ENVOY DISTAL ACCESS GUIDING CATHETER
Device Facts
| Record ID | K120229 |
|---|---|
| Device Name | ENVOY DISTAL ACCESS GUIDING CATHETER |
| Applicant | Codman & Shurtleff, Inc. |
| Product Code | DQY · Cardiovascular |
| Decision Date | Feb 24, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for 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.
Device Story
ENVOY® Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered, PTFE-lined lumen; facilitates intravascular passage of interventional/diagnostic devices. Distal segment is flexible for navigation; hydrophilic coating reduces friction. Radiopaque distal section aids fluoroscopic visualization; luer fitting on hub allows accessory attachment. Used in peripheral, coronary, and neurovasculature; operated by physicians. Peel-away introducer included for insertion. Device provides a conduit for guide wires and other interventional tools, enabling access to distal anatomy for clinical procedures.
Clinical Evidence
No clinical data. Substantial equivalence established through non-clinical bench testing and biocompatibility evaluation. Bench testing included visual inspection, torque, stiffness, tensile strength, coating integrity, trackability, kink resistance, and system leakage. Biocompatibility testing followed ISO 10993-1 and G95-1, covering cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, thrombogenicity, genotoxicity, and physicochemical properties.
Technological Characteristics
Variable stiffness, braided catheter; PTFE-lined inner lumen; hydrophilic coating; radiopaque distal marker. Materials meet ISO 10993-1 and G95-1 biocompatibility standards. Available with preshaped tips. Includes peel-away introducer. Non-powered, manual device.
Indications for Use
Indicated for patients requiring intravascular introduction of interventional or diagnostic devices in peripheral, coronary, and neurovasculature.
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® Guiding Catheter (K982770)
- Neuropath® Guiding Catheter (K052004)
- REVIVE™ Intermediate Catheter (K112828)
Submission Summary (Full Text)
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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
f
(As Required By 21 CFR 807.92(a))
## A. Submitter Information
| Submitter's name: | Codman & Shurtleff, Inc. |
|---------------------|------------------------------------------|
| Address: | 325 Paramount Drive<br>Raynham, 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/<br>Concurrence Date | Product<br>Code | Predicate For: |
|--------------------------------------------------------|----------------------------------------------------|------------------------------------|-----------------|-----------------------------------------------------------------------|
| Primary<br>Predicate:<br>ENVOY®<br>Guiding<br>Catheter | Codman & Shurtleff,<br>Inc. | K982770 | DQY | Intended Use<br>Design<br>Materials<br>Manufacturing<br>Sterilization |
| Neuropath®<br>Guiding<br>Catheter | Codman & Shurtleff,<br>Inc. (previously<br>Micrus) | K052004 | DQY | Materials |
| REVIVE™<br>Intermediate<br>Catheter | Codman & Shurtleff,<br>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.
