(30 days)
Not Found
No
The device description and summary of performance studies focus on the physical characteristics and mechanical performance of a guiding catheter, with no mention of AI or ML capabilities.
No
The device is described as an "introducer" for other interventional/diagnostic devices, facilitating their passage within the body rather than directly providing a therapeutic effect itself.
No
The device is described as facilitating the intravascular introduction of interventional/diagnostic devices, acting as a guiding catheter rather than performing diagnosis itself.
No
The device description clearly describes a physical catheter with various material properties, coatings, and a luer fitting, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intravascular introduction of interventional/diagnostic devices" within the peripheral, coronary, and neurovasculature. This describes a device used within the body to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a catheter designed for navigation within blood vessels, with features like a hydrophilic coating, PTFE lining, and radiopaque markers for visualization under fluoroscopy. These are characteristics of an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Envoy Distal Access Guiding Catheter is an invasive medical device, not an IVD.
N/A
Intended Use / 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.
Product codes
DQY
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 hydrophilic coating that reduces friction during manipulation in the vasculature. The lubricious PTFE lined inner lumen is designed to facilitate 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 is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral, coronary, and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical testing data to demonstrate that the device performs according to its requirements and is analogous to the predicate device. Clinical testing was not required to establish substantial equivalence.
Results of verification and validation conducted on the ENVOY DA Guiding Catheter demonstrated that the device performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new issues of safety and effectiveness.
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.
- Kink 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.
- Irritation.
- Systemic Toxicity.
- Hemocompatibility.
- Thrombogenicity.
- Genotoxicity.
- Physicochemical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Codman & Shurtleff, Inc.
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 |
| 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/
Concurrence Date | Product
Code | Predicate For: |
|--------------------------------------------------------|----------------------------------------------------|------------------------------------|-----------------|-----------------------------------------------------------------------|
| Primary
Predicate:
ENVOY®
Guiding
Catheter | Codman & Shurtleff,
Inc. | K982770 | DQY | Intended Use
Design
Materials
Manufacturing
Sterilization |
| Neuropath®
Guiding
Catheter | Codman & Shurtleff,
Inc. (previously
Micrus) | K052004 | DQY | Materials |
| REVIVE™
Intermediate
Catheter | 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
1
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.
2
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 �
3
- 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.
4
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.
5
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
6
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.