RadialSeal Introducer Kit

K181855 · Great Batch Medical · DYB · Jul 26, 2018 · Cardiovascular

Device Facts

• Record ID: K181855
• Device Name: RadialSeal Introducer Kit
• Applicant: Great Batch Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

The RadialSeal Introducer Kit is a sterile, single-use procedural kit used by clinicians to establish vascular access via the radial artery. The kit includes an introducer sheath with a hemostasis valve and side-port, a dilator, and entry components (needle or IV catheter and guidewire). The clinician uses the needle/catheter and guidewire to puncture the artery; the dilator and sheath are then advanced over the guidewire to create an atraumatic transition into the vessel. Once positioned, the dilator and guidewire are removed, leaving the sheath in place to provide a conduit for subsequent diagnostic or interventional catheters. The hemostasis valve minimizes blood loss and air intake during the procedure. The device is used in clinical settings where radial artery access is required for cardiovascular interventions. It benefits patients by providing a reliable, low-friction access point for treatment devices while maintaining vessel integrity.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing (ISO 11070, ISO 594-1/2, USP 788, ASTM standards) and a GLP acute porcine animal study comparing the subject device to the predicate. Bench testing verified surface integrity, corrosion resistance, radiodetectability, leakage, hemostasis, tensile force, and coating performance. Animal study confirmed equivalent performance in an in vivo model.

Technological Characteristics

Introducer sheath (EFEP/BaSO4), dilator (polypropylene), and guidewire (stainless steel or Nitinol/polyurethane). Features hydrophilic coating, hemostasis valve, and 3-way stopcock. Sizes: 4F, 5F, 6F; lengths: 10cm, 16cm, 25cm. Sterilized via 100% Ethylene Oxide (ISO 11135-1). Mechanical device; no software or electronic components.

Indications for Use

Indicated for facilitating catheter placement through the skin into the radial artery.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Terumo Glidesheath Slender (K142183)

Submission Summary (Full Text)

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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);

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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

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# 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)

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#### 510(k) Summary

Submitter's Name: Address:

Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441

| Primary Contact: | Phyllis Piet-Hughes<br>Senior Manager of Clinical and Regulatory<br>Telephone: [phone]<br>Fax: [phone]<br>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

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## 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).

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

### Predicate Device (Glidesheath Slender) Comparison to RadialSeal

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

# Predicate Device (Glidesheath Slender) Comparison to RadialSeal Continued

# Materials Comparison

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

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

# Materials Comparison Continued

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| Device Characteristic | Predicate Device Terumo<br>Glidesheath Slender® | Proposed Device RadialSeal™<br>Introducer Kit | |
|-----------------------|-------------------------------------------------|------------------------------------------------------|----------------------------------------------|
| | (K142183) | | |
| | Shaft | Polypropylene with bismuth<br>subcarbonate (BiO)2CO3 | Polypropylene with Barium Sulfate<br>(BaSO4) |
| Dilator | Hub | Polypropylene with stainless steel<br>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.

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# 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<br>(Freedom from Leakage from<br>Sheath Introducer) | ISO 11070 Sec 7.3 |
| Hemostasis<br>(Freedom from Leakage through<br>Hemostasis Valve) | ISO 11070 Sec 7.4 |
| Peak Tensile Force<br>(Force at Break) | ISO 11070 Sec 7.6 |
| Sheath to dilator fit, rollback test,<br>Puncture model test, Kink Angle,<br>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<br>resistance( cycle testing) | Internal Standard |
| Hydrophilic coating particulate<br>evaluation (In vitro particulate test) | FDA Guidance, USP 788 |
| Dimensional Verification | ISO 11070 Sec 7.2 |
| Hub | ISO 11070 Sec 7.5,<br>ISO 594-1, ISO 594-2 |

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| Stainless Steel Needle<br>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;<br>ISO 594-1, ISO 594-2 |
| Strength of Union<br>(Needle Tube to Hub) | ISO 11070 Sec. 5.4.2 |
| Radio-detectability | ISO 11070 Sec 4.5 |

# Catheter Performance Testing

| IV Catheter<br>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<br>ISO 11070 section 6.4 |
| Strength of Union<br>(Needle Tube to Hub) | ISO11070 Sec.7.6. |
| Dimensional Verification | ISO 11070 Sec. 7.2 |

## IV Needle Performance Testing

| IV Needle<br>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<br>ISO 11070 section 5.4.1 |
| Strength of Union<br>(Needle tube to hub) | ISO 11070 Sec. 5.4.2 |

## Plastic Guidewire Performance Testing

| Plastic Guidewire<br>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<br>Core | ISO11070 Sec. 8.6 |

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| Stainless Steel<br>Guidewire<br>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<br>Performance Testing | Method |
|---------------------------------------|------------------------------------|
| Surface | ISO 11070 Sec 4.3 |
| Corrosion Resistance | ISO 11070 Sec 4.4 |
| Strength of Union<br>(dilator to hub) | ISO 11070 Sec. 9.3.3 |
| Dimensional Verification | ISO 11070 Sec. 9.2 |
| Conical Fitting | ISO 594-2, ISO 11070<br>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 (<24 hours). This is the same classification as the predicate device.

Biocompatibility testing was completed on final, finished (fully assembled and sterilized) RadialSeal™ Introducer Kit devices per ISO 10993-1:2009. The testing included Characterization with Toxicological Risk Assessment, Cytotoxicity-MEM Elution-Guinea Pig Maximization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogen, Hemolysis-Direct and Indirect, C3a and SC5b-9 Complement Activation, In Vivo Thromboresistance.

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#### Sterilization / Packaging / Shelf Life

The new device is sterilized by ethylene oxide to an SAL level of 106. The sterilization method and SAL are identical to the predicate device. The RadialSeal™ Introducer Kit is terminally sterilized using a 100% ETO sterilization cycle. The sterilization method used follows ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of sterilization process for medical devices and TIR28:2009 product adoption and process equivalency for ethylene oxide sterilization.

Package integrity testing included ASTM F2096, ASTM F88, and ASTM F1886 after conditioning per ISTA 2A and ASTM D4169.

Shelf life testing was performed to support 6 months shelf life.

### Animal testing

Performance testing was conducted on both devices in an animal model, where both devices were found to perform equivalently. The GLP Acute Animal Porcine study was conducted at American Preclinical Services between new device and predicate device. The tests were applied to the assembled device, sheath introducer, valve, dilator, guidewire and bare needle and IV catheter.

### Statement of Equivalence

The RadialSeal™ Introducer Kit is substantially equivalent in its intended use, principles of operation, design features, materials, performance as the market cleared Terumo Glidesheath Slender® (K142183). Verification testing was conducted and demonstrated that the RadialSeal Device meets design inputs and equivalent requirements as the predicate device, the Glidesheath Slender, for relevant standards as described in the summary of testing. The differences between the predicate device and proposed device do not raise any new issues regarding safety and effectiveness. In conclusion, the RadialSeal™ Introducer Kit is considered substantially equivalent to the predicate device.