AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System

K152218 · Osprey Medical · DXT · Sep 21, 2015 · Cardiovascular

Device Facts

• Record ID: K152218
• Device Name: AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
• Applicant: Osprey Medical
• Product Code: DXT · Cardiovascular
• Decision Date: Sep 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The AVERT™ Contrast Modulation System is intended for the controlled infusion of radiopaque contrast media for angiographic procedures.

Device Story

AVERT Contrast Modulation System modulates contrast media during manual coronary or peripheral angiographic injections. System comprises reusable non-sterile contrast modulator and disposable sterile modulation reservoir with 4-way stopcock and extension line. Modulator applies adjustable mechanical force to reservoir to divert portion of manual contrast injection. Device mounted on wheeled stand near patient, outside sterile field. Physician operates system to control contrast volume delivered to patient; modulation reduces total contrast dose, potentially benefiting patients by lowering risk of contrast-induced nephropathy.

Clinical Evidence

No clinical testing performed. Bench testing leveraged from predicate included flow rate, peak pressure reduction, contrast diversion, mechanical cycle testing, image analysis, and compatibility. Biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and shelf-life/shipping (ASTM D4169) testing leveraged from predicate. All tests passed.

Technological Characteristics

Reusable contrast modulator with disposable sterile reservoir, 4-way stopcock, and extension line. Mechanical force application via adjustable pin mechanism. Sterilization: Ethylene Oxide (ISO 11135-1). Biocompatibility: ISO 10993-1. Packaging/Distribution: ASTM D4169.

Indications for Use

Indicated for controlled infusion of radiopaque contrast media during angiographic procedures using Iodixanol (270 or 320 mg/mL), Iohexol (300 or 350 mg/mL), Iopamidol (300 or 370 mgI/mL), or Ioxilan (350mgI/mL).

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)
• AVERT Contrast Modulation System (K150485)

Submission Summary (Full Text)

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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

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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

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)

| <span style="font-size:10px"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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: [phone] Fax: [phone] [e-mail]

#### 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

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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.