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 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 The needle is withdrawn, leaving the guidewire in place.

AI/ML Overview

The provided FDA 510(k) document for the MicroTaper Needle Introducer Set (K151076) does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in a clinical or AI performance context.

This document is a premarket notification for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a clinical trial report or an evaluation of an AI-powered device. Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable to this type of regulatory submission.

However, I can extract information regarding the non-clinical performance tests conducted to support the substantial equivalence claim, which serve as a form of acceptance criteria for the device's functional and safety aspects.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI or clinical performance study, the "acceptance criteria" here refer to the successful completion of various non-clinical performance, packaging/labeling, sterilization, and biocompatibility tests. The "reported device performance" is indicated by the statement of "successful completion" of these tests.

Acceptance Criterion (Test Category)	Reported Device Performance
Performance Tests	Successful completion
- Surface Inspection	(Implied)
- Dimensional Inspection	(Implied)
- Hub / Needle Bond Strength	(Implied)
- Hub / Blunting Cannula Bond Strength	(Implied)
- Protective Sheath Puncture	(Implied)
- Needle Penetration	(Implied)
- Conical Fittings (Luer Taper)	(Implied)
- Guidewire Fracture, Flexing, and Peak Tensile Force	(Implied)
- Guidewire Compatibility	(Implied)
- Corrosion Resistance	(Implied)
- Guidewire Torque Strength, Torqueability, and Tip Flexibility	(Implied)
- Sharps Injury Protection Indication	(Implied)
- Sharps Injury Protection Activation	(Implied)
- Sharps Injury Protection Locking Mechanism Challenge	(Implied)
- Access To The Sharp In Safe Mode	(Implied)
- Other Capabilities (Needle Echogenicity and Guidewire Radiopacity)	(Implied)
- Simulated Use	(Implied)
Packaging/Labelling Tests	Successful completion
- Environmental Conditioning and Distribution Simulation	(Implied)
- Package Integrity (Visual Inspection, Bubble Leak Test, Seal Strength Test)	(Implied)
- Stability Testing (Accelerated Aging Visual Inspection, Bubble Leak, Seal Strength)	(Implied)
- Symbols to be used with medical device labels	(Implied)
Sterilization Tests	Successful completion
- Electron Beam Irradiation Sterilization Qualification using Dose Substantiation Method VDmax25	(Implied)
- Bacterial Endotoxins - LAL Test	(Implied)
Biocompatibility Tests	Successful completion
- Cytotoxicity	(Implied)
- Sensitization	(Implied)
- Irritation or Intracutaneous Reactivity	(Implied)
- System Toxicity (Acute)	(Implied)
- Genotoxicity	(Implied)
- Hemocompatibility	(Implied)
- Pyrogenicity	(Implied)

2. Sample size used for the test set and the data provenance:

Not applicable. This document describes non-clinical engineering and biological tests, not a clinical study on a patient test set. The tests would likely involve a statistically appropriate number of device units or components, but specific sample sizes for each test are not provided in this summary. Data provenance is not specified as these are internal manufacturer tests based on recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of expert consensus is not relevant here as it's not a diagnostic AI device or a clinical outcome study. The "ground truth" for these non-clinical tests would be the established scientific and engineering principles, and the pass/fail criteria defined by the relevant standards (e.g., ISO, FDA guidance). The experts involved would be engineers, microbiologists, and other technical specialists conducting the tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert labeling or diagnoses, which is not relevant to non-clinical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study was not done. This device is not an AI-powered diagnostic tool, but a medical instrument (needle introducer set).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm. The device performance is standalone (i.e., the physical device itself is tested), but in a non-clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Non-clinical test standards and specifications. The "ground truth" for these tests are the pre-defined pass/fail criteria established by international standards (e.g., ISO 10993-1 for biocompatibility, ISO 23908 for sharps injury protection) and internal engineering specifications, based on physical and chemical properties and functional requirements of the device.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no training set in this context.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set.

Summary Statement regarding the study:

The study proving the device meets its "acceptance criteria" is a series of non-clinical performance and biological evaluations. As stated in the "CONCLUSION OF SAFETY AND EFFECTIVENESS" section: "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."

The document also explicitly states: "No clinical studies were performed to demonstrate substantial equivalence." (Page 7). This confirms that the evidence presented is based entirely on non-clinical testing and comparison to a predicate device, rather than patient data or trials.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a central graphic. The graphic features a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The overall design is simple and professional, reflecting the department's role in public health and human services.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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.

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PSC Poblushing Services (301) 444-6740

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Submitter:	Summit Access, LLC14 Inverness Drive East, Suite H-136Englewood, CO 80112(303) 951-8768Contact: 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)Note: one reference device [TFX Medical Safety Needle withIntroducer (510(k) K000665)] was used for the sharps injuryprevention 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

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 OFCOMPARISON	SUBJECT DEVICE	CLAIMED SE DEVICE	The MicroTaper Needle Introducer Set is substantially equivalent to the predicateNavilyst 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 safetyand effectiveness:
Regulation	21 CFR 870.1310	21 CFR 870.1310	- Indications for Use: Subject device specifies use in peripheral vasculature, whichis not stated in the predicate device. Both are introducer sets used in theperipheral vasculature. In addition, the subject device incorporates a bluntingmechanism to reduce accidental needle stick injury. The sharps protectionfeature does not affect the intended use as compared to the predicate.
Indications for Use	The MicroTaper™ Needle Introducer Setis used for percutaneous introduction of aguidewire into the peripheral vasculature.The MicroTaper needle incorporates ablunting mechanism to reduce the risk ofaccidental needle stick injury.	The NMI Coaxial Microintroducer Set isused for the percutaneous introduction ofa guidewire into the vascular system.	- Components: SE device uses a dilator while MicroTaper needle tapers to largerdiameter, thus eliminating the need for dilator. Intended use of introduction ofguidewire into the vasculature is the same.
Labeling	Introducer set labeled for single-use,sterile.Package label includes productidentification, lot number, and expirationdate.Instructions for use established.	Introducer set labeled for single-use,sterile.Package label includes productidentification, lot number, and expirationdate.Instructions for use established.	- Lengths: While 7cm length needle could be used for any peripheral access, theMicroTaper needle lengths available include shorter (3 & 4 cm) for user to moreeasily manage when a superficial vessel is accessed, such as a radial artery.Longer (10 & 15 cm) may be needed to access a deeper vessel (e.g. morbidlyobese patient). The longer guidewire (15cm in additional length) will allow forplacement of longer sheaths that are now available in marketplace which can be45-55cm in length. The length differences do not affect intended use or changethe vasculature accessed.
Components	One 21 Gauge Tapered Needle,EchogenicOne 0.018" / 0.035" Tapered Guidewire	One 21 Gauge Standard Needle,Echogenic;One Coaxial Sheath/Dilator;One 0.018" Guidewire	- Materials (Patient Contacting): material of MicroTaper guidewire includesPEEK polymer jacket, which was chosen for its lubricity, durability, andflexibility. PEEK is used for other medical device applications. Needle cannulaincludes shrink sleeve, which is used for needle expansion operation. Devicematerials have been evaluated to ISO 10993-1 and meets biocompatibilityrequirements.
Lengths	Needle - 7 cm standard and various otherlengths available (3, 4, 10, and 15 cm);Guidewire - 60 cm	Needle - 7 cm;Dilator - 10 cm;Guidewire - 45 cm	- Sharps Injury Prevention: the subject device incorporates a blunting mechanismto reduce accidental needle stick injury whereas the SE device does not. Thesharps protection feature does not affect the intended use and the design is notnew or unique as compared to reference device. The MicroTaper Needle SharpsInjury Prevention feature has been tested to meet FDA Recognized ConsensusStandard 6-273 ISO 23908 Sharps injury protection - Requirements and testmethods - Sharps protection features for single-use hypodermic needles,introducers for catheters and needles used for blood sampling which encompassthe following aspects: Sharps Injury Protection Activation Indication, SharpsInjury Protection Activation, Sharps Injury Protection Locking MechanismChallenge, and Access To The Sharp In Safe Mode.
Diameters	Needle - 21 Gauge (0.9 mm), Tapered to18 Gauge (max OD = 1.27 mm);Guidewire - 0.018 inch (0.46 mm)tapered to 0.035 inch (0.89 mm)	Needle - 21 Gauge (0.9 mm);Dilator - 4F or 5F(max OD =1.73 mm);Guidewire - 0.018 inch (0.46 mm)
Materials (PatientContacting)	Needle Cannula - Stainless Steel withshrink sleeve;Guidewire – Nitinol with Tungsten Tipand PEEK polymer jacket	Needle Cannula - Stainless Steel;Dilator - Thermoplastic;Guidewire – Nitinol with Tungsten Tip
Proximal Hub	Standard Luer Lock;Translucent	Standard Luer Lock;Translucent
Sharps InjuryPrevention	The MicroTaper needle incorporates ablunting mechanism to reduce the risk ofaccidental needle stick injury. Through-the-lumen blunting safety feature, i.e.blunter advances beyond the tip of theneedle.	No sharps injury prevention featureincorporated.

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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.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
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.(b)
Classification. Class II (performance standards).