Dyevert Contrast Modulation System

K151746 · Osprey Medical, Inc. · DXT · Oct 9, 2015 · Cardiovascular

Device Facts

• Record ID: K151746
• Device Name: Dyevert Contrast Modulation System
• Applicant: Osprey Medical, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The DyeVert" Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Device Story

DyeVert Contrast Modulation System is a sterile, single-use, disposable apparatus for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. Device features a secondary fluid pathway with flow resistance to divert and store excess contrast in a reservoir chamber away from the patient. During aspiration, the system refills the injection syringe with preference to the diverted contrast volume before drawing from the primary source. Used in cath labs by physicians to reduce contrast volume delivered to patients and mitigate hand fatigue. Output is the controlled delivery of contrast media for imaging; clinical benefit includes potential reduction in contrast-induced nephropathy risk.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing, including flow rate, peak pressure, leak testing, mechanical cycle testing, and simulated use (cath lab) validation. Biocompatibility testing (ISO 10993-1:2009) and sterilization validation (ISO 11135-1:2007) were successfully completed.

Technological Characteristics

Mechanical angiographic injector system; single-use, disposable. Features a reservoir chamber and flow resistance mechanism for contrast diversion. Materials validated per ISO 10993-1:2009. Sterilization via Ethylene Oxide (ISO 11135-1:2007). Distribution testing per ASTM D4169:2009. No software or electronic components.

Indications for Use

Indicated for controlled infusion of radiopaque contrast media (Iodixanol 320 mg/mL, Iohexol 350 mg/mL, Iopamidol 370 mg/mL) during angiographic procedures.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• AVERT™ Contrast Modulation System (K140425)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> </span> </span> 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: [phone] Fax: [phone]

Contact Person:

Melanie Hess Vice President, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail]

#### 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

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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

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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.