TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE

K141306 · Teva Medical Ltd., Migada Plant · FPA · Jun 12, 2014 · General Hospital

Device Facts

• Record ID: K141306
• Device Name: TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE
• Applicant: Teva Medical Ltd., Migada Plant
• Product Code: FPA · General Hospital
• Decision Date: Jun 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/or fluids from a container to a patient vascular system.

Device Story

The Teva Medical I.V. Administration Set is a single-use, sterile, non-pyrogenic device designed to deliver intravenous fluids or medications from a container (e.g., I.V. bag) to a patient's vascular system. The device consists of generic components including a hollow spike for bag penetration, tubing, Y-sites, clamps, Luer connectors, and needleless injection sites (specifically ULTRASITE). The subject submission introduces two new configurations: a connecting set and a spike port adaptor, both incorporating the ULTRASITE injection site. These devices are used in clinical settings to facilitate fluid delivery. The healthcare provider connects the set to the fluid source and the patient's vascular access device. The device functions as a passive conduit for fluid administration; it does not contain active electronic components, sensors, or software. The design changes relative to the predicate include shorter tubing lengths, the removal of drip chambers/flow control/air venting in the new configurations, and the addition of a 'twist-off' component.

Clinical Evidence

No clinical data. Bench testing only. The manufacturer performed verification and validation of design changes under their quality management system in compliance with 21 CFR 820.

Technological Characteristics

Single-use, sterile, non-pyrogenic I.V. administration set. Components include spike, Y-site, tubing, clamp, needleless injection site (ULTRASITE), twist-off, and Luer connections. Materials are identical to those previously cleared in K121269 and K071741. No electronic components, software, or energy sources.

Indications for Use

Indicated for the administration of drugs and/or fluids from a container to a patient's vascular system via a needle or catheter.

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

• I.V. Administration Set (K121269)

Reference Devices

• I.V. Administration Set (K071741)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains two logos. The first logo on the left is a simple, abstract design featuring the letters "VN" in a bold, sans-serif font. The second logo on the right is more complex, with the word "Medical" in a stylized font at the top. Below "Medical" is smaller text that reads "1993 Medical Ltd."

# Appendix E

# JUN 1 2 2014

ﺮ

510(k) Summary in accordance with 21 CFR 807.92(c)

| Device Name: | Teva Medical I.V. Administration Set |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) submission: | Special |
| Date of Submission: | 16 May 2014 |
| Manufacturer: | Teva Medical Ltd., MIGADA Plant<br>North Industrial Zone<br>Kiryat Shmona 10258<br>ISRAEL |
| FDA Registration Number: | 9611423 |
| Owner/Operator Number: | 9001925 |
| 510(k) Owner: | Teva Medical Ltd., MIGADA Plant<br>North Industrial Zone<br>Kiryat Shmona 10258<br>ISRAEL |
| Phone:<br>Fax: | [phone]<br>[phone] |
| 510(k) Submitter and Contact: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome<br>Italy<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| FDA Product Code: | FPA |
| FDA Regulation Number: | 880.5440 |
| FDA Classification Name: | Set, Administration, Intravascular |
| Classification Panel: | General Hospital |
| Common Name: | I.V. Administration Set |
| FDA Classification: | Class II |
| FDA Identification: | An intravascular administration set is a device used to<br>administer fluids from a container to a patient's vascular system<br>through a needle or catheter inserted into a vein. The device. |

Special 510(k) for IV Teva Medical Administration Set

(

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with the text "Medical" in a stylized font. The word "Medical" is in white text on a black background. Below "Medical" is the text "love medical" in a smaller font. To the left of the text is a symbol that appears to be "VN".

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.

The I.V. Administration Set is a single use, sterile I.V. set for administration of Indications for Use: drugs and/ or fluids from a container to a patient vascular system.

#### Device Description:

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.

The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, Y-site, tubing, clamp, needless injection site, 'twist-off' and Luer connection.

The purpose of this Special 510(k) is to add the following two new designs of IV Administration Sets to the one already cleared for sale in the US under K121269:

- TEVADAPTOR Connecting Set with ULTRASITE Injection Site �
- TEVADAPTOR Spike Port Adaptor with ULTRASITE Injection Site .

All components used in the two new Administration Sets were used in the predicate device cleared under K121269, except for two, which are identical to components cleared under K071741.

Because none of the materials are new, and all components have been previously cleared for use in V administration sets, no additional biocompatibility data is included in this submission.

Comparison with predicate device:

The predicate device selected for comparison with the I.V. Administration Set is:

| Predicate Device: | I.V. Administration Set |
|----------------------|------------------------------------|
| 510(k) Sponsor: | Teva Medical |
| 510(k) Number: | K121269 |
| Clearance Date: | 22 January 2013 |
| FDA Product Code: | FPA |
| Classification Name: | Set, Administration, Intravascular |
| Regulation No: | 880.5440 |

The following aspects of the subject and predicate devices are identical:

- . Indications for use
- . Fundamental technology
- Single use only .
- . Sterilization
- Biocompatibility �
- . Interconnecting features

Special 510(k) for IV Teva Medical Administration Set

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains two distinct elements. On the left, there's a stylized graphic that appears to be a logo or symbol. To the right, there's a rectangular graphic with the word "Medical" prominently displayed in a stylized font, with the words "Iowa Medical, Ltd." underneath it.

- Interaction with patient and other devices .
- . Safety features

The following aspects of the devices are different:

- The lengths of the new devices are shorter than the predicate. .
- No drip chamber, flow control or air venting in the new devices. �
- Addition of the twist-off component in one of the new devices.
- Labeling has changed as a result of the above differences. 해
- . Packaging materials and process has changed

The two additional (subject) devices have been reviewed under the control of Teva Medical's quality management system and none of the changes from the predicate device have been identified as having any significant effect on safety and effectiveness compared with the original FDA-cleared device. Where verification/validation of applicable changes was required, these have been carried out under the control of Teva Medical's quality system, which is in compliance with 21 CFR 820.

#### Substantial Equivalence Conclusion:

Based on the information contained within this submission, the additional subject device administration sets do not raise any additional safety and effectiveness issues. It is concluded that the additional devices are substantially equivalent to the identified predicate device cleared under K121269, which is already in interstate commerce within the USA.

・・
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

{3}------------------------------------------------

Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, represented by three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2014

:

Teva Medical Limited, MIGADA Plant C/O Mr. Roger Gray Donawa Lifescience Consulting Piazza Albania 10 00153 Rome Italy

Re: K141306

Trade/Device Name: Teva Medical I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: II Product Code: FPA Dated: May 16, 2014 Received: May 19, 2014

Dear Mr. Gray:

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.

{4}------------------------------------------------

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

· Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

.
* *
*
*

.

Enclosure

{5}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141306

Device Name

Teva Medical I.V. Administration Set

Indications for Use (Describe)

The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/or fluids from a container to a patient vascular system.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY |
|------------------------------------------------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Digitally signed by |
| Richard C. Chapman -S |
| Date: 2014.06.12 |
| 13:24:34 -04'00' |

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."