(42 days)
Not Found
No
The summary describes a simple disposable medical device for transferring fluids and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a disposable transfer set for delivering contrast media and saline into a syringe, which is a preparatory step for diagnostic imaging, not a therapeutic intervention itself.
No.
The device is intended for the delivery of contrast media and saline, which is a therapeutic or delivery function, not a diagnostic one. It facilitates the administration of substances used for imaging but does not itself provide diagnostic information.
No
The device description clearly states it is a "medical disposable device" with physical components like a vented spike, connector tube, and luer, indicating it is a hardware device, not software-only.
Based on the provided information, the Medrad Transfer Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver contrast media and saline into a syringe for subsequent injection into a patient. This is a device used in vivo (within a living organism) for diagnostic imaging procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details components for transferring fluids from a container to a syringe, which aligns with an in vivo delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing information about a patient's health status based on in vitro testing.
Therefore, the Medrad Transfer Set is a medical device used for the administration of substances into a patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.
Product codes (comma separated list FDA assigned to the subject device)
LHI, FPK
Device Description
The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
KO22 431
SEP 5 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter's Name: Submitter's Address: Telephone Number: Fax Number: Contact Person: Date:
Proprietary Name: Common Name: Classification Name: Classification:
Medrad Inc. One Medrad Drive, Indianola, PA 15051 USA (412) 767-2400, ext. 3536 (412) 767-2499 Frank Pelc July 24, 2002
Medrad Transfer Set Intravascular Administration Set Intravascular Administration Set 80 FPK, Class II
Predicate Device:
Merit Contrast Management System (K961794)
Device Description - The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.
Substantial Equivalence - The information provided in this premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed Medrad Transfer Set is substantially equivalent to the Merit Contrast Management System (K961794). Both devices have the same intended use to deliver contrast media (and saline solutions) for diagnostic imaging procedures, and both allow multiple filling from one reservoir up to a 6 hour time limit.
A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below.
| Feature | Predicate Device (Merit
Contrast Management
System) K961794 | Proposed Device: Medrad
Transfer Set |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Contrast media delivery system | Same |
| System
Configuration | 2 Part System
- multi-fill spike system
- per patient administration set | 1 Part System
- multi-fill spike system |
| Multi-fill | Yes, until reservoir is empty or
time limit exceeded. | Same |
| Time limit | 6 hours maximum | Same |
| Materials | Clear flexible plastic tubing, rigid
plastic spike and stopcock | Polyvinyl chloride tubing,
Acylontrile-butadiene-styrene |
| Packaging | Pouch, sealed | Same |
| Sterility | Ethylene Oxide (EtO) Sterilized | Same |
| Shelf Life | 5 Years | 1 Year (The shelf life will be
extended to 5 years when
satisfactory test results are
completed.) |
| Connection method | ISO 594 Luer | ISO 594 Luer |
| Sterile caps provided
to cap connection
port between fillings | Yes | Yes |
COMPARISON DATA
1
Summary of differences between predicate and proposed devices -
The predicate device includes a separate disposable single-patient use tubing component. This component is attached to the open port on the administration set and leads to the patient, allowing fluid to be delivered to the patient without removing the filling component.
Medrad's transfer set will not include a separate tubing section. Medrad's transfer set must be removed from the syringe before the syringe can be connected to the patient; therefore it cannot come in contact with patient fluid through the syringe or administration set tubing. Additionally, the product labeling will state that the product is for single patient use only.
Intended Use – The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002 SEP
Mr. Frank W. Pelc III Regulatory Affairs Coordinator Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051
Re: K022431
Trade/Device Name: Medrad Transfer Set Regulation Number: 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: LHI and FPK Dated: July 24, 2002 Received: July 25, 2002
Dear Mr. Pelc:
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.
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.
3
Page 2 -- Mr. Pelc
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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). 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,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
. . .
510(k) Number: K022 431
·
Device Name: Medrad Transfer Set
Indications for Use/Intended Use:
The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Viola Hubbard for Pat Ciuente
(Division Sigr Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K022431
Prescription Use (Per 21 CFR 801.109) OR
. .
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)