ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB

K140080 · Codman & Shurtleff, Inc. · DQY · Apr 24, 2014 · Cardiovascular

Device Facts

• Record ID: K140080
• Device Name: ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
• Applicant: Codman & Shurtleff, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Device Story

Variable stiffness, braided catheter; large non-tapered lumen; hydrophilic outer coating; PTFE-lined inner lumen. Distal segment flexible for navigation; radiopaque marker band 3mm from distal tip. Available with preshaped tips. Used in peripheral, coronary, and neurovasculature; operated by physicians. Facilitates intravascular passage of interventional/diagnostic devices (e.g., guide wires). Provides access to distal vasculature; aids visualization under fluoroscopy. Peel-away introducer included for sheath insertion.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including visual inspection, tensile strength, coating integrity, leakage, stiffness, track testing, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility).

Technological Characteristics

Variable stiffness braided catheter; stainless steel reinforcement; PTFE inner liner; hydrophilic outer coating. Radiopaque marker band (Pellethane with filler). 6F outer diameter; 0.071" inner diameter. Sterilized via Ethylene Oxide (EtO). Complies with ISO 594-1/2 (Luer), ISO 10555-1 (catheters), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for use in peripheral, coronary, and neurovasculature for intravascular introduction of interventional/diagnostic devices.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• ENVOY® Distal Access (DA) Guiding Catheter (K120229)
• ENVOY Guiding Catheters (K093184)

Submission Summary (Full Text)

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### SECTION 005 510(k) Summary [As Required By 21 CFR 807.92(a)]

. APR 2 4 2014

| <b>A. Sponsor</b> | |
|----------------------------------------------------------|----------------|
| <b>Submitter's Name:</b> Codman & Shurtleff, Inc. | |
| <b>Address:</b> 325 Paramount Drive<br>Raynham, MA 02767 | |
| Primary Contact: | Hannah Foley |
| Telephone: | [phone] |
| Fax: | [phone] |

| Secondary Contact: | Amarilys Machado |
|--------------------|------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

- B. Date Prepared: January 10, 2014
#### C. Device Name and Classification:

| Proprietary Name: | ENVOY® Distal Access (DA) Guiding Catheter |
|----------------------|---------------------------------------------------|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250), Class II |
| Product Code: | DQY |

#### D. Predicate Devices

This 510(k) submission provides pre-market notification for the ENVOY® Distal Access (DA) Guiding Catheter line extension and modifications. The proposed line extension and modifications have not altered the fundamental technology of the predicate devices or the devices' intended use.

| Table 1: Prior 510(k) Clearances | | | | | |
|----------------------------------|--------------|------------------------------------------|-----------------------------|--------------|--------------------------------------------------------------------|
| 510(k)<br>Number | Date Cleared | Name | Manufacturer | Product Code | Predicate For: |
| Predicate<br>K120229 | 02/24/2012 | ENVOY® Distal Access<br>Guiding Catheter | Codman &<br>Shurtleff, Inc. | DQY | Intended Use Design<br>Materials<br>Manufacturing<br>Sterilization |
| Predicate<br>K093184 | 11/06/2009 | ENVOY Guiding Catheters | Codman &<br>Shurtleff. Inc. | DQY | Packaging |

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#### E. Device Description

The ENVOY Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The catheter has an outer hydrophilic coating on the outer surface that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the distal tip is clearly distinguished by a radiopaque marker band which is approximately 3mm from the distal tip. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.

#### F. Indications for Use

The ENVOY Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

## G. Summary of Technological Characteristics of the Proposed Device to the Predicate Device

The proposed ENVOY® Distal Access (DA) Guiding Catheter is substantially equivalent to the predicate ENVOY® Distal Access (DA) Guiding Catheter. No new technological characteristics are being introduced with the proposed device.

The proposed ENVOY® Distal Access (DA) Guiding Catheter has the same intended use, sterilization process, function, mechanism of action, and clinical utility as the predicate ENVOY® Distal Access (DA) Guiding Catheter, and is similar in regards to design, material, and manufacturing. The proposed ENVOY DA was shown to be substantially equivalent to the predicate device through comparison of indications for use, function, operating principle, bench testing, biocompatibility, and materials. A summary table including characteristics of the proposed device compared with those of the predicate device is provided in Table 2A and 2B.

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1

| Description | Predicate Device:<br>ENVOY® DA Guiding Catheter<br>(K120229) | This Submission:<br>ENVOY® DA Guiding Catheter |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Envoy Distal Access Guiding Catheter is<br>intended for use in the peripheral, coronary and<br>neuro vasculature for the intravascular introduction<br>of interventional/ diagnostic devices | Same as predicate |
| Device Description | The ENVOY Distal Access (DA) Guiding Catheter<br>is a variable stiffness, braided catheter with a large<br>non-tapered lumen that facilitates the intravascular<br>passage of interventional devices. The distal<br>segment is flexible for navigation into distal<br>vasculature. The catheter has an outer hydrophilic<br>coating that reduces friction during manipulation in<br>the vessel. The lubricious PTFE lined inner lumen<br>is designed to facilitate movement of the guide<br>wires and other devices. A luer fitting located on<br>the end of the catheter hub can be used to attach<br>accessories. The distal section of the catheter is<br>radiopaque to aid visualization under fluoroscopy,<br>and the distal tip is clearly distinguished by a<br>radiopaque marker. The catheter is available with<br>preshaped tips to facilitate positioning. A peel away<br>introducer is included to facilitate insertion into the<br>sheath. | The ENVOY Distal Access (DA) Guiding Catheter is a<br>variable stiffness, braided catheter with a large non-<br>tapered lumen that facilitates the intravascular passage<br>of interventional devices. The distal segment is flexible<br>for navigation into distal vasculature. The catheter has<br>an outer hydrophilic coating that reduces friction<br>during manipulation in the vessel. The lubricious PTFE<br>lined inner lumen is designed to facilitate movement of<br>the guide wires and other devices. A luer fitting located<br>on the end of the catheter hub can be used to attach<br>accessories. The distal section of the catheter is<br>radiopaque to aid visualization under fluoroscopy, and<br>the distal tip is clearly distinguished by a radiopaque<br>marker band which is approximately 3mm from the<br>distal tip. The catheter is available with preshaped tips<br>to facilitate positioning. A peel away introducer is<br>included to facilitate insertion into the sheath. |
| Product Code | DQY | Same as predicate |
| Classification | 21 CFR 870.1250, Class II | Same as predicate |
| Length/ Working<br>Length (cm) | 95cm & 105cm | Same as predicate |
| Catheter Inner<br>Diameter | 0.071" (1.8mm) | Same as predicate |
| Catheter Outer<br>Diameter | 6.0F (0.082"/2.0mm) | Same as predicate |
| Shapes | Straight<br>Multi-purpose D (MPD) | Straight<br>Multi-purpose D (MPD)<br>Multi-purpose C (MPC) |
| Transition Segment<br>Length | Standard Transition Segment Length<br>(Standard) | Standard Transition Segment Length<br>Standard<br>Shorter Transition Segment Lengths for Extra<br>Backup Support XB |
| Distal Tip<br>Radiopaque Marker | Pellethane Compound with Radiopaque Filler | Pellethane Compound with Radiopaque Filler & Metal<br>Marker Band |
| Reinforcing Member<br>(Braid) | Stainless Steel | Same as predicate |
| Liner | PTFE Liner | Same as predicate |
| Sterilization | EtO | Same as predicate |
| Product Shelf-Life | 1 year | 3 years |

Table 2B provides a packaging comparison between the existing ENVOY® Distal Access (DA) Guiding Catheter, the ENVOY Guiding Catheter and proposed ENVOY® Distal Access (DA) Guiding Catheter.

·

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| Table 2B: Predicate Packaging Comparison Information | | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Description | Predicate Device Packaging:<br>ENVOY® DA Guiding Catheter<br>(K120229) | Predicate Device Packaging:<br>ENVOY® Guiding Catheter<br>(K093184) | This Submission:<br>Proposed Device Packaging<br>ENVOY® DA Guiding Catheter |
| Dimensions | | | |
| Pouch Size | 49.21" x 3.95" | 46.5" x 4.0" | 49.91" x 4.09" |
| Carton Size | 47"x 4" x 0.75" | 47" x 4" x 0.75" | Same as K120229 |
| Mounting Card | 46"x 2.75" x 0.012" | 42.75" x 2.687" | Same as K120229 |
| Material | | | |
| Pouch Material | Top Web: MRM4820PU (RLE-<br>005) 48GA PET/.002 LDPE<br>Bottom Web: Uncoated 1073B<br>Tyvek | Top Web: MRM002075 (M-2075)<br>48GA PET/.002 LDPE<br>Bottom Web: Uncoated 1073B Tyvek | Same as K093184 |
| Carton Material | .024" Clay Coated Solid Bleached<br>Surface | .024" Clay Coated Solid Bleached<br>Surface | Same as K120229 |
| Mounting Material | 0.012" Clay Coated Solid<br>Bleached Sulfate | Clay Coated Solid Bleached Sulfate | Same as K120229 |
| Sterilization | | | |
| Sterilization | EtO | Same | Same as predicate |
| Shelf-Life | | | |
| Packaging<br>Shelf-Life | 1 year | 3years | Same as K093184 |

#### H. Summary of Nonclinical Testing

The proposed ENVOY® Distal Access (DA) Guiding Catheter has the same intended use, sterilization process, function, mechanism of action, and clinical utility as the predicate ENVOY® Distal Access (DA) Guiding Catheter, and is similar in regard to design, material, and manufacturing. The testing conducted to assess the line extension and modifications include performance assessments per the following recognized standards:

| Table 3: Performance Standards | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Standard/Guidance/Directive | Description |
| BS EN ISO 11607-1: 2009 | Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for<br>Materials. Sterile Barrier Systems and Packaging Systems |
| BS EN ISO 11135-1: 2007 | Sterilization of Healthcare products Ethylene Oxide: Part 1 Requirements for<br>development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 10993-7: 2008 | Biological Evaluation of medical devices: Ethylene oxide sterilization residuals - Part 7 |
| BS EN ISO 10555-1: 2009 | Sterile. single use intravascular catheters Part 1: General requirements; Sterile |
| ISO 594-1: 1986 (E) | Conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical<br>equipment: Part 1 - General Requirements |
| ISO 594-2 : 1998 (E) | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical<br>equipment: Part 2 - Local fittings |
| AAMI / ANSI HE75 : 2009 | Human Factors Engineering - Design of Medical Devices |
| BS EN 62366: 2008 | Medical Devices. Application of usability engineering to Medical Devices |
| BS EN ISO 10993-1: 2009 | Biological evaluation of medical devices: Evaluation & Testing - Part 1 |
| BS EN ISO 10993-5: 2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| BS EN ISO 10993-4: 2009 | Biological evaluation of medical devices Part 4: Selection for tests for interactions with<br>blood |
| USP <661> (2013) | Containers - Plastic. Physicochemical Tests |
| ISO 10993-10: 2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11: 2009 | Biological evaluation of medical devices Part11: Test for systemic toxicity |
| ISO 10993-3: 2009 | Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity,<br>and reproductive toxicity |

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#### Bench Testing

Results of verification and validation testing that was conducted on the proposed ENVOY® Distal Access (DA) Guiding Catheter demonstrates that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new questions of safety and effectiveness. Appropriate testing was identified based on a review of the products' risk analyses and previous validation and verification testing.

The following Verification and Validation tests were conducted to verify the modified design ENVOY® Distal Access (DA) Guiding Catheter:

- . Visual Inspection
- . Catheter Shape
- Catheter Dimensional Verification ◆
- � Tensile Strength Testing
- Hydrophilic Coating Integrity ◆
- System Liquid Leakage Testing .
- Delamination of PTFE Liner Testing .
- Lateral Stiffness Testing .
- Linear Stiffness Testing
- Back-Up Support
- Track Testing .
- Sheath Introducer Compatibility .
- Hub Luer Taper ●
- System Air Leakage ●
- . Shaft Peel Strength

The following Packaging Validation Testing was conducted with the proposed ENVOY® Distal Access (DA) Guiding Catheter:

- Visual Inspection .
- Dve Leak
- Seal Strength .

The following Biocompatibility Testing was conducted with the proposed ENVOY® Distal Access (DA) Guiding Catheter:

- . In Vitro Cytotoxicity – MEM Elution
- · · Sensitization Guinea Pig Maximization
- Intracutaneous/Irritation Reactivity .
- Acute Systemic Toxicity .

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#### Page 28 of 109 K140080

- Material Mediated Pyrogenicity .
- . Genotoxicity
- o · In Vitro Bacterial Mutagenicity Ames Assay
- o In Vitro Mouse Lymphoma Assay with extended treatment
- o In Vivo Mouse Micronucleus Assay
- Hemocompatibility .
- In Vitro Hemolysis Direct & Extract Method o
- Partial Thromboplastin Time (PTT) o
- Complement Activation C3a & SC5b-9 Assay 0
- In Vivo Thrombogenicity o
- . Physicochemical Aqueous Extraction Tests

In addition, the new sterile pouch packaging material was evaluated for in vitro cytotoxicity and was tested per ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.

The following Sterilization Test was conducted with the ENVOY® Distal Access (DA) Guiding Catheter:

. USP Limumus Amebocyte Lysate (LAL) Test - Kinetic Chromogenic Method

#### I. Animal Testing

No animal studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

#### J. Summary of Clinical testing:

No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

#### Conclusion:

Based upon the design, materials, function, intended use, and the non-clinical testing performed by Codman it is concluded that the proposed ENVOY® Distal Access (DA) Guiding Catheter is substantially equivalent to the current ENVOY® Distal Access (DA) Guiding Catheter (K120229), and therefore, does not raise any new questions of safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that resemble a bird in flight. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002

April 24, 2014

Codman & Shurtleff. Inc. Hannah Foley Regulatory Affairs Specialist II 325 Paramount Dr. Raynham, MA 02767-0350 US

Re: K140080

> Trade/Device Name: ENVOY Distal Access (DA) Guiding Catheter, 6F, 95cm & 105cm. Straight & XB. MPD & XB. MPC & XB Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 26, 2014 Received: March 27, 2014

Dear Ms. Folev.

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. Iisting 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.

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Page 2 - Ms. Foley

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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 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, Bram D. Zuckerm

> Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

K140080 510(k) Number (if Known):

Device Name: ENVOY® Distal Access (DA) Guiding Catheter

#### Indications for Use:

The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Prescription Use: _ X (Part 21 CFR 801Subpart D)

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

:

AND/OR

Over-The-Counter Use: (Part 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)

# Bram D. Zuckerman -S 2014.04.24 16:56:39 -04'00'