RadialSeal Introducer Kit

• K Number: K181855
• Device Name: RadialSeal Introducer Kit
• Manufacturer: Greatbatch Medical
• Date Cleared: 2018-07-26 ( 15 days)
• Product Code: DYB
• Regulation Number: 870.1340

Intended Use

The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

Device Description

The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy. An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly). A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s). The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.

Predicate Devices

K142183

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and mechanical performance of the introducer kit, with no mention of AI or ML capabilities.

Therapeutic

No

Explanation: The RadialSeal™ Introducer Kit is a device used to facilitate the placement of a catheter into the radial artery. It is an access device, not a device that directly treats a medical condition or disease.

Diagnostic

No.
The device is used to facilitate the placement of a catheter into the radial artery for treatment, not for diagnosing a condition. Its primary function is to provide access for other treatment devices.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple physical components made of materials like stainless steel and plastic, including a sheath, dilator, needle, and guidewire. The performance studies also involve bench testing and animal models of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "facilitate placing a catheter through the skin into the radial artery." This describes a procedure performed directly on a patient's body for therapeutic or diagnostic purposes within the body.
• Device Description: The device components (introducer, sheath, dilator, needle, guidewire) are all designed for accessing a blood vessel and facilitating the insertion of another device (a catheter) into that vessel. This is an invasive procedure.
• Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are specifically designed for this type of testing.

In summary, the RadialSeal™ Introducer Kit is a medical device used for an interventional procedure, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

Product codes (comma separated list FDA assigned to the subject device)

DYB

Device Description

The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy.

An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly).

A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s).

The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Radial Artery

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)

Non-Clinical performance bench testing was summarized in tables, indicating no new issues of safety and effectiveness were raised and results were within predetermined acceptance criteria. Side-by-side testing between the predicate device and RadialSeal was performed against ISO 11070 section A.1, and also for valve insertion force, introducer insertion force, external surface sliding force, hydrophilic coating separation resistance (cycle testing), and In Vitro Particulate Evaluation. The devices performed equivalently.
Performance testing was conducted on both devices in an animal model (GLP Acute Animal Porcine study at American Preclinical Services), where both devices were found to perform equivalently. The tests were applied to the assembled device, sheath introducer, valve, dilator, guidewire and bare needle and IV catheter.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142183

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 26, 2018

Greatbatch Medical % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K181855

Trade/Device Name: RadialSeal Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: July 9, 2018 Received: July 11, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Finn E. Donaldson" in large, bold font. Below the name, the word "for" is written in a smaller font. To the right of the name, there is a digital signature block that includes information such as the signer's name, date, and other details related to the digital signature. The date of the signature is July 26, 2018.

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) K181855

Device Name RadialSeal™ Introducer Kit

Indications for Use (Describe)

The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

Type of Use (Select one or both, as applicable)

X 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 [e-mail]

"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

Submitter's Name: Address:

Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441

| Primary Contact: | Phyllis Piet-Hughes
Senior Manager of Clinical and Regulatory
Telephone: [phone]
Fax: [phone]
Email: [e-mail] |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 19, 2018 |

Device Information

Trade Name: RadialSeal™ Introducer Kit Common Name: Introducer Sheath Classification Name: Introducer, Catheter Product Code: DYB Regulatory Class: Class II 21 CFR 870.1340 Panel: Cardiovascular

4

Predicate Device

Greatbatch Medical is identifying the Terumo Glidesheath Slender® (K142183) as the predicate device. The Terumo Glidesheath Slender has not been subject to a design related recall.

Device Description

The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy.

An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly).

A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s).

The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.

Indications for Use

The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

The differences in technology between the RadialSeal™ Introducer Kit and the predicate device do not alter the intended therapeutic use of the device. Both the subject and predicate device have the same intended use.

The conclusions drawn from the non-clinical and pre-clinical testing on the RadialSeal™ Introducer Kit demonstrate that the device is as safe, as effective and performs as well as the legally marketed predicate device (Terumo Glidesheath Slender® (K142183).

5

Technological Characteristics Comparison

The RadialSeal™ Introducer Kit has the same indication for use and principles of operation as the market cleared Terumo Glidesheath Slender® (K142183). In addition, functional characteristics of the RadialSeal™ Introducer are substantially equivalent to the Glidesheath Slender, with similar materials, dimensions, and method of construction. The design modifications to the new device include differences in material for the coating and the sheath, and the elimination of a metal ferrule. Additional sizes are also available with the new device (4F and 25cm).

The RadialSeal Introducer Kit is comparable to the predicate device in terms of intended use, duration of use, principles of operation, insertion method and anatomical location. The results of the non-clinical performance and biocompatibility testing indicates that the new device performs as well as the predicate device.

A risk analysis was conducted in accordance with ISO 14971 taking into account the modifications to the previous device and it was determined that there are no new issues of safety or effectiveness.

| Device Characteristic | Predicate Device Terumo
Glidesheath Slender®
(K142183) | Proposed Device
RadialSeal™
Introducer Kit |
|----------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Indications for Use | The Glidesheath Slender® is used to
facilitate placing a catheter through
the skin into the Radial artery. | Same |
| FDA Classification | Class II, DYB | Same |
| Anatomical Region | Radial Artery | Same |
| Basic Principles of
Operation | The Glidesheath Slender® is
operated manually or by a manual
process. | Same |

Predicate Device (Glidesheath Slender) Comparison to RadialSeal

6

| Device Characteristic | Predicate Device Terumo
Glidesheath Slender®
(K142183) | Proposed Device
RadialSeal™
Introducer Kit |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Configuration | 5, 6, or 7F sheath of usable length
10 or 16cm Plastic or stainless
steel guidewire | 4, 5, or 6F sheath of usable length
10, 16, or 25cm Plastic or stainless
steel guidewire |
| French Sizes | 5F, 6F, 7F | 4F, 5F, 6F |
| Useable Length | 100mm, 160mm | 100mm, 160mm, 250mm |
| Kit Contents | Dilator Sheath
Plastic or stainless steel guidewire
(0.018", 0.021", 0.025", 0.035" OD)
and 45 or 80 cm length) Stainless steel
entry needle or SurfloIV Catheter | Dilator Sheath
Plastic or stainless steel guidewire
(0.021" OD, 45 cm or 0.021"OD 80
cm length) Stainless steel entry
needle or IV catheter |
| Device Features | Side-port with three-way stopcock
Hemostasis valve | Side-port with three-way stopcock
Hemostasis valve |

Predicate Device (Glidesheath Slender) Comparison to RadialSeal Continued

Materials Comparison

| Device Characteristic | | Predicate Device Terumo
Glidesheath Slender®
(K142183) | Proposed Device
RadialSeal™
Introducer Kit |
|-----------------------|---------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Sheath | Valve/
Lubricant | Silicone rubber | Silicone rubber with silicone liquid
lubricant |
| | Coating | Hydrophilic coating on sheath | Hydrophilic coating on sheath |
| | Hub | Polypropylene | Nylon 12 w/10% Glass |
| | Strain
Relief | Styrene-ethylene-butylene- styrene
block copolymer | Santoprene, colored |
| | Shaft | Ethylene-Tetraflouoroethylene
copolymer (ETFE), Bismuth
trioxide(Bi2O3), with stainless steel
ferrule | Ethylene- Tetrafluoroethylene-
Hexafluoropropylene-
Fluoroterpolymer (EFEP) w/Barium
Sulfate (BaSO4), Sodium
Naphthalene |

7

| Device Characteristic | | Predicate Device Terumo
Glidesheath Slender®
(K142183) | Proposed Device RadialSeal™
Introducer Kit |
|-----------------------------|-----------------|------------------------------------------------------------------|------------------------------------------------------------------------|
| Sheath Side-port Assembly | | Polybutadiene, polyethylene,
polypropylene, polycarbonate | Carbothane, polycarbonate, Delrin |
| IV Catheter | Hub | Polypropylene | Polypropylene |
| | Bushing | Stainless steel | Stainless steel |
| | Cannula | Ethylene-Tetrafluoroethylene
copolymer (ETFE), barium sulfate | Fluorinated Ethylene Propylene |
| | Needle hub | Polycarbonate | Methyl methacrylate- acrylonitrile-
butadiene-styrene (MABS), clear |
| | Needle | Stainless steel | Stainless steel |
| | Filter assembly | Polystyrene, Polyester- chlorinated
polyvinyl chloride | Versapor acrylic MABS, clear |
| Introducer Needle | Hub | Polycarbonate | Polycarbonate |
| | Cannula | Stainless Steel | Stainless Steel |
| Guidewire – stainless steel | | Stainless Steel | Stainless Steel |
| Guidewire - plastic | | Nickel-Titanium alloy Tungsten,
Polyurethane | Nickel-Titanium alloy Black
Polyurethane, 50%Tungsten |
| J straightener | | Polyethylene | Polypropylene, natural |

Materials Comparison Continued

8

| Device Characteristic | Predicate Device Terumo
Glidesheath Slender® | Proposed Device RadialSeal™
Introducer Kit | |
|-----------------------|-------------------------------------------------|------------------------------------------------------|----------------------------------------------|
| | (K142183) | | |
| | Shaft | Polypropylene with bismuth
subcarbonate (BiO)2CO3 | Polypropylene with Barium Sulfate
(BaSO4) |
| Dilator | Hub | Polypropylene with stainless steel
ferrule | Polypropylene, colored |
| | Lubricant | Unknown | Silicone |

Materials Comparison Continued

Performance Testing

Non-Clinical performance bench testing is summarized in the following tables. Results indicated that no new issues of safety and effectiveness were raised and the results were within the predetermined acceptance criteria.

Side by side testing between the predicate device and RadialSeal was performed against ISO 11070 section A.1. Side by side testing between the predicate device and RadialSeal also was performed for valve insertion force, introducer insertion force, external surface sliding force, hydrophilic coating separation resistance, (cycle testing) and In Vitro Particulate Evaluation. The devices performed equivalently.

9

Sheath Performance Testing

Sheath Performance Testing	Method
Surface	ISO 11070 Sec 4.3
Corrosion Resistance	ISO 11070 Sec 4.4
Radio-detectability	ISO 11070 Sec 4.5
Dimensions- Size Designation	ISO 11070 Sec 7.2
Sheath Introducer leakage
(Freedom from Leakage from
Sheath Introducer)	ISO 11070 Sec 7.3
Hemostasis
(Freedom from Leakage through
Hemostasis Valve)	ISO 11070 Sec 7.4
Peak Tensile Force
(Force at Break)	ISO 11070 Sec 7.6
Sheath to dilator fit, rollback test,
Puncture model test, Kink Angle,
Radius of Curvature	ISO 11070 Sec A.1
Valve Insertion Force	Internal Standard
Introducer Insertion Force	Internal Standard
External surface sliding force	Internal Standard
Hydrophilic coating separation
resistance( cycle testing)	Internal Standard
Hydrophilic coating particulate
evaluation (In vitro particulate test)	FDA Guidance, USP 788
Dimensional Verification	ISO 11070 Sec 7.2
Hub	ISO 11070 Sec 7.5,
ISO 594-1, ISO 594-2

10

| Stainless Steel Needle

Performance Testing	Method
Surface (surface defects)	ISO11070 Sec 4.3
Corrosion Resistance	ISO 11070 Sec. 4.4
Dimensional Verification	ISO 11070 Sec. 5.2
Needle Point	ISO 11070 Sec 5.3
Conical Fitting	ISO 11070 Sec. 5.4.1;
ISO 594-1, ISO 594-2
Strength of Union
(Needle Tube to Hub)	ISO 11070 Sec. 5.4.2
Radio-detectability	ISO 11070 Sec 4.5

Catheter Performance Testing

| IV Catheter

Performance Testing	Method
Surface (Surface defects)	ISO 11070 Sec. 4.3
Corrosion Resistance	ISO 11070 Sec. 4.4
Radio-detectability	ISO 11070 Sec. 4.5
Catheter to needle Fit	ISO 11070 Sec. 6.2
Peak Tensile Force	ISO 11070 Sec. 6.3
Size Designation	ISO 11070 Sec. 6.5
Conical Fitting/Hub	ISO 594-1
ISO 11070 section 6.4
Strength of Union
(Needle Tube to Hub)	ISO11070 Sec.7.6.
Dimensional Verification	ISO 11070 Sec. 7.2

IV Needle Performance Testing

| IV Needle

Performance Testing	Method
Surface	ISO11070 Sec. 4.3
Corrosion Resistance	ISO 11070 Sec. 4.4
Radio-detectability	ISO 11070 Sec. 4.5
Dimensional Verification	ISO 11070 Sec. 5.2
Needle Point	ISO 11070 Sec. 5.3
Conical Fitting	ISO 594-2
ISO 11070 section 5.4.1
Strength of Union
(Needle tube to hub)	ISO 11070 Sec. 5.4.2

Plastic Guidewire Performance Testing

| Plastic Guidewire

Performance Testing	Method
Surface	ISO11070 Sec 4.3
Radio-detectability	ISO11070 Sec.4.5
Dimensional Verification	ISO11070 Sec. 8.2
Test for Fracture	ISO11070 Sec. 8.4
Test for Flexing	ISO11070 Sec. 8.5
Strength of Jacket and
Core	ISO11070 Sec. 8.6

11

| Stainless Steel
Guidewire

Performance Testing	Method
Surface	ISO11070 Sec 4.3
Corrosion Resistance	ISO11070 Sec 4.4
Radio-detectability	ISO11070 Sec. 4.5
Dimensional Verification	ISO11070 Sec. 8.2
Test for Fracture	ISO11070 Sec. 8.4
Test for Flexing	ISO11070 Sec. 8.5
Strength of Jacket and Core	ISO11070 Sec. 8.6

Stainless Steel Guidewire Performance Testing

| Dilator

Performance Testing	Method
Surface	ISO 11070 Sec 4.3
Corrosion Resistance	ISO 11070 Sec 4.4
Strength of Union
(dilator to hub)	ISO 11070 Sec. 9.3.3
Dimensional Verification	ISO 11070 Sec. 9.2
Conical Fitting	ISO 594-2, ISO 11070
Sec. 9.3.2
Radio-detectability	ISO 11070 Section 4.5

Dilator Performance Testing

Biocompatibility

Biocompatibility of the new device was evaluated based upon ISO 10993-1. The new device including the sheath, dilator, guidewire and entry needed are classified as externally communicating devices, circulating blood, limited contact (