(45 days)
Not Found
No
The device description and performance studies focus on mechanical modulation of contrast media flow and do not mention any AI/ML components or algorithms.
No.
The device is intended for the controlled infusion of radiopaque contrast media for angiographic procedures. While contrast media is used in diagnostic procedures that can lead to therapeutic interventions, the device itself is not described as directly treating or curing a disease or condition. It facilitates imaging, which is a diagnostic aid.
No
The device is described as an "infusion system" for "controlled infusion of radiopaque contrast media." Its purpose is to modulate contrast agent delivery for imaging, not to diagnose a condition.
No
The device description explicitly details a "reusable, non-sterile apparatus (contrast modulator)" which is a physical hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled infusion of radiopaque contrast media for angiographic procedures." This describes a device used during a medical procedure to administer a substance into the body for imaging purposes.
- Device Description: The description details a mechanical system that modulates the flow of contrast media during manual injections. It's a physical device used in a clinical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
The AVERT™ Contrast Modulation System is a medical device used in conjunction with contrast media for imaging procedures, not a device for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The AVERT™ Contrast Modulation System is intended for the controlled infusion of radiopaque contrast media for angiographic procedures.
The AVERT™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mgI/mL, Iopamidol 300 or 370 mgI/mL and Ioxilan 350mgI/mL.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The Osprey Medical AVERT™ Contrast Modulation System allows for the modulation of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT System consists of a reusable, non-sterile apparatus (contrast modulator), which applies a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral
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)
Bench testing was performed or leveraged from the predicate to support the AVERT™ System and results demonstrate the AVERT™ System meets product specification and performance requirements. The following testing was successfully completed:
- Device performance testing included flow rate, peak pressure reduction, contrast diversion, flow rate adjustability. Testing was leveraged from the predicate for mechanical cycle testing, image analysis and compatibility to Osprey Medical Contrast Monitoring System. All testing passed and demonstrated product performance met all prior established acceptance criteria.
- Sterilization conditions have been validated and leveraged from the predicate in accordance with ISO 11135-1:2007, Sterilization of health care products – Ethylene Oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level of 10-6. All testing passed.
- Simulated use (animal) and post-market design validation was performed and leveraged from the predicate. Testing included assessment of injection pressure, contrast diversion and image analysis. Testing demonstrated no new or different question of safety or effectiveness were raised.
- Shelf-life, shipping and distribution testing performed per ASTM D4169 was leveraged from the predicate. Testing included visual inspection, cycle testing, dye leak test, seal strength test and functional testing. All testing passed and demonstrated product performance met all prior established acceptance criteria.
- Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing. Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, genotoxicity, chemical characterization. All testing passed and meet prior established acceptance criteria.
All test results demonstrate that the materials, manufacturing processes and design of the Osprey Medical AVERT™ Contrast Modulation System meet the established performance criteria and will perform as intended.
No clinical testing was performed to support this Special 510(k) Premarket Notification.
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
§ 870.1650 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2015
Osprey Medical, Inc. % Melanie Hess Vice President, Regulatory Affairs 5600 Rowland Road, Suite 250 Minnetonka, MN 55343
Re: K152218
Trade/Device Name: AVERT Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: August 6, 2015 Received: August 7, 2015
Dear Melanie Hess:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (21 CFR 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,
M.A. Hillebrand
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152218
Device Name
AVERT Contrast Modulation System
Indications for Use (Describe)
The AVERT™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL, Iopamidol 300 or 370 mgI/mL and Ioxilan 350mgI/mL
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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510(k) Summary
510(k) Summary As required by 21CFR 807.92(c)
510(k) Number: K152218
Date Prepared:
August 06, 2015
Submitter's Name/Address:
Osprey Medical 5600 Rowland Road Suite 250 Minnetonka, MN 55343
Contact Person:
Melanie Hess Vice President, Regulatory Affairs Tel: 952-955-8252 Fax: 952-955-8171 Mhess@ospreymed.com
Device Information:
| Trade Name/Proprietary Name: | AVERT™ Contrast Modulation System |
|---|---|
| Common Name: | Injector and Syringe, Angiographic |
| Classification Registration: | 21 CFR § 870.1650 |
| Product Code: | DXT |
| FDA Center/Branch: | CDRH/Interventional Cardiology Devices Branch (ICDB) |
Device Description:
The Osprey Medical AVERT™ Contrast Modulation System allows for the modulation of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT System consists of a reusable, non-sterile apparatus (contrast modulator), which applies a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing the amount of force
4
applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.
Intended Use:
The AVERT™ Contrast Modulation System is intended for the controlled infusion of radiopaque contrast media for angiographic procedures.
Indications for Use:
The AVERT™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg[/mL, Iohexol 300 or 350 mg1/mL, Iopamidol 300 or 370 mg1/mL and Ioxilan 350mg1/mL.
Primary Predicate(s):
| Trade Name/Proprietary Name: | AVERT Contrast Modulation System |
|---|---|
| Common Name: | Injector and Syringe, Angiographic |
| Classification Registration: | 21 CFR § 870.1650 |
| Product Code: | DXT |
| 510(k) number(s) | K140425 |
Secondary Predicate(s):
| Trade Name/Proprietary Name: | AVERT Contrast Modulation System |
|---|---|
| Common Name: | Injector and Syringe, Angiographic |
| Classification Registration: | 21 CFR § 870.1650 |
| Product Code: | DXT |
| 510(k) number(s) | K150485 |
Comparison to the Predicate Devices:
The AVERT™ System is substantially equivalent and unchanged from the predicate AVERT™ System in that they are identical systems with the exception of the minor labeling modification to include a new AVERT™ System model number, RMS-OXI-350-C. The subject device is identical to the predicate in that:
- . The proposed device consists of the same material; and
- . No changes have been made to the product performance or design specifications, sterilization process, manufacturing processes or risk assessment; and
- The intended use, indications for use and fundamental scientific technology remains unchanged. .
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- No new or different questions of safety or effectiveness are raised with the proposed modification. .
Summary of Non-Clinical Testing:
Bench testing was performed or leveraged from the predicate to support the AVERT™ System and results demonstrate the AVERT™ System meets product specification and performance requirements. The following testing was successfully completed:
- Device performance testing included flow rate, peak pressure reduction, contrast diversion, flow . rate adjustability. Testing was leveraged from the predicate for mechanical cycle testing, image analysis and compatibility to Osprey Medical Contrast Monitoring System. All testing passed and demonstrated product performance met all prior established acceptance criteria.
- . Sterilization conditions have been validated and leveraged from the predicate in accordance with ISO 11135-1:2007, Sterilization of health care products – Ethylene Oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level of 10-6. All testing passed.
- Simulated use (animal) and post-market design validation was performed and leveraged from the . predicate. Testing included assessment of injection pressure, contrast diversion and image analysis. Testing demonstrated no new or different question of safety or effectiveness were raised.
- . Shelf-life, shipping and distribution testing performed per ASTM D4169 was leveraged from the predicate. Testing included visual inspection, cycle testing, dye leak test, seal strength test and functional testing. All testing passed and demonstrated product performance met all prior established acceptance criteria.
- . Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing. Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, genotoxicity, chemical characterization. All testing passed and meet prior established acceptance criteria.
All test results demonstrate that the materials, manufacturing processes and design of the Osprey Medical AVERT™ Contrast Modulation System meet the established performance criteria and will perform as intended.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.
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Clinical Testing:
No clinical testing was performed to support this Special 510(k) Premarket Notification.
Statement of Equivalence:
The AVERT™ System with the proposed modification is substantially equivalent in intended use, indications for use and method of operation to the predicate AVERT™ System. Based on the substantially equivalent assessment and data collected in accordance with Osprey Medical Quality System Procedure in compliance with EN ISO 13485:2003 Medical Devices – Quality management systems – requirements for regulatory purposes and EN ISO 14971: 2012 Risk management for medical devices, the AVERT™ System has been shown to be substantially equivalent under 21 CFR Part 807 subpart E Part 807 subpart E.