TBA

K121269 · Migada Plant · FPA · Jan 22, 2013 · General Hospital

Device Facts

• Record ID: K121269
• Device Name: TBA
• Applicant: Migada Plant
• Product Code: FPA · General Hospital
• Decision Date: Jan 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

I.V. Administration Set is a single-use, sterile, non-pyrogenic device for delivering intravenous fluids or drugs from a container to a patient's vascular system. Components include a spike for infusion bag connection, drip chamber, tubing, flow regulator, clamp, and luer connection. Includes a needle-free ULTRASITE injection site (K031923) to facilitate fluid administration and prevent needle-stick injuries. Used in clinical settings by healthcare providers to manage patient fluid/drug delivery. Device is latex-free.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-use, sterile, non-pyrogenic I.V. administration set. Components: spike, drip chamber, Y-site, tubing, flow regulator, clamp, needle-free injection site, and luer connection. Latex-free. No electronic or software components.

Indications for Use

Indicated for the administration of drugs and/or fluids from a container to the vascular system of patients requiring intravenous therapy.

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

• ULTRASITE In Injection site (K031923)

Submission Summary (Full Text)

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TEND Medical Lat

igada

# 510(k) Summary:

Company Name:

Migada Plant

Contact Person:

Ido Kanyon Manager, Quality Assurance and Regulatory affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

121269

x

## US Agent:

Mr. Stephen H. Lieberman Donowa Consulting LLC 4545 N. Ocean Blvd., Unit 11A Boca Raton, Florida 33431 Phone: [phone] E-mail: [e-mail]

Date prepared: April 15, 2012 (revised on December, 2012)

Trade Name: I.V. Administration Set

Common/usual name: I.V. administration set

Classification name: Set, Administration, Intravascular

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JAN 2 2 2013

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TEND Medical use

## Product Code: FPA

Regulation No.: 880.5440

Class: II

### Panel identification: General Hospital Panel

### Description of the device:

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. This device is not made with natural rubber latex.

The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, drip chamber, Y-site, tubing, flow regulator, clamp, needless injection site and luer connection. The set may include two unique components:

- 1. Spike: The Spike is intended for connection to the spike port of an infusion bag. In cases when a drug needs to be introduced, a septum enables connection to the Tevadaptor™ Syringe Adaptor for withdrawal of diluents or introduction of drug.
- 2. ULTRASITE In Injection site (cleared under 510(k) No. K031923). The Ultrasite Valve is a needle-free, cap less positive displacement valve to be use in place of needles for the administration of fluids. The ULTRASITE™ Valve may be accessed with standard male luer connectors and requires no special accessories devices. The Ultrasite device eliminates the use of needles to access the set during IV administration and aids in the prevention of needle stick injuries.

Teva Medical Migada Plant offers both standard and custom sets with tubing of various lengths to meet customer requirements and specifications.

#### Intended 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.

## Conclusion -

The evaluation of the I.V. Administration Set does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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Teva Medical Ltd. Migada Plant - Industrial Zone Kiryat Shmona, ISRAEL, Tel: [phone]

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

### January 22, 2013

Mr. Ido Kanyon Manager, Quality Assurance and Regulatory Affairs Migada Plant North Industrial Zone Kiryat Shmona, Israel 10258

Re: K121269

Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 6, 2012 Received: December 13, 2012

Dear Mr. Kanyon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regary the Medical Device Ameral Food and Food Food Food Drys commerce prov to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, uevices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market the do requirements for annual registration, listing of general controls provisions of uabeling, and prohibitions against misbranding and devices, good manufacturing pravates, not evaluate information related to contract liability autheration. I lease note: ODAT doos not over in the 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 your device is classified (see above) . Existing major regulations affecting your device can be It may be subject to additional controllar shilling millions and 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 Please be advised that IDA is issualled of a backed on a suith other requirements of the Act that I DA has made a decommandinan administered by other Federal agencies. You must or any Federal statures and regulations daminding, but not limited to: registration and listing (21 comply with all the Act 3 requirements, morations, morting (reporting (reporting of medical CFK Fall 607), labeling (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 iorul in the quality systems (Q5) regalicns (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 If you desire specific advice for your devices of our accessor offices/ucm 115809.htm for go to mip://www.ida.gov/About Drives.html s (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of COLORE Box the Center 10 Devices and Radionegroung by reference to premarket notification" (21 CFR Part note the regulation entitled, "Misorananing of reference to presents 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 You may obtain other general miorinations on Joan Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] of (2017) 720 Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthong to min

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, ·Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**TEVA** Medical Ltd

igada

INDICATIONS FOR USE

| 510(k) Number (if | K121269 |
|-------------------|------------------------------------------|
| known): | Carolina Collegal Concession of Children |

Device Name:

I.V. Administration Set

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.

OR Prescription Use X (Part 21 CFR 801 Subpart D)

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):

Digitally signed by Richard C. Chapman Date: 2013.01.22 14:09:12 -05'00'

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

17.1269 510(k) Number:_

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Teva Medical Ltd. Migada Plant - Industrial Zone Kiryat Shmona, ISRAEL, Tei: [phone]