MicroTaper Needle Introducer Set

K151076 · Summit Access, LLC · DRE · May 22, 2015 · Cardiovascular

Device Facts

• Record ID: K151076
• Device Name: MicroTaper Needle Introducer Set
• Applicant: Summit Access, LLC
• Product Code: DRE · Cardiovascular
• Decision Date: May 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The MicroTaper™ Needle Introducer Set is used for percutaneous introduction of a guidewire into the peripheral vasculature. The MicroTaper needle incorporates a blunting mechanism to reduce the risk of accidental needle stick injury.

Device Story

The MicroTaper Needle Introducer Set facilitates percutaneous vascular access. The system includes a 21G echogenic tapered stainless steel needle and a nitinol guidewire with a PEEK polymer jacket. The clinician inserts the needle into the peripheral vasculature; the guidewire is advanced through the needle to confirm placement. The device features a pass-through blunting mechanism activated by twisting the hub, which expands the needle's distal end and advances a blunter beyond the needle tip to prevent accidental needle stick injuries. Audible feedback confirms activation and locking. The needle is then withdrawn, leaving the guidewire in place for subsequent catheterization. The device is intended for use by clinicians in clinical settings. The blunting mechanism enhances safety without altering the fundamental clinical workflow of guidewire introduction.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including dimensional inspection, bond strength, needle penetration, guidewire mechanical properties (fracture, flexing, tensile force), sharps injury protection validation (ISO 23908), and biocompatibility testing (ISO 10993-1).

Technological Characteristics

Needle: Stainless steel cannula with shrink sleeve, 21G tapered to 18G (max OD 1.27mm). Guidewire: Nitinol with tungsten tip and PEEK polymer jacket. Features: Pass-through blunting mechanism, echogenic needle, standard female luer lock hub. Sterilization: Electron beam irradiation (VDmax25). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for percutaneous introduction of a guidewire into the peripheral vasculature in patients requiring vascular access.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Navilyst Medical NMI Coaxial Microintroducer Set (K123445)

Reference Devices

• TFX Medical Safety Needle with Introducer (K000665)

Submission Summary (Full Text)

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

May 22, 2015

Summit Access, LLC c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K151076

Trade/Device Name: MicroTaper Needle Introducer Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: April 21, 2015 Received: April 22, 2015

Dear Mark Job:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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" (21CFR 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.

Sincerelv vours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K151076

Device Name MicroTaper™ Needle Introducer Set

Indications for Use (Describe)

The MicroTaper™ Needle Introducer Set is used for percutaneous introduction of a guidewire into the peripheral vasculature. The MicroTaper needle incorporates a blunting mechanism to reduce the risk of accidental needle stick injury.

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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| Submitter: | Summit Access, LLC<br>14 Inverness Drive East, Suite H-136<br>Englewood, CO 80112<br>[phone]<br>Contact: Fred Piazza |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | March 31, 2015 |
| Trade/Device Name: | MicroTaper™ Needle Introducer Set |
| Regulation Number: | 870.1310 |
| Regulation Name: | Vessel dilator for percutaneous catheterization |
| Regulatory Class: | Class II |
| Product Code: | DRE |
| Predicate Device: | Vessel Dilator / Introducer Sheath (510(k) K123445)<br>Note: one reference device [TFX Medical Safety Needle with<br>Introducer (510(k) K000665)] was used for the sharps injury<br>prevention feature (blunting mechanism) in this submission. |

#### DEVICE DESCRIPTION

The Summit Access Needle Introducer Set consists of:

1 - 0.018 inch (0.46 mm) / 0.035 inch (0.89 mm) Tapered Guidewire, Angled, Nitinol

1 - 21G (0.9 mm) Tapered Needle, 18G (1.27 mm) Max Outside Diameter, Echogenic

The tapered needle consists of a stainless steel cannula with expansion feature and a translucent standard female luer lock hub. Needle is available in lengths of 3. 4. 7. 10. and 15 cm. The needle is used to gain percutaneous access to the vein or artery. The 0.018 inch tapered segment of the guidewire is advanced through the needle allowing confirmation of guidewire placement in the vasculature. The pass-through blunting mechanism is then actuated by twisting hub to needle main body, expanding the needle distal end. An audible confirmation of the actuation and locking confirms the blunting mechanism advances beyond the tip of the needle. The 0.035 inch segment of the guidewire is then advanced through the needle to desired placement. The needle is withdrawn, leaving the guidewire in place.

## INDICATIONS FOR USE

The MicroTaper™ Needle Introducer Set is used for percutaneous introduction of a guidewire into the peripheral vasculature. The MicroTaper needle incorporates a blunting mechanism to reduce the risk of accidental needle stick injury.

#### TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

Legally marketed vessel dilator for percutaneous catheterization to which substantial equivalence is claimed: Navilyst Medical NMI Coaxial Microintroducer Set (510(k) K123445).

> Page 1 of 5 510(k) =

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| ELEMENT OF<br>COMPARISON | SUBJECT DEVICE | CLAIMED SE DEVICE | Comparison Discussion | The MicroTaper Needle Introducer Set is substantially equivalent to the predicate<br>Navilyst Medical NMI Coaxial Microintroducer Set for the following elements: |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MicroTaper™ Needle Introducer Set | NMI Coaxial Microintroducer Set | | - Labeling; |
| Manufacturer Name | Summit Access, LLC | Navilyst Medical, Inc. | | - Diameters; |
| 510(k) Number | TBD | K123445 | | - Proximal Hub. |
| Product Code | DRE | DRE | | The following differences are noted but do not affect substantial equivalence of safety<br>and effectiveness: |
| Regulation | 21 CFR 870.1310 | 21 CFR 870.1310 | | - Indications for Use: Subject device specifies use in peripheral vasculature, which<br>is not stated in the predicate device. Both are introducer sets used in the<br>peripheral vasculature. In addition, the subject device incorporates a blunting<br>mechanism to reduce accidental needle stick injury. The sharps protection<br>feature does not affect the intended use as compared to the predicate. |
| Indications for Use | The MicroTaper™ Needle Introducer Set<br>is used for percutaneous introduction of a<br>guidewire into the peripheral vasculature.<br>The MicroTaper needle incorporates a<br>blunting mechanism to reduce the risk of<br>accidental needle stick injury. | The NMI Coaxial Microintroducer Set is<br>used for the percutaneous introduction of<br>a guidewire into the vascular system. | | - Components: SE device uses a dilator while MicroTaper needle tapers to larger<br>diameter, thus eliminating the need for dilator. Intended use of introduction of<br>guidewire into the vasculature is the same. |
| Labeling | Introducer set labeled for single-use,<br>sterile.<br>Package label includes product<br>identification, lot number, and expiration<br>date.<br>Instructions for use established. | Introducer set labeled for single-use,<br>sterile.<br>Package label includes product<br>identification, lot number, and expiration<br>date.<br>Instructions for use established. | | - Lengths: While 7cm length needle could be used for any peripheral access, the<br>MicroTaper needle lengths available include shorter (3 & 4 cm) for user to more<br>easily manage when a superficial vessel is accessed, such as a radial artery.<br>Longer (10 & 15 cm) may be needed to access a deeper vessel (e.g. morbidly<br>obese patient). The longer guidewire (15cm in additional length) will allow for<br>placement of longer sheaths that are now available in marketplace which can be<br>45-55cm in length. The length differences do not affect intended use or change<br>the vasculature accessed. |
| Components | One 21 Gauge Tapered Needle,<br>Echogenic<br>One 0.018" / 0.035" Tapered Guidewire | One 21 Gauge Standard Needle,<br>Echogenic;<br>One Coaxial Sheath/Dilator;<br>One 0.018" Guidewire | | - Materials (Patient Contacting): material of MicroTaper guidewire includes<br>PEEK polymer jacket, which was chosen for its lubricity, durability, and<br>flexibility. PEEK is used for other medical device applications. Needle cannula<br>includes shrink sleeve, which is used for needle expansion operation. Device<br>materials have been evaluated to ISO 10993-1 and meets biocompatibility<br>requirements. |
| Lengths | Needle - 7 cm standard and various other<br>lengths available (3, 4, 10, and 15 cm);<br>Guidewire - 60 cm | Needle - 7 cm;<br>Dilator - 10 cm;<br>Guidewire - 45 cm | | - Sharps Injury Prevention: the subject device incorporates a blunting mechanism<br>to reduce accidental needle stick injury whereas the SE device does not. The<br>sharps protection feature does not affect the intended use and the design is not<br>new or unique as compared to reference device. The MicroTaper Needle Sharps<br>Injury Prevention feature has been tested to meet FDA Recognized Consensus<br>Standard 6-273 ISO 23908 Sharps injury protection - Requirements and test<br>methods - Sharps protection features for single-use hypodermic needles,<br>introducers for catheters and needles used for blood sampling which encompass<br>the following aspects: Sharps Injury Protection Activation Indication, Sharps<br>Injury Protection Activation, Sharps Injury Protection Locking Mechanism<br>Challenge, and Access To The Sharp In Safe Mode. |
| Diameters | Needle - 21 Gauge (0.9 mm), Tapered to<br>18 Gauge (max OD = 1.27 mm);<br>Guidewire - 0.018 inch (0.46 mm)<br>tapered to 0.035 inch (0.89 mm) | Needle - 21 Gauge (0.9 mm);<br>Dilator - 4F or 5F<br>(max OD =<br>1.73 mm);<br>Guidewire - 0.018 inch (0.46 mm) | | |
| Materials (Patient<br>Contacting) | Needle Cannula - Stainless Steel with<br>shrink sleeve;<br>Guidewire – Nitinol with Tungsten Tip<br>and PEEK polymer jacket | Needle Cannula - Stainless Steel;<br>Dilator - Thermoplastic;<br>Guidewire – Nitinol with Tungsten Tip | | |
| Proximal Hub | Standard Luer Lock;<br>Translucent | Standard Luer Lock;<br>Translucent | | |
| Sharps Injury<br>Prevention | The MicroTaper needle incorporates a<br>blunting mechanism to reduce the risk of<br>accidental needle stick injury. Through-<br>the-lumen blunting safety feature, i.e.<br>blunter advances beyond the tip of the<br>needle. | No sharps injury prevention feature<br>incorporated. | | |

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# NON-CLINICAL PERFORMANCE DATA

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. Performance, packaging/labelling, sterilization, and biocompatibility testing of the subject MicroTaper Needle Introducer Set was conducted based on the risk analysis and based on the requirements of recognized and unrecognized international standards and FDA guidance documents.

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## Performance

- Surface Inspection
- Dimensional Inspection ●
- Hub / Needle Bond Strength .
- Hub / Blunting Cannula Bond Strength .
- . Protective Sheath Puncture
- Needle Penetration ●
- Conical Fittings with a 6% (Luer) Taper: Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, and Stress Cracking
- Guidewire Fracture, Flexing, and Peak Tensile Force
- Guidewire Compatibility ●
- Corrosion Resistance
- Guidewire Torque Strength, Torqueability, and Tip Flexibility ●
- Sharps Injury Protection Indication .
- Sharps Injury Protection Activation ●
- Sharps Injury Protection Locking Mechanism Challenge ●
- Access To The Sharp In Safe Mode ●
- Other Capabilities - Needle Echogenicity and Guidewire Radiopacity
- . Simulated Use

# Packaging/Labelling

- Environmental Conditioning and Distribution Simulation
- Package Integrity [Visual Inspection, Bubble Leak Test and Seal Strength Test] ●
- Stability Testing [Accelerated Aging Visual Inspection, Bubble Leak and Seal ● Strength]
- Symbols to be used with medical device labels ●

# Sterilization

- . Electron Beam Irradiation Sterilization Qualification using Dose Substantiation Method VDmax25
- Bacterial Endotoxins - LAL Test

# Biocompatibility

- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity ●
- . System Toxicity (Acute)
- . Genotoxicity
- Hemocompatibility
- Pyrogenicity ●

Page 4 of 5 510(k)

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#### CLINICAL PERFORMANCE DATA

No clinical studies were performed to demonstrate substantial equivalence.

## CONCLUSION OF SAFETY AND EFFECTIVENESS

The successful completion of:

- · performance tests;
- · compliance to biological standard ISO 10993-1; and
- comparison of similarities and differences with predicate device; .

demonstrate that the Summit Access MicroTaper Needle Introducer Set is as safe, as effective, and performs as well as or better than the legally marketed predicate device NMI Coaxial Microintroducer Set.