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

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 outer surface has a hydrophilic coating that reduces friction during manipulation in the vasculature. The lubricious PTFE lined inner lumen is designed to facilitate the passage of 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 catheter has a radiopaque marker. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ENVOY® Distal Access Guiding Catheter:

Summary of Device Performance and Acceptance Criteria:

The provided document describes a special 510(k) submission, which means the device is substantially equivalent to a previously cleared device and does not introduce new technological characteristics. As such, the acceptance criteria are primarily focused on demonstrating that the new device performs as designed and is equivalent to the predicate devices in terms of safety and effectiveness, without raising new issues.

The device's performance is demonstrated through a battery of preclinical tests. Since this is a substantial equivalence claim for a new iteration of an existing device, the "acceptance criteria" are implied to be that the new device meets the same performance standards and safety profiles as the predicate devices in these tests. The document doesn't provide specific numerical thresholds for acceptance criteria, but rather states that the device "met all" requirements or "performs as designed."

Here's a table summarizing the tests, which serve as the de facto acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Performed)	Reported Device Performance
Aseptic removal of the guiding catheter from the packaging	Performed as designed / Met requirements (Implied by overall conclusion)
Visual Inspection/ Hub Transition	Performed as designed / Met requirements (Implied by overall conclusion)
Catheter Shape (post sterilization)	Performed as designed / Met requirements (Implied by overall conclusion)
Catheter Dimensional Verification	Performed as designed / Met requirements (Implied by overall conclusion)
Coating Length Verification	Performed as designed / Met requirements (Implied by overall conclusion)
Torque Testing	Performed as designed / Met requirements (Implied by overall conclusion)
Proximal Lateral Stiffness Test	Performed as designed / Met requirements (Implied by overall conclusion)
Back up Support	Performed as designed / Met requirements (Implied by overall conclusion)
Distal Tip lateral and Linear Stiffness Test	Performed as designed / Met requirements (Implied by overall conclusion)
Catheter Shaft Tensile Strength	Performed as designed / Met requirements (Implied by overall conclusion)
Catheter Tip Tensile Strength	Performed as designed / Met requirements (Implied by overall conclusion)
Hub Attachment Tensile Strength	Performed as designed / Met requirements (Implied by overall conclusion)
Coating Integrity	Performed as designed / Met requirements (Implied by overall conclusion)
Compatibility with Guidewires	Performed as designed / Met requirements (Implied by overall conclusion)
Trackability	Performed as designed / Met requirements (Implied by overall conclusion)
Kink Resistance (Distal & Proximal Shaft)	Performed as designed / Met requirements (Implied by overall conclusion)
Ovalization Testing	Performed as designed / Met requirements (Implied by overall conclusion)
System Liquid Leakage	Performed as designed / Met requirements (Implied by overall conclusion)
System Air Leakage	Performed as designed / Met requirements (Implied by overall conclusion)
Stability with Access Devices	Performed as designed / Met requirements (Implied by overall conclusion)
Hub Luer Taper	Performed as designed / Met requirements (Implied by overall conclusion)
Compatibility with REVIVE Intermediate Catheter	Performed as designed / Met requirements (Implied by overall conclusion)
Delamination of PTFE liner	Performed as designed / Met requirements (Implied by overall conclusion)
Peel Away Introducer Tests:
Visual Inspection (Introducer)	Performed as designed / Met requirements (Implied by overall conclusion)
Dimensional Verification (Introducer)	Performed as designed / Met requirements (Implied by overall conclusion)
Shaft Peel Strength (Introducer)	Performed as designed / Met requirements (Implied by overall conclusion)
Hub detachment from the shaft (Introducer)	Performed as designed / Met requirements (Implied by overall conclusion)
Biocompatibility Requirements (ISO 10993 Part I & G95-1):
Cytotoxicity	Met all biocompatibility requirements (Explicitly stated)
Sensitization	Met all biocompatibility requirements (Explicitly stated)
Irritation	Met all biocompatibility requirements (Explicitly stated)
Systemic Toxicity	Met all biocompatibility requirements (Explicitly stated)
Hemocompatibility	Met all biocompatibility requirements (Explicitly stated)
Thrombogenicity	Met all biocompatibility requirements (Explicitly stated)
Genotoxicity	Met all biocompatibility requirements (Explicitly stated)
Physicochemical	Met all biocompatibility requirements (Explicitly stated)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document refers to "preclinical testing data" and "results of verification and validation." These are typically conducted on a sample of manufactured devices, but the exact number isn't quantified in this summary.
Data Provenance: The tests are "preclinical testing data" and "verification and validation" conducted by Codman & Shurtleff, Inc. This indicates it's retrospective data gathered from tests performed on prototypes or early production samples during the device development and manufacturing process. The country of origin for the data is implicitly the United States, where Codman & Shurtleff, Inc. is located.
Clinical Testing: The document explicitly states: "Clinical testing was not required to establish substantial equivalence."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not Applicable. This is a special 510(k) for a medical device (catheter) based on substantial equivalence and preclinical testing. There is no mention of human expert evaluation or a "ground truth" derived from expert consensus in the context of clinical images or patient data to establish the device's basic functional and safety characteristics. The "ground truth" here is the pass/fail criteria for the engineering and biocompatibility tests themselves.

4. Adjudication Method for the Test Set:

Not Applicable. As per point 3, there was no expert evaluation requiring adjudication. The tests conducted are objective, pass/fail engineering and biocompatibility evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is a type of clinical study often used for imaging diagnostic devices or AI algorithms evaluating human performance. This document explicitly states that "Clinical testing was not required to establish substantial equivalence" for this device. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is provided.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This device is a physical medical instrument (a catheter), not an artificial intelligence (AI) algorithm. Therefore, the concept of a "standalone algorithm" performance study is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the specified engineering and biocompatibility requirements and standards (e.g., ISO 10993 Part I, General Program Memorandum # G95-1, internal design specifications for dimensions, strength, flexibility, etc.). The device was tested against these predetermined objective criteria.

8. The Sample Size for the Training Set:

Not Applicable. The device is not an AI algorithm, so there is no "training set." The development of the device would involve engineering design and iterative prototyping, but not in the same sense as training a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through established engineering principles, material science, clinical needs for similar devices, and regulatory standards.

Summary

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Codman & Shurtleff, Inc.

K120229

Special 510(K) ENVOY® Distal Access Guiding Catheter

SECTION 5. 510(k) Summary

FEB 2 4 2012

(As Required By 21 CFR 807.92(a))

A. Submitter Information

Submitter's name:	Codman & Shurtleff, Inc.
Address:	325 Paramount DriveRaynham, MA 02767
Telephone:	508-828-3312
Fax:	508-977-6428
Contact Person:	Catherine Kilshaw
Date of Submission:	December 16, 2011

B. Trade/Device Name: ENVOY® Distal Access Guiding Catheter ENVOY® Distal Access Guiding Catheter Common Name: Classification Name: Percutaneous Catheter Olass III an Number: Class II per 21 CFR 870.1250

C. Predicate Devices:

Device	Company	510(k) Number/Concurrence Date	ProductCode	Predicate For:
PrimaryPredicate:ENVOY®GuidingCatheter	Codman & Shurtleff,Inc.	K982770	DQY	Intended UseDesignMaterialsManufacturingSterilization
Neuropath®GuidingCatheter	Codman & Shurtleff,Inc. (previouslyMicrus)	K052004	DQY	Materials
REVIVE™IntermediateCatheter	Codman & Shurtleff,Inc.	K112828	DQY	Materials

D. Device Description:

The ENVOY® Distal Access (DA) Guiding Catheter is a variable stiffness, braided The ENVOTO Blotal Nosses (
catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal interventional do nover hydrophilic coating that reduces friction during vasoulaturer - The Iubricious PTFE lined inner lumen is designed to manipulation in the voorent of the guide wires and other devices. A luer fitting located on the end of the cathere hub can be used to attach accessories. The distal section of the end of the battler frub can a
catheter is radiopaque to aid visualization under fluoroscopy, and the schenest tine to catherer is factopaque marker. The catheter is available with preshaped tips to

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facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.

E. Intended Use:

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

F. Summary of technological characteristics of the proposed to the predicate device:

The ENVOY DA Guiding Catheter is substantially equivalent to the Codman ENVOY Guiding Catheter. No new technological characteristics are being introduced with the proposed device.

The ENVOY DA has the same intended use as the Codman ENVOY Guiding Catheter, and it is similar with regard to design, materials, manufacturing, and sterilization process.

The ENVOY DA also has the same intended use as the Neuropath Guiding Catheter and the REVIVE Intermediate Catheter. ENVOY DA is similar to Neuropath and REVIVE IC with regard to materials.

G. Testing Summary:

Preclinical testing data to demonstrate that the device performs according to its r roolinour tosang and accomplex to this device. Clinical testing was not required to establish substantial equivalence.

Results of verification and validation conducted on the ENVOY DA Guiding Catheter Nesults of vehicular in performs as designed, is suitable for its intended use, is demonation that he predicate device and therefore, does not raise any new issues of safety and effectiveness.

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The following tests were conducted on the ENVOY DA guiding catheter:

Aseptic removal of the guiding catheter from the packaging .
Visual Inspection/ Hub Transition .
Catheter Shape (post sterilization) .
Catheter Dimensional Verification .
Coating Length Verification .
Torque Testing .
Proximal Lateral Stiffness Test .
Back up Support ●
Distal Tip lateral and Linear Stiffness Test .
Catheter Shaft Tensile Strength .
Catheter Tip Tensile Strength .
Hub Attachment Tensile Strength .
Coating Integrity ●
Compatibility with Guidewires .
Trackability .
King Resistance (Distal & Proximal Shaft) .
Ovalization Testing .
System Liquid Leakage .
System Air Leakage .
Stability with Access Devices .
Hub Luer Taper .
Compatibility with REVIVE Intermediate Catheter .
Delamination of PTFE liner .

The following tests were conducted on the Peel Away Introducer:

Visual Inspection .
Dimensional Verification .
Shaft Peel Strength .
Hub detachment from the shaft .

The ENVOY DA met all the biocompatibility requirements as specified by the ISO 10993 Part I, and the General Program Memorandum # G95-1 on Biological Evaluation of Medical Devices. The following tests were conducted:

Cytotoxicity .
Sensitization �

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Irritation .
Systemic Toxicity .
Hemocompatibility .
Thrombogenicity .
Genotoxicity ●
Physicochemical .

Based upon the design, materials, function, intended use, comparison with currently Bacod apon the non-clinical testing performed by Codman & Shurtleff, manolou Concluded that the ENVOY DA Guiding Catheter is substantially equivalent inol, in Containg Catheter, Neuropath Guiding Catheter and REVIVE lo the ENTO - Catheter and therefore, does not raise any new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure.

Public Health Service

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

Codman & Shurtleff. Inc. c/o Ms. Catherine Kilshaw Regulatory Affairs Specialist II 325 Paramount Drive . Raynham, MA 02767-6428

FEB 2 4 2012

Re: K120229

Trade/Device Name: Envoy® Distal Access Guiding Catheter Regulation Number: 21 CFR 870.1250. Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: January 24, 2012 Received: January 25, 2012

Dear Ms. Kilshaw:

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.

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Page 2 - Ms. Catherine Kilshaw

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E.K.K. 102

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):__K120229

Device Name:_Envoy Distal Access Guiding Catheter

Indications For Use:

The Envoy Distal Access 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 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUNTER

Page 1 of

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

VIZO229

510(k) Number.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).