(63 days)
No
The device description focuses on mechanical components (reservoir, diversion valve) that respond to manual pressure, with no mention of AI/ML algorithms for decision-making or modulation.
No.
The device is intended for controlled infusion and reduction of contrast media during angiographic procedures, which is a diagnostic purpose, not a therapeutic one. Its function is to modulate fluid flow and minimize excess contrast, not to treat a disease or medical condition.
No
The device is described as a "Contrast Modulation System" used for the "controlled infusion of radiopaque contrast media" and "contrast volume reduction" during angiographic procedures. Its function is to minimize "excess contrast volume" while maintaining image quality, rather than interpreting images or providing a diagnosis.
No
The device description clearly states it consists of a "disposable, single-use sterile device including a Reservoir and Diversion Valve," which are physical hardware components.
Based on the provided information, the DyeVert™ NG Contrast Modulation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body.
- DyeVert™ NG Function: The DyeVert™ NG system is used during an angiographic procedure to manage the infusion of contrast media into the patient's vasculature. It directly interacts with the patient's circulatory system and the contrast agent within the body.
- Intended Use: The intended use clearly states it's for "controlled infusion of radiopaque contrast media for angiographic procedures" and "contrast volume reduction... in the patient's vasculature." This describes a device used in vivo (within the living body).
Therefore, the DyeVert™ NG Contrast Modulation System is a medical device used in vivo during a medical procedure, not an IVD device used for testing specimens in vitro.
N/A
Intended Use / Indications for Use
The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Product codes
DXT
Device Description
The Osprey Medical DyeVert™ NG Contrast Modulation System (DyeVert System) is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality.
The DyeVert System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.
The DyeVert System has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.
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)
Bench testing was performed or leveraged from the predicate to support the DyeVert System and results demonstrate the DyeVert System meets all product specification and performance requirements. The following testing was successfully completed:
- Device performance testing was performed and leveraged for flow rate, peak pressure reduction, contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations. Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength. 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.
- Shelf-life, shipping and distribution testing was performed and leveraged. Distribution testing was conducted per ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems. Testing 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. Packaging was deemed to be in compliance with ISO 11607 part 1 and 2:2006 Packaging for terminally sterilized medical devices. Seal strength testing was performed per ASTM F88-09 and seal integrity by dye penetration was performed per ASTM F1886-09. All testing passed.
- 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 and hemocompatibility. All testing passed and meet prior established acceptance criteria.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.
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)
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
Osprey Medical, Inc. Melanie Hess Vice President Regulatory Affairs 5600 Rowland Road Suite 250 Minnetonka, Minnesota 55343
Re: K161505
Trade/Device Name: DyeVert NG Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 30, 2016 Received: July 5, 2016
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 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.
1
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 vours.
Mude Jellman
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBD K161505
Device Name DyeVert NG Contrast Modulation System
Indications for Use (Describe)
The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgIlmL. Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/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: K161505
Date Prepared:
May 31, 2016
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: | DyeVert™ NG 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 DyeVert™ NG Contrast Modulation System (DyeVert System) is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality.
The DyeVert System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via
4
the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.
The DyeVert System has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.
Intended Use:
The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Indications for Use:
The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgVmL and Iopamidol 370 mgI/mL.
Predicate Device:
| Trade Name/Proprietary Name: | DyeVert™ Contrast Modulation System |
|---|---|
| Common Name: | Injector and Syringe, Angiographic |
| Classification Registration: | 21 CFR § 870.1650 |
| Product Code: | DXT |
| 510(k) number(s) | K153141 |
| Reference Predicate Device(s): | |
|---|---|
| Trade Name/Proprietary Name: | AVERT™ Contrast Modulation System |
| Manufacturer: | Osprey Medical Inc. |
| Product Code: | DXT |
| 510(k) number(s) | K151300 |
| Trade Name/Proprietary Name: | Medallion (VACLOK)™ Syringe |
| Manufacturer: | Merit Medical Systems, Inc. |
| Product Code: | FMF |
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510(k) Summary
K994253
Comparison to the Predicate Device:
The DyeVert™ NG System is substantially equivalent and unchanged from the predicate DyeVert™ System in that they are identical systems with the exception of the minor design modification to the reservoir and tubing inner diameter modification of the reservoir from a balloon style to a plunger style does not change the primary function of the reservoir as a passive component which temporarily holds diverted contrast until physician directed aspiration. There is no change to the diversion valve assembly mechanism for the diversion of excess contrast to the passive reservoir. No changes have been made to the product performance specifications, materials, sterilization process, directions for use, manufacturing processes or risk assessment. The intended use, indications for use and fundamental scientific technology remains unchanged. No new or different questions of safety or effectiveness were raised with the modification.
Summary of Non-Clinical Testing:
Bench testing was performed or leveraged from the predicate to support the DyeVert System and results demonstrate the DyeVert System meets all product specification and performance requirements. The following testing was successfully completed:
- Device performance testing was performed and leveraged for flow rate, peak pressure reduction, . contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations. Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength. 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.
- Shelf-life, shipping and distribution testing was performed and leveraged. Distribution testing was . conducted per ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems. Testing 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. Packaging was deemed to be in compliance with ISO 11607 part 1 and 2:2006 Packaging for terminally sterilized medical devices. Seal strength testing was
6
performed per ASTM F88-09 and seal integrity by dye penetration was performed per ASTM F1886-09. All testing passed.
- . 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 and hemocompatibility. All testing passed and meet prior established acceptance criteria.
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 performed to support this Special 510(k) Premarket Notification.
Statement of Equivalence:
The DyeVert System with the proposed modifications is substantially equivalent in intended use, indications for use and method of operation to the predicate DyeVert System. Based on the substantially equivalent assessment and data collected in accordance with Osprey Medical Quality System Procedure in compliance with EN ISO 13485:2012 Medical Devices – Quality management systems – requirements for regulatory purposes and EN ISO 14971:2012 Risk management for medical devices, the DyeVert System has been shown to be substantially equivalent under 21 CFR Part 807 subpart E.