(36 days)
Not Found
No
The summary describes a software-controlled injection system with user-programmed parameters, but there is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No.
The device is used for injecting contrast medium for diagnostic imaging (angiographic studies), not for treating a disease or condition.
No
The device is an injection system used to administer contrast medium for angiographic studies, not to diagnose a condition itself. Its purpose is to facilitate imaging, which is then used for diagnosis.
No
The device description explicitly states it is an "automated injection system" used to inject contrast agents from a "150 ml disposable syringe," indicating it includes hardware components beyond just software.
Based on the provided information, the MEDRAD® Mark 7 Arterion Injection System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for injecting contrast medium and flushing solutions into humans for angiographic studies. This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism) diagnostic test.
- Device Description: The description reinforces its function as an automated injection system for delivering substances into a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are hallmarks of IVD devices.
Therefore, the MEDRAD® Mark 7 Arterion Injection System is a medical device used for therapeutic or diagnostic imaging procedures performed directly on a patient, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.
Product codes
DXT
Device Description
The MEDRAD Mark 7 Arterion Iniector 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.
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)
Verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective. Performance testing performed with MEDRAD Mark 7 Arterion Injection System which was provided in previous 510(k)s remains applicable.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2019 Bayer Medical Care Inc. Kelly Frank Project Manager 1 Bayer Drive Indianola, Pennsylvania 15051
Re: K193028
Trade/Device Name: MEDRAD Mark 7 Arterion Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: November 4, 2019 Received: November 5, 2019
Dear Kelly Frank:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193028
Device Name MEDRAD Mark 7 Arterion Injection System
Indications for Use (Describe)
MEDRAD® Mark 7 Arterion Injection System
The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Imaging System Interface (ISI)
The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.
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) |
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Image /page/3/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with each letter in a bold, sans-serif font. The word is surrounded by a circular design, with the top half of the circle in green and the bottom half in blue. The logo is simple and recognizable, and it is often used to represent the Bayer company.
510(k) Summary
| Submitter: | Bayer Medical Care, Inc.
1 Bayer Drive
Indianola, PA 15051 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kelly Frank
Project Manager
Phone: (412) 576-7583
Email: kelly.frank@bayer.com |
| Date Prepared: | October 24, 2019 |
| Device Trade Name: | MEDRAD® Mark 7 Arterion Injection
System |
| Common Name: | Angiographic Injector and Syringe |
| Classification Name: | Injector and Syringe, Angiographic [21 CFR
870.1650] |
| Product Code: | DXT |
| Classification: | Class II |
| Predicate Device: | The subject device is substantially
equivalent to the following device:
MEDRAD® Mark 7 Arterion Injection
System, K132928. |
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Image /page/4/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is encircled by two curved lines, one in green and the other in blue, forming a ring around the name.
Device Description:
The MEDRAD Mark 7 Arterion Iniector 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.
Indications for Use:
MEDRAD Mark 7 Arterion Injection System
The MEDRAD Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Imaging System Interface (ISI)
The ISI option is indicated for the specific purpose of allowing a MEDRAD Mark 7 Arterion Injection System to interface with an angiography imaging system.
Comparison to the Predicate Device:
The modification is an administrative update to include mention of the ISI (Imaging System Interface) module in the Indications for Use for the MEDRAD Mark 7 Arterion Injection System. This update does not involve any changes to the MEDRAD Mark 7 Arterion Injection System Syringe Kit. Table 1 provides a comparison of the proposed MEDRAD Mark 7 Arterion Injection System with the predicate device, the MEDRAD Mark 7 Arterion Injection System cleared per K132928.
The fundamental scientific technology, principle of operation, and intended use are unchanged from the predicate device, the MEDRAD Mark 7 Arterion Injection System cleared per K132928. The differences between the proposed device and the predicate device do not introduce new issues of safety and effectiveness.
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Image /page/5/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are a dark blue color. The wordmark is encircled by a ring that is green on the top half and blue on the bottom half.
Table 1. Comparison of MEDRAD Mark 7 Arterion Injection System (proposed device) with predicate device.
| PARAMETER | PREDICATE
DEVICE | PROPOSED
DEVICE | RATIONALE FOR
CHANGE |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | Mark 7 Arterion
Injection System
(K132928) | Mark 7 Arterion
Injection System | |
| 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 Injection
System is indicated
to be used
specifically for the
purposes of injecting
contrast medium and
common flushing
solutions into
humans for
angiographic studies.
The ISI option is
indicated for the
specific purpose of
allowing a MEDRAD
Mark 7 Arterion
Injection System to
interface with an
angiography imaging
system. | Administrative
update to add ISI
module specific
indications for use
statement |
| Fill Volume | 1 – 150 ml in 1 ml
increments | Same | No change |
| Fill Speed (user) | 1 — 10 ml/sec | Same | No change |
| PARAMETER | PREDICATE
DEVICE
Mark 7 Arterion
Injection System
(K132928) | PROPOSED
DEVICE
Mark 7 Arterion
Injection System | RATIONALE FOR
CHANGE |
| configurable for
AutoFill) | | | |
| Fill Speed
(manual control
by user) | 1 - 20 ml/sec | Same | 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 (ml/m
protocol) | Same | No change |
| Variable Flow
Rate | 1.0 – 10.0 ml/sec in
0.1 ml/sec
increments | Same | No change |
| Flow Rate Rise
Time | 0.0 to 9.9 seconds in
0.1sec increments | Same | No change |
| Delay | 0.0 to 9.9 seconds in
0.1sec increments | Same | No change |
| Pressure Limit
(150 ml syringe) | 100-1200 psi or 689-
8273 kPa in
increments of 1 psi
(kPa) | Same | No change |
| Syringe Heat
Maintainer | 35°C + 5°C | Same | No change |
| Protocol Memory | 40 protocols | Same | No change |
| Injection History | 50 injections | Same | No change |
| PARAMETER | PREDICATE
DEVICE
Mark 7 Arterion
Injection System
(K132928) | PROPOSED
DEVICE
Mark 7 Arterion
Injection System | RATIONALE FOR
CHANGE |
| Memory | | | |
| Information
Display | Color LCD | Same | No change |
| Programming
Keys | Software-generated
via an LCD touch
screen | Same | No change |
| Touch Screen | Yes | Same | No change |
| Multi-Phase | 4 phases per protocol | Same | No change |
| Arming Modes | Single and Multi-
arming modes | Same | No change |
| Syringe System | Single (150 ml)
syringe | Same | No change |
| Manual Retract
Control | Yes | Same | No change |
| Check for Air
Control | Yes | Same | No change |
| Variable Flow
Option | Yes | Same | No change |
| Hand Switch
(start switch) | Yes | Same | No change |
| Foot Switch
(start switch) | Yes | Same | No change |
| Variable Flow
Hand Controller | Yes | Same | No change |
| Splash Guard | Yes | Same | No change |
| Wiper Seal | Optional | Same | No change |
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Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are arranged in the center of a circle that is divided into two halves. The top half of the circle is green, and the bottom half is blue.
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Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are arranged in the center of a circle that is divided into two halves. The top half of the circle is green, and the bottom half is blue.
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Image /page/8/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with each letter in a bold, sans-serif font. The word is enclosed in a circular shape, with the top half of the circle being green and the bottom half being blue. The logo is simple and modern, and the colors are bright and eye-catching.
Performance Data:
Verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective. Performance testing performed with MEDRAD Mark 7 Arterion Injection System which was provided in previous 510(k)s remains applicable.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.
Clinical Testing:
No clinical testing was required or performed to support this Special 510(k) Premarket Notification.
Conclusion:
Bayer Medical Care Inc. considers the MEDRAD Mark 7 Arterion Injection System to be substantially equivalent to the predicate device listed above. The fundamental scientific technology, principle of operation, and intended use are unchanged from the predicate device. The differences between the proposed device and the predicate device do not introduce new issues of safety and effectiveness.