PENTADEFLUE IV SOLUTION ADMINISTRATION SETS

K041495 · Pentaferte S.P.A · FPA · Apr 15, 2005 · General Hospital

Device Facts

• Record ID: K041495
• Device Name: PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
• Applicant: Pentaferte S.P.A
• Product Code: FPA · General Hospital
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To Administer IV Fluids/medications to the patient's vascular system.

Device Story

PENTADEFLU IV Administration Sets are single-use, sterile, non-pyrogenic devices designed for gravity-controlled delivery of IV fluids and medications into a patient's vascular system. The device consists of standard tubing and components for fluid administration. It is intended for use in clinical settings by healthcare professionals. The device functions by facilitating the flow of fluids from a container to the patient's venous access site. It provides a basic delivery mechanism for therapeutic fluids, supporting patient hydration and medication administration.

Clinical Evidence

Bench testing only. The device underwent performance and safety testing to verify mechanical properties, functioning, biocompatibility, and sterility using FDA-recognized standards.

Technological Characteristics

Single-use, sterile, non-pyrogenic IV administration set. Operates via gravity control. Materials and design are equivalent to legally marketed predicate devices. Sterilization method is implied by the sterile claim.

Indications for Use

Indicated for the administration of IV fluids into a patient's vascular system via gravity control.

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

• Victus IV Administration Sets (K023469)

Submission Summary (Full Text)

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APR 1 5 2005 510(k) Number: Ko41495

## 510(k) SUMMARY (As Required by 21 CFR 807. 92)

| Submitted by: | Dr. Vittorio Servidori<br>General Manager<br>PENTAFERTE S.p.A<br>Loc. Nocelia Statale 262<br>64012 Campli (Teramo), Italy<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>effectiveness of the PENTADEFLU IV Administration Sets |
| Device Description | The PENTADEFLU IV Administration Sets<br>are Single Use, Sterile, Non-Pyrogenic devices used to administer IV<br>fluids/medications to a patient's vascular system via gravity control. |
| Intended Use: | To Administer IV Fluids/medications to the patient's<br>vascular system. |
| Technological | The PENTADEFLU IV Administration Sets have the same<br>technological characteristics as the legally marketed predicative IV<br>Administration Sets. |
| Testing: | The PENTADEFLU IV Administration Sets have been<br>subjected to performance and safety testing to verify<br>mechanical properties and functioning, as well as<br>biocompatibility and sterility, using FDA recognized<br>Standards, where applicable |

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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.

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## 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 [phone]. 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 [phone] or [phone] 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

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## 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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