(102 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics for contrast modulation, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No
The device is used for the controlled infusion of contrast media for diagnostic imaging (angiography), not for treating a disease or condition. Its function is to manage and divert contrast, not to provide therapy.
No
Explanation: The device is used for the "controlled infusion of radiopaque contrast media for angiographic procedures," and for "manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging." It modifies the delivery of contrast media during imaging but does not perform any diagnostic function itself. The diagnostic part is the angiographic imaging, not this device.
No
The device description clearly states it is a "sterile, single-use, fully-disposable apparatus" with physical components like a reservoir chamber, tubes, and a manifold, indicating it is a hardware device.
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 radiopague contrast media for angiographic procedures." This describes a device used during a medical procedure to administer a substance, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a system for managing the flow of contrast media during angiography, involving a reservoir chamber and pathways for the contrast. This is a mechanical system for fluid delivery and management within the body during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The DyeVert™ Contrast Modulation System does not fit this description.
N/A
Intended Use / Indications for Use
The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: Iodixanol 320 mgI/mL and Iopamidol 370 mgI/mL.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The Osprey Medical DyeVert™ Contrast Modulation System (DyeVert System) allows for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. The Dyevert System consists of a sterile, single-use, fully-disposable apparatus which provides a secondary fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic
Anatomical Site
coronary or peripheral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician-modulated / 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 and results demonstrate the DyeVert System materials, design considerations and manufacturing processes meet product specifications and performance requirements. The following testing was successfully completed:
- Device performance testing included flow rate, peak pressure, leak testing, contrast diversion, mechanical cycle testing and visual verifications to design specific contrasts and catheter configurations. All testing passed and demonstrated product performance met all prior established acceptance criteria.
- Sterilization conditions have been validated and leveraged 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.
- Packaging, shelf life and distribution testing was performed or leveraged. Distribution testing was conducted per ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems. 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.
- Biocompatibility testing was performed and leveraged in accordance with ISO 10993-1:2009 ● Biological Evaluation of Medical Devices – Part I: Evaluation and Testing. Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity and hemocompatibility. All testing passed and met prior established acceptance criteria.
- Simulated Use (Cath Lab) and Design Validation was performed and leveraged for injection pressure, contrast diversion and image analysis testing. Testing included an assessment of the ease of use, system set up and device priming ability (usability). All testing passed and met prior established acceptance criteria.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in black, uppercase letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2015
Osprey Medical, Inc. Melanie Hess Vice President Regulatory Affairs 5600 Rowland Road Suite 250 Minnetonka, Minnesota 55343
Re: K151746
Trade/Device Name: DyeVert™ Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 4, 2015 Received: September 8, 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 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
Bram D. Zuckerman, M.D. 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) K151746
Device Name
DyeVert(tm) Contrast Modulation System
Indications for Use (Describe)
The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: lodixanol 320 mg/mL and Iopanidol 370 mg/l 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 - K151746
This summary of 510(k) information is submitted in accordance with 21 CFR 807.92(c)
510(k) Number: K151746 Date Prepared: Applicant Information:
June 26, 2015 Osprey Medical 5600 Rowland Road Suite 250 Minnetonka, MN 55343 Phone: 952-955-8230 Fax: 952-955-8171
Contact Person:
Melanie Hess Vice President, Regulatory Affairs Phone: 952-955-8252 Fax: 952-955-8171 Mhess@ospreymed.com
Device Information:
| Trade Name/Proprietary Name: | DyeVert™ Contrast Modulation System |
|---|---|
| Common/Classification Name: | Angiographic Injector |
| Classification: | II |
| Classification Registration: | 21 CFR § 870.1650 |
| Product Code: | DXT |
| FDA Center/Branch: | CDRH/Interventional Cardiology Devices Branch (ICDB) |
Device Description:
The Osprey Medical DyeVert™ Contrast Modulation System (DyeVert System) allows for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. The Dyevert System consists of a sterile, single-use, fully-disposable apparatus which provides a secondary
4
fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.
Intended Use:
The DyeVert" Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Indications for Use:
The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 320 mg1/mL, Iohexol 350 mgI/mL and Iopamidol 370 mgI/mL.
Predicate Device:
| Trade Name/Proprietary Name: | AVERT™ Contrast Modulation System |
|---|---|
| Common/Classification Name: | Angiographic Injector |
| Classification: | II |
| Classification Registration: | 21 CFR § 870.1650 |
| Product Code: | DXT |
| 510(k) number(s) | K140425 |
Predicate Indications for Use:
The AVERT™ Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL, and Iopamidol 370 mgI/mL.
Comparison to the Predicate Device:
The proposed DyeVert™ Contrast Modulation System is substantially equivalent in intended use, indication for use, method of operation, performance specifications and technical aspects to the predicate device, Osprey Medical AVERT™ Contrast Modulation System (K140425). The method of operation (mechanism of action) is entirely mechanical for both devices divert and temporarily store
5
excess radiopaque contrast media away from the patient; and both function to reduce the users hand fatigue during routine angiographic procedures.
Summary of Non-Clinical Testing:
Bench testing was performed and results demonstrate the DyeVert System materials, design considerations and manufacturing processes meet product specifications and performance requirements. The following testing was successfully completed:
- . Device performance testing included flow rate, peak pressure, leak testing, contrast diversion, mechanical cycle testing and visual verifications to design specific contrasts and catheter configurations. All testing passed and demonstrated product performance met all prior established acceptance criteria.
- . Sterilization conditions have been validated and leveraged 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.
- . Packaging, shelf life and distribution testing was performed or leveraged. Distribution testing was conducted per ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems. 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.
- Biocompatibility testing was performed and leveraged in accordance with ISO 10993-1:2009 ● Biological Evaluation of Medical Devices – Part I: Evaluation and Testing. Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity and hemocompatibility. All testing passed and met prior established acceptance criteria.
- Simulated Use (Cath Lab) and Design Validation was performed and leveraged for injection . pressure, contrast diversion and image analysis testing. Testing included an assessment of the ease of use, system set up and device priming ability (usability). All testing passed and met prior established acceptance criteria.
Clinical Testing:
No clinical testing was performed to support this Traditional 510(k) Premarket Notification.
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Statement of Equivalence:
The DyeVert System has a substantially equivalent intended use, indications for use statement, performance specifications and fundamental scientific technology as the predicate device. Based on this equivalence and the data collected in accordance with Osprey Medical Quality System Procedures in compliance with BS EN ISO 13485: 2012 Medical Devices - Quality management systems requirements for regulatory purposes and EN ISO 14791:2012 Risk management for medical devices, the DyeVert System has been shown to be substantially equivalent under 21 CFR Part 807 subpart E.