(271 days)
Not Found
No
The device description details standard components of an I.V. administration set and does not mention any AI or ML capabilities.
No.
The device administers drugs and fluids, but does not inherently provide a therapeutic effect itself. Instead, it is a conduit for therapeutic substances.
No
Explanation: The device description states its purpose is for "administration of drugs and/ or fluids from a container to a patient vascular system," which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components like spikes, drip chambers, tubing, and valves, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of drugs and/ or fluids from a container to a patient vascular system." This describes a device used in vivo (within the body) for delivering substances directly into the bloodstream.
- Device Description: The description details components like spikes, drip chambers, tubing, and luer connections, all of which are characteristic of devices used for intravenous administration to a patient. It also mentions accessing the "patient's vascular system."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. IVDs are used to perform tests on samples, not to administer substances to a patient.
Therefore, the I.V. Administration Set described is a medical device for drug/fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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. 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:
-
- 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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
TEND Medical Lat
igada
510(k) Summary:
Company Name:
Migada Plant
Contact Person:
Ido Kanyon Manager, Quality Assurance and Regulatory affairs Phone: +972-4-690-8826 Fax: +972-3-9267865 E-mail: ido.kanyon@teva.co.il
121269
x
US Agent:
Mr. Stephen H. Lieberman Donowa Consulting LLC 4545 N. Ocean Blvd., Unit 11A Boca Raton, Florida 33431 Phone: (561) 302 0777 E-mail: Lieberman@donawa.com
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
5-2
JAN 2 2 2013
1
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:
-
- 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.
-
- 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.
5-3
Teva Medical Ltd. Migada Plant - Industrial Zone Kiryat Shmona, ISRAEL, Tel: +972-4-6908800
2
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.
3
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 (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 036-2041 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
4
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:_
4-2
Teva Medical Ltd. Migada Plant - Industrial Zone Kiryat Shmona, ISRAEL, Tei: +972-4-6908800