(66 days)
Not Found
No
The summary describes a simple connector tube for transferring fluids and does not mention any AI/ML capabilities or related performance metrics.
No
The device is a connector tubing used to transfer contrast media and flushing solutions; it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is a high-pressure connector tubing used for delivering contrast media and flushing solutions during angiographic procedures, not for diagnosing a condition or disease.
No
The device description clearly states it is a "sterile, single-use only, disposable connector tube," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver contrast media and flushing solutions during angiographic procedures. This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description confirms it's a connector tube used to transfer solutions from an injector to an administration set during angiographic procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a delivery system for substances used in vivo (within the living body) during a medical procedure.
N/A
Intended Use / Indications for Use
The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.
Product codes (comma separated list FDA assigned to the subject device)
FPK
Device Description
The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.
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)
Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing: Performance, Package Integrity, System level testing with a MEDRAD automated injector.
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
Image /page/0/Picture/1 description: The image shows the number 131517 at the top of the image. Below the number is the Bayer company logo. The logo is a circle with the word "Bayer" written vertically inside of it.
510(k) Summary
Submitter:
MEDRAD, Inc. Bayer Medical Care, Inc. One Medrad Drive Indianola, PA 15051
Phone: (412) 406-37 80
Email: lisa.ewing@bayer.com
Fax: (412) 406-4052
Principal Regulatory Affairs Specialist
MEDRAD Twist & Go High Pressure
Connector Tubing / Tubing, Fluid Delivery
Tubing, Fluid Delivery [21 CFR 880.5440]
Lisa A. Ewing
May 24, 2013
FPK
Class II
Connector Tubing
Contact Person:
Date Prepared:
Device Trade Name:
Common Name:
Classification Name:
Product Code:
Classification:
Predicate Device(s):
The subject device is equivalent to the following device: MEDRAD High Pressure Connecting Tube K810924, April 17, 1981
The MEDRAD Twist & Go High Pressure Device Description: Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.
AUG 02 2013
MEDRAD, INC.
One Medrad Drive Indianola, PA 15051 U.S.A.
(412) 767-2400
1
Image /page/1/Picture/1 description: The image is a black and white logo for Bayer. The logo consists of the word "BAYER" arranged in a cross shape, with the letters "B", "A", "Y", "E", and "R" forming the arms of the cross. The entire logo is enclosed within a double-lined circle.
:
:
.
| | Automated injection systems with which the
MEDRAD Twist & Go High Pressure
Connector Tubing is intended to be used
include the MEDRAD Mark 7 Arterion
Injection System and equivalent injectors. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Twist & Go High Pressure Connector
Tubing is intended to be used in the delivery
of contrast media and common flushing
solutions. The device is indicated for single
use only with MEDRAD injectors. |
| Performance Data: | Bench and laboratory testing were
performed to support a determination of
substantial equivalence to the predicate
devices. Results from the testing provide
assurance that the proposed device
conforms to the requirements for its
intended use. This included the following
testing:
• Performance
• Package Integrity
• System level testing with a MEDRAD
automated injector |
.
.
:
:
.
2
.
Image /page/2/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with the letters "B", "A", "Y", "E", and "R" forming the arms of the cross. The entire logo is enclosed within a double circle.
Comparison of Features in MEDRAD High Pressure Connecting Tube (Predicate) and MEDRAD Twist & Go High Pressure Connector Tubing (Proposed)
| Item | Predicate Device: MEDRAD High Pressure Connecting Tube (K810924) | Proposed Device: MEDRAD Twist & Go High Pressure Connector Tube | |
|---|---|---|---|
| Labeling | Intended Use | The device, intended to be used by individuals with adequate training and experience in diagnostic imaging studies, are to be used to deliver contrast media during angiographic procedures. | The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions with Twist & Go Syringes. The device is indicated for single use only with MEDRAD injectors. |
| Description | Polycarbonate hub insert molded to a PVC tube | Polycarbonate hub UV bonded to a flexible polyurethane nylon tube | |
| Construction | Syringe connection | Clear Polycarbonate Female Luer | Clear Polycarbonate Twist & Go Fasturn Nut |
| Administration Set Connection | Clear Polycarbonate standard male luer | Clear Polycarbonate rotating male luer | |
| Tubing Material | Clear Polyvinyl Chloride | Clear Polyurethane and nylon | |
| Tubing Volumes | 1.00 - 4.78 ml | 1.22 – 4.33 ml | |
| Tubing Lengths | 25-122 cm | 50-150 cm | |
| Outer Diameter | .478 cm (.188") | .368 cm (.145") | |
| Inner Diameter | .224 cm (.088") | .183 cm (.072") | |
| Adhesive | None | UV adhesive | |
| Packaging | Type | Pouch | Pouch |
| Material | Tyvek and clear polymer film | Tyvek and clear polymer film | |
| Shelf Life | 3 years | 3 years | |
| Biological | Biocompatibility | Compliant to applicable sections of ISO/AAMI 10993-1:2009 | Compliant to applicable sections of ISO/AAMI 10993-1:2009 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic fluid path | |
| Latex content | Not made with natural rubber latex | Not made with natural rubber latex | |
| Sterilization Type | Ethylene Oxide | Ethylene Oxide | |
| Sterilization Assurance Level (SAL) | 10-6 | 10-6 | |
| Perfor- mance | Pressure Rating | 1000 psi | 1200 psi |
MEDRAD, Inc.
:
:
3
Image /page/3/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with each letter of the word forming one arm of the cross. The entire logo is enclosed within a double-lined circle.
Conclusion:
MEDRAD considers the MEDRAD Twist & Go High Pressure Connector Tubing to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, fundamental scientific technology, and principles of operation.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name encircling the symbol on the left and a stylized symbol on the right. The symbol is a stylized representation of an eagle, with three wing-like shapes extending upwards and to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
MEDRAD, Incorporated Bayer Medical Care, Incorporated C/O Ms. Lisa A. Ewing Principal Regulatory Affairs Specialist One Medrad Drive INDIANOLA PA 15051
Re: K131517
Trade/Device Name: MEDRAD Twist & Go High Pressure Connector Tubing Regulation Number: 21 CFR 880.5440 Regulation Name: Tubing, Fluid Delivery Regulatory Class: II Product Code: FPK Dated: July 8, 2013 Received: July 9, 2013
Dear Ms. Ewing:
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.
5
Page 2 - Ms. Ewing
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number:
Device Name:
MEDRAD Twist & Go High Pressure Connector Tubing
Indications for Use:
The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.
Prescription Use _ × (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
2
Richard C. Chapman 2013.07.31 10:31:46 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K131517