(85 days)
Not Found
No
The device description and performance studies focus on mechanical principles (gravity, pressure dampening) and do not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a system for controlling the infusion of contrast media during angiographic procedures, not as a device that treats a disease or condition itself.
No
This device is designed for the controlled infusion of contrast media for angiographic procedures. Its purpose is to modulate the delivery of contrast, not to diagnose a condition or disease.
No
The device description explicitly details physical hardware components including a Linear Slide Apparatus, Pressure Dampening Plates, and a Wheeled Stand. It also mentions the use of a syringe, stopcock, and extension line. There is no mention of software as a component of the device.
Based on the provided information, the Osprey Medical AVERT Contrast Modulation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled infusion of radiopaque Iodixanol 270 mg/ml contrast media for angiographic procedures." This describes a device used in vivo (within the body) during a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a mechanical system (linear slide, pressure dampening plates, wheeled stand) used in conjunction with syringes and tubing to deliver contrast media. This aligns with a device used for administering substances to a patient, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Osprey Medical AVERT Contrast Modulation System is a medical device used for administering contrast media during angiographic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Osprey Medical AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque Iodixanol 270 mg/ml contrast media for angiographic procedures.
Product codes
DXT
Device Description
The Osprey Medical AVERT Contrast Modulation System (AVERT System) consists of a Linear Slide Apparatus, Pressure Dampening Plates, and a Wheeled Stand. The nonsterile, reusable stainless steel dampening plates are attached to a non-sterile, reusable aluminum linear slide, positioned above a 6 cc syringe. The plates apply a constant force (using gravity) on the 6 cc syringe plunger acting as pressure dampener. The number of plates can be changed depending on the injection requirements. The Linear Slide Apparatus is attached to the Wheeled Stand, near the patient outside of the sterile field. The AVERT System is used in conjunction with standard disposable, sterile, off-the-shelf items including a 6 cc syringe, a 4-way stopcock, and an extension line that are provided in a Convenience Kit with the system (CK-100).
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
The Osprey Medical AVERT System has been evaluated using the following in vitro bench testing to confirm the performance characteristics:
- . Flow Rate
- Peak Pressure Reduction .
- · Flow Rate Adjustability
- . Mechanical Cycle Testing
- Contrast Reduction .
All test results demonstrated the materials, manufacturing processes, and design of the Osprey Medical AVERT System met the established performance criteria, will perform as intended and in a manner that is substantially equivalent to the predicated devices cited.
Key Metrics
Not Found
Predicate Device(s)
K993774, K991103, K000013, K052744, K093830
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.
0
AUG 1 5 2013
8. 510(K) SUMMARY
. も
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ · · ·
Applicant Information:
| Date Prepared: | July 12, 2013 |
|---|---|
| Name: | Osprey Medical |
| Address: | 5600 Rowland Road, Suite 250 |
| Minnetonka, MN 55343 | |
| Phone: 651-270-0572 | |
| Fax: 952-955-8171 | |
| Contact Person: | Jill Munsinger |
| Phone Number: | 651-270-0572 |
| E-mail: | jmunsinger@visi.com |
Device Information:
| Trade Name | Common Name | Classification Name | Class |
|---|---|---|---|
| AVERT Contrast Modulation | |||
| System | Angiographic Injector | Angiographic Injector | Class II |
Predicate Devices:
The Osprey Medical AVERT Contrast Modulation System is substantially equivalent in intended use and/or method of operation and technical aspects to the following predicate devices:
| Device | Reference 510(k) Number | Indication for Use |
|---|---|---|
| Acist Angiographic Injection System | K993774, K991103, | |
| K000013, and K052744 | ...intended to be used for | |
| the controlled infusion of | ||
| radiopaque contrast media | ||
| for angiographic procedures | ||
| Medline Angiographic Control Syringe | K093830 | An angiographic syringe is a |
| device that consists of a | ||
| syringe which is used to | ||
| inject contrast material into | ||
| the heart, great vessels, and | ||
| coronary arteries during | ||
| angiographic or CT | ||
| procedures. |
1
Device Description:
The Osprev Medical AVERT Contrast Modulation System (AVERT System) consists of a Linear Slide Apparatus, Pressure Dampening Plates, and a Wheeled Stand. The nonsterile, reusable stainless steel dampening plates are attached to a non-sterile, reusable aluminum linear slide, positioned above a 6 cc syringe. The plates apply a constant force (using gravity) on the 6 cc syringe plunger acting as pressure dampener. The number of plates can be changed depending on the injection requirements. The Linear Slide Apparatus is attached to the Wheeled Stand, near the patient outside of the sterile field. The AVERT System is used in conjunction with standard disposable, sterile, off-the-shelf items including a 6 cc syringe, a 4-way stopcock, and an extension line that are provided in a Convenience Kit with the system (CK-100).
Intended Use:
The Osprey Medical AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque Iodixanol 270 mg/ml contrast media for angiographic procedures.
Comparison to Predicate Device(s):
The design of the AVERT System is comparable to the Acist Angiographic Injection System and the Medline Angiographic Control Syringe. The indication for use statement of the Acist Angiographic Injection System and the AVERT System are similar with the A VERT System having a more specific indication of contrast media type. The indication for use statement of the Medline Angiographic Control Syringe is similar in intention to the AVERT System. The Medline indication relies on the user's ability to inject fluid to control the infusion. While this is different from the AVERT System, it is not considered a critical different in that they are both designed to inject materials into blood vessels/arteries.
The AVERT System is manually adjusted via addition/subtraction of plates to divert injection pressure and control infusion. Whereas the Acist system is a powered injector adjusted via the user interface and the Medlin syringe is manually controlled.
Performance Data:
The Osprey Medical AVERT System has been evaluated using the following in vitro bench testing to confirm the performance characteristics:
-
. Flow Rate
-
Peak Pressure Reduction .
-
· Flow Rate Adjustability
-
. Mechanical Cycle Testing
-
Contrast Reduction .
2
All test results demonstrated the materials, manufacturing processes, and design of the Osprey Medical AVERT System met the established performance criteria, will perform as intended and in a manner that is substantially equivalent to the predicated devices cited.
Summary:
Based upon the intended use and descriptive information provided in this pre-market notification, the Osprey Medical AVERT System has been shown to be substantially equivalent to the currently marketed predicate devices.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2013
Osprey Medical C/O Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K131478
Trade/Device Name: AVERT Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class; II Product Code: DXT Dated: June 26, 2013 Received: June 27, 2013
Dear Mr. Job:
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
4
Page 2 - Mr. Mark Job
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/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 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 yours,
Bram D. Zuglierman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
7. INDICATIONS FOR USE STATEMENT
510(k) Number: K131478
Device Name: AVERT Contrast Modulation System
Indications For Use:
The Osprey Medical AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque lodixanol 270 mg/ml contrast media for angiographic procedures.
Prescription Use X (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)
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