(66 days)
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.
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.
The provided text describes the MEDRAD Twist & Go High Pressure Connector Tubing and its clearance through the FDA 510(k) process. This document is a summary for a medical device (tubing for contrast media delivery) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a comprehensive clinical study to prove performance against specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic algorithm.
Therefore, many of the requested elements (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, type of ground truth for learning algorithms) are not applicable to this type of device submission as it is not an AI/ML-based algorithm or a diagnostic tool requiring such rigorous evaluation against clinical endpoints.
Instead, the "acceptance criteria" here are largely defined by equivalence to the predicate device and adherence to bench and laboratory testing standards relevant for a fluid delivery tube.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a direct "acceptance criteria" table with numerical targets in the same way an AI/ML study would. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device (MEDRAD High Pressure Connecting Tube K810924) and passing various bench and laboratory tests.
The comparison of features table (page 2) serves as the primary evidence for demonstrating functional equivalence.
| Item | Acceptance Criteria (Implied by Predicate Equivalence & Testing) | Reported Device Performance (MEDRAD Twist & Go High Pressure Connector Tube) |
|---|---|---|
| Intended Use | Delivery of contrast media during angiographic procedures. Compatibility with MEDRAD injectors. | Delivery of contrast media and common flushing solutions with Twist & Go Syringes. Single use only with MEDRAD injectors. (Broader than predicate by including flushing solutions, but within acceptable scope) |
| Material/Construction | Appropriate materials for medical use, luer connections. | Polycarbonate hub UV bonded to a flexible polyurethane nylon tube. Clear Polycarbonate Twist & Go Fasturn Nut for syringe. Clear Polycarbonate rotating male luer for administration. |
| Tubing Volumes | Within acceptable range for contrast delivery (1.00 - 4.78 ml equivalent). | 1.22 – 4.33 ml (Within predicate's range) |
| Tubing Lengths | Within acceptable range for angiographic procedures (25-122 cm equivalent). | 50-150 cm (Within predicate's range, with some extension) |
| Outer Diameter | Equivalent to predicate (.478 cm (.188")). | .368 cm (.145") (Smaller than predicate, implying potential for different flow dynamics or material strength, addressed by testing) |
| Inner Diameter | Equivalent to predicate (.224 cm (.088")). | .183 cm (.072") (Smaller than predicate, implying potential for different flow dynamics or material strength, addressed by testing) |
| Adhesive | Secure connections without leakage. | UV adhesive (Predicate did not use adhesive, implying this was evaluated for safety/performance) |
| Packaging | Sterile pouch, Tyvek and clear polymer film. | Pouch, Tyvek and clear polymer film (Equivalent) |
| Shelf Life | 3 years. | 3 years (Equivalent) |
| Biocompatibility | Compliant to ISO/AAMI 10993-1:2009. | Compliant to applicable sections of ISO/AAMI 10993-1:2009 (Equivalent) |
| Pyrogenicity | Non-pyrogenic. | Non-pyrogenic fluid path (Equivalent) |
| Latex Content | Not made with natural rubber latex. | Not made with natural rubber latex (Equivalent) |
| Sterilization Type | Ethylene Oxide. | Ethylene Oxide (Equivalent) |
| Sterilization Assurance Level (SAL) | 10-6. | 10-6 (Equivalent) |
| Pressure Rating | 1000 psi. | 1200 psi (Exceeds predicate, indicating improved performance in this aspect) |
| Overall Performance | Safe and effective for intended use, equivalent to predicate. | Bench and laboratory testing performed to support substantial equivalence, including Performance, Package Integrity, and System level testing with a MEDRAD automated injector. Results provide assurance that the device conforms to requirements for its intended use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of a "test set" for a diagnostic algorithm. The testing described is bench and laboratory testing on device prototypes or production samples. The number of samples for each specific test (e.g., pressure rating, leak testing, material property verification) is not provided in this summary.
- Data Provenance: The data is generated from bench and laboratory testing conducted by MEDRAD, Inc. (Bayer Medical Care, Inc.) in Indianola, PA, USA. There is no mention of country of origin of clinical data, as this is a device component, not a clinical diagnostic. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical device (connector tubing) and does not involve AI/ML or a diagnostic test where expert-established ground truth would be required. The "ground truth" for a connector tube's performance relies on engineering specifications and physical test results (e.g., pressure resistance, flow rates, biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device or a diagnostic requiring a reader study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device. The "standalone performance" refers to the physical and functional performance of the tubing itself when subjected to specified conditions (e.g., pressure, flow). The summary states "System level testing with a MEDRAD automated injector" which implies testing the device in its intended use environment, but this is not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device type is primarily based on engineering specifications, material science standards, and performance test results. For example, pressure rating is verified against a specified mechanical test standard, and biocompatibility is confirmed against ISO standards. There is no pathology or outcomes data mentioned for this type of device component in a 510(k) summary.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. Device design and development would involve various iterations and testing, but not in the sense of training a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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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
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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.
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| Automated injection systems with which theMEDRAD Twist & Go High PressureConnector Tubing is intended to be usedinclude the MEDRAD Mark 7 ArterionInjection System and equivalent injectors. | |
|---|---|
| Intended Use: | The Twist & Go High Pressure ConnectorTubing is intended to be used in the deliveryof contrast media and common flushingsolutions. The device is indicated for singleuse only with MEDRAD injectors. |
| Performance Data: | Bench and laboratory testing wereperformed to support a determination ofsubstantial equivalence to the predicatedevices. Results from the testing provideassurance that the proposed deviceconforms to the requirements for itsintended use. This included the followingtesting:• Performance• Package Integrity• System level testing with a MEDRADautomated injector |
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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.
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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.
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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.
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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
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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) | ||||
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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
§ 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.