(119 days)
The Flow Switch is an angiographic accessory intended for use as an on-off device for angiography and other high pressure applications.
The Flow Switch is a device used to connect in line to liquid flow. This uses a Female Luer lock (inlet) and Male Luer lock (outlet) connection. Shut off is by means of a non-slip sliding handle that can be operated one-handed and gives an audible click into the OFF position. Flow directions are indicated by arrows on the handle.
Here's an analysis of the acceptance criteria and study information for the Merit Marquis® Flow Switch, based on the provided document:
Overall Assessment:
The provided document is a 510(k) summary for the "Merit Marquis® Flow Switch," which is essentially a regulatory submission to demonstrate substantial equivalence to a predicate device. This type of document primarily focuses on showing that the new device is as safe and effective as a previously cleared device, rather than providing a detailed clinical study demonstrating superiority or a specific effect size. Therefore, some of the requested information (like MRMC studies, specific effect sizes, or detailed clinical ground truth establishment for a training set) is not typically found in this type of submission for a Class II device like a flow switch.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes various tests performed to demonstrate that the device meets critical design specifications and clinical performance attributes. It does not explicitly lay out "acceptance criteria" in a quantitative table format but implies that successful completion of the listed tests against established standards (ISO, ASTM, USP) constitutes meeting the criteria.
| Test Category | Specific Test / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical/Mechanical Performance | Surface Inspection | Meets visual inspection standards for quality and integrity. | Succesfully completed. |
| Male and Female Luer Conical Fittings (6% Taper) | Conforms to ISO 594-1:1996 and ISO 594-2:1998 standards. | Succesfully completed (by implication of "conical fittings with a 6% (Luer)"). | |
| Pressure in OFF position | Withstands specified pressure without leakage or failure. | Succesfully completed. | |
| Pressure in ON position (Open) | Withstands specified pressure without leakage or failure. | Succesfully completed. | |
| Slider Handle Motion Test | Smooth, functional movement, indicating proper on-off operation. | Succesfully completed. | |
| Slider Force Test | Operable within appropriate force ranges. | Succesfully completed. | |
| Flow Test | Achieves specified flow rates without obstruction or impediment. | Succesfully completed. | |
| Biocompatibility | L929 MEM Elution (MEM extraction) | Non-cytotoxic. | Succesfully completed. |
| Kligman Maximization (Saline and cottonseed oil extractions) | Non-sensitizing. | Succesfully completed. | |
| Intracutaneous Injection (Saline and cottonseed oil extractions) | Non-irritating. | Succesfully completed. | |
| Systemic Injection (Saline and cottonseed oil extractions) | Non-toxic systemically. | Succesfully completed. | |
| Material Mediated Rabbit Pyrogen Test (Saline extraction) | Non-pyrogenic. | Succesfully completed. | |
| Hemocompatibility - In-Vitro Hemocompatibility - Indirect | Acceptable blood compatibility (e.g., minimal hemolysis, thrombosis). | Succesfully completed. | |
| Hemocompatibility - Hemolysis Indirect | Acceptable levels of hemolysis. | Succesfully completed. | |
| Hemocompatibility - Prothrombin Time Assay (PT) Indirect | No significant alteration of coagulation cascade. | Succesfully completed. | |
| Hemocompatibility - Unactivated Partial Thromboplastin Time Assay (UPTT) Indirect | No significant alteration of coagulation cascade. | Succesfully completed. | |
| Heavy Metals Content (USP <661>) | Within specified limits for heavy metal content. | Succesfully completed. | |
| Packaging Performance | Bubble Emission (after aging/shipping) | No gross leaks, passes ASTM F 2096-04. | Succesfully completed. |
| Dye Penetration (after aging/shipping) | No seal leaks, passes ASTM F 1929-98 (Reapproved 2004). | Succesfully completed. | |
| Seal Peel Tensile Strength (after aging/shipping) | Meets minimum seal strength, passes ASTM F 88-07. | Succesfully completed. | |
| Burst Strength (after aging/shipping) | Withstands internal pressure without bursting. | Succesfully completed. | |
| Visual Inspection (after aging/shipping) | Packaging maintains integrity and legibility. | Succesfully completed. | |
| Sterilization | Sterilization Process (Ethylene oxide) | Validated per ISO 11135:2007 to achieve sterility. | Succesfully completed (as indicated by reference to standard). |
Study Proving Acceptance Criteria:
The document states: "A battery of tests performed on the Merit Marquis® Flow Switch were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use." The successful completion of all tests listed in the table above is the "study" that proves the device meets its acceptance criteria for substantial equivalence. These tests are based on recognized international and national standards (ISO 11070, ISO 594-1, ISO 594-2, ASTM F 2096-04, ASTM F 1929-98, ASTM F 88-07, ASTM D4169 – 09, ISO 11135:2007, ISO 10993-1: 2009, USP <661>).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual test. It refers to "a battery of tests." For device-specific physical and mechanical tests, industry practice and standard requirements often involve testing a representative sample (e.g., typically 3-10 units for destructive tests, or a larger batch for statistical process validation). For biocompatibility, specific numbers of animals or cell cultures would be used as per the mentioned ISO 10993 guidelines.
- Data Provenance: The tests were conducted by the manufacturer, Merit Medical Ireland Ltd., or their designated testing facilities. The tests are for a new device submission, implying the data is prospective as it was generated specifically for this premarket notification. The company (Merit Medical Ireland Ltd.) and its parent company (Merit Medical Systems, Inc.) are based in Ireland and the USA, respectively, implying the testing likely occurred in these regions or by accredited labs serving these regions.
3. Number of Experts Used and Qualifications for Ground Truth
- Not Applicable. This device is a mechanical accessory (flow switch). Its performance is evaluated by engineering and biological testing against established standards, not by expert interpretation of clinical images or data that would require a "ground truth" derived from human experts (e.g., radiologists, pathologists). The "ground truth" for this device's performance is objective measurements against specifications and standards.
4. Adjudication Method for the Test Set
- Not Applicable. As detailed in point 3, the evaluation of a mechanical device's function and biocompatibility relies on objective measurements and adherence to specified standards, not on subjective expert consensus or adjudication of clinical interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is typically used for diagnostic imaging devices or software where human readers interpret medical cases. The Merit Marquis® Flow Switch is an angiographic accessory, not a diagnostic imaging device or AI software, so an MRMC study is not relevant or applicable here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in essence. The entire battery of tests described (physical, mechanical, biocompatibility, packaging) represents a standalone evaluation of the device's intrinsic performance without human interaction in its evaluation process, beyond operating the test equipment. The device itself is a "human-in-the-loop" device by design as it requires a clinician to operate it. However, the performance assessment described in the submission focuses solely on the device's technical specifications and safety attributes independent of a user study.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is derived from established engineering specifications, international/national standards (ISO, ASTM, USP), and validated test methods. For example, a Luer fitting's ground truth is its conformance to ISO 594, and biocompatibility's ground truth is a pass/fail outcome against ISO 10993 criteria.
8. Sample Size for the Training Set
- Not Applicable. "Training set" refers to data used to train artificial intelligence or machine learning models. This device is a mechanical flow switch and does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As per point 8, there is no AI/ML model or "training set" for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract bird or human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Merit Medical Ireland Ltd. C/O Ms. Stephanie Erskine 1600 West Merit Parkway South Jordan, UT 84095
Re: K110643
Trade/Device Name: Merit Marquis Flow Switch Regulation Number: 21 CFR 870.4290 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DTL Dated: April 20, 2011 Received: April 22, 2011
Dear Ms. Erskine:
This letter corrects our substantially equivalent letter of July 1, 2011.
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Stephanie Erskine
forth in the quality systems (QS) 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" (21CFR 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.
Eric E. Richardson -S
for Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4
Indications for Use Statement
510(k) Number (if known):
Device Name: Merit Marquis® Flow Switch
Indications for Use:
The Flow Switch is an anglographic accessory intended for use as an on-off device for angiography and other high pressure applications.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) :
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fli. Gual ho BDZ
ion Sidh-Off n of Cardiovascular Devices
510(k) Number_K110643
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Section 5
| 510(k) Summary | ||
|---|---|---|
| GeneralProvisions | Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | (801) 208-4349 | |
| Fax Number: | (801) 253-6967 | |
| Contact Person: | Stephanie Erskine | |
| Registration Number: | 1721504 | |
| Correspondent Name: | Merit Medical Ireland Ltd. | |
| Address: | Parkmore Business Park,Galway, Ireland | |
| Telephone Number: | (353) 91 703 761 | |
| Fax Number: | (353) 91 771 888 | |
| Contact Person: | Mark Mullaney | |
| Date of Preparation: | 21-Apr-2011 | |
| Registration Number: | 9616662 | |
| SubjectDevice | Trade Name: | Merit Marquis® Flow Switch |
| Common/Usual Name: | High pressure angiographic flow controlswitch / stopcock | |
| Classification Name: | Adaptor, Stopcock, Manifold, Fitting,Cardiopulmonary Bypass | |
| PredicateDevice | Trade Name: | FLOSWITCH(R) HP |
| Classification Name: | Catheter, intravascular, diagnostic | |
| Premarket Notification: | K913871 | |
| Manufacturer: | BOSTON SCIENTIFIC CORP. | |
| Classification | Class II | |
| FDA Product Code: | DTL | |
| 21 CFR § 870.4290 | ||
| Division of Cardiovascular Devices | ||
| Intended Use | The Flow Switch is an angiographic accessory intended for use asan on-off device for angiography and other high pressureapplications. | |
| DeviceDescription | The Flow Switch is a device used to connect in line to liquid flow.This uses a Female Luer lock (inlet) and Male Luer lock (outlet)connection. Shut off is by means of a non-slip sliding handle thatcan be operated one-handed and gives an audible click into the OFFposition. Flow directions are indicated by arrows on the handle. | |
| TechnologicalCharacteristics | Technological characteristics of the subject Merit Marquis® FlowSwitch are substantially equivalent to those of the predicate, thecurrently marketed BOSTON SCIENTIFIC CORP. FLOSWITCH(R),HP [K913871]. | |
| Safety &PerformanceTests | No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. However, abattery of tests performed on the Merit Marquis® Flow Switch weredesigned to demonstrate that the device meets critical designspecifications as well as clinical performance attributes for itsintended use. Where appropriate, the tests were based on therequirements of the following documents:ISO 11070: 1998, Sterile Single-Use Intravascular CatheterIntroducers. ISO 594-1:1996, Conical fittings with a 6 % (Luer) taper forsyringes, needles and certain other medical equipment –Part 1: General requirements ISO 594-2:1998, Conical fittings with 6% (Luer) taper forsyringes, needles and certain other medical equipment –Part 2: Lock fittings ASTM F 2096-04; Standard Test Method for Detecting GrossLeaks in Medical Packaging by Internal Pressurization(Bubble Test) ASTM F 1929-98 (Reapproved 2004); Standard Test Methodfor Detecting Seal Leaks in porous Medical Packaging byDye Penetration ASTM F 88-07; Standard Test Method for Seal Strength ofFlexible Barrier Materials. ASTM D4169 – 09 Standard Practice for PerformanceTesting of Shipping Containers and Systems1 ISO 11135:2007 – Sterilization of health care products –Ethylene oxide – Part 1: Requirements for development,validation and routine control of a sterilization process formedical devices ISO 10993-1: 2009, Biological Evaluation of medical DevicesPart 1: Evaluation and Testing within a risk managementprocess, and the FDA Modified ISO 10993 Test Profile |
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The Merit Marquis® Flow Switch was compared to the predicate device for various performance attributes that demonstrate the safety or efficacy of the device. The following is a list of all significant testing that was successfully completed:
- . Surface inspection
- Male and Female Luer conical fittings with a 6% (Luer) .
- Pressure in OFF position .
- Pressure in open/ON position .
- Slider Handle motion test ●
- Slider force test ●
- . Flow Test
Biocompatibility testing included:
- L929 MEM Elution: MEM extraction .
- Kligman Maximization: Saline and cottonseed oil extractions .
- Intracutaneous Injection: Saline and cottonseed oil . extractions
- . Systemic Injection: Saline and cottonseed oil extractions
- . Material Medicated Rabbit Pyrogen Test: Saline extraction
- Hemocompatibility - In-Vitro Hemocompatibility - Indirect
- Hemocompatibilitv Hemolysis Indirect ●
- Hemocompatibility Prothrombin Time Assay (PT) Indirect .
- Hemocompatibility Unactivated Partial Thromboplastin . Time Assay (UPTT) Indirect
- . Heavy Metals Content: USP Physicochemical Tests for Plastics USP <661>
Packaging performance before and after exposure to accelerated aging and simulated shipping and handling conditions:
- Bubble emission .
- Dye penetration ●
- Seal peel tensile strength ●
- Burst strength ●
- Visual inspection .
Summary of Substantial Equivalence Based on the indications for use, design, safety, and performance testing, the subject Merit Marquis® Flow Switch meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device. the currently marketed FLOSWITCH(R) HP manufactured by currently marketed BOSTON SCIENTIFIC CORP.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).