(28 days)
The YOGA Microcatheter is intended for use in peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
The YOGA Microcatheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. The catheter shaft is composed of a variable pitch stainless steel braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with a polymer material, which encapsulates the stainless steel braid construction. The distal end of the catheter has a radiopaque marker band and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a hub and an ID band is placed at the distal end of the hub over a strain relief. A steam shaping mandrel is provided in the package. The two new YOGA Microcatheters are provided in back up (XB) and extra backup (XXB) configurations, i.e. a stiffer distal end to provide additional support.
The provided text is for a 510(k) premarket notification for a medical device called the "YOGA Microcatheter". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, the document does not contain the detailed information necessary to answer the prompt's questions. The prompt is designed to elicit information about a study that assesses AI/algorithm performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance), which typically involves a test set, ground truth experts, and statistical analysis against predefined acceptance criteria. This 510(k) submission, however, details the physical and functional characteristics of a medical catheter and demonstrates its similarity to a previously approved device through bench testing, not a diagnostic study involving AI or image analysis.
Here's why the information isn't present:
- Device Type: The YOGA Microcatheter is a physical medical device (a catheter), not a software algorithm, diagnostic imaging tool, or AI system. Its performance is evaluated through physical and functional characteristics (e.g., stiffness, trackability, biocompatibility, sterilization) rather than diagnostic accuracy metrics.
- Regulatory Pathway: A 510(k) submission seeks to establish "substantial equivalence" to a predicate device. This often involves demonstrating similar technological characteristics and performance through bench testing, not necessarily conducting large-scale clinical trials or diagnostic accuracy studies like those performed for AI/CAD devices.
- Nature of Testing: The "Performance Data" section describes "Bench Test Summary" including Linear Stiffness, Lateral Stiffness, and Track Testing. These are engineering tests, not studies involving human readers, ground truth consensus for imaging data, or AI performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria for an AI/algorithm, sample sizes for test/training sets, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) document.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three human profiles in a row.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2017
Codman & Shurtleff, Inc. Yoon Hee Beatty Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K171653
Trade/Device Name: YOGA Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 2, 2017 Received: June 5, 2017
Dear Ms. Yoon Hee 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 device
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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 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.
Sincerely,
Carlos L. Pena -S ---
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) K171653
Device Name YOGA Microcatheter
Indications for Use (Describe)
The YOGA Microcatheter is intended for use in 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
Codman & Shurtleff, Inc. I. Submitter 325 Paramount Drive Raynham, MA 02767
Tel: (305) 265-2919 Fax: (305) 265-6889
Contact Person: Yoon Hee Beatty Date Prepared: June 2, 2017
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 device listed in Table 2 below is applicable to the device in this submission.
| Table 2. Predicate 510(k) Clearance | |||
|---|---|---|---|
| 510(k)Number | DateCleared | Device Name | Manufacturer |
| K162563 | 01/05/2017 | YOGA Microcatheter | Codman & Shurtleff, Inc. |
The YOGA Microcatheter is a variable stiffness, single lumen catheter designed to IV. Device Description access small, tortuous vasculature. The catheter shaft is composed of a variable pitch stainless steel braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with a polymer material, which encapsulates the stainless steel braid construction. The distal end of the catheter has a radiopaque marker band and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a hub and an ID band is placed at the distal end of the hub over a strain relief. A steam shaping mandrel is provided in the package. The two new YOGA Microcatheters are provided in back up (XB) and extra backup (XXB) configurations, i.e. a stiffer distal end to provide additional support.
The YOGA Microcatheter is intended for use in peripheral, coronary, and neuro V. Indications for Use vasculature for the intravascular introduction of interventional/diagnostic devices.
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510(k) Summary, Continued
| Characteristics | Predicate Device:YOGA Microcatheter(K162563) | This Submission:YOGA 32XB and YOGA32XXB Microcatheters |
|---|---|---|
| Intended Use | The YOGA Microcatheter is intended foruse in peripheral, coronary, and neurovasculature 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 | 150cm | Same as Predicate |
| Internal Diameter | 0.024", 0.028", 0.032" | Same as Predicate |
| Outer Diameter | 2.4F - 3.4F | Same as Predicate |
| Polymers | Pebax, Vestamid, Nylon compounds | Same as Predicate |
| Reinforcementshaft | Stainless Steel/PTFE | Same as Predicate |
| Marker BandMaterial | 90% Platinum / 10% Iridium | Same as Predicate |
| Hub | Grilamid | Same as Predicate |
| Strain Relief | Pebax | Same as Predicate |
| Packaging | hoop, pouch, carton | Same as Predicate |
| Shelf Life | 3 years | Same as Predicate |
Table 3 below provides a comparison of technological characteristics of the subject
VII. Performance Data
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the predicate YOGA Microcatheter which was cleared under K162563. 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:
| Table 4: Bench Test Summary | ||
|---|---|---|
| Test | Test Method Summary | Result |
| Linear StiffnessTest | Linear Stiffness was measured using Instron tester, holdingfixture and ruler | 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 |
Continued on next page
VI.
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510(k) Summary, Continued
Performance Testing - Animal
Performance Data, Continued
VII.
No in vivo testing was 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.
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 process to ensure sterility assurance level (SAL) of 106 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.
Biocompatibility Testing
Based on the same materials used to manufacture the YOGA Microcatheters (K162563), it was determined that the biocompatibility data from the predicate device can be leveraged. The tests were previously completed in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation of Testing within a Risk Management Process", FDA Bluebook Memorandum G95-1, and FDA's Guidance Document entitled "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April 23, 2013.
Conclusion
Based upon the intended use, design, materials, function, side-by-side in-vitro testing and packaging testing it is concluded that the subject device, YOGA Microcatheter, is substantially equivalent to the predicate device YOGA Microcatheter cleared under 510(k) K162563. Therefore, the modified YOGA Microcatheter 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).