catheter |
| Product Code: | PND |

## 3. Predicate and Reference Devices

Arrow Peripherally Inserted Midline Catheter (K963257) - Predicate

ArrowEvolution™ Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) - Reference

## 4. Device Description

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution

{4}------------------------------------------------

technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.

## 5. Indications for Use

The Arrow Pressure Injectable Midline Catheter with Chlorag ard® Antimicrobial and Antithrombogenic Technology 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 injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis or vein thrombosis.

## 6. Technological Characteristics and Substantial Equivalence

The Arrow Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the predicate Arrow Peripherally Inserted Midline Catheter (K963257) in terms of Indications for use. Both the predicate and the subject Indications for Use refer to use for peripheral access to the venous system. The difference in the Indications for use is that the subject Indications for use specifies in more detail the uses for the device and includes the ability to use the device for pressure injection as well as describing the antimicrobial and antithrombogenic properties of the subject catheter. (The predicate device does not contain antimicrobial and antithrombogenic properties.)

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the reference device, the ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) in terms of overall design, manufacturing process, functional performance, and materials of construction. The indications for use for the subject catheter are the same as the reference device (K112896) in all aspects aside from providing central venous access and the ability to use the device

{5}------------------------------------------------

for central venous pressure monitoring. The tip of the reference device (K112896) is intended to terminate in the Superior Vena Cava (central venous system) whereas the tip of the subject device is intended to terminate below the axillary line (venous system).

The same Chlorag+ard Technology treatment that is used for the reference device, the ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) is used for the subject device. The process of application of the Chlorag+ard Technology treatment is also the same as that of the reference device.

| Design<br>Characteristic | Predicate Device<br>Arrow Peripherally<br>Inserted Midline Catheter<br>(K963257) | Reference Device<br>AM/AT PICC (K112896) | Subject Pressure<br>Injectable CG+<br>MIDLINE |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Midline Catheter<br>permits venous access to the<br>peripheral circulation. It<br>offers an alternative method<br>of intravenous access for<br>select adult and pediatric<br>patients. | The Pressure Injectable<br>Peripherally Inserted<br>Central Catheters are<br>intended for short-term or<br>long-term peripheral access<br>to the central venous<br>system for intravenous<br>therapy and blood<br>sampling. | The Pressure Injectable<br>Midline Catheters are<br>intended for short-term<br>peripheral access to the<br>venous system for<br>intravenous therapy and<br>blood sampling. |
| Indications<br>for<br>Use | The Midline Catheter<br>permits venous access to the<br>peripheral circulation. It<br>offers an alternative method<br>of intravenous access for<br>select adult and pediatric<br>patients. | The ArrowEVOLUTION™<br>Pressure Injectable PICC<br>with Chlorag+ard<br>Antimicrobial and<br>Antithrombogenic<br>Technology is indicated for<br>short-term or long-term<br>peripheral access to the<br>central venous system for<br>intravenous therapy, blood<br>sampling, infusion, pressure<br>injection of contrast media,<br>and allows for central<br>venous pressure<br>monitoring. The maximum<br>pressure of pressure<br>injector equipment used<br>with the | The Arrow Pressure<br>Injectable Midline<br>Catheter with<br>Chlorag+ard<br>Antimicrobial and<br>Antithrombogenic<br>Technology is indicated<br>for short-term (< 30 days)<br>peripheral access to the<br>venous system for<br>intravenous therapy,<br>blood sampling, infusion,<br>and pressure injection of<br>contrast media. The<br>maximum pressure of<br>pressure injector<br>equipment used with the<br>Arrow Antimicrobial and<br>Antithrombogenic |
| Design<br>Characteristic | Predicate Device<br>Arrow Peripherally<br>Inserted Midline Catheter<br>(K963257) | Reference Device<br>AM/AT PICC (K112896) | Subject Pressure<br>Injectable CG+<br>MIDLINE |
| | | Pressure Injectable PICC<br>may not exceed 300 psi.<br>Chlorag+ard Technology<br>treatment on the external<br>surface of the catheter body<br>as well as the entire fluid<br>pathway of the catheter has<br>been shown to be effective<br>in reducing microbial<br>colonization and thrombus<br>accumulation on catheter<br>surfaces. Antimicrobial<br>and antithrombogenic<br>effectiveness were<br>evaluated using <i>in vitro</i> and<br><i>in vivo</i> test methods and no<br>correlation between these<br>testing methods and clinical<br>outcome has currently been<br>ascertained. It is not<br>intended to be used for the<br>treatment of existing<br>infections or vein<br>thrombosis. | Pressure Injectable<br>Midline Catheter may not<br>exceed 300 psi<br>(2068.4kPa). The<br>maximum pressure<br>injection flow rate for the<br>specific lumen being used<br>for pressure injection is<br>printed on the extension<br>line hub.<br>Chlorag+ard Technology<br>treatment on the external<br>surface of the catheter<br>body as well as the entire<br>fluid pathway of the<br>catheter has been shown<br>to be effective in<br>reducing microbial<br>colonization and<br>thrombus accumulation<br>on catheter surfaces.<br>Antimicrobial and<br>antithrombogenic<br>effectiveness were<br>evaluated using <i>in vitro</i><br>and <i>in vivo</i> test methods<br>and no correlation<br>between these testing<br>methods and clinical<br>outcome has currently<br>been ascertained. It is not<br>intended to be used for<br>the treatment of existing<br>infections or vein<br>thrombosis. |
| Catheter OD | 3, 4 and 5 Fr | 4.5 Fr and 5.5 Fr | Same as reference device:<br>4.5 Fr and 5.5 Fr. |
| Catheter<br>Usable Length | 15 cm | 40, 50, and 55 cm | Same as predicate device:<br>15 cm. |
| Design<br>Characteristic | Predicate Device<br>Arrow Peripherally<br>Inserted Midline Catheter<br>(K963257) | Reference Device<br>AM/AT PICC (K112896) | Subject Pressure<br>Injectable CG+<br>MIDLINE |
| Number<br>of Lumens | 3, 4 and 5 Fr. - 1 lumen<br>4 and 5 Fr. - 2 lumens | 4.5 Fr. - 1 lumen<br>5.5 Fr. - 2 lumens | Same as reference device:<br>4.5 Fr. - 1 lumen<br>5.5 Fr. - 2 lumens |
| Internal<br>Lumen<br>Configuration | Round<br>Circle/crescent | 4.5 Fr. - Round<br>5.5 Fr. - Double D | Same as reference device:<br>4.5 Fr. - Round<br>5.5 Fr. - Double D |
| Catheter Tip<br>Configuration | Blunt Tip | Blue FlexTip | Same as reference device:<br>Blue FlexTip |
| Pressure<br>Injection<br>Capabilities | None | Distal lumen – 5 mL/sec,<br>Pressure Injectable<br>Proximal lumen – 5<br>mL/sec, Pressure Injectable | Distal lumen - 5 mL/sec,<br>Pressure Injectable<br>Proximal lumen- Not<br>labeled for Pressure<br>Injection |
| Chlorhexidine<br>-Based<br>Coating<br>Performance | None | Antimicrobial Efficacy<br>Effective in reducing<br>microbial colonization<br>Antithrombogenic Efficacy<br>Effective in reducing<br>thrombus accumulation | Same as reference device:<br>Antimicrobial Efficacy<br>Effective in reducing<br>microbial colonization<br>Antithrombogenic<br>Efficacy<br>Effective in reducing<br>thrombus accumulation |
| Catheter Body<br>Material | White Polyurethane with<br>20% Barium Sulfate | Blue Polyurethane<br>with 30% Bismuth<br>Oxychloride | Same as reference device:<br>Blue Polyurethane<br>with 30% Bismuth<br>Oxychloride |
| Catheter Tip<br>Material | White Polyurethane with<br>20% Barium Sulfate | Blue Polyurethane with<br>30% Bismuth Oxychloride | Same as reference device:<br>Blue Polyurethane with<br>30% Bismuth<br>Oxychloride |
| Juncture<br>Hub Material | White Polyurethane | Transparent Light Blue<br>Polyurethane | Same as reference device:<br>Transparent Light Blue<br>Polyurethane |
| Extension Line | Clear Polyurethane | Clear Polyurethane | Same as reference device: |
| Design<br>Characteristic | Predicate Device<br>Arrow Peripherally<br>Inserted Midline Catheter<br>(K963257) | Reference Device<br>AM/AT PICC (K112896) | Subject Pressure<br>Injectable CG+<br>MIDLINE |
| Material | | | Clear Polyurethane |
| Extension<br>Hub<br>Material | Natural Polyurethane | Distal - Pink Polyurethane<br>Proximal – White<br>Polyurethane | Same as reference device:<br>Distal – Pink<br>Polyurethane<br>Proximal – White<br>Polyurethane |
| Printing Ink | Printing Ink NT16 Black Ink<br>Black Hot Stamp Printing<br>Foil | Printing Ink 2405 Black Ink | Same as reference device:<br>Printing Ink 2405 Black<br>Ink |
| Safety and<br>Performance<br>Testing | Mechanical testing to:<br>• ISO 10555-1<br>• ISO 10555-3<br>Biocompatibility testing | Mechanical testing to:<br>• ISO 10555-1<br>• ISO 10555-3<br>Biocompatibility testing | Same as both predicate<br>and reference device:<br>Mechanical testing to:<br>• ISO 10555-1<br>• ISO 10555-3<br>Biocompatibility testing |

## Predicate, Reference and Subject Device Comparison

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

# 7. Nonclinical Testing

The following performance testing related to the device changes has been completed to support the substantial equivalence of the subject devices to the predicate and reference devices:

- O priming volume
- gravity flow rate O
- 10 psi pumped flow rate O
- O rate limited pressure injection
- pressure limited injection O
- static burst O
- mechanical hemolysis O
- tensile testing (extension line to luer hub) O

The following standards were used in the non-clinical testing listed above:

- o ASTM F756-08
- o ISO 10555-1
- ISO 10555-3 O
- o ISO 10993-7
- o ISO 11135

# 8. Conclusions

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is the same device as the reference device, the ArrowEVOLUTION Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) with the exception of usable catheter length, extension line hub design (on proximal lumen of 2 lumen midline catheter) and extension line text. The results of the testing performed have demonstrated that the devices are safe, effective, and perform as intended. The subject device and predicate and reference devices (K963257 and K112896 respectively) have the same insertion site and associated insertion procedure. The final indwelling tip position of the subject and predicate (K963257) device is the same because they are both midline catheters per the proposed indications for use.

In conclusion, the Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the predicate Arrow Peripherally Inserted Midline Catheter (K963257) and the reference device, the ArrowEVOLUTION Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896).