Stiletto Extended Dwell Catheter

K210047 · Piper Access, LLC · PND · Aug 27, 2021 · General Hospital

Device Facts

• Record ID: K210047
• Device Name: Stiletto Extended Dwell Catheter
• Applicant: Piper Access, LLC
• Product Code: PND · General Hospital
• Decision Date: Aug 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injectors.

Device Story

Stiletto Extended Dwell Catheter is a sterile, single-use midline catheter for peripheral vascular access; duration <28 days. Device features integrated catheter, hub, and insertion components; utilizes introducer needle and sheathing cannula for percutaneous insertion without guidewire. Unique tip geometry provides support during advancement. Available in 18G (10/12 cm) and 20G (8/10 cm) sizes. Used by clinicians to sample blood or administer fluids; compatible with power injectors. Benefits include reliable insertion method and short-term vascular access. Performance verified via bench testing and biocompatibility assessment.

Clinical Evidence

No clinical testing performed. Evidence consists of bench testing (ISO 10555-1, ISO 10555-5, ISO 7864, ISO 9626, ISO 80369, ASTM F640) and biocompatibility testing (ISO 10993 series). All tests passed.

Technological Characteristics

Materials: Polyurethane (shaft/hub), Stainless Steel (needle). Sensing/Actuation: Mechanical insertion via sheathing cannula. Dimensions: 18G/20G, 8-12 cm lengths. Connectivity: None. Sterilization: Ethylene Oxide (EO). Software: None.

Indications for Use

Indicated for any patient population requiring short-term (<28 days) intravenous fluid administration or blood sampling via peripheral vascular access, with consideration for vascular anatomy and procedure appropriateness. Suitable for power injection.

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

• PowerGlide Pro™ Midline Catheter (K162377)

Submission Summary (Full Text)

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August 27, 2021

Piper Access, LLC Jay Muse President and CEO 6030 W. Harold Gatty Dr. Salt Lake City, Utah 84116

Re: K210047

Trade/Device Name: Stiletto Extended Dwell Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: January 7, 2021 Received: January 8, 2021

Dear Jay Muse:

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 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

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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 (QS) 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.

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) K210047

Device Name

Stiletto Extended Dwell Catheter

#### Indications for Use (Describe)

The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may patient population with consideration given to adequacy of vascular anatomy and appropriateness of the Stiletto Extended Dwell Catheter is suitable for use with power injectors.

| 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 (21 CFR 807.92(c))

#### SUBMITTER I.

| Submitter Name: | Piper Access, LLC |
|-----------------|--------------------------------------------------------|
| Address: | 6030 West Harold Gatty Dr.<br>Salt Lake City, UT 84116 |
| Telephone: | 801-210-2886 |

| Contact Person: | Jay Muse |
|-------------------|--------------------------|
| Email of Contact: | [e-mail] |
| Date Prepared: | 26 August 2021 |

#### II. DEVICE

| Trade Name: | Stiletto Extended Dwell Catheter |
|--------------------|----------------------------------|
| Common/Usual Name: | Midline Catheter |
| Regulation Name: | Intravascular catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Product Code: | PND |
| Device Class: | Class II |
| Review Panel: | General Hospital |

### III. PREDICATE DEVICE

| Predicate Name: | PowerGlide Pro™ Midline Catheter |
|------------------------------|-------------------------------------|
| Common/Usual Name: | Intravascular Catheter, Therapeutic |
| Short-Term Less Than 30 Days | |
| Classification Name: | Intravascular catheter |
| Premarket Notification: | K162377 |
| Product Code: | FOZ |
| Manufacturer: | Bard Access Systems, Inc. |

#### DEVICE DESCRIPTION IV.

The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (<28 days) through a peripherally inserted catheter. The Stiletto EDC utilizes an introducer needle and sheathing cannula to support advancement of a single lumen, power-injectable, catheter into peripheral vasculature. Unique catheter tip geometry is employed that works in conjunction with a sheathing cannula to provide support as the catheter advances into the vessel, providing a reliable method of insertion without need of a guidewire. The

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Image /page/4/Picture/0 description: The image shows the logo for Piper Access. The logo consists of a stylized bird-like graphic above the text "PIPERACCESS™". The graphic is a curved line, with the top portion in orange and the bottom portion in gray. The text "PIPERACCESS" is in a sans-serif font, with "PIPER" in gray and "ACCESS" in orange, and the trademark symbol is in black.

catheter, hub and insertion components are integrated into a single housing to enhance ease of use.

The Stiletto EDC will be available in 8 cm and 10 cm lengths with a 20 gauge catheter, and 10 cm and 12 cm lengths with an 18 gauge catheter.

#### INDICATIONS FOR USE V.

The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injectors.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The following table provides a comparison of technological characteristics basis for a substantial equivalence determination utilizing the PowerGlide Pro™ Midline Catheter as the predicate device.

| Attribute | Predicate Device | Subject Device | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Device Name | PowerGlide ProTM<br>Midline Catheter | Stiletto Extended Dwell<br>Catheter | Substantially<br>Equivalent or<br>Identical to<br>Predicate |
| Variants | • 18 Gauge Catheter<br>• 20 Gauge Catheter<br>• 22 Gauge Catheter | • 18 Gauge Catheter<br>• 20 Gauge Catheter | Different |
| Attribute | Predicate Device | Subject Device | Substantially<br>Equivalent or<br>Identical to<br>Predicate |
| Device Name | PowerGlide Pro™<br>Midline Catheter | Stiletto Extended Dwell<br>Catheter | |
| Indications for<br>Use | The PowerGlide Pro™<br>Midline Catheter is<br>intended to be inserted in<br>the patient's vascular<br>system for short term use<br>(less than 30 days) to<br>sample blood or<br>administer fluids<br>intravenously. These<br>catheters may be used for<br>any patient population<br>with consideration given<br>to adequacy of vascular<br>anatomy and<br>appropriateness of the<br>procedure. The<br>PowerGlide Pro™<br>Midline Catheter is<br>suitable for use with<br>power injectors. | The Stiletto Extended<br>Dwell Catheter is<br>inserted into a patient's<br>vascular system for short-<br>term use (<28 days) to<br>sample blood or<br>administer fluids<br>intravenously. These<br>catheters may be used for<br>any patient population<br>with consideration given<br>to adequacy of vascular<br>anatomy and<br>appropriateness of the<br>procedure. The Stiletto<br>Extended Dwell Catheter<br>is suitable for use with<br>power injectors. | Different |
| Duration of Use | Short Term (less than 30<br>days) | Short Term (less than 28<br>days) | Different |
| Insertion Site | Peripheral | Peripheral | Identical |
| Insertion<br>Method | Percutaneous, over a<br>guidewire | Percutaneous, over a<br>needle (utilizing a<br>sheathing cannula) | Different |
| Specific Drug<br>Use | None | None | Identical |
| Lumens | Single Lumen | Single Lumen | Identical |
| Attribute | Predicate Device | Subject Device | Substantially<br>Equivalent or<br>Identical to<br>Predicate |
| Device Name | PowerGlide Pro™<br>Midline Catheter | Stiletto Extended Dwell<br>Catheter | Substantially<br>Equivalent or<br>Identical to<br>Predicate |
| Catheter<br>Dimensions | 18 Gauge Catheter<br>Length: 8 and 10 cm<br>20 Gauge Catheter<br>Length: 8 and 10 cm<br>22 Gauge Catheter<br>Length: 8 cm | 18 Gauge Catheter<br>Length: 10 and 12 cm<br>20 Gauge Catheter<br>Length: 8 and 10 cm | Different |
| Needle<br>Dimensions | 18 Gauge Device<br>Needle OD: 21 gauge<br>20 Gauge Device<br>Needle OD: 22 gauge<br>22 Gauge Device<br>Needle OD: 24 gauge | 18 Gauge Device<br>Needle OD: 22 gauge<br>20 Gauge Device<br>Needle OD: 24 gauge | Different |
| Catheter Base /<br>Needle Base<br>Materials | Shaft tubing:<br>Polyurethane<br>Luer hub: Polyurethane<br>Needle: Stainless Steel | Shaft tubing:<br>Polyurethane<br>Luer hub: Polyurethane<br>Needle: Stainless Steel | Identical |
| Power Injection<br>Maximum Flow<br>Rate | 18 Gauge Catheter:<br>7mL/sec<br>20 Gauge Catheter:<br>5mL/sec<br>22 Gauge Catheter:<br>2mL/sec | 18 Gauge Catheter:<br>7mL/sec<br>20 Gauge Catheter:<br>5mL/sec | Different |
| Needle Bevel | B Bevel | B Bevel | Identical |
| Single-Use | Yes | Yes | Identical |
| Target<br>Population | Any patient population<br>with consideration given<br>to adequacy of vascular<br>anatomy and<br>appropriateness of the<br>procedure | Any patient population<br>with consideration given<br>to adequacy of vascular<br>anatomy and<br>appropriateness of the<br>procedure | Identical |
| Attribute | Predicate Device | Subject Device | |
| Device Name | PowerGlide Pro™<br>Midline Catheter | Stiletto Extended Dwell<br>Catheter | Substantially<br>Equivalent or<br>Identical to<br>Predicate |
| Shelf Life | 24 Months | 60 Days:<br>20G-10cm<br><br>6 Months:<br>18G - 10cm<br>18G - 12cm<br>20G-8cm | Different |
| Packaging | Device provided in a<br>sterile pouch. Entire<br>pouch is EO sterilized | Device provided in a<br>sterile pouch. Entire<br>pouch is EO sterilized | Identical |
| Sterilization | Provided Sterile (EO) | Provided Sterile (EO) | Identical |
| Biocompatibility | ISO 10993 Compliant | ISO 10993 Compliant | Identical |

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### Discussion

- . Trade Name: Both trade names are appropriate for identifying the subject and predicate devices. The trade names are therefore substantially equivalent.
- Product Code, Duration of Use: The PND Product Code is specific to midline . catheters, which was determined by the Agency to be more appropriate for the subject device than the more general FOZ Product Code. The PND Product Code specifies short term use as <28 days, rather than <30 days for FOZ. Therefore, the duration of use for the subject device was adjusted accordingly. The slightly shorter patient contact time does not introduce any new risks to safety or efficacy for the subject device, as verified through biocompatibility testing per ISO 10993 series of applicable standards, and is therefore substantially equivalent to the predicate device.
- Variants: The subject device size variants are bracketed by the predicate device . size variants. All device variants were thoroughly tested in their worst case configurations via benchtop, simulated use/human factors, and biocompatibility testing (See Section VII), and no new risks of safety or efficacy were identified. The subject device variants are therefore substantially equivalent to the predicate device variants.
- . Indications for Use: The indications for use are identical with the exception of the duration of use. The slightly shorter patient contact time does not introduce

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any new risks to safety or efficacy for the subject device, as discussed above. The subject device is therefore substantially equivalent to the predicate device.

- Insertion Method: The use of a sheathing cannula to insert the subject devices . has been evaluated through both validation and verification testing. No new concerns of safety or efficacy were identified in either validation or verification testing. The subject device is therefore substantially equivalent to the predicate device.
- . Catheter Dimensions: Outer diameters of 18G and 20G catheters were verified to be compliant with ISO 10555-5 and applicable color coding. With respect to other catheter dimensions, the subject device catheters underwent benchtop verification testing in their worst-case dimensional configurations (See Section VII for a comprehensive list) and were shown to comply with applicable performance criteria specified in ISO 10555-1 and ISO 10555-5. All predetermined acceptance criteria were met, and the slight variations in dimensions introduced no new concerns of safety or efficacy. The subject device is therefore substantially equivalent to the predicate device.
- Needle Dimensions: The needle dimensions for the two subject device offerings . are bracketed by the predicate device offerings. Furthermore, engineering evaluations, including FMEA, dimensional, benchtop, and simulated use/human factors testing, established that the needle dimensions of the subject device are adequate for the intended use of the device. Needles were inspected and verified to be compliant with needle requirements per ISO 10555-5 and applicable portions of ISO 9626 and ISO 7864, including criteria for needle point. The subject device needle dimensions are therefore substantially equivalent to the predicate device needle dimensions.
- . Power Injection Maximum Flow Rate: The maximum flow rate for the two comparable device sizes between the subject device and predicate devices are identical. The subject device catheters were evaluated in compliance with ISO 10555-1 for power injection and maximum flow rates and comply with all associated criteria. The predicate device offers a smaller device outside of the subject device offerings which is not applicable for comparison. The subject device power injection maximum flow rates are therefore substantially equivalent to the comparable size offerings of the predicate device.
- . Shelf Life: The subject device and predicate device are both verified through their respective labeled shelf lives without performance degradation by benchtop evaluations following shelf life conditioning. Testing following shelf life conditioning was performed on appropriate characteristics that have the potential to be affected by time and adequately assess the potential for performance degradation. Shelf life testing raised no new concerns of safety or efficacy for the subject device, and applicable acceptance criteria were met following conditioning. The subject device and predicate device are therefore substantially equivalent for their respective labeled shelf lives.

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Image /page/9/Picture/0 description: The image shows the logo for Piper Access. The logo consists of a stylized line drawing above the company name. The line drawing is a curved line that is orange at the top and transitions to gray at the bottom. The company name, "PIPERACCESS," is written in a sans-serif font, with "PIPER" in gray and "ACCESS" in orange, followed by a trademark symbol.

## VII. PERFORMANCE DATA

## Bench Testing

Bench tests are listed below in Table 2.

| Standard | Test Name | Result |
|----------------------|--------------------------------------------|--------|
| ISO 7864 | | |
| ISO 9626 | Needle Surface and Sharpness | Passed |
| ISO 10555-1 | | |
| Internal Requirement | Dimensions – Needle Effective Length | Passed |
| ISO 10555-5 | Catheter to Needle Bevel Heel Lie Distance | Passed |
| ISO 10555-1 | Radiopacity | Passed |
| ASTM F640 | | |
| Internal Requirement | Needle Cap Removal Force | Passed |
| ISO 10555-5 | Flashback Detection | Passed |

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| Standard | Test Name | Result |
|-----------------------------|----------------------------------------------------------------|--------|
| ANSI/AAMI HE75<br>ISO 23908 | Assembly Force/Safety Activation Force | Passed |
| Internal Requirement | Insertion Tool Withdrawal Force | Passed |
| Internal Requirement | Catheter Kink Diameter | Passed |
| FDA Guidance<br>Document | Dimensions – Catheter Effective Length | Passed |
| ISO 10555-5 | Dimensions – Catheter OD | Passed |
| ISO 10555-1 | Ink Permanence | Passed |
| ISO 10555-1 | Leak | Passed |
| Internal Requirement | Pump Flow | Passed |
| Internal Requirement | Assembly Tensile – Cannula – PEEK to<br>Stainless Steel | Passed |
| ISO 23908<br>ANSI/AAMI HE75 | Needle Safety Override Force | Passed |
| ISO 7864 | Assembly Tensile – Needle to Top Case | Passed |
| ISO 9626 | Needle Tubing Stiffness | Passed |
| Internal Requirement | Assembly Tensile – Cannula – Stainless Steel<br>to Thumb Slide | Passed |
| ISO 9626 | Cannula Resistance to Breakage | Passed |
| ISO 9626 | Needle Resistance to Breakage | Passed |
| ISO 10555-5 | Needle Loosening | Passed |
| FDA Guidance<br>Document | Priming Volume | Passed |
| Internal Requirement | Gravity Flow | Passed |
| Internal Requirement | Catheter Collapse | Passed |
| Internal Requirement | Dimensions – Catheter Outer Diameter (Optical<br>Micrometer) | Passed |
| ISO 10555-1 | Assembly Tensile – Catheter Shaft to Core Hub | Passed |
| ISO 10555-1 | Catheter Shaft Tensile | Passed |
| ISO 10555-1 | Catheter Burst | Passed |
| ISO 80369 | Luer/Hub Evaluations Per ISO 80369 | Passed |

## Clinical Testing

No Clinical Testing was performed.

## Biocompatibility

| Biological Effect | Mitigation Step | Result |
|---------------------------|-----------------------------------|----------------|
| Cytotoxicity | MEM Elution | Non-cytotoxic |
| Sensitization | Magnusson-Kligman<br>Maximization | Non-sensitizer |
| Irritation | Intracutaneous Reactivity | Non-irritant |
| Systemic Toxicity (Acute) | Systemic Injection | Non-toxic |

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| Biological Effect | Mitigation Step | Result | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Material Mediated Pyrogen | Non-pyrogenic | |
| Hemocompatibility | Hemolysis (indirect) | Non-hemolytic | |
| | Hemolysis (direct) | Non-hemolytic | |
| | Partial Thromboplastin Time | Minimal Activator | |
| | Complement Activation | Similar to<br>Comparison Device | |
| | Dog Thrombogenicity | Equivocal | |
| | Implantation | Rationalization for evaluation<br>with previous testing on<br>representative test sample (See<br>M114-006) | Non-irritant |
| Acute/Subacute/Subchronic<br>Toxicity<br>Genotoxicity<br>Chronic Toxicity<br>Carcinogenicity | Assessed through chemical<br>evaluation of leachates and a<br>Toxicological Risk Assessment | MOS > 1 for all<br>compounds and<br>populations | |
| | Particulate Matter | Sizing and Counting Particulate<br>Matter: Light Obscuration<br>Method | Acceptable per USP<br><788> and Legally<br>Marketed<br>Comparative Device |

## VIII. CONCLUSION

Through performance bench testing results, it has been demonstrated that the subject device is substantially equivalent to the predicate device, PowerGlide Pro™ Midline Catheter (K162377)with respect to the intended use, target populations, treatment method, and technological characteristics. The identified differences between the devices do not raise any new questions of safety or effectiveness.