Passage Hemostasis Valve

K143429 · Merit Medical Systems, Inc. · DTL · Dec 22, 2014 · Cardiovascular

Device Facts

• Record ID: K143429
• Device Name: Passage Hemostasis Valve
• Applicant: Merit Medical Systems, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Dec 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

Device Story

Passage Hemostasis Valve is a Y-adaptor device used during percutaneous transluminal angioplasty; maintains fluid-tight seal around catheters and guidewires; minimizes blood loss. Device features transparent polycarbonate Y-body for air visualization; female luer lock connector; male luer lock rotator; adjustable hemostasis valve (0 to 0.097"). Used in clinical settings by physicians/clinicians during interventional procedures. Y-body design facilitates contrast injection and device placement. Device is a mechanical accessory; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data. Testing included rotator rotation, compression seal hemostasis, high-pressure capability (up to 200 psi), air ingress under vacuum, and biocompatibility. All results met acceptance criteria and were comparable to the predicate device.

Technological Characteristics

Y-adaptor with hemostasis valve; polycarbonate body; EPDM O-ring; silicone lubricant. Dimensions: 0 to 0.097" (approx. 7 French). Connectivity: Luer lock fittings (ISO 594-2). Sterilization: Ethylene oxide (ISO 11135). Standards: ISO 11070 (catheter introducers), ASTM F1980-07 (accelerated aging), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires during diagnostic and interventional procedures to minimize blood loss.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Passage Hemostasis Valve (K925419)

Reference Devices

• Rotating Adapter (K140475)

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2014

Merit Medical Systems, Inc. Siobhan King Regulatory Affairs Specialist II Parkmore Business Park West Galway, Ireland

K143429 Re:

Trade/Device Name: Passage Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, Or Fitting Regulatory Class: Class II Product Code: DTL Dated: November 27, 2014 Received: December 1, 2014

Dear Ms. King.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleman

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

**Indications for Use**

| | Form Approved: OMB No. 0910-0120 |
|--|-----------------------------------|
| | Expiration Date: January 31, 2017 |
| | See PRA Statement below. |

| 510(k) Number (if known) | K143429 |
|--------------------------|---------|
|--------------------------|---------|

Device Name

Passage Hemostasis Valve

Indications for Use (Describe)

The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

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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PSC Ful: Eshing Services (301)-445-5740 EF

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| Section 5<br>510(k) Summary | | |
|-----------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. |
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | ([phone] (3061) |
| | Fax Number: | ([phone] |
| | Contact Person:<br>Registration Number: | Mark Mullaney<br>1721504 |
| | Correspondent Name: | Merit Medical Ireland Ltd. |
| | Address: | Parkmore Business Park West<br>Galway, Ireland |
| | Telephone Number: | ([phone] (3052) |
| | Fax Number: | ([phone] |
| | Contact Person:<br>Date of Preparation:<br>Registration Number: | Siobhan King<br>27/11/2014<br>9616662 |
| Subject<br>Device | Trade Name: | Passage |
| | Common/Usual Name: | Hemostasis Valve |
| | Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold,<br>Fitting, Cardiopulmonary Bypass |
| Predicate<br>Device | Primary Predicate Device #1: | |
| | Trade Name: | Passage |
| | Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold,<br>Fitting, Cardiopulmonary Bypass |
| | Premarket Notification:<br>Manufacturer: | K925419<br>Merit Medical Systems, Inc. |
| | Reference Device #2: | |
| | Trade Name: | Rotating Adapter |
| | Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold,<br>Fitting, Cardiopulmonary Bypass |
| | Premarket Notification:<br>Manufacturer: | K140475<br>Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR 870.4290<br>FDA Product Code: DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass<br>Review Panel: Division of Cardiovascular Devices |

## Section 5

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| Intended Use | The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires. |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|

The Passage Hemostasis Valve minimizes blood loss during diagnostic and interventional procedures. The Merit Passage Hemostasis Valve consists of a Y-adaptor with a hemostasis valve which also incorporates a female luer lock connector and a male luer lock rotator. The polycarbonate used to manufacture the adaptor is transparent to aid in visualizing entrapped air. The hemostatic valve adjusts between 0 to 0.097" (approximately 7 French). The Y-body design allows both injection of contrast and placement of interventional devices.

## Device Description

The Passage Hemostasis Valve is comprised of a stand-alone rotator assembly bonded to the polycarbonate Y-body, using a UV cured adhesive. The seal and washer are inserted into the Y-body valve port. A thin coat of silicone is applied to the threaded portion of the Y-body and the cap is assembled. The standalone rotator assembly is comprised of individually molded polycarbonate parts(housing connector, retaining collar, hub) and an EPDM(Ethylene Propylene Diene Monomer) O-Ring.

Comparison to Predicate

The technological characteristics of the subject Merit Passage Hemostasis Valve are substantially equivalent to the Predicate Merit Passage Hemostasis Valve [K925419]. Both devices use the same components and materials, with the exception of the O-Ring, which has undergone a material change from silicone to EPDM. The device design and indications remain unchanged. The O-Ring material change was previously assessed under the Reference Device#2 Merit Rotating Adaptor, K140475.

No performance standards have been established under section 514 of the Food. Drug and Cosmetic Act for these devices. Performance testing of the subject Merit Passage Hemostasis Valve was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

Where appropriate, the tests were based on the requirements of the following documents:

| Safety & | · ISO 11070:1998, Sterile Single-Use Intravascular Catheter | | |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Performance | Introducers. | | |
| Tests | · ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes,<br>needles and certain other medical equipment - part 2: Lock<br>fittings | | |
| | · ISO 11135:2014 Sterilization of health care products-Ethylene | | |

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| Safety &<br>Performance<br>Tests<br>continued | oxide-Requirements for the development, validation and routine<br>control of a sterilization process for medical devices.<br>• ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile<br>Barrier Systems for Medical Devices<br>• ISO 10993-1:2009, Biological Evaluation of Medical Devices Part<br>1: Evaluation and Testing within a risk management process, and<br>the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.<br>The following is a list of all significant testing that was successfully<br>completed:<br>• Rotator Rotation<br>• Compression Seal – Hemostasis Characteristics (low pressure)<br>• High Pressure Capability (Maximum 200psi)<br>• Air Ingress under Vacuum<br>• Biocompatibility |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All test results were comparable to the predicate device and the subject<br>Merit Passage Hemostasis Valve met the acceptance criteria applicable<br>to the safety and effectiveness of the device. This has demonstrated the<br>subject device is substantially equivalent to the predicate device. |
| Summary of<br>Substantial<br>Equivalence | Based on the Indications for Use, design, safety and performance<br>testing, the subject Merit Passage Hemostasis Valve is substantially<br>equivalent to the predicate device, the cleared Merit Passage<br>Hemostasis Valve, K925419, manufactured by Merit Medical Systems<br>Inc. |