(21 days)
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.
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.
This document is a 510(k) premarket notification for the "Passage Hemostasis Valve" and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a comparative effectiveness study involving AI or human reader performance. Therefore, many of the requested items related to AI device performance and human studies are not present.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Rotator Rotation | Not explicitly stated in the provided text, but implied to demonstrate functional rotation. | Successfully completed. All test results were comparable to the predicate device and met acceptance criteria. |
| Compression Seal – Hemostasis Characteristics (low pressure) | Not explicitly stated in the provided text, but implied to achieve a fluid-tight seal to minimize blood loss. | Successfully completed. All test results were comparable to the predicate device and met acceptance criteria. |
| High Pressure Capability (Maximum 200psi) | Withstand maximum 200psi | Successfully completed. All test results were comparable to the predicate device and met acceptance criteria. |
| Air Ingress under Vacuum | Not explicitly stated in the provided text, but implied to prevent air ingress under vacuum conditions. | Successfully completed. All test results were comparable to the predicate device and met acceptance criteria. |
| Biocompatibility | Meet ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile G95-1 | Successfully completed. All test results were comparable to the predicate device and met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each test set. It mentions that "A battery of testing was conducted" and refers to "risk analysis" for determining the extent of testing. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. Given the device is manufactured by Merit Medical Systems, Inc. (with an address in South Jordan, UT, USA, and Merit Medical Ireland Ltd. in Galway, Ireland), the testing could have occurred in either location or a contracted lab.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical medical device (hemostasis valve), not an AI imaging or diagnostic algorithm. Therefore, "ground truth" as typically defined for AI performance studies (e.g., expert consensus on image findings) is not relevant. The performance is assessed through engineering and biological testing.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a physical device and performance is assessed through objective testing against pre-defined engineering and biological criteria, not through expert adjudication of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device. "Standalone performance" in the context of AI algorithms is not applicable here. The device itself is "standalone" in its intended mechanical and fluid dynamic function.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the defined acceptance criteria for the engineering and biocompatibility tests. These criteria are based on:
- Industry standards (e.g., ISO 11070:1998, ISO 594-2:1998, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009).
- Requirements outlined in guidance documents.
- Risk analysis.
- Comparison to the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; thus, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. Since there is no training set, there is no ground truth to be established for it.
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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
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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 (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
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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Ful: Eshing Services (301)-445-5740 EF
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| Section 5510(k) Summary | ||
|---|---|---|
| GeneralProvisions | Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | (+353) 91 703700 (3061) | |
| Fax Number: | (+353) 91 703772 | |
| Contact Person:Registration Number: | Mark Mullaney1721504 | |
| Correspondent Name: | Merit Medical Ireland Ltd. | |
| Address: | Parkmore Business Park WestGalway, Ireland | |
| Telephone Number: | (+353) 91 703700 (3052) | |
| Fax Number: | (+353) 91 703772 | |
| Contact Person:Date of Preparation:Registration Number: | Siobhan King27/11/20149616662 | |
| SubjectDevice | Trade Name: | Passage |
| Common/Usual Name: | Hemostasis Valve | |
| Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold,Fitting, Cardiopulmonary Bypass | |
| PredicateDevice | Primary Predicate Device #1: | |
| Trade Name: | Passage | |
| Classification Name: | 21 CFR 870.4290 Adaptor, Stopcock, Manifold,Fitting, Cardiopulmonary Bypass | |
| Premarket Notification:Manufacturer: | K925419Merit 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: | K140475Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR 870.4290FDA Product Code: DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassReview 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,needles and certain other medical equipment - part 2: Lockfittings | ||
| · ISO 11135:2014 Sterilization of health care products-Ethylene |
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| Safety &PerformanceTestscontinued | oxide-Requirements for the development, validation and routinecontrol of a sterilization process for medical devices.• ASTM F1980-07 Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices• ISO 10993-1:2009, Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a risk management process, andthe FDA Modified ISO 10993 Test Profile FDA Memo G95-1.The following is a list of all significant testing that was successfullycompleted:• 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 subjectMerit Passage Hemostasis Valve met the acceptance criteria applicableto the safety and effectiveness of the device. This has demonstrated thesubject device is substantially equivalent to the predicate device. | |
| Summary ofSubstantialEquivalence | Based on the Indications for Use, design, safety and performancetesting, the subject Merit Passage Hemostasis Valve is substantiallyequivalent to the predicate device, the cleared Merit PassageHemostasis Valve, K925419, manufactured by Merit Medical SystemsInc. |
§ 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.