M-Y Sheath

K190369 · Ram Medical Innovations, Inc. · DYB · Apr 17, 2019 · Cardiovascular

Device Facts

• Record ID: K190369
• Device Name: M-Y Sheath
• Applicant: Ram Medical Innovations, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The M-Y Sheath is intended to enable delivery of interventional and diagnostic devices into the human vasculature, excluding coronary and neuro vasculature.

Device Story

M-Y Sheath is a contralateral access guiding sheath featuring a proximal hemostatic valve and an integrated fixed wire at the distal end. The fixed wire, attached to the sheath sidewall, extends beyond the tip to provide support. During use, the wire is introduced through an ipsilateral femoral sheath, snared, and externalized through a contralateral sheath. The device is positioned over the bifurcation using a 'flossing' technique. Once positioned, the wire is externally secured (e.g., via pin vise) to stabilize the sheath for advancing interventional tools like balloons or stents. Compatible with 7 French femoral sheaths; accommodates 5 French therapeutic/diagnostic devices. Used by clinicians in clinical settings to facilitate peripheral vascular interventions; benefits patients by providing enhanced sheath stability during complex procedures.

Clinical Evidence

Bench testing only. No human clinical data. Testing included biocompatibility (ISO 10993-4, -5, -10, -11), dimensional specifications, simulated use, radiopacity, corrosion resistance, leakage (sheath/valve), hub/luer conformance (ISO 594-2), tensile strength, and wire fracture/flexing tests. Sterilization validated per ISO 11135-1 (SAL 10^-6). Comparative in-vitro 3-D anatomy simulation model performed against predicate device in peripheral anatomy, including worst-case total occlusion scenarios, demonstrating equivalent performance.

Technological Characteristics

Contralateral access guiding sheath with proximal hemostatic valve and integrated fixed distal wire. Compatible with 7F femoral sheaths; 5F luminal diameter. Materials tested for biocompatibility per ISO 10993. Hub/Luer fittings conform to ISO 594-2. Sterilization via Ethylene Oxide (ISO 11135-1). Mechanical features include fixed wire for stability and flossing-based positioning.

Indications for Use

Indicated for patients requiring delivery of interventional and diagnostic devices into peripheral vasculature; excludes coronary and neuro vasculature.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Cook, Flexor® Check-Flo Introducer Sheath, RAABE Modification (K142829)

Reference Devices

• Abbott Vascular, Hi-Torque Whisper MS Guidewire (0.014") (K101116)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Drive<br>Springfield, OH 45503<br>USA |
| Phone Number: | [phone] |
| Contact Person: | Lloyd H. Griese, Quality & Regulatory Consultant<br>LamaMed Solutions, Inc.<br>709 Sandoval Way<br>Hayward, CA 94544<br>USA |
| Phone Number: | [phone] |
| Email: | [e-mail] |

## 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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