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 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.

AI/ML Overview

This document is a 510(k) summary for a "Special" submission regarding Teva Medical I.V. Administration Sets, dated May 16, 2014. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K121269) rather than presenting a study with specific acceptance criteria and performance data for a novel device.

Therefore, the requested information, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training data details, are not explicitly provided or applicable in the context of this 510(k) Special submission.

Here's an explanation based on the provided text:

1. A table of acceptance criteria and the reported device performance:

This document does not present a table of quantitative acceptance criteria and reported device performance in the way that would typically be seen for a new device's efficacy or accuracy study.
Instead, the submission aims to demonstrate "substantial equivalence" of modified I.V. Administration Set designs to a predicate device. The "performance" assessment is qualitative, focusing on whether changes have a significant effect on safety and effectiveness.

2. Sample sized used for the test set and the data provenance:

Not applicable / Not explicitly stated. This submission is not based on a new clinical or laboratory study with a defined "test set" in the traditional sense. It's a "Special 510(k)" which usually relies on a comparison to an already cleared predicate device, and verification/validation activities performed under the manufacturer's quality system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth" establishment by external experts described for a test set in this kind of regulatory submission. The evaluation is conducted internally by the manufacturer against regulatory standards and comparison to a predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As there is no external "test set" in the context of a clinical study, there is no adjudication method described.

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 document pertains to an I.V. Administration Set, which is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithmic or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the safety and effectiveness profile of the predicate device (K121269), which has already been cleared by the FDA. The submission's "truth" is that the new designs are equally safe and effective.

8. The sample size for the training set:

Not applicable. This is not a machine learning device and therefore does not have a "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary of Device and Acceptance Criteria (as implied by a Special 510(k)):

The core "acceptance criteria" for a Special 510(k) is the demonstration of Substantial Equivalence (SE) to a predicate device. This means showing that the modified device is as safe and effective as the legally marketed predicate. For a Special 510(k), this typically involves:

No new Indications for Use: The current device maintains the same intended use as the predicate. (Stated as identical).
Fundamental Technology: The core operational principle remains the same. (Stated as identical).
Performance (Safety and Effectiveness): Any changes in design, materials, or features do not adversely affect safety or effectiveness. This is assessed through internal verification and validation activities under the manufacturer's quality system (21 CFR 820). The document states: "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."
Biocompatibility, Sterilization, Single-use only, Interconnecting features, Interaction with patient and other devices, Safety features: These aspects are stated as identical to the predicate.

Differences Noted:

Shorter lengths of devices.
No drip chamber, flow control, or air venting in new devices.
Addition of a twist-off component in one device.
Changed labeling.
Changed packaging materials and process.

The document implicitly states that these differences were evaluated under the quality management system and found to not raise any additional safety and effectiveness issues, leading to the conclusion of substantial equivalence.

Summary

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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 PlantNorth Industrial ZoneKiryat Shmona 10258ISRAEL
FDA Registration Number:	9611423
Owner/Operator Number:	9001925
510(k) Owner:	Teva Medical Ltd., MIGADA PlantNorth Industrial ZoneKiryat Shmona 10258ISRAEL
Phone:Fax:	+972 (0)46 908822+972 (0)39 267865
510(k) Submitter and Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItalyPhone: +39 06 578 2665Fax: +30 06 574 3786Email: rgray@donawa.com
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 toadminister fluids from a container to a patient's vascular systemthrough a needle or catheter inserted into a vein. The device.

Special 510(k) for IV Teva Medical Administration Set

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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 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

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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.

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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'

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

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Regulation Number and Section

§ 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.