PINNACLE PRECISION ACCESS SYSTEM

K111606 · Terumo Medical Corp. · DYB · Oct 3, 2011 · Cardiovascular

Device Facts

• Record ID: K111606
• Device Name: PINNACLE PRECISION ACCESS SYSTEM
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.

Device Story

The Pinnacle Precision Access System is a manual introducer kit used to gain vascular access. It consists of an introducer sheath, dilator, metallic entry needle, mini guide wire, and guide wire inserter. The clinician uses the entry needle to access the vein or artery, inserts the mini guide wire through the needle, removes the needle, and then advances the sheath and dilator over the guide wire. Once the sheath is positioned, the dilator and guide wire are removed, allowing for subsequent catheter insertion. The sheath and dilator are radiopaque due to bismuth content. The device is used in clinical settings by healthcare professionals to facilitate interventional procedures. It benefits patients by providing a stable, controlled pathway for catheter delivery into the vasculature.

Clinical Evidence

Bench testing only. Performance testing included needle and guide wire mechanical integrity (joint strength, leakage, corrosion resistance, tip penetration), sheath/dilator functional testing (radiopacity, snap fit, wire passage), and simulated use in an anatomical model. Biocompatibility testing was performed per ISO 10993, including cytotoxicity, hemolysis, thrombogenicity, and systemic toxicity, confirming the device is non-hemolytic and non-cytotoxic.

Technological Characteristics

Materials: ETFE with bismuth/titanium dioxide (sheath), polypropylene (hubs/sleeves), stainless steel or Nitinol (guide wires), silicone rubber (valve). Principle: Manual percutaneous vascular access. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Form factor: 4Fr-8Fr sheath sizes. Radiopacity: Bismuth-loaded sheath/dilator.

Indications for Use

Indicated for facilitating catheter placement into a vein or artery via percutaneous access. No specific patient population, age, or gender restrictions are stated.

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

• Radifocus Introducer II (K954234)
• Glidesheath (K102008)

Submission Summary (Full Text)

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OCT - 3 2011

K1116.06

Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary

# SECTION II. 510(K) SUMMARY

#### A. Device Name

| Proprietary Name | Pinnacle Precision Access System |
|---------------------|---------------------------------------|
| Classification Name | Catheter Introducer (as per 870.1340) |
| Common Name | Introducer Sheath |
| Product Code | DYB |

#### B. Intended Use

The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.

## C. Device Description

The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy

The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire.

The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model.

A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.

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Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary

### D. Principle of Operation / Technology

The Pinnacle Precision Access System and its accessories are operated manually or by a manual process.

The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the Sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

#### E. Design / Materials and Comparison to Predicate Devices

The primary components of the Pinnacle Precision Access System in this submission (the Sheath and Dilator) are unchanged from those of the Radifocus Introducer II predicate device (K954234). The Pinnacle Precision Access System differs from the Radifocus Introducer II predicate device in the addition of the metallic entry needle and the optional Nitinol Mini Guide Wire. A metallic entry needle and Nitinol Mini Guide Wire are included in the Glidesheath predicate device (K102008).

The Pinnacle Precision Access System submitted in this 510(k), the Radifocus Introducer II (K954234) and the Glidesheath (K102008) have similar components which function in the same manner. Material differences between the devices, as shown in the following table, do not raise any new issues of safety and effectiveness.

| Component | Radifocus Introducer II (K954234) | Glidesheath (K102008) | Pinnacle Precision Access System |
|-------------------|--------------------------------------------|--------------------------------------------|-------------------------------------------------------|
| Wire | Stainless Steel | Nitinol w/Palladium<br>distal coil | Stainless Steel or Nitinol<br>w/Palladium distal coil |
| Needle | N/A | Stainless Steel | Stainless Steel |
| Needle Hub | N/A | Styrene-Butadiene<br>copolymer | Styrene-Butadiene<br>copolymer |
| Protective Sleeve | N/A | Polypropylene | Polypropylene |
| Dilator Tubing | Polypropylene<br>w/Bismuth<br>subcarbonate | Polypropylene<br>w/Bismuth<br>subcarbonate | Polypropylene<br>w/Bismuth subcarbonate |
| Dilator Stiffener | N/A | N/A | Stainless Steel (optional<br>on 4Fr and 5Fr) |

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## Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary

| Dilator Caulking<br>Pin | Stainless Steel | Stainless Steel | Stainless Steel |
|-------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Dilator Hub | Polypropylene | Polypropylene | Polypropylene |
| Sheath Tubing | ETFE w/15% BiO3,<br>w/2% TiO2 | ETFE w/15% BiO3,<br>w/2% TiO2 | ETFE w/15% BiO3,<br>w/2% TiO2 |
| Sheath Caulking<br>Pin | Stainless Steel | Stainless Steel | Stainless Steel |
| Sheath Housing | Polypropylene | Polypropylene | Polypropylene |
| Sheath Support | Styrene elastomer | Styrene elastomer | Styrene elastomer |
| Valve | Silicone rubber | Silicone rubber | Silicone rubber |
| Cap | Polypropylene | Polypropylene | Polypropylene |
| Sidetube | Polybutadiene | Polybutadiene | Polybutadiene |
| 3 WSC | Polycarbonate,<br>Polyethylene,<br>Polypropylene | Polycarbonate,<br>Polyethylene,<br>Polypropylene | Polycarbonate,<br>Polyethylene,<br>Polypropylene |
| Guide wire<br>inserter | Polypropylene | Polypropylene | Polypropylene |

### F. Specifications and Comparison to Predicate Devices

The Pinnacle Precision Access System submitted in this 510(k), the Radifocus Introducer II (K954234) and the Glidesheath (K102008) have similar device specifications. Differences in specifications between the devices do not raise any new issues of safety and effectiveness.

| | Radifocus Introducer<br>II (K954234) | Glidesheath<br>(K102008) | Pinnacle Precision<br>Access System |
|-----------------------|--------------------------------------|--------------------------|-------------------------------------|
| Sheath Sizes | 4Fr - 11Fr | 5Fr and 6Fr | 4Fr through 8Fr |
| Sheath Length | 5cm - 100cm | 10 cm | 10 cm |
| Sheath Coating | Silicone | Hydrophilic | Silicone |
| Dilator Length | 6cm - 110cm | 15.5 cm | 15.5cm or 16.0cm |
| Guide Wire OD | .021" - .038" | .021" | .021" |
| Guide Wire<br>Length | 40cm - 100cm | 45cm | 45cm |
| Entry Needle:<br>Size | N/A | 21G<br>1.5" | 21G/19G<br>2.75" |

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Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary

# G. Performance

.

The Pinnacle Precision Access System successfully passed all of the following performance tests: .

| | Pinnacle Precision Access System Performance Testing |
|----------------|----------------------------------------------------------|
| Needle: | Needle surface free from defects |
| | Needle OD |
| | Needle length |
| | Needle ID |
| | Needle hub conical entry angle |
| | Bevel indicator visibility |
| | Bevel indicator position |
| | Needle to hub joint strength |
| | Gauge luer taper |
| | Liquid leakage from fitting assembly under pressure |
| | Air leakage into the fitting assembly during aspiration |
| | Separation force of fitting assembly |
| | Unscrewing torque of fitting assembly |
| | Ease of assembly |
| | Resistance to overriding |
| | Stress cracking |
| | Tip penetration through thin film |
| | Corrosion resistance |
| Guidewires: | Guidewire surface free from defects |
| | Tip buckling test |
| | Test for resistance of guidewires to damage by flexing |
| | Test for fracture of guidewires |
| | Test for distal tip retention and proximal end retention |
| | Guidewire OD |
| | Guidewire length |
| | Corrosion resistance |
| | Radiopacity |
| Dilator: | Dilator surface free from defects |
| | Dilator tip ID |
| | Dilator to hub joint strength |
| | Dilator length |
| | Dilator OD at sheath tip interface |
| | Dilator hub to sheath hub snap fit strength |
| | Hypotube length |
| | Hypotube to hub joint strength |
| | Hypotube fall-out |
| | Wire passage |
| | |
| Sheath: | Corrosion resistance (hypotube) |
| | Sheath surface free from defects |
| | Sheath tip ID |
| | Sheath length |
| | Sheath tip cracks |
| | Radiopacity |
| Simulated Use: | System use in anatomical model |
| | Dilator and sheath tip penetration |

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Terumo Medical Corporation Premarket Notification - Pinnacle Precision Access System™ Section II. 510(k) Summary

# H. Biocompatibility and Sterilization

Biocompatibility testing was conducted in accordance with the FDA General Program memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing''.

The Pinnacle Precision Access System is classified as an Externally Communicating Device, Circulating Blood, Prolonged Contact (up to 30 days), the same as the Radifocus Introducer II Sheath predicate device. Biocompatibility of the Radifocus Introducer II Sheath, classified as Externally Communicating Device, Circulating Blood, Prolonged Contact (24 hours - 30 days) has been established under K954234. Differences in materials between the Pinnacle Precision Access System and the Radifocus Introducer II Sheath affect only those portions of the system that contact the patient for a short period of time (less than 24 hours). Therefore, the full battery of biocompatibility tests was performed on the whole device for Externally Communicating Devices, Circulating Blood, Limited Contact (up to 24 hours).

Testing was performed on the worse case configuration of the system: Introducer sheath with stiffener, stainless steel guide wire and echogenic step needle. Results are presented in the following table.

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# Terumo Medical Corporation Premarket Notification -- Pinnacle Precision Access System™ Section II. 510(k) Summary

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

: :

| Biocompatibility Testing on non aged, 2x EO sterile Pinnacle Precision Access System | | |
|--------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------|
| Test | Standard | Result |
| Physicochemical profile | USP | Meets requirements |
| Cytotoxicity | ISO 10993-5 | Not considered to have cytotoxic potential |
| Hemolysis | ASTM F756 | Non-hemolytic |
| In vitro<br>Hemocompatibility Assay | ISO 10993-4 | Pass |
| Thrombogenicity Study in<br>Dogs | ISO 10993-4 | Thrombosis was not considered significant |
| Complement Activation | ISO 10993-4 | Meets requirements |
| Unactivated Partial<br>Thromboplastin time | ISO 10993-4 | Meets requirements |
| Prothrombin Time | ISO 10993-4 | No adverse effect on the prothrombin time of<br>human plasma |
| Sensitization | ISO 10993-10 | Meets requirements |
| Intracutaneous Reactivity | ISO 10993-10 | Meets requirements |
| Acute Systemic Toxicity | ISO 10993-11 | Negative |
| Pyrogenicity | ISO 10993-11 | Meets requirements |
| Genotoxicity | ISO 10993-3 | Not considered to be mutagenic |

Alkalinity/acidity and extractables testing was performed per ISO 7864: Sterile Hypodermic Needles for Single Use on 2x EO sterile, non-aged needles.

| Pinnacle Precision Access System Echogenic Taper Needle (non-aged, 2xEO sterile) | | |
|----------------------------------------------------------------------------------------|--------------------------|--------------------|
| Test | Standard | Results |
| Analysis of Metals in<br>Extract by Inductively<br>Coupled Plasma Mass<br>Spectrometry | (ICP-MS) Per<br>ISO 7864 | Meets requirements |

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Limited screening tests were conducted on accelerated aged, 2x EO sterile devices to demonstrate that aging does not affect the device's biocompatibility.

| Test | Standard | Results |
|-------------------------|-------------|--------------------------------------------|
| Physicochemical profile | USP | Meets requirements |
| Cytotoxicity | ISO 10993-5 | Not considered to have cytotoxic potential |
| Hemolysis | ASTM F756 | Non-hemolytic |

Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use, based on ISO 10993-7. Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.

The Pinnacle Precision Access System is certified to be non-pyrogenic in the unopened and undamaged package. Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) test is performed on each lot of production accordance to the United States Pharmacopoeia (USP) <85> Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices"; 1987.

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Terumo Medical Corporation Premarket Notification – Pinnacle Precision Access System™ Section II. 510(k) Summary

# I. Substantial Equivalence

The performance of the Pinnacle Precision Access System in this submission is substantially equivalent to the performance of the predicate devices. The equivalence was shown through comparison of component materials and specifications, performance and biocompatibility testing and sterilization validation.

The Pinnacle Precision Access System is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate devices the Radifocus Introducer II (K954234) and the Glidesheath (K102008). Differences between the devices do not raise any significant issues of safety or effectiveness.

### J. Submitter Information

| Prepared By: | Mr. Daniel R. Plonski<br>Regulatory Affairs Specialist |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation<br>950 Elkton Blvd.<br>Elkton, MD 21921<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 8, 2011 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a symbol that looks like a stylized human figure with three lines representing the arms and legs. The figure is facing to the right.

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

Terumo Medical Corporation c/o Mr. Daniel R. Plonski, RAČ Regulatory Affairs Specialist 950 Elkton Blvd. Elkton. MD 21921

OCT - 3 2011

Re: K111606

Trade/Device Name: Pinnacle Precision Access System™ Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 23, 2011 Received: September 26, 2011

Dear Mr. Plonski:

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.

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

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Page 2 – Mr. Daniel R. Plonski, RAC

(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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.him 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

sincerely yours,

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): _

K111606

Pinnacle Precision Access System™ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number K111606

: