MEDRAD MANUAL SYRINGE LOADER

K031483 · Medrad, Inc. · DXT · Aug 1, 2003 · Cardiovascular

Device Facts

• Record ID: K031483
• Device Name: MEDRAD MANUAL SYRINGE LOADER
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Medrad Manual Syringe Loader is designed as an accessory to Medrad's line of angiographic injectors and syringes. It is intended to facilitate manual syringe contrast filling. It is not intended for patient use or use as a contrast injector.

Device Story

Manual accessory for Medrad CT/MR angiographic injectors; facilitates manual filling of disposable contrast/saline syringes. Device provides manual alternative to electronic filling function of injector heads. Used by medical imaging/hospital staff in clinical settings; not intended for use inside scanning rooms. Device does not inject contrast into patients; serves solely as a mechanical aid for syringe preparation. Benefits include simplified manual contrast loading workflow for clinicians.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical manual syringe loader; two models available for compatibility with specific CT or MR syringe configurations. Non-electronic; non-MR hardened. Designed for manual operation by hospital staff.

Indications for Use

Indicated for medical imaging/hospital staff to facilitate manual filling of disposable contrast or saline syringes for CT or MR angiographic injectors. Not for patient use or use as a contrast injector.

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

• Spectris Solaris MR Injector System (K012950)
• Stellant CT Injector System (K023183)

Submission Summary (Full Text)

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## AUG - 1 2003

## 510(k) Summary – Medrad Manual Syringe Loader

| OFFICIAL CONTACT: | Andrew P. Zeltwanger<br>Regulatory Affairs Analyst<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] ext. 3005 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Angiographic Injector and Syringe [21 CFR<br>870.1650] |
| COMMON NAME: | Syringe Loader |
| PROPRIETARY NAME(s): | Medrad Manual Syringe Loader |
| PREDICATE DEVICES: | Spectris Solaris MR Injector System (K012950)<br>Stellant CT Injector System (K023183) |
| DEVICE DESCRIPTION: | The Medrad Manual Loader is designed as an<br>accessory to Medrad's CT and MR angiographic<br>injectors and syringes. The system offers a manual<br>alternative to the electronic filling function of the<br>injectors. Due to the different configurations of the<br>syringes for the MR and CT injectors, two options<br>of the Manual Loader will be available, each<br>compatible with either CT syringes or MR Syringes. |
| INTENDED USE: | The Medrad Manual Syringe Loader is designed as<br>an accessory to Medrad's line of angiographic<br>injectors and syringes. It is intended to facilitate<br>manual syringe contrast filling. It is not intended<br>for patient use or use as a contrast injector. |

· Medrad, Inc. · 510(k) Premarket Submission ·

- Medrad Manual Syringe Loader •

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COMPARISON TO PREDICATE:

The Medrad Manual Loader is substantially equivalent to the filling function of the injector head of the Spectris Solaris MR angiographic injector. The Medrad Manual Loader has the same intended use as the syringe filling function of Medrad angiographic injectors.

In the table below, Medrad presents a comparison of the relevant device parameters between the Medrad Manual Loader and the MR/CT Injector Product Line.

| Characteristics | Medrad Manual Loader | Stellant CT/Spectris Solaris<br>MR Injectors |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Manual filling of<br>disposable contrast or<br>saline syringes for either<br>CT or MR angiographic<br>injectors | Electro-mechanical filling of<br>disposable contrast/saline<br>syringes and control of delivery<br>of contrast agent to patient<br>during angiographic imaging<br>with CT or MR scanners |
| Target Population | Medical imaging/Hospital<br>staff | Medical imaging/Hospital staff |
| Compatibility with<br>Environment and<br>other Devices | Two models available - one<br>compatible with syringes<br>for each imaging modality | Disposable contrast syringes<br>marketed for each injector |
| MR/CT<br>Compatibility | Not intended to be installed<br>within the scanning rooms | MR hardened for use in the MR<br>environment |

· Medrad, Inc. · 510(k) Premarket Submission ·

- Medrad Manual Syringe Loader •

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Medrad, Inc. c/o Andrew P. Zeltwanger Regulatory Affairs Analyst One Medrad Drive Indianola, PA 15051

Re: K031483 Medrad Manual Syringe Loader

Regulation Number: 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: May 9, 2003 Received: July 23, 2003

Dear Mr. Zeltwanger:

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. Andrew P. Zeltwanger

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Intended Use

Indications for Use Statement

510(k) Number:

KO31483

Device Name: Medrad Manual Syringe Loader

Indications for Use:

The Medrad Manual Syringe Loader is designed as an accessory to Medrad's line of angiographic injectors and syringes. It is intended to facilitate manual syringe contrast filling. It is not intended for patient use or use as a contrast injector.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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Over-the-Counter Use

510(k) Numbe

- · Medrad, Inc. · 510(k) Premarket Submission ·
- · Medrad Manual Syringe Loader ·