(113 days)
The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
The YOGA Microcatheter is a variable stiffness, end to end braided single lumen catheter designed to access small, tortuous vasculature. The microcatheter has an outer hydrophilic coating that provides lubricity during navigation of vessels. The lubricious PTFE lined inner lumen is designed to facilitate movement of guide wires and other devices. A radiopaque marker band is provided at the catheter tip to aid fluoroscopic visualization. A luer fitting located on the proximal end of the catheter hub is used to attach accessories. A steam shaping mandrel is provided in the package.
The provided document describes the substantial equivalence determination for the YOGA Microcatheter (K162563) based on its comparison to a predicate device, the ENVOY DA Guiding Catheter (K140080), and other reference devices. The focus of the provided text is on demonstrating the device's functional integrity and biological compatibility through various performance tests, rather than clinical efficacy as would be seen with an AI/ML device.
Here's an analysis of the "acceptance criteria and the study that proves the device meets the acceptance criteria" based on the provided text, structured to address your specific points:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the YOGA Microcatheter are implicitly defined by the "PASS" results for each of the performance tests listed. The device is deemed to meet these criteria if its performance matches or is equivalent to established standards or those of the predicate device.
| Test Title | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Samples meet established acceptance criteria (e.g., no defects) | PASS |
| Catheter ID | Catheter ID verified to pass requirements | PASS |
| Catheter OD | Catheter OD measured within established specifications | PASS |
| Catheter Working Length | Catheter working length measured within established specifications | PASS |
| Distal Tip Length | Distal Tip Length measured within established specifications | PASS |
| Catheter Tensile Strength | Withstands specified tensile forces | PASS |
| Hub Luer Taper | Complies with ISO 594-1 and ISO 594-2 | PASS |
| Air Leak testing | No air leakage observed | PASS |
| Flow Rate (static) | Complies with ISO 10555-1 specified flow rates | PASS |
| System Liquid Leakage | No liquid leakage under specified pressure | PASS |
| Flow Rate (dynamic) | Meets dynamic flow rate specifications at 100/300 psi | PASS |
| Burst Pressure (static) | Withstands specified burst pressure | PASS |
| Lumen flush | Meets particulate count requirements per USP<788> | PASS |
| Coating Integrity | Meets particulate count requirements per USP<788> after simulated use | PASS |
| Delamination of PTFE Liner | No delamination of PTFE liner observed | PASS |
| Aseptic Removal | Facilitates aseptic removal per procedure | PASS |
| Steam Shaping | Successful shaping per Instructions for Use | PASS |
| Linear Stiffness Test | Meets linear stiffness specifications | PASS |
| Lateral Stiffness Test | Meets lateral stiffness specifications | PASS |
| Track Testing | Force required to track through anatomical model within limits | PASS |
| Radiopacity (Animal Model) | Distal end of catheter visible under fluoroscopy | PASS |
| Biocompatibility (various tests) | Complies with ISO 10993 series and FDA Bluebook Memorandum G95-1 | PASS |
| Sterilization Assurance Level (SAL) | Achieves SAL of 10^-6 | PASS |
| Shelf-Life (3 years) | Demonstrated shelf-life equivalent to predicate devices | PASS |
Study Details
The provided document describes physical and biological performance testing for a medical device (microcatheter), not an AI/ML device. Therefore, many of your specific questions regarding AI/ML studies (like ground truth, experts, MRMC, standalone performance) are not applicable to this submission. However, I will answer the relevant points based on the provided text.
-
Sample size used for the test set and the data provenance:
- Sample Size: The document states that "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." However, specific sample sizes for each test are not provided in this document.
- Data Provenance: The tests are "bench" (in vitro) and "animal" (in vivo) tests conducted by the manufacturer, Codman & Shurtleff, Inc. The document does not specify the country of origin for the animal studies, but the manufacturer is based in Raynham, Massachusetts, USA. The studies are prospective as they were conducted to support the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes performance testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO, ASTM, USP).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically relevant for human review of AI/ML outputs or clinical endpoints with subjective interpretation. For the physical and biological tests described, the determination of "PASS" or "FAIL" would be based on objective measurements against pre-defined acceptance criteria, not an adjudication process involving multiple human reviewers.
-
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:
- This is not applicable. This document describes the clearance of a physical medical device and does not involve AI or human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a microcatheter, a physical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is based on established engineering standards, international standards (ISO, ASTM, USP), and validated internal design control procedures. For example, tensile strength is measured against engineering specifications, biocompatibility against ISO 10993 standards, and flow rates against ISO 10555-1. For radiopacity, the ground truth is the visual confirmation by a qualified individual (presumably a radiologist or veterinarian during the animal study) that the catheter is visible under fluoroscopy.
-
The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- This is not applicable. There is no "training set" for this physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Codman & Shurtleff, Inc. Yoon Hee Beatty Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K162563
Trade/Device Name: YOGA Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 5, 2016 Received: December 6, 2016
Dear Ms. Beatty:
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.
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerelv.
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162563
Device Name YOGA Microcatheter
Indications for Use (Describe)
The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
I. Submitter Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767
Tel: (305) 265-2919 Fax: (305) 265-6889
Contact Person: Yoon Hee Beatty Date Prepared: September 12, 2016
II. Device
| Table 1. Device | |
|---|---|
| Device Proprietary Name | YOGA Microcatheter |
| Common or Usual Name | Catheter, Percutaneous |
| Classification Name | Catheter, Percutaneous, Class II, 21 CFR 870.1250 |
| Regulatory Classification | II |
| Product Code | DQY |
III. Predicate Device
The predicate and reference devices listed in Table 2 below are applicable to the device in this submission.
| Table 2. Predicate 510(k) Clearance | |||
|---|---|---|---|
| 510(k)Number | DateCleared | Device Name | Manufacturer |
| K140080 | 04/24/2014 | ENVOY Distal Access (DA)Guiding Catheter | Codman & Shurtleff, Inc. |
| Reference Devices | |||
| K092702 | 11/20/2009 | Micrus Microcatheter, ModelCourier 270 (rebranded as"PROWLER 27" Microcatheter) | Codman & Shurtleff, Inc. |
| K112828 | 10/25/2011 | REVIVE Intermediate Catheter | Codman & Shurtleff, Inc. |
| K021591 | 05/22/2002 | PROWLER SELECT (10, 14,and Plus) Infusion Catheterswith and without pre-shaped tips | Codman & Shurtleff, Inc. |
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| IV. DeviceDescription | The YOGA Microcatheter is a variable stiffness, end to end braided single lumencatheter designed to access small, tortuous vasculature. The microcatheter has anouter hydrophilic coating that provides lubricity during navigation of vessels. Thelubricious PTFE lined inner lumen is designed to facilitate movement of guide wiresand other devices. A radiopaque marker band is provided at the catheter tip to aidfluoroscopic visualization. A luer fitting located on the proximal end of the catheterhub is used to attach accessories. A steam shaping mandrel is provided in thepackage. |
|---|---|
| V. Indicationsfor Use | The YOGA Microcatheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices. |
| Continued on next page |
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VI. Comparison of Technological Characteristics with the Predicate Device
Table 3 below provides a comparison of technological characteristics of the subject and predicate devices.
| Table 3. Comparison of the Subject and Predicate Device | ||
|---|---|---|
| Predicate Device: | ||
| Characteristics | ENVOY DA Guiding Catheter(K140080) | This Submission:YOGA Microcatheter |
| Intended Use | The ENVOY Guiding Catheter is intendedfor use in the peripheral, coronary, andneuro vasculature for the intravascularintroduction of interventional/diagnosticdevices. | Same as Predicate. |
| Product Code | DQY | Same as Predicate |
| Classification | 21 CFR 870.1250 – Class II | Same as Predicate |
| SterilizationMethod | Ethylene Oxide | Same as Predicate |
| SterilizationAssurance Level(SAL) | 10-6 | Same as Predicate |
| Length | 95cm & 105cm | 150cm1 |
| Internal Diameter | 0.071" (1.8mm) | 0.024", 0.028", 0.032"2 |
| Outer Diameter | 6.0F (0.082"/2.0mm) | 2.4F – 3.4F2 |
| Polymers | Pebax, Vestamid, Nylon compounds | Same as Predicate3 |
| Reinforcementshaft | Stainless Steel/PTFE | Same as Predicate |
| Marker BandMaterial | 90% Platinum / 10% Iridium | Same as Predicate |
| Hub | Pebax | Grilamid4 |
| Strain Relief | Pebax | Pebax |
| Packaging | Pouch and Carton | Hoop, Pouch and Carton5 |
| Shelf Life | 3 years | Same as Predicate |
| 1 Same as PROWLER 27 (K092702). | ||
| 2 Similar size as PROWLER 27 (K092702). | ||
| 3Distal Tip material of ENVOY DA is not present in YOGA Microcatheter. |
4Same as REVIVE IC (K112828).
Same as PROWLER 27 (K092702) hoop and REVIVE IC (K112828) pouch and carton.
VII. Performance Data
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the predicate ENVOY DA Guiding Catheter which was cleared under K140080. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests:
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VII. Performance
Data, Continued
| Test | Test Method Summary | Result |
|---|---|---|
| VisualInspection | Entire length of the catheter was inspected with amicroscope | PASS:Samples met the establishedacceptance criteria |
| Catheter ID | Catheter ID was verified by inserting pre-determined IDcheck mandrel through the catheter | PASS:Samples met the establishedacceptance criteria |
| Catheter OD | Catheter OD was measured along the length of the catheterby using laser micrometer | PASS:Samples met the establishedacceptance criteria |
| CatheterWorkingLength | Catheter working length was measured with a ruler | PASS:Samples met the establishedacceptance criteria |
| Distal TipLength | Distal Tip Length was measured using Smart Scope VideoMeasuring system from the distal end of the catheter to thedistal end of the marker band | PASS:Samples met the establishedacceptance criteria |
| CatheterTensileStrength | Testing was conducted using an Instron Pull Tester | PASS:Samples met the establishedacceptance criteria |
| Hub LuerTaper | Testing was conducted per ISO 594-1 and ISO 594-2 | PASS:Samples met the establishedacceptance criteria |
| Air Leaktesting | Testing was conducted by occluding the distal end of thecatheter and using a syringe partially filled with waterconnected to the hub of the catheter to aspirate whileobserving for air leakage | PASS:Samples met the establishedacceptance criteria |
| Flow Rate(static) | Testing was conducted per ISO 10555-1 | PASS:Samples met the establishedacceptance criteria |
| System LiquidLeakage | System liquid leakage was tested using a burst leak tester | PASS:Samples met the establishedacceptance criteria |
| Flow Rate(dynamic) | Testing was completed using a dynamic flow rate test fixtureat 100 and 300 psi, using Saline and Omnipaque 300 asinjectates | PASS:Samples met the establishedacceptance criteria |
| Burst Pressure(static) | Testing was completed by occluding the distal end of thecatheter and using a hydraulic burst leak tester to applyhydrostatic pressure to the catheter | PASS:Samples met the establishedacceptance criteria |
| Lumen flush | Lumen flush was conducted by flushing the catheter andcounting the particulate per USP<788> | PASS:Samples met the establishedacceptance criteria |
| CoatingIntegrity | Coating integrity was verified by simulated use of thecatheter and counting the particulate per USP<788> | PASS:Samples met the establishedacceptance criteria |
| Delaminationof PTFE Liner | Testing was completed by slicing and flattening the catheterand pulling the PTFE from the polymer material usingtweezers | PASS:Samples met the establishedacceptance criteria |
| Aseptic Removal | Aseptic removal was verified by opening the pouch bypeeling and allowing the product to drop on a surfacesimulating a sterile field | PASS:Samples met the establishedacceptance criteria |
| Steam Shaping | Steam shaping was conducted by following the Instructionsfor Use | PASS:Samples met the establishedacceptance criteria |
| Linear StiffnessTest | Linear Stiffness test was conducted using an Instron PullTester | PASS:Samples met the establishedacceptance criteria |
| Lateral StiffnessTest | Lateral stiffness was measured using the dynamic three pointbend tester and a pin gage | PASS:Samples met the establishedacceptance criteria |
| Track Testing | Trackability measured the force to push each device througha representative tortuous anatomical model | PASS:Samples met the establishedacceptance criteria |
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VII. Performance Testing - Animal Radiopacity testing was conducted in an in vivo animal model to ensure the user can Performance visualize the distal end of the catheter under fluoroscopy. Data, Continued
Performance Testing - Clinical
No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Sterilization
The YOGA Microcatheter is sterilized using a validated Ethylene Oxide sterilization cycle. Based on similarities with the predicate device, the YOGA Microcatheter can be adopted into the validated sterilization process to ensure sterility assurance level (SAL) of 10th in accordance with ISO 11135-1.
Shelf-Life Testing
The YOGA Microcatheter will have a shelf life of 3 years based on the shelf life of currently cleared products, such as ENVOY DA (K140080) and REVIVE IC (K112828). A successful 3-vear shelf life has been demonstrated on the ENVOY DA and the REVIVE IC as well as the sterile barrier system. The materials. manufacturing process and designs have been leveraged for the YOGA Microcatheter. Based on the material and processing methods, it can be concluded that the successful aging testing of the ENVOY DA and the REVIVE IC as well as the sterile barrier system are applicable to the YOGA Microcatheter.
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Biocompatibility Testing
Performance Data, Continued
VII.
Biocompatibility Testing
The biocompatibility testing performed on the ENVOY DA Guiding Catheter (K140080) and REVIVE Intermediate Catheter (K112828) are also applicable to the proposed YOGA Microcatheter. Additional screening tests have been completed on YOGA Microcatheter in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." and FDA Bluebook Memorandum G95-1.
| Table 5: Biocompatibility | ||
|---|---|---|
| Test | Test Method | Result |
| In Vitro Cytotoxicity – ISO MEM Elution | ISO 10993-5 | PASS |
| Guinea Pig Sensitization – ISO Maximization | ISO 10993-10 | PASS* |
| Intracutaneous/Irritation Reactivity – ISO Irritation Study in Rabbits | ISO 10993-10 | PASS* |
| Acute Systemic Toxicity – ISO Systemic Toxicity in Mice | ISO 10993-11 | PASS* |
| In Vitro Hemolysis (ASTM Method –Extract and Direct Contact) | ISO 10993-4ASTM F756 | PASS |
| ASTM Partial Thromboplastin Time | ISO 10993-4ASTM F2382 | PASS* |
| SC5b-9 Complement Activation | ISO 10993-4 | PASS* |
| C3a Complement Activation | ISO 10993-4 | PASS* |
| Material Medicated Pyrogenicity – USP Rabbit Pyrogen | ISO 10993-11General Chapter <151> | PASS* |
| In Vivo Thromboresistance in Dogs | ISO 10993-4 | PASS* |
| USP Physicochemical Tests | USP <661> | PASS* |
| Chemical Characterization of Extractables | ISO 10993-18 | PASS |
| Toxicology Risk Assessment | ISO 10993-17 | PASS |
| * Results are based on testing conducted on ENVOY DA and REVIVE IC. |
Conclusion
Based upon the intended use, design, materials, function, in vitro testing and animal testing, it is concluded that the subject device, YOGA Microcatheter, is substantially equivalent to the predicate device, ENVOY DA Guiding Catheter, therefore, does not raise different issues of safety and effectiveness.
§ 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).