(73 days)
The ENVOY® Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
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.
The provided document, K140307, describes a 510(k) submission for a line extension of the ENVOY® Guiding Catheter to include a new 7 French (Fr) diameter size. The submission asserts substantial equivalence to the predicate ENVOY® 6 French (Fr) Guiding Catheter (K093184).
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical catheter. For such devices, acceptance criteria are typically defined by compliance with recognized performance standards and successful execution of specific bench tests designed to ensure safety and effectiveness. The document lists the tests performed, which inherently serve as the performance criteria. The "reported device performance" in this context is the successful completion of these tests, demonstrating that the 7Fr Guiding Catheter meets the design requirements and is substantially equivalent to the predicate.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Visual Inspection | Passed |
| Catheter Shape | Passed |
| Catheter Dimensional Verification | Passed |
| Tensile Strength Testing | Passed |
| System Liquid Leakage Testing | Passed |
| Lateral Stiffness Testing | Passed |
| Linear Stiffness Testing | Passed |
| Back-Up Support | Passed |
| Track Testing | Passed |
| Sheath Introducer Compatibility | Passed |
| Multiple In-dwelling device | Passed |
| Cytotoxicity (MEM Elution) | Passed |
| Hemocompatibility (In vitro Hemolysis) | Passed |
| USP Physicochemical Aqueous Extraction Test | Passed |
| Compliance with BS EN ISO 11607-1 | Documented Compliance |
| Compliance with BS EN ISO 11135-1 | Documented Compliance |
| Compliance with BS EN ISO 10993-7 | Documented Compliance |
| Compliance with BS EN ISO 10555-1 | Documented Compliance |
| Compliance with ISO 594-1 | Documented Compliance |
| Compliance with ISO 594-2 | Documented Compliance |
| Compliance with AAMI / ANSI HE75 | Documented Compliance |
| Compliance with BS EN ISO 10993-1 | Documented Compliance |
| Compliance with BS EN ISO 10993-5 | Documented Compliance |
| Compliance with BS EN ISO 10993-4 | Documented Compliance |
| Compliance with USP <661> | Documented Compliance |
| Compliance with ISO 14971 | Documented Compliance |
| Compliance with BS EN ISO 15223-1 | Documented Compliance |
Study Proving Acceptance Criteria Met:
The study that proves the device meets the acceptance criteria is a non-clinical bench testing program combined with biocompatibility testing.
The document states: "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."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performed bench tests. It only lists the types of tests.
Regarding data provenance, the testing was conducted by Codman & Shurtleff, Inc., the device submitter. The document does not explicitly state the country of origin for the testing, but the submitter's address is in Raynham, MA, USA, suggesting the testing was likely conducted in the US. The study is retrospective in the sense that the testing was performed on manufactured devices after their design, as part of the verification and validation process for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of submission. This 510(k) is for a medical device (catheter) based on substantial equivalence to an existing predicate. The "ground truth" for these types of submissions is established through engineering specifications, recognized standards, and the performance characteristics of the predicate device. Expert human interpretation of data for "ground truth" (like in AI/diagnostic device studies) is not relevant here.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as clinical trials or studies establishing ground truth from multiple expert opinions. The testing described here is objective bench testing and standard compliance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a guiding catheter, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This refers to AI algorithm performance without human intervention, which is not relevant for a physical medical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, recognized national and international performance standards (e.g., ISO, AAMI, USP), and the established performance and safety profile of the predicate device. The tests conducted (e.g., dimensional verification, tensile strength, leakage, biocompatibility) are designed to verify that the device meets these pre-defined, objectively measurable criteria.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device. There is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this is not an AI/machine learning device.
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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 DriveRaynham, 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 | DateCleared | Name | Manufacturer | ProductCode | Predicate For: |
| PredicateK093184 | 11/06/2009 | ENVOY® Guiding Catheters | Codman & Shurtleff. Inc. | DQY | Intended UseDesignMaterialsManufacturingSterilizationPackaging |
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 usein the peripheral, coronary and neurovasculature for the intravascular introduction ofinterventional/ diagnostic devices | Same predicate |
| Device Description | The ENVOY® Guiding Catheter is a singlelumen, braided catheter with a large non-taperedlumen that facilitates the intravascular passage of interventional devices. The guiding catheteris preshaped to facilitate positioning. | Same predicate |
| Product Code | DQY | Same as predicate |
| Classification | 21 CFR 870.1250, Class II | Same as predicate |
| Length/ WorkingLength (cm) | '90cm & 100cm | Same as predicate |
| Catheter InnerDiameter | 0.070" (1.8mm) | 0.078" (2.0mm) |
| Catheter OuterDiameter | 6.0F (0.082"/2.0mm) | 7.0F (0.092"/2.3mm) |
| Shapes | StraightMulti-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 |
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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. SterileBarrier 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 <661> (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 besupplied |
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 ●
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- 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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).