(81 days)
Not Found
No
The description focuses on a mechanical accessory for manual filling and makes no mention of AI or ML.
No.
The device description states it is "not intended for patient use or use as a contrast injector," indicating it does not directly treat or diagnose a medical condition.
No
Explanation: The device is described as an accessory for filling syringes with contrast, specifically stating "It is not intended for patient use or use as a contrast injector." Its function is purely facilitative for preparing contrast, not for diagnosing medical conditions.
No
The device description clearly states it is a "Manual Loader" and describes physical components compatible with syringes and injectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "facilitat[ing] manual syringe contrast filling" and is an "accessory to Medrad's line of angiographic injectors and syringes." It is explicitly stated as "not intended for patient use or use as a contrast injector."
- Device Description: The description reinforces its role as a manual alternative for filling syringes used with imaging injectors.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with patient specimens in this way.
The device is an accessory for medical imaging procedures, specifically related to contrast administration, but it does not perform diagnostic testing on biological samples.
N/A
Intended Use / 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.
Product codes
DXT
Device Description
The Medrad Manual Loader is designed as an accessory to Medrad's CT and MR angiographic injectors and syringes. The system offers a manual alternative to the electronic filling function of the injectors. Due to the different configurations of the syringes for the MR and CT injectors, two options of the Manual Loader will be available, each compatible with either CT syringes or MR Syringes.
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
Medical imaging/Hospital staff
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
AUG - 1 2003
510(k) Summary – Medrad Manual Syringe Loader
| OFFICIAL CONTACT: | Andrew P. Zeltwanger
Regulatory Affairs Analyst
Medrad, Inc.
One Medrad Drive
Indianola, PA 15051
(412) 767-2400 ext. 3005 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Angiographic Injector and Syringe [21 CFR
870.1650] |
| COMMON NAME: | Syringe Loader |
| PROPRIETARY NAME(s): | Medrad Manual Syringe Loader |
| PREDICATE DEVICES: | Spectris Solaris MR Injector System (K012950)
Stellant CT Injector System (K023183) |
| DEVICE DESCRIPTION: | The Medrad Manual Loader is designed as an
accessory to Medrad's CT and MR angiographic
injectors and syringes. The system offers a manual
alternative to the electronic filling function of the
injectors. Due to the different configurations of the
syringes for the MR and CT injectors, two options
of the Manual Loader will be available, each
compatible with either CT syringes or MR Syringes. |
| 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. |
· Medrad, Inc. · 510(k) Premarket Submission ·
- Medrad Manual Syringe Loader •
1
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
MR Injectors |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Manual filling of
disposable contrast or
saline syringes for either
CT or MR angiographic
injectors | Electro-mechanical filling of
disposable contrast/saline
syringes and control of delivery
of contrast agent to patient
during angiographic imaging
with CT or MR scanners |
| Target Population | Medical imaging/Hospital
staff | Medical imaging/Hospital staff |
| Compatibility with
Environment and
other Devices | Two models available - one
compatible with syringes
for each imaging modality | Disposable contrast syringes
marketed for each injector |
| MR/CT
Compatibility | Not intended to be installed
within the scanning rooms | MR hardened for use in the MR
environment |
· Medrad, Inc. · 510(k) Premarket Submission ·
- Medrad Manual Syringe Loader •
2
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.
3
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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
✓
Over-the-Counter Use
510(k) Numbe
- · Medrad, Inc. · 510(k) Premarket Submission ·
- · Medrad Manual Syringe Loader ·