Who is the manufacturer of MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE?

Medrad, Inc. / Bayer Medical Care, Inc. filed the 510(k) submission for MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE (K132928).

What is the FDA product code for MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE?

DXT. It is classified under 21 CFR 870.1650 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE?

510(k) clearance (submission type: Special).

What are the predicate devices for MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE?

MEDRAD Mark 7 Arterion Injection System (K113133); MEDRAD Mark 7 Arterion Syringe (K112086).

Who can help prepare an FDA 510(k) submission like MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE

K132928 · Medrad, Inc. / Bayer Medical Care, Inc. · DXT · Jan 23, 2014 · Cardiovascular

Device Facts

Record ID	K132928
Device Name	MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
Applicant	Medrad, Inc. / Bayer Medical Care, Inc.
Product Code	DXT · Cardiovascular
Decision Date	Jan 23, 2014
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1650
Device Class	Class 2

Intended Use

The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

Device Story

Automated injection system for contrast media and flushing solutions in angiographic studies; comprises software-controlled injector head, 150 ml disposable syringe, and optional VFlow hand controller. Operator programs volume and flow rate via LCD touch screen. VFlow hand controller allows precise, instantaneous variable flow rate adjustment during injection or puffing; enables clinician to step away from radiation source. Syringes are front-loading, polycarbonate for improved air visualization; Twist & Go variant allows single-handed tubing attachment. System provides automated delivery, enhancing procedural control and clinician safety.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench and laboratory testing, including performance, safety, EMC, package integrity, environmental, and pressure/burst testing.

Technological Characteristics

Software-controlled angiographic injector; 150 ml polycarbonate syringes with silicone coating; polyisoprene plunger cover. Variable flow rate (1.0-10.0 ml/sec) and fixed flow rate (0.1-45.0 ml/sec) modes. Connectivity via LCD touch screen. Sterilization via Gamma radiation (syringes). Pressure limit up to 1200 psi.

Indications for Use

Indicated for use in humans undergoing angiographic studies requiring the injection of contrast media and flushing solutions.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, 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

MEDRAD Mark 7 Arterion Injection System (K113133)
MEDRAD Mark 7 Arterion Syringe (K112086)

Related Devices

K113133 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE · Medrad, Inc. · Dec 15, 2011
K193028 — MEDRAD Mark 7 Arterion Injection System · Bayer Medical Care, Inc. · Dec 5, 2019
K963982 — ACIST ANGIOGRAPHIC INJECTOR · Invasatec · Dec 5, 1997
K112086 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE · Medrad, Inc. · Oct 14, 2011
K991103 — MODIFICATION TO ACIST CL 100H · Acist Medical Systems · May 31, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with the letters "B", "A", "Y", "E", and "R" forming the arms of the cross. The entire logo is enclosed within a double-lined circle. MEDRAD, INC. (412) 767-2400 www.ri.bayer.com U.S.A. One Medrad Drive Indianola, PA 15051 K132928 JAN 23 2014 # 510(k) Summary #### Submitter: MEDRAD, Inc. / Bayer Medical Care, Inc. One Medrad Drive Indianola, PA 15051 Contact Person: Lisa A. Ewing Principal Regulatory Affairs Specialist Phone: (412) 406-3780 Fax: (412) 406-4052 Email: lisa.ewing@bayer.com Date Prepared: Device Trade Name: Common Name: Classification Name: Product Code: Classification: Predicate Device(s): September 16, 2013 MEDRAD Mark 7 Arterion Injection System MEDRAD Mark 7 Arterion Syringe MEDRAD Twist & Go Syringe Angiographic Injector and Syringe Injector and Syringe, Angiographic [21 CFR 870.1650] DXT Class II The subject devices are equivalent to the following devices: MEDRAD Mark 7 Arterion Injection System K113133, December 15, 2011 O K112086, October 14, 2011 o {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically inside of a circle. The letters are bolded and in a sans-serif font. The circle has a double-line border. #### Device Description: ### MEDRAD Mark 7 Arterion Injector The MEDRAD Mark 7 Arterion Injector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user-programmed volume and flow rate. #### MEDRAD VFlow Hand Controller For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations. When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once horizontally and once vertically, intersecting at the "Y" to form a cross shape. The logo is enclosed within a circle. ### Mark 7 Arterion Syringe and Twist & Go Syringe The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe. The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. #### Intended Use: {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circle. The letters are stacked on top of each other, with the "A" in the center. The logo is black and white. ### Comparison to Predicate: Design changes were made to the predicate device which included: updating injector software to include a new variable flow rate option, adding a variable flow rate ("VFIow") hand controller and adding a new configuration of the Arterion Syringe, which is called the Twist and Go Syringe. #### Performance Data: Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use. This included the following testing: - . Pérformance - Safety . - EMC . - . Package Integrity - Environmental . - . Pressure, burst, wet friction testing (syringe) - System level testing with a MEDRAD . automated injector (syringe) {4}------------------------------------------------ ## Comparison Tables . Table 1. Comparison of Features in MEDRAD Mark 7 Arterion Injection System (predicate) and the modified MEDRAD Mark 7 Arterion Injection System (proposed). | Specification / Feature | Predicate Device: MEDRAD Mark 7 Arterion Injection System (K113133) | Proposed Device: MEDRAD Mark 7 Arterion Injection System | Rationale for Change | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use / Intended Use | The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. | The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. | No change. | | Fill Volume | 1 - 150 ml in 1 ml increments | 1 - 150 ml in 1 ml increments | No change. | | Fill Speed (user configurable for AutoFill) | 1 - 10 ml/sec | 1 - 10 ml/sec | No change. | | Fill Speed (manual control by user) | 1 - 20 ml/sec | 1 - 20 ml/sec | No change. | | Fixed Flow Rate | 0.1 to 45.0 ml/sec in 0.1 ml increments (single and phased protocols) 0.1 to 59.9 ml/min in 0.1 ml/min increments (single ml/min protocol) | 0.1 to 45.0 ml/sec in 0.1 ml increments (Single and Phased protocols) 0.1 to 59.9 ml/min in 0.1 ml/min increments (ml/m protocol) | No change. | | Variable Flow Rate | N/A - not available | Variable: 1.0 - 10.0 ml/sec in 0.1 ml/sec increments | Variable Flow Rate is being added as an additional, optional feature to inject a set volume of contrast at a flow rate determined by the hand controller. | | Flow Rate Rise Time | 0.0 to 9.9 seconds in 0.1sec increments | 0.0 to 9.9 seconds in 0.1 sec increments | No change. | | Delay Time | 0.0-99.9 seconds in 0.1 sec increments | 0.0-99.9 seconds in 0.1 sec increments | No change. | | Pressure Limit (150 ml syringe) | 100-1200 psi or 689- 8273 kPa in increments of 1 psi (kPa) | 100-1200 psi or 689- 8273 kPa in increments of 1 psi (kPa) | No change. | | | | | | | Syringe Heat Maintainer | $35°C ± 5°C$ | $35°C ± 5°C$ | No change. | | Protocol Memory | 40 Protocols | 40 Protocols | No change. | | Injection History Memory | 50 Injections | 50 Injections | No change. | | Information Display | Color LCD | Color LCD | No change. | | Programming Keys | Software generated via an LCD touch screen | Software generated via an LCD touch screen | No change. | | Touch Screen | Yes | Yes | No change. | | Multi-Phase | 4 phases per protocol | 4 phases per protocol | No change. | | Arming Modes | Single and Multi arming modes | Single and Multi arming modes | No change. | | Syringe System | Single (150 ml) syringe | Single (150 ml) syringe | No change. | | Manual Retract Control | Yes | Yes | No change. | | Check for Air Control | Yes | Yes | No change. | | Variable Flow Option | No | Yes | Variable Flow Rate is being offered as an additional, optional feature to inject a set volume of contrast at a flow rate determined by the hand controller. | | Hand Switch (start switch) | Yes | Yes | No change. | | Foot Switch (start switch) | Yes | Yes | No change. | | Variable Flow Hand Controller | No | Yes | Hand controller is being offered as an additional, optional accessory for use with the new variable flow rate software feature. | | Splash Guard | Yes | Yes | No change. | | Wiper Seal | Yes | Optional | Wiper seal is a redundant feature and is not a required | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circle. The letters are in a bold, sans-serif font and are black. The circle is also black and has a thin outline. . : · {6}------------------------------------------------ . 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically inside of a circle. The letters are in a bold, sans-serif font and are black in color. The circle is also black and has a slightly textured appearance. Table 2. Comparison of Features in MEDRAD Mark 7 Arterion Syringe (predicate), MEDRAD Mark 7 Arterion Syringe (proposed) and the MEDRAD Twist & Go Syringe (proposed). . . . . | | Component / Feature | Predicate Device: MEDRAD Mark 7 Arterion Syringe (K112086, K113133) | Proposed Device: MEDRAD Mark 7 Arterion Syringe | Proposed Device: MEDRAD Twist & Go Syringe | Rationale for Change | |----------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Labeling | Intended Use | The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System in the x-ray angiography environment. | The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. | The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. | No change in intended use, only updated syringe product name. | | | Syringe Volume | 150 mL | 150 mL | 150 mL | No change. | | | Syringe Length | 8.61 inches | 8.61 inches | 8.61 inches | No change. | | | Barrel OD | 1.81 inches | 1.81 inches | 1.81 inches | No change. | | | Barrel ID | 1.60 inches | 1.60 inches | 1.60 inches | No change. | | | FasTurn Nut at Syringe Tip | Yes | Yes | No | FasTurn Nut is not required for Twist & Go connection | | | Construction | Dust Cover | Yes (sized to fit syringe tip with FasTurn nut) | Yes (sized to fit syringe tip with FasTurn nut) | Yes (sized to fit syringe tip without FasTurn nut) | | | | Tubing Set Compatibility | Connects to female luer on high pressure connector tubing | Connects to female luer on high pressure connector tubing | Connects to Twist & Go luer connector on the MEDRAD Twist & Go High Pressure Connector Tubing | | | | Detents | Yes, molded in to syringe tip | Yes, molded in to syringe tip | No | : {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically inside a circle. The letters are stacked on top of each other, with the "A" in the middle being slightly larger than the other letters. | Materials | Syringe Barrel | Polycarbonate | Polycarbonate | Polycarbonate | No change. | |------------|------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|-------------------------------------------------------------| | | Syringe Barrel ID. Coating | Silicone | Silicone | Silicone | No change. | | | Plunger | Polycarbonate | Polycarbonate | Polycarbonate | No change. | | | Plunger Rubber Cover | Polyisoprene | Polyisoprene | Polyisoprene | No change. | | | Plunger Coating | Silicone | Silicone | Silicone | No change. | | | FasTurn Nut | Polycarbonate | Polycarbonate | N/A | FasTurn Nut is not required for Twist & Go connection | | | | | | | | | Packaging | Dust Cover | Polypropylene | Polypropylene | Polypropylene | No change. | | | Type | Tyvek lid covering polystyrene tray | Tyvek lid covering polystyrene tray | Tyvek lid covering polystyrene tray | No change. | | | | | | | | | Biological | Sterilization | E-beam radiation | Gamma radiation | Gamma radiation | Updated mode of sterilization; SAL is unchanged. | | | Sterility Assurance Level (SAL) | 10-6 | 10-6 | 10-6 | No change. | | | Shelf Life | 2 years | 2 years | 2 years | No change. | | | Pyrogenicity | Non-Pyrogenic Fluid Path | Non-Pyrogenic Fluid Path | Non-Pyrogenic Fluid Path | No change. | | | Latex content | Not made with natural rubber latex | Not made with natural rubber latex | Not made with natural rubber latex | No change. | | | Performance | Pressure rating | 1200 psi | 1200 psi | 1200 psi | | | | | | | | Conclusion: MEDRAD considers the MEDRAD Mark 7 Arterion Injection System, Mark 7 Arterion Syringe and Twist & Go Syringe to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, fundamental scientific technology, and principles of operation. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally. Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 23, 2014 MEDRAD, Inc. C/O Ms. Lisa A. Ewing Principal Regulatory Affairs Specialist One Medrad Drive Indianola, PA 1505 I Re: K132928 Trade/Device Name: MEDRAD Mark 7 Arterion Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: DXT Dated: December 23, 2013 Received: December 24, 2013 Dear Ms. Ewing: 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 {9}------------------------------------------------ Page 2 - Ms. Lisa A. Ewing 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indications for Use Statement 510(k) Number: K132928 Device Name: MEDRAD Mark 7 Arterion Injection System MEDRAD Mark 7 Arterion Syringe MEDRAD Twist & Go Syringe #### Indications for Use: The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies. Prescription Use 2 (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) M.A. Hillerman Page 1 of 1