(30 days)
No
The description focuses on mechanical features and material properties, with no mention of AI/ML algorithms or data processing.
No
Explanation: This device is used for percutaneous introduction of a guidewire, which facilitates access to vasculature for other procedures. It does not provide any therapeutic intervention itself.
No
This device is used for percutaneous introduction of a guidewire into the peripheral vasculature, which is an interventional procedure. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly details physical components like needles, guidewires, and hubs, and the performance studies focus on physical properties and interactions, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous introduction of a guidewire into the peripheral vasculature." This is a procedure performed directly on a patient's body for access, not for testing samples in vitro (outside the body).
- Device Description: The description details a needle, guidewire, and blunting mechanism used for accessing blood vessels. This aligns with a surgical or interventional device, not a diagnostic test kit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for accessing the vasculature for subsequent medical procedures.
N/A
Intended Use / 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.
Product codes
DRE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were performed to demonstrate substantial equivalence. 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.
Performance tests included:
- 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 tests included:
- 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 tests included:
- Electron Beam Irradiation Sterilization Qualification using Dose Substantiation Method VDmax25
- Bacterial Endotoxins - LAL Test
Biocompatibility tests included:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- System Toxicity (Acute)
- Genotoxicity
- Hemocompatibility
- Pyrogenicity
Key Results: Successful completion of performance tests, compliance to biological standard ISO 10993-1, and comparison of similarities and differences with predicate device demonstrated the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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PSC Poblushing Services (301) 444-6740
3
| Submitter: | Summit Access, LLC
14 Inverness Drive East, Suite H-136
Englewood, CO 80112
(303) 951-8768
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)
Note: one reference device [TFX Medical Safety Needle with
Introducer (510(k) K000665)] was used for the sharps injury
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) =
4
| ELEMENT OF
COMPARISON | SUBJECT DEVICE | CLAIMED SE DEVICE | Comparison Discussion | The MicroTaper Needle Introducer Set is substantially equivalent to the predicate
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
and effectiveness: |
| Regulation | 21 CFR 870.1310 | 21 CFR 870.1310 | | - Indications for Use: Subject device specifies use in peripheral vasculature, which
is not stated in the predicate device. Both are introducer sets used in the
peripheral vasculature. In addition, the subject device incorporates a blunting
mechanism to reduce accidental needle stick injury. The sharps protection
feature does not affect the intended use as compared to the predicate. |
| 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. | The NMI Coaxial Microintroducer Set is
used for the percutaneous introduction of
a guidewire into the vascular system. | | - Components: SE device uses a dilator while MicroTaper needle tapers to larger
diameter, thus eliminating the need for dilator. Intended use of introduction of
guidewire into the vasculature is the same. |
| Labeling | Introducer set labeled for single-use,
sterile.
Package label includes product
identification, lot number, and expiration
date.
Instructions for use established. | Introducer set labeled for single-use,
sterile.
Package label includes product
identification, lot number, and expiration
date.
Instructions for use established. | | - Lengths: While 7cm length needle could be used for any peripheral access, the
MicroTaper needle lengths available include shorter (3 & 4 cm) for user to more
easily 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. morbidly
obese patient). The longer guidewire (15cm in additional length) will allow for
placement of longer sheaths that are now available in marketplace which can be
45-55cm in length. The length differences do not affect intended use or change
the vasculature accessed. |
| Components | One 21 Gauge Tapered Needle,
Echogenic
One 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 includes
PEEK polymer jacket, which was chosen for its lubricity, durability, and
flexibility. PEEK is used for other medical device applications. Needle cannula
includes shrink sleeve, which is used for needle expansion operation. Device
materials have been evaluated to ISO 10993-1 and meets biocompatibility
requirements. |
| Lengths | Needle - 7 cm standard and various other
lengths 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 mechanism
to reduce accidental needle stick injury whereas the SE device does not. The
sharps protection feature does not affect the intended use and the design is not
new or unique as compared to reference device. The MicroTaper Needle Sharps
Injury Prevention feature has been tested to meet FDA Recognized Consensus
Standard 6-273 ISO 23908 Sharps injury protection - Requirements and test
methods - Sharps protection features for single-use hypodermic needles,
introducers for catheters and needles used for blood sampling which encompass
the following aspects: Sharps Injury Protection Activation Indication, Sharps
Injury Protection Activation, Sharps Injury Protection Locking Mechanism
Challenge, and Access To The Sharp In Safe Mode. |
| Diameters | Needle - 21 Gauge (0.9 mm), Tapered to
18 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 (Patient
Contacting) | Needle Cannula - Stainless Steel with
shrink sleeve;
Guidewire – Nitinol with Tungsten Tip
and 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 Injury
Prevention | The MicroTaper needle incorporates a
blunting mechanism to reduce the risk of
accidental needle stick injury. Through-
the-lumen blunting safety feature, i.e.
blunter advances beyond the tip of the
needle. | No sharps injury prevention feature
incorporated. | | |
5
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.
6
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)
7
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.