(119 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI or ML.
No.
The device is described as an "angiographic accessory intended for use as an on-off device for angiography and other high pressure applications," which indicates it controls flow during a procedure rather than directly treating a condition.
No
The device is described as an "angiographic accessory" and an "on-off device for angiography and other high pressure applications." Its function is to control liquid flow. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly describes a physical, mechanical device with Luer lock connections and a sliding handle. The performance studies also focus on physical properties like pressure, flow, and biocompatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an on-off device for angiography and other high pressure applications." This describes a mechanical function for controlling fluid flow during a medical procedure performed on a patient.
- Device Description: The description details a physical device with Luer lock connections and a sliding handle for controlling liquid flow. This aligns with a device used in a clinical setting for patient treatment or diagnosis in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The testing described focuses on the device's mechanical performance, pressure handling, biocompatibility, and packaging integrity, not on analyzing biological samples.
Therefore, the Flow Switch is an accessory used during medical procedures performed on a patient, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Flow Switch is an angiographic accessory intended for use as an on-off device for angiography and other high pressure applications.
Product codes (comma separated list FDA assigned to the subject device)
DTL
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, 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. Where appropriate, the tests were based on the requirements of the following documents:
ISO 11070: 1998, Sterile Single-Use Intravascular Catheter Introducers.
ISO 594-1:1996, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
ASTM F 2096-04; Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
ASTM F 1929-98 (Reapproved 2004); Standard Test Method for Detecting Seal Leaks in porous Medical Packaging by Dye Penetration
ASTM F 88-07; Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM D4169 – 09 Standard Practice for Performance Testing 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 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
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
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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
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: | (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 | |
| Subject | ||
| Device | Trade Name: | Merit Marquis® Flow Switch |
| Common/Usual Name: | High pressure angiographic flow control | |
| switch / stopcock | ||
| Classification Name: | Adaptor, Stopcock, Manifold, Fitting, | |
| Cardiopulmonary Bypass | ||
| Predicate | ||
| Device | 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 as | |
| an on-off device for angiography and other high pressure | ||
| applications. | ||
| Device | ||
| Description | 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. | ||
| Technological | ||
| Characteristics | Technological characteristics of the subject Merit Marquis® Flow | |
| Switch are substantially equivalent to those of the predicate, the | ||
| currently marketed BOSTON SCIENTIFIC CORP. FLOSWITCH(R) | ||
| ,HP [K913871]. | ||
| Safety & | ||
| Performance | ||
| Tests | No performance standards have been established under Section 514 | |
| of the Food, Drug and Cosmetic Act for these devices. However, 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. Where appropriate, the tests were based on the | ||
| requirements of the following documents: | ||
| ISO 11070: 1998, Sterile Single-Use Intravascular Catheter | ||
| Introducers. ISO 594-1:1996, Conical fittings with a 6 % (Luer) taper for | ||
| syringes, needles and certain other medical equipment – | ||
| Part 1: General requirements ISO 594-2:1998, Conical fittings with 6% (Luer) taper for | ||
| syringes, needles and certain other medical equipment – | ||
| Part 2: Lock fittings ASTM F 2096-04; Standard Test Method for Detecting Gross | ||
| Leaks in Medical Packaging by Internal Pressurization | ||
| (Bubble Test) ASTM F 1929-98 (Reapproved 2004); Standard Test Method | ||
| for Detecting Seal Leaks in porous Medical Packaging by | ||
| Dye Penetration ASTM F 88-07; Standard Test Method for Seal Strength of | ||
| Flexible Barrier Materials. ASTM D4169 – 09 Standard Practice for Performance | ||
| Testing 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 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 |
4
・
5
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
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.