(113 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No.
Explanation: The device is intended for the introduction of interventional/diagnostic devices, not for therapeutic action itself.
No
The YOGA Microcatheter is designed to facilitate the intravascular introduction of interventional/diagnostic devices, but it is not itself a diagnostic device. Its purpose is to provide access for other devices.
No
The device description clearly outlines a physical catheter with various material properties, coatings, and a radiopaque marker band. The performance studies also focus on bench and animal testing of the physical device's characteristics. There is no mention of software as the primary or sole component.
No, the YOGA Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "intravascular introduction of interventional/diagnostic devices." This describes a device used within the body to deliver or facilitate the use of other devices, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for navigating blood vessels and facilitating the movement of other devices. This aligns with an interventional or diagnostic tool used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The YOGA Microcatheter's function is entirely focused on accessing and navigating the vasculature within the body.
N/A
Intended Use / Indications for Use
The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
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.
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)
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. All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures. Tests included Visual Inspection, Catheter ID, Catheter OD, Catheter Working Length, Distal Tip Length, Catheter Tensile Strength, Hub Luer Taper, Air Leak testing, Flow Rate (static), System Liquid Leakage, Flow Rate (dynamic), Burst Pressure (static), Lumen flush, Coating Integrity, Delamination of PTFE Liner, Aseptic Removal, Steam Shaping, Linear Stiffness Test, Lateral Stiffness Test, Track Testing. All samples met the established acceptance criteria.
Performance Testing - Animal: Radiopacity testing was conducted in an in vivo animal model to ensure the user can visualize the distal end of the catheter under fluoroscopy.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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.
1
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
2
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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3
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 | Date | ||
| Cleared | Device Name | Manufacturer | |
| K140080 | 04/24/2014 | ENVOY Distal Access (DA) | |
| Guiding Catheter | Codman & Shurtleff, Inc. | ||
| Reference Devices | |||
| K092702 | 11/20/2009 | Micrus Microcatheter, Model | |
| Courier 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 Catheters | |||
| with and without pre-shaped tips | Codman & Shurtleff, Inc. |
4
| IV. Device
Description | 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. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| V. Indications
for Use | The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro
vasculature for the intravascular introduction of interventional/diagnostic devices. |
| | Continued on next page |
5
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 intended | |
| for use in the peripheral, coronary, and | ||
| neuro vasculature for the intravascular | ||
| introduction of interventional/diagnostic | ||
| devices. | Same as Predicate. | |
| Product Code | DQY | Same as Predicate |
| Classification | 21 CFR 870.1250 – Class II | Same as Predicate |
| Sterilization | ||
| Method | Ethylene Oxide | Same as Predicate |
| Sterilization | ||
| Assurance 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 |
| Reinforcement | ||
| shaft | Stainless Steel/PTFE | Same as Predicate |
| Marker Band | ||
| Material | 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:
6
VII. Performance
Data, Continued
| Test | Test Method Summary | Result |
|---|---|---|
| Visual | ||
| Inspection | Entire length of the catheter was inspected with a | |
| microscope | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter ID | Catheter ID was verified by inserting pre-determined ID | |
| check mandrel through the catheter | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter OD | Catheter OD was measured along the length of the catheter | |
| by using laser micrometer | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter | ||
| Working | ||
| Length | Catheter working length was measured with a ruler | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Distal Tip | ||
| Length | Distal Tip Length was measured using Smart Scope Video | |
| Measuring system from the distal end of the catheter to the | ||
| distal end of the marker band | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter | ||
| Tensile | ||
| Strength | Testing was conducted using an Instron Pull Tester | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Hub Luer | ||
| Taper | Testing was conducted per ISO 594-1 and ISO 594-2 | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Air Leak | ||
| testing | Testing was conducted by occluding the distal end of the | |
| catheter and using a syringe partially filled with water | ||
| connected to the hub of the catheter to aspirate while | ||
| observing for air leakage | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Flow Rate | ||
| (static) | Testing was conducted per ISO 10555-1 | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| System Liquid | ||
| Leakage | System liquid leakage was tested using a burst leak tester | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Flow Rate | ||
| (dynamic) | Testing was completed using a dynamic flow rate test fixture | |
| at 100 and 300 psi, using Saline and Omnipaque 300 as | ||
| injectates | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Burst Pressure | ||
| (static) | Testing was completed by occluding the distal end of the | |
| catheter and using a hydraulic burst leak tester to apply | ||
| hydrostatic pressure to the catheter | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Lumen flush | Lumen flush was conducted by flushing the catheter and | |
| counting the particulate per USP | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Coating | ||
| Integrity | Coating integrity was verified by simulated use of the | |
| catheter and counting the particulate per USP | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Delamination | ||
| of PTFE Liner | Testing was completed by slicing and flattening the catheter | |
| and pulling the PTFE from the polymer material using | ||
| tweezers | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Aseptic Removal | Aseptic removal was verified by opening the pouch by | |
| peeling and allowing the product to drop on a surface | ||
| simulating a sterile field | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Steam Shaping | Steam shaping was conducted by following the Instructions | |
| for Use | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Linear Stiffness | ||
| Test | Linear Stiffness test was conducted using an Instron Pull | |
| Tester | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Lateral Stiffness | ||
| Test | Lateral stiffness was measured using the dynamic three point | |
| bend tester and a pin gage | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Track Testing | Trackability measured the force to push each device through | |
| a representative tortuous anatomical model | PASS: | |
| Samples met the established | ||
| acceptance criteria |
7
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.
8
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 10993-4 | |
| ASTM F756 | PASS | |
| ASTM Partial Thromboplastin Time | ISO 10993-4 | |
| ASTM F2382 | PASS* | |
| SC5b-9 Complement Activation | ISO 10993-4 | PASS* |
| C3a Complement Activation | ISO 10993-4 | PASS* |
| Material Medicated Pyrogenicity – USP Rabbit Pyrogen | ISO 10993-11 | |
| General Chapter | PASS* | |
| In Vivo Thromboresistance in Dogs | ISO 10993-4 | PASS* |
| USP Physicochemical Tests | USP | 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.