(21 days)
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
No
The device is described as a valve for maintaining a fluid-tight seal and minimizing blood loss during diagnostic and interventional procedures, not for treating a disease or condition.
No
The device is described as minimizing blood loss during "diagnostic and interventional procedures" and for maintaining a fluid-tight seal around catheters and guidewires. Its function is to facilitate procedures, not to diagnose a condition.
No
The device description clearly outlines physical components made of polycarbonate and EPDM, and the performance studies focus on mechanical properties like rotation, sealing, and pressure capability, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain a fluid-tight seal around catheters and guidewires during percutaneous transluminal angioplasty procedures. This is a function performed in vivo (within the body) during a medical procedure, not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a mechanical valve and adaptor designed to manage blood loss and allow access during a procedure. It does not describe any components or functions related to analyzing biological samples for diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other biological samples, nor any reference to diagnostic testing, assays, or laboratory procedures.
Therefore, the Passage Hemostasis Valve is a medical device used during interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.
Product codes
DTL
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Specific tests conducted include:
- Rotator Rotation
- Compression Seal – Hemostasis Characteristics (low pressure)
- High Pressure Capability (Maximum 200psi)
- Air Ingress under Vacuum
- Biocompatibility
All test results were comparable to the predicate device and the subject Merit Passage Hemostasis Valve met the acceptance criteria applicable to the safety and effectiveness of the device. This has demonstrated the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
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.(b)
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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one above the other.
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
1
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 (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 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Ful: Eshing Services (301)-445-5740 EF
3
| Section 5
| 510(k) Summary | ||
|---|---|---|
| General | ||
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (+353) 91 703700 (3061) | |
| Fax Number: | (+353) 91 703772 | |
| Contact Person: | ||
| Registration Number: | Mark Mullaney | |
| 1721504 | ||
| Correspondent Name: | Merit Medical Ireland Ltd. | |
| Address: | Parkmore Business Park West | |
| Galway, Ireland | ||
| Telephone Number: | (+353) 91 703700 (3052) | |
| Fax Number: | (+353) 91 703772 | |
| Contact Person: | ||
| Date of Preparation: | ||
| Registration Number: | Siobhan King | |
| 27/11/2014 | ||
| 9616662 | ||
| Subject | ||
| Device | Trade Name: | Passage |
| Common/Usual Name: | Hemostasis Valve | |
| Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold, | |
| Fitting, Cardiopulmonary Bypass | ||
| Predicate | ||
| Device | Primary Predicate Device #1: | |
| Trade Name: | Passage | |
| Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold, | |
| Fitting, Cardiopulmonary Bypass | ||
| Premarket Notification: | ||
| Manufacturer: | K925419 | |
| Merit Medical Systems, Inc. | ||
| Reference Device #2: | ||
| Trade Name: | Rotating Adapter | |
| Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold, | |
| Fitting, Cardiopulmonary Bypass | ||
| Premarket Notification: | ||
| Manufacturer: | K140475 | |
| Merit Medical Systems, Inc. | ||
| Classification | Class II | |
| 21 CFR 870.4290 | ||
| FDA Product Code: DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | |
| Review Panel: Division of Cardiovascular Devices |
Section 5
4
| 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, | ||
| needles and certain other medical equipment - part 2: Lock | |||
| fittings | |||
| · ISO 11135:2014 Sterilization of health care products-Ethylene |
5
| Safety &
Performance
Tests
continued | oxide-Requirements for the development, validation and routine
control of a sterilization process for medical devices.
• ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices
• ISO 10993-1:2009, Biological Evaluation of Medical Devices Part
1: Evaluation and Testing within a risk management process, and
the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
The following is a list of all significant testing that was successfully
completed:
• Rotator Rotation
• Compression Seal – Hemostasis Characteristics (low pressure)
• High Pressure Capability (Maximum 200psi)
• Air Ingress under Vacuum
• Biocompatibility |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All test results were comparable to the predicate device and the subject
Merit Passage Hemostasis Valve met the acceptance criteria applicable
to the safety and effectiveness of the device. This has demonstrated the
subject device is substantially equivalent to the predicate device. |
| Summary of
Substantial
Equivalence | Based on the Indications for Use, design, safety and performance
testing, the subject Merit Passage Hemostasis Valve is substantially
equivalent to the predicate device, the cleared Merit Passage
Hemostasis Valve, K925419, manufactured by Merit Medical Systems
Inc. |