(61 days)
The M-Y Sheath is intended to enable delivery of interventional and diagnostic devices into the human vasculature, excluding coronary and neuro vasculature.
The M-Y Sheath is a contralateral access guiding sheath with a proximal hemostatic valve and an integrated fixed wire at its distal end. The fixed wire is attached to the sidewall of the sheath and extends beyond the distal tip of the sheath and is used to provide sheath support during use. The wire distal end is first introduced through the ipsilateral in-dwelling femoral sheath introducer. then snared and externalized through an in-dwelling contralateral sheath introducer, thereby allowing the sheath to be positioned over the bifurcation by gentle simultaneous pushing and pulling the device using a "flossing" technique. Once the M-Y sheath tip is positioned at the desired location in the contralateral vasculature. the wire can be externally secured (e.g. using a pin vise), thereby providing stability and support when advancing interventional tools (e.g. angioplasty balloons, stents, etc.). The M-Y Sheath is compatible to fit through a standard 7 French femoral sheath introducer placed in the ipsilateral leg. The M-Y Sheath luminal diameter is sized to be compatible with 5 French therapeutic and diagnostic devices.
The document provided describes the M-Y Sheath, a catheter introducer, and its performance testing for a 510(k) premarket notification (K190369). The information provided focuses on demonstrating substantial equivalence to a predicate device through various performance, biocompatibility, and sterilization tests. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts.
Therefore, many of the requested elements are not applicable to the information contained in the provided text.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Attribute Tested | Acceptance Criteria (Implied: "Pass") | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity (MEM Elution) | Pass | Pass |
| Sensitization | Pass | Pass |
| Intracutaneous Reactivity | Pass | Pass |
| Material Mediated Pyrogenicity | Pass | Pass |
| Systemic Toxicity | Pass | Pass |
| Hemocompatibility | Pass | Pass |
| Bench Testing (Device Attributes & Performance) | ||
| Device Dimensional Specifications | Pass | Passed |
| Device Visual Requirements | Pass | Passed |
| Device Preparation and Delivery, Deployment, and Retraction | Pass | Passed |
| Simulated Use Testing | Pass | Passed |
| Radiopacity Testing | Pass | Passed |
| Corrosion Resistance | Pass | Passed |
| Freedom from Sheath Introducer Leakage | Pass | Passed |
| Freedom from Hemostasis Valve Leakage | Pass | Passed |
| Hub/Luer Fitting conformance with ISO 594-2 | Pass | Passed |
| Device Junctions Tensile Strength | Pass | Passed |
| Fracture Test for Fixed Wire | Pass | Passed |
| Flexing Test for Fixed Wire | Pass | Passed |
| Air Leakage During Aspiration | Pass | Passed |
| Transportation, Sterilization, and Shelf-life Testing | ||
| Sterility (Sterility Assurance Level (SAL)) | 10⁻⁶ | Achieved SAL of 10⁻⁶ |
| Transit Testing | Pass | Passed |
| Sterile Barrier Integrity (Bubble Test) | Pass | Passed |
| Packaging & Product Visual Inspection | Pass | Passed |
| Pouch Seal Testing | Pass | Passed |
| Clinical Simulation Bench Model | Specified criteria met | Successfully completed and passed all specified criteria |
| In-vitro 3-D anatomy simulation model (Comparative) | All specified acceptance criteria satisfied | Satisfied all specified acceptance criteria |
2. Sample size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. It refers to general "testing" and "evaluations."
- Biocompatibility testing: Per applicable requirements of ISO 10993. (Sample size not specified for each specific test within this standard).
- Bench testing: Does not specify sample sizes for individual attribute tests.
- Sterilization and Transportation testing: Does not specify sample sizes.
- Clinical simulation bench model: Does not specify sample size (e.g., number of simulated procedures).
- In-vitro 3-D anatomy simulation model: Does not specify sample size (e.g., number of devices tested, number of simulated procedures).
Data Provenance: The studies are described as "bench testing," "in-vitro," and "clinical simulation bench model," indicating laboratory or simulated environments, not human clinical trials. The origin is implicitly the manufacturer (RAM Medical Innovations, Inc.) or its contracted testers. The data is retrospective in the sense that it was collected prior to this submission, but it's not data from patient records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Not applicable. This device is not an AI/ML device that requires ground truth established by medical experts. The testing involves physical properties, material compatibility, and functional performance in simulated environments. The "ground truth" for these tests is based on engineering specifications, recognized standards (ISO), and observable physical outcomes (e.g., "Pass/Fail," successful deployment, absence of leakage).
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not an AI/ML device requiring expert adjudication of results. The tests have objective pass/fail criteria.
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
Not applicable. This device is a physical medical instrument (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device's testing is based on:
- Engineering specifications and design requirements: For mechanical performance, dimensions, and visual requirements.
- International Standards (ISO): Specifically ISO 10993 (biocompatibility), ISO 11135-1 (sterilization), and ISO 594-2 (hub/luer fittings).
- Objective physical measurements and observations: For leakage, tensile strength, fracture, flexing, radiopacity, corrosion, etc.
- Pre-defined acceptance criteria: For the successful completion of simulated use and clinical simulation models.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve a "training set."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 17, 2019
RAM Medical Innovations, Inc. % Lloyd Griese Quality and Regulatory Consultant LamaMed Solutions, Inc. 709 Sandoval Way Hayward, California 94544
Re: K190369
Trade/Device Name: M-Y Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 19, 2018 Received: February 15, 2019
Dear Mr. Griese:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K190369
Applicant Information:
| Date Prepared: | April 16, 2019 |
|---|---|
| Name: | RAM Medical Innovations, Inc. |
| Address: | 326 Braytonburne DriveSpringfield, OH 45503USA |
| Phone Number: | (937) 215-0878 |
| Contact Person: | Lloyd H. Griese, Quality & Regulatory ConsultantLamaMed Solutions, Inc.709 Sandoval WayHayward, CA 94544USA |
| Phone Number: | (925) 786-8617 |
| Email: | lloyd@lamamed.solutions |
Device Information:
| Device Trade Name: | M-Y Sheath |
|---|---|
| Common Name: | Catheter Introducer |
| Classification Name(s): | Catheter Introducer |
| Product Code/ Regulation: | DYB / 870.1340 |
| Classification: | Class II |
Predicate Device:
Cook, Flexor® Check-Flo Introducer Sheath, RAABE Modification (K142829)
Reference Device:
Abbott Vascular, Hi-Torque Whisper MS Guidewire (0.014") (K101116)
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Device Description:
The M-Y Sheath is a contralateral access guiding sheath with a proximal hemostatic valve and an integrated fixed wire at its distal end. The fixed wire is attached to the sidewall of the sheath and extends beyond the distal tip of the sheath and is used to provide sheath support during use. The wire distal end is first introduced through the ipsilateral in-dwelling femoral sheath introducer. then snared and externalized through an in-dwelling contralateral sheath introducer, thereby allowing the sheath to be positioned over the bifurcation by gentle simultaneous pushing and pulling the device using a "flossing" technique. Once the M-Y sheath tip is positioned at the desired location in the contralateral vasculature. the wire can be externally secured (e.g. using a pin vise), thereby providing stability and support when advancing interventional tools (e.g. angioplasty balloons, stents, etc.). The M-Y Sheath is compatible to fit through a standard 7 French femoral sheath introducer placed in the ipsilateral leg. The M-Y Sheath luminal diameter is sized to be compatible with 5 French therapeutic and diagnostic devices.
Indications for Use:
The M-Y Sheath is intended to enable delivery of interventional and diagnostic devices into the human vasculature, excluding coronary and neuro vasculature.
Comparison to Predicate Device:
The M-Y Sheath has the same intended use and similar indication, mechanism of action, and procedural outcomes as the Cook Flexor® Check-Flo Introducer Sheath, RAABE Modification (the predicate device). The M-Y Sheath and predicate device are intended to be used as introducer sheaths, allowing the introduction of subsequent devices into the vascular system. The M-Y Sheath functions in a substantially equivalent manner to the predicate device. The technological differences between the M-Y Sheath and its predicate do not raise new questions of safety or effectiveness. Performance data demonstrate substantial equivalence in terms of safety and performance to the predicate device.
Performance Testing
Biocompatibility testing per applicable requirements of ISO 10993 was completed.
| Item # | Test | Standard Reference | Results |
|---|---|---|---|
| 1 | Cytotoxicity (MEM Elution) | ISO 10993-5:2009 | Pass |
| 2 | Sensitization | ISO 10993-10: 2010 | Pass |
| 3 | Intracutaneous Reactivity | ISO 10993-10: 2010 | Pass |
| 4 | Material Mediated Pyrogenicity | ISO 10993-11:2017 | Pass |
| 5 | Systemic Toxicity | ISO 10993-11:2017 | Pass |
| 6 | Hemocompatibility | ISO 10993-4:2017 | Pass |
Bench testing to evaluate conformance with required device attributes and performance was completed. This testing included the following evaluations:
| Attribute Tested | Pass/Fail |
|---|---|
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| Device Dimensional Specifications | Passed |
|---|---|
| Device Visual Requirements | Passed |
| Device Preparation and Delivery, Deployment, and Retraction | Passed |
| Simulated Use Testing | Passed |
| Radiopacity Testing | Passed |
| Corrosion Resistance | Passed |
| Freedom from Sheath Introducer Leakage | Passed |
| Freedom from Hemostasis Valve Leakage | Passed |
| Hub/Luer Fitting conformance with ISO 594-2 | Passed |
| Device Junctions Tensile Strength | Passed |
| Fracture Test for Fixed Wire | Passed |
| Flexing Test for Fixed Wire | Passed |
| Air Leakage During Aspiration | Passed |
Transportation, sterilization, and shelf-life testing was completed to evaluate conformance with required attributes and performance. Sterilization vas performed in conformance with all applicable requirements of ISO 11135-1: Sterilization of Health Care Products - Ethylene Oxide. Results demonstrate achievement of a sterility assurance level (SAL) of 10°.
Transportation and packaging validation included the following:
| Attribute Tested | Pass/Fail |
|---|---|
| Transit Testing | Passed |
| Sterile Barrier Integrity (Bubble Test) | Passed |
| Packaging & Product Visual Inspection | Passed |
| Pouch Seal Testing | Passed |
The validation of the functional performance of the M-Y Sheath in a clinical simulation bench model was successfully completed and passed all specified criteria.
Additionally, the M-Y Sheath was evaluated in an in-vitro 3-D anatomy simulation model. This evaluation was conducted with both the M-Y Sheath and predicate device to enable side-by-side comparative performance. The two devices were evaluated in an in-vitro 3-D anatomy simulation model by performing a clinical use simulation of a diagnostic/interventional procedure in the peripheral anatomy (e.g. below the knee).
In addition, the performance of the M-Y Sheath and predicate device were challenged by conducting a procedure in a worst case anatomical condition. A simulated total occlusion at the
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target treatment site was included to test the ability of the sheath to provide support when the interventional device is delivered and advanced to cross the occlusion.
The test results satisfied all specified acceptance criteria and substantiated that the M-Y Sheath performs in a manner substantially equivalent to the cited predicate.
Summary:
Based upon the device description and test data provided in this pre-market notification the M-Y Sheath is substantially equivalent to the cited predicate device.
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§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).