MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

K131517 · Medrad, Inc. / Bayer Medical Care, Inc. · FPK · Aug 2, 2013 · General Hospital

Device Facts

• Record ID: K131517
• Device Name: MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
• Applicant: Medrad, Inc. / Bayer Medical Care, Inc.
• Product Code: FPK · General Hospital
• Decision Date: Aug 2, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

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.

Device Story

Sterile, single-use, disposable connector tubing; transfers contrast media and flushing solutions from automated injector syringe to administration set during angiographic procedures. Features polycarbonate Twist & Go Fasturn Nut for syringe connection and rotating male luer for administration set connection. Tubing constructed of polyurethane and nylon; UV bonded. Used in clinical settings (e.g., radiology/angiography suites) by trained healthcare professionals. Output is fluid delivery to patient via administration set; facilitates diagnostic imaging. Benefits include secure, high-pressure connection (up to 1200 psi) for automated contrast delivery.

Clinical Evidence

Bench testing only. Testing included performance, package integrity, and system-level testing with MEDRAD automated injectors to verify pressure ratings and mechanical integrity. No clinical data provided.

Technological Characteristics

Materials: Polycarbonate hub, polyurethane and nylon tubing, UV adhesive. Sterilization: Ethylene Oxide (SAL 10^-6). Pressure rating: 1200 psi. Connection: Twist & Go Fasturn Nut (syringe side), rotating male luer (administration set side). Biocompatibility: Compliant with ISO/AAMI 10993-1:2009. Non-pyrogenic fluid path. Not made with natural rubber latex.

Indications for Use

Indicated for delivery of contrast media and flushing solutions during angiographic procedures using MEDRAD automated injectors. Single-use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MEDRAD High Pressure Connecting Tube (K810924)

Submission Summary (Full Text)

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### 510(k) Summary

Submitter:

MEDRAD, Inc. Bayer Medical Care, Inc. One Medrad Drive Indianola, PA 15051

Phone: [phone]

Email: [e-mail]

Fax: [phone]

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.

[phone]

www.ri.bayer.com

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| | Automated injection systems with which the<br>MEDRAD Twist & Go High Pressure<br>Connector Tubing is intended to be used<br>include the MEDRAD Mark 7 Arterion<br>Injection System and equivalent injectors. |
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| Intended Use: | The Twist & Go High Pressure Connector<br>Tubing is intended to be used in the delivery<br>of contrast media and common flushing<br>solutions. The device is indicated for single<br>use only with MEDRAD injectors. |
| Performance Data: | Bench and laboratory testing were<br>performed to support a determination of<br>substantial equivalence to the predicate<br>devices. Results from the testing provide<br>assurance that the proposed device<br>conforms to the requirements for its<br>intended use. This included the following<br>testing:<br>• Performance<br>• Package Integrity<br>• System level testing with a MEDRAD<br>automated 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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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 [phone] or [phone] 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:

K131517

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)

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Richard C. Chapman 2013.07.31 10:31:46 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K131517