(315 days)
Not Found
No
The summary describes a standard IV administration set that uses gravity control and does not mention any AI or ML capabilities.
No
The device is used to administer IV fluids/medications, which are therapeutic, but the device itself is a delivery system, not a therapeutic agent.
No
The device is described as an "IV Administration Set" used to administer fluids/medications, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a physical device ("Single Use, Sterile, Non-Pyrogenic devices") used to administer IV fluids, and performance studies focus on mechanical properties, biocompatibility, and sterility, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Administer IV Fluids/medications to the patient's vascular system." This describes a device used in vivo (within the body) for therapeutic or supportive purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces the intended use, stating it's used to "administer IV fluids/medications to a patient's vascular system."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a general medical device used for fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To Administer IV Fluids/medications to the patient's vascular system.
Product codes
FPA
Device Description
The PENTADEFLU IV Administration Sets are Single Use, Sterile, Non-Pyrogenic devices used to administer IV fluids/medications to a patient's vascular system via gravity control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
The PENTADEFLU IV Administration Sets have been subjected to performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility, using FDA recognized Standards, where applicable
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.
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.
Not Found
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
APR 1 5 2005 510(k) Number: Ko41495
510(k) SUMMARY (As Required by 21 CFR 807. 92)
| Submitted by: | Dr. Vittorio Servidori
General Manager
PENTAFERTE S.p.A
Loc. Nocelia Statale 262
64012 Campli (Teramo), Italy
Tel: 011 39 0532 778811
Fax: 011 39 0532 778812 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | March 23, 2003 |
| Device Name: | PENTADEFLU IV Administration Sets |
| Common Name: | Intra Vascular Administration Set |
| Classification Name: | Intra Vascular Administration Set |
| Class: | 2 |
| Product Code: | FPA |
| Regulation Number: | 21 CFR 880. 5440 |
| Predicative Device: | Victus IV Administration Sets (K023469) |
| Modifications: | There are no modifications to the device design that affect safety and
effectiveness of the PENTADEFLU IV Administration Sets |
| Device Description | The PENTADEFLU IV Administration Sets
are Single Use, Sterile, Non-Pyrogenic devices used to administer IV
fluids/medications to a patient's vascular system via gravity control. |
| Intended Use: | To Administer IV Fluids/medications to the patient's
vascular system. |
| Technological | The PENTADEFLU IV Administration Sets have the same
technological characteristics as the legally marketed predicative IV
Administration Sets. |
| Testing: | The PENTADEFLU IV Administration Sets have been
subjected to performance and safety testing to verify
mechanical properties and functioning, as well as
biocompatibility and sterility, using FDA recognized
Standards, where applicable |
1
Image /page/1/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure with three arms or wings extending upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2005
PENTAFERTE S.p.A C/O Mr. Victor Pereira Consultant 7410 NW 6501 Lane Parkland, Florida 33067
Re: K041495
Trade/Device Name: PENTADEFLU™ IV Administration Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 29, 2005 Received: April 6, 2005
Dear Mr. Pereira:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Mr. Pereira
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cus L
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number K041495
Device Name: PENTADEFLU™ IV Administration Sets
INDICATIONS FOR USE: To administer IV Fluids into a patient's vascular system
Prescription Use: X 9part 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
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton V. Inc.
. . . 74 5000-000 ୍ରାଚନ mection Control. Deala Devices
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