MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM

K042784 · Medrad, Inc. · DXT · Dec 10, 2004 · Cardiovascular

Device Facts

• Record ID: K042784
• Device Name: MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.

Device Story

Syringe-based fluid delivery system for MRI procedures; delivers contrast media and flushing solutions into human vascular system. Comprised of Injector Head/Stand (HSU) and Display Control Unit (DCU); communicates via fiber optics. Operated by trained healthcare professionals in clinical settings. Features include multi-phase protocol storage, flow rate control, pressure limiting, and KVO (Keep Vein Open) functionality. Provides automated, controlled injection to assist clinicians in diagnostic imaging; benefits patient through precise contrast administration.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Syringe-based injector; PET barrels; polycarbonate plungers/luer fittings; PVC tubing. Fiber optic communication. Compatible with 0.2-3T MRI environments. Ethylene Oxide sterilization. System components: Injector Head/Stand and Display Control Unit. Pressure limit: 311 PSI (Syringe A), 310 PSI (Syringe B).

Indications for Use

Indicated for delivery of contrast media and flushing solutions into the human vascular system for diagnostic MRI procedures. Intended for use by trained healthcare professionals.

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

• Medrad Spectris Solaris MR Injector System (3T Compatible) (K033247)

Submission Summary (Full Text)

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K042784

## DEC 1 0 2004

## 510(k) Summary

| OFFICIAL CONTACT: | John M Kiste<br>Regulatory Affairs Specialist<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] ext. 3444 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic |
| COMMON NAME(S): | Powered Injector with Syringe |
| PROPRIETARY NAME: | Medrad Spectris Solaris EP MR Injector System |
| PREDICATE DEVICE: | Medrad Spectris Solaris MR Injector System (3T<br>Compatible) (K033247) |
| INTENDED USE: | The Spectris Solaris EP MR Injection System is a<br>syringe-based fluid delivery system indicated for<br>delivery of contrast media during MR applications.<br>It is intended to be used for the specific purpose of<br>injecting intravenous MR contrast media and<br>common flushing solutions into the human<br>vascular system for diagnostic studies in magnetic<br>resonance imaging (MRI) procedures. Only trained<br>healthcare professionals are intended to operate<br>this device. |

DEVICE DESCRIPTION AND COMPARISON TO PREDICATE:

The Medrad Spectris Solaris EP MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially undein a manner similar to the predicate device.

The Spectris Solaris EP MR Injector is comprised of the same two main components as the predicate device - Injector Head/Stand (HSU) and Display Control Unit (DCU). Differences between the predicate device and the new Spectris Solaris EP MR (DCO) are detailed in the table below. The following Comparison Matrix identifies the similarities and differences between the new device and the predicate device.

| Feature:<br>Injector System | Medrad Spectris Solaris MR Injector<br>(3T Compatible)<br>(K033247)<br>Predicate | Medrad Spectris Solaris EP MR<br>Injector |
|-----------------------------|----------------------------------------------------------------------------------|-------------------------------------------|
| Flow Rate Injector | 1 ml/sec to 10 ml/sec<br>$+/-(10%+/-0.02 ml/sec)$ | Same |
| | 0.01ml/sec to 0.99ml/sec<br>$+/-(10%+0.005ml/sec)$ | |

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| Feature:<br>Injector System | Medrad Spectris Solaris MR Injector<br>(3T Compatible)<br>(K033247)<br>Predicate | Medrad Spectris Solaris EP MR<br>Injector |
|--------------------------------|----------------------------------------------------------------------------------|-------------------------------------------|
| Fractional volumes | Yes | Same |
| Remote Information<br>Display | Color Touch screen | Same |
| Multi-Phase | 6 | Same |
| Protocol Storage<br>Capability | Yes; 3 step procedure<br>32 protocols | Same |
| Hold Capability | Yes | Same |
| Safety Stop<br>Mechanism | Yes | Same |
| Syringe System | 2 total, 1- 115 ml syringe and 1- 65 ml<br>syringe | Same |
| Air Detection Device | User observable | Same |
| Syringe Sensing | Yes | Same |
| Volume Remaining<br>Readout | Graduation on syringe; LCD on<br>Program Panel | Same |
| Programmed Volume | Yes, 1 to 63 ml and 1-115 ml | Same |
| Fill Rate | Configurable up to a maximum of 10<br>ml/sec | Same |
| Flow Rate | Variable | Same |
| KVO | Yes; 0.25 ml, time adjustable. Defaults<br>at every 30 sec. | Same |
| Pressure Limit | 311 PSI for Syringe A<br>310 PSI for Syringe B | Same |
| Start/Stop switch | Yes, Located at injector head or at<br>display unit. | Same |
| Communication | Fiber Optic | Same |
| System Compatibility | 0.2 - 3 T | Same |

:

| Feature: | | |
|------------------------------|------------------------------------------------------------------------|------|
| Disposable System | | |
| Syringe System | 2 total, 1- 115 ml syringe and 1-<br>65 ml syringe, 2 - 65 ml syringes | |
| Intended Use | Saline/Contrast delivery | Same |
| Barrel Material Composition | PET | Same |
| Barrel length | 4.5" | Same |
| Barrel OD | 1.565" | Same |
| Barrel ID | 1.415 | Same |
| Plunger Material Composition | Polycarbonate | Same |
| Barrel Flange | Quik-Fit Design | Same |
| Packaging | Polystyrene tray with Tyvek Lid | Same |
| Sterilization | Ethylene Oxide | Same |
| Medrad -T connector | | |
| T-connector | Polycarbonate | Same |
| Tubing | PVC | Same |
| Luer Fitting | Polycarbonate | Same |
| Length | 96" | Same |
| Tubing ID | 0.075" | Same |
| Maximum Pressure | 350 PSI | Same |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2004

Medrad, Inc. c/o Mr. John M. Kiste Regulatory Affairs Specialist One Medrad Drive Indianola, PA 15051

K042784 Re:

> Medrad Spectris Solaris MR Injector System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: November 9, 2004 Received: November 10, 2004

Dear Mr. Krite:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. John M. Kiste

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Singerely yours.

Prem D. Zuckerman, M.D.

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:

K042784

Device Name: Medrad Spectris Solaris EP MR Injector

Indications for Use:

The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the nysessions intravellous MIC connals media and common resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.

Prescription Use x (Per 21 CFR 801 Subpart D)

AND/ OR

Over-The-Counter Use (21CFR 801 Subpart C)

(PLEASE DO NOT WRITE ON THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | k042784 |

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