(61 days)
No
The device description and performance studies focus on the mechanical design and function of a guiding sheath and do not mention any AI/ML components or capabilities.
No
The M-Y Sheath is intended to facilitate the delivery of other interventional and diagnostic devices, rather than providing therapy itself.
No
The M-Y Sheath is described as a "contralateral access guiding sheath" intended to "enable delivery of interventional and diagnostic devices." It is a tool for delivering other devices, not a device that itself diagnoses. While it facilitates the use of diagnostic devices, it is not a diagnostic device itself.
No
The device description clearly details a physical medical device (sheath with a fixed wire) and the performance studies focus on bench testing, biocompatibility, and in-vitro simulations of a physical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enable delivery of interventional and diagnostic devices into the human vasculature". This describes a device used within the body to facilitate procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical sheath with a wire, designed for insertion into blood vessels. This is consistent with an interventional/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 determining the presence or absence of a disease or condition through in vitro testing.
Therefore, the M-Y Sheath is a medical device used for interventional and diagnostic procedures within the human body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, excluding coronary and neuro vasculature.
peripheral anatomy (e.g. below the knee)
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)
Biocompatibility testing per applicable requirements of ISO 10993 was completed.
Bench testing to evaluate conformance with required device attributes and performance was completed. This testing included the following evaluations: Device Dimensional Specifications, Device Visual Requirements, Device Preparation and Delivery, Deployment, and Retraction, Simulated Use Testing, Radiopacity Testing, Corrosion Resistance, Freedom from Sheath Introducer Leakage, Freedom from Hemostasis Valve Leakage, Hub/Luer Fitting conformance with ISO 594-2, Device Junctions Tensile Strength, Fracture Test for Fixed Wire, Flexing Test for Fixed Wire, Air Leakage During Aspiration. All tests passed.
Transportation, sterilization, and shelf-life testing was completed. Sterilization was performed in conformance with all applicable requirements of ISO 11135-1: Sterilization of Health Care Products - Ethylene Oxide, demonstrating a sterility assurance level (SAL) of 10-6.
Transportation and packaging validation included: Transit Testing, Sterile Barrier Integrity (Bubble Test), Packaging & Product Visual Inspection, Pouch Seal Testing. All tests 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.
The M-Y Sheath was evaluated in an in-vitro 3-D anatomy simulation model, with a side-by-side comparative performance evaluation with the predicate device in a clinical use simulation of a diagnostic/interventional procedure in the peripheral anatomy (e.g. below the knee). Performance was also challenged by conducting a procedure in a worst case anatomical condition with a simulated total occlusion at the target treatment site.
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.
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
§ 870.1340 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).
0
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
1
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
2
510(k) Number: K190369
Applicant Information:
| Date Prepared: | April 16, 2019 |
|---|---|
| Name: | RAM Medical Innovations, Inc. |
| Address: | 326 Braytonburne Drive |
| Springfield, OH 45503 | |
| USA | |
| Phone Number: | (937) 215-0878 |
| Contact Person: | Lloyd H. Griese, Quality & Regulatory Consultant |
| LamaMed Solutions, Inc. | |
| 709 Sandoval Way | |
| Hayward, CA 94544 | |
| USA | |
| 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)
3
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 |
|---|---|
4
| 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
5
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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