(73 days)
Not Found
No
The summary describes a physical guiding catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device (ENVOY® Guiding Catheter) is intended for the introduction of interventional/diagnostic devices, not for direct therapeutic action or treatment itself.
No
The device is a guiding catheter intended to facilitate the introduction of other "interventional/diagnostic devices", but it is not itself a diagnostic device. Its purpose is to guide, not to diagnose.
No
The device description clearly states it is a physical catheter, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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 to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for guiding other devices, consistent with its intended use. There is no mention of reagents, sample analysis, or any components typically associated with in vitro diagnostics.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, metabolites, etc.)
- Providing diagnostic information based on sample analysis
Therefore, the ENVOY® Guiding Catheter is a medical device used for interventional and diagnostic procedures in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ENVOY® 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® Guiding Catheter is a single lumen, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional/diagnostic devices. The guiding catheter is pre-shaped to facilitate positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The testing conducted to assess the line extension includes performance assessments per the following recognized standards:
BS EN ISO 11607-1: 2009 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials. Sterile Barrier Systems and Packaging Systems
BS EN ISO 11135-1: 2007 Sterilization of Healthcare products Ethylene Oxide: Part I Requirements for 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 equipment: Part 1 - General Requirements
ISO 594-2 : 1998 (E) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment: Part 2 - Local fittings
AAMI / ANSI HE75 : 2009 Human Factors Engineering - Design of 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 blood
USP (2013) Containers - Plastic, Physicochemical Tests
ISO 14971: 2012 Medical Devices - Application of risk management to medical device
BS EN ISO 15223-1: 2012 Medical Device - Symbols to be used with medical device labels. labeling and information to be supplied
Bench Testing:
Results of verification and validation testing that was conducted on the proposed ENVOY® 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® Guiding Catheter:
- Visual Inspection
- Catheter Shape
- Catheter Dimensional Verification
- Tensile Strength Testing
- System Liquid Leakage Testing
- Lateral Stiffness Testing
- Linear Stiffness Testing
- Back-Up Support
- Track Testing
- Sheath Introducer Compatibility
- Multiple In-dwelling device
The following Biocompatibility Testing was conducted with the proposed ENVOY® Guiding Catheter:
- Cytotoxicity: MEM Elution
- Hemocompatibility - In vitro Hemolysis (Direct & Extract)
- USP Physicochemical Aqueous Extraction Test
Animal Testing:
No animal studies were required as appropriate verification and validation of the ENVOY® Guiding Catheter line extension was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical testing:
No clinical studies were required as appropriate verification and validation of the ENVOY® Guiding Catheter line extension was 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® 7Fr Guiding Catheter is substantially equivalent to the predicate ENVOY® 6Fr Guiding Catheter (K093184), and therefore, does not raise any new questions of safety or effectiveness.
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
K140307
SECTION 005 510(k) Summary [As Required By 21 CFR 807.92(a)]
A. Sponsor
ﺮ ﺳﺎ
| Submitter's Name: | Codman & Shurtleff, Inc. |
|---|---|
| Address: | 325 Paramount Drive |
| Raynham, MA 02767 |
| Primary Contact: | Hannah Foley |
|---|---|
| Telephone: | (305) 265-6810 |
| Fax: | (508) 977-6979 |
| Secondary Contact: | Amarilys Machado |
|---|---|
| Telephone: | (305) 265-6869 |
| Fax: | (508) 977-6979 |
- B. Date Prepared: February 6, 2014
C. Device Name and Classification:
| Proprietary Name: | ENVOY® Guiding Catheter |
|---|---|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250), Class I |
| Product Code: | DQY |
D. Predicate Devices
This 510(k) submission provides pre-market notification for the proposed ENVOY® Guiding Catheter line extension. The line extension will include a new diameter size 7 French (Fr) with same lengths, pre-shaped configurations and XB (extra backup) options as the predicate ENVOY® 6 French (Fr) Guiding Catheter. The proposed line extension has not altered the fundamental technology or the predicate device's intended use.
| Table 1: Prior 510(k) Clearances | |||||
|---|---|---|---|---|---|
| 510(k) | |||||
| Number | Date | ||||
| Cleared | Name | Manufacturer | Product | ||
| Code | Predicate For: | ||||
| Predicate | |||||
| K093184 | 11/06/2009 | ENVOY® Guiding Catheters | Codman & Shurtleff. Inc. | DQY | Intended Use |
| Design | |||||
| Materials | |||||
| Manufacturing | |||||
| Sterilization | |||||
| Packaging |
E. Device Description
The ENVOY® Guiding Catheter is a single lumen, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional/diagnostic devices. The guiding catheter is pre-shaped to facilitate positioning.
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F. Indications for Use
The ENVOY® 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 7Fr ENVOY® Guiding Catheter is substantially equivalent to the predicate ENVOY® Guiding Catheter (K093184). No new technological characteristics are being introduced with the proposed device. The proposed ENVOY® Guiding Catheter has the same intended use, function, mechanism of action, clinical utility, design, manufacturing process and sterilization process as the predicate ENVOY® Guiding Catheter. The proposed ENVOY® Guiding Catheter also has the same materials as the current ENVOY® Guiding Catheter (K093184) except for the orange ink used on the ID Band. The proposed ENVOY® 7Fr Guiding Catheter 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 2.
| Table 2: Predicate Comparison Profile | ||
|---|---|---|
| Description | Predicate Device: | |
| ENVOY® 6Fr Guiding Catheter | ||
| (K093184) | This Submission: | |
| ENVOY® 7Fr Guiding Catheter | ||
| Indications for Use | The Envoy Guiding Catheter is intended for use | |
| in the peripheral, coronary and neuro | ||
| vasculature for the intravascular introduction of | ||
| interventional/ diagnostic devices | Same predicate | |
| Device Description | The ENVOY® Guiding Catheter is a single | |
| lumen, braided catheter with a large non-tapered | ||
| lumen that facilitates the intravascular passage of interventional devices. The guiding catheter | ||
| is preshaped to facilitate positioning. | Same predicate | |
| Product Code | DQY | Same as predicate |
| Classification | 21 CFR 870.1250, Class II | Same as predicate |
| Length/ Working | ||
| Length (cm) | '90cm & 100cm | Same as predicate |
| Catheter Inner | ||
| Diameter | 0.070" (1.8mm) | 0.078" (2.0mm) |
| Catheter Outer | ||
| Diameter | 6.0F (0.082"/2.0mm) | 7.0F (0.092"/2.3mm) |
| Shapes | Straight | |
| Multi-purpose D (MPD) | ||
| Multi-purpose C (MPC) | ||
| Modified Cerebral (Burke)(CBL) | ||
| Head-hunter 1 (H1) | ||
| Simmons 2 | Same as predicate | |
| Reinforcing Member | ||
| (Braid) | Stainless Steel | Same as predicate |
| Liner | PTFE Liner | Same as predicate |
| Sterilization | EtO | Same as predicate |
2
H. Summary of Nonclinical Testing
. "
The proposed ENVOY® Guiding Catheter has the same intended use, function, mechanism of action, clinical utility, design, manufacturing process and sterilization process as the predicate ENVOY® Guiding Catheter. The proposed ENVOY® Guiding Catheter also has the same materials as the current ENVOY® Guiding Catheter (K093184) except for the orange ink used on the ID Band. The testing conducted to assess the line extension includes 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 Materials. Sterile |
| Barrier Systems and Packaging Systems | |
| BS EN ISO 11135-1: 2007 | Sterilization of Healthcare products Ethylene Oxide: Part I Requirements for 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 equipment: |
| Part 1 - General Requirements | |
| ISO 594-2 : 1998 (E) | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment: |
| Part 2 - Local fittings | |
| AAMI / ANSI HE75 : 2009 | Human Factors Engineering - Design of 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 blood |
| USP (2013) | Containers - Plastic, Physicochemical Tests |
| ISO 14971: 2012 | Medical Devices - Application of risk management to medical device |
| BS EN ISO 15223-1: 2012 | Medical Device - Symbols to be used with medical device labels. labeling and information to be |
| supplied |
Bench Testing
Results of verification and validation testing that was conducted on the proposed ENVOY® 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® Guiding Catheter:
- . Visual Inspection
- Catheter Shape ●
- Catheter Dimensional Verification
- Tensile Strength Testing .
- . System Liquid Leakage Testing
- Lateral Stiffness Testing .
- Linear Stiffness Testing ●
3
- Back-Up Support .
- Track Testing .
- Sheath Introducer Compatibility �
- Multiple In-dwelling device .
The following Biocompatibility Testing was conducted with the proposed ENVOY® Guiding Catheter:
- . Cytotoxicity: MEM Elution
- . Hemocompatibility - In vitro Hemolysis (Direct & Extract)
- . USP Physicochemical Aqueous Extraction Test
I. Animal Testing
No animal studies were required as appropriate verification and validation of the ENVOY® Guiding Catheter line extension was 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 ENVOY® Guiding Catheter line extension was 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® 7Fr Guiding Catheter is substantially equivalent to the predicate ENVOY® 6Fr Guiding Catheter (K093184), and therefore, does not raise any new questions of safety or 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 & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2014
Codman & Shurtleff, Inc. Hannah Foley 325 Paramount Dr. Raynham, MA 02767-0350 US
Re: K140307
Trade/Device Name: ENVOY Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 21, 2014 Received: March 23, 2014
Dear Hannah Folcy.
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
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 (2) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm,
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
K140307 510(k) Number (if Known):
Device Name: ENVOY® Guiding Catheter
Indications for Use:
The ENVOY® Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
Prescription Use: × (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. Zuc