K Number
K042129
Device Name
F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK
Manufacturer
Date Cleared
2005-01-27

(174 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cedic srl Intravenous Gravity Set is used for IV fluid administration. This device serves as a connection between the IV fluid container and an indwelling catheter.
Device Description
The Cedic srl Intravenous Gravity Set is a universal non-DEHP tubing set that allows IV solutions to be infused into the patient in conjunction with an indwelling catheter. The drip chamber fiker precludes passage of gross particle potentially generated during spiking of the IV solution container. The vent filter is 3u aerosol microbial barrier . The device consists of a spike, drip chamber with disk filter (15 um approx.), roller clamp, latex free flash bulb injection site, and male luer slip connector (Cedie product code: F 00010) or male luer lock connector (Cedic product code: F 00027).
More Information

No
The device description and performance studies focus on the physical components and mechanical functionality of a standard IV gravity set, with no mention of AI or ML.

No.
The device is used for IV fluid administration and delivery, which is a supportive function, not a direct therapeutic treatment of a disease or condition.

No
The device is described as an "Intravenous Gravity Set" used for IV fluid administration, serving as a connection between an IV fluid container and an indwelling catheter. Its function is to infuse solutions, not to diagnose.

No

The device description clearly outlines physical components such as tubing, spike, drip chamber, roller clamp, and connectors, indicating it is a hardware medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for IV fluid administration" and serves as a "connection between the IV fluid container and an indwelling catheter." This describes a device used to deliver substances into the body, not to perform tests on samples taken from the body.
  • Device Description: The description details components like a spike, drip chamber, tubing, clamp, and connectors. These are all consistent with a device for administering fluids intravenously. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing diagnostic information about a patient's health status

Therefore, the Cedic srl Intravenous Gravity Set is a medical device used for fluid delivery, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Cedic srl Intravenous Gravity Set is used for IV fluid administration. This device serves as a connection between the IV fluid container and an indwelling catheter.

Product codes

FPA

Device Description

The Cedic srl Intravenous Gravity Set is a universal non-DEHP tubing set that allows IV solutions to be infused into the patient in conjunction with an indwelling catheter. The drip chamber fiker precludes passage of gross particle potentially generated during spiking of the IV solution container. The vent filter is 3u aerosol microbial barrier . The device consists of a spike, drip chamber with disk filter (15 um approx.), roller clamp, latex free flash bulb injection site, and male luer slip connector (Cedie product code: F 00010) or male luer lock connector (Cedic product code: F 00027). The components and the processes used to manufacture these Intravenous Gravity sets are substantially equivalent to like products currently legally marketed by Venusa Ltd, under K843692. The Cedic srl Intravenous Gravity set will be packaged in PE bags and sterilized per ISO 11135 guidelines.

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)

Cedic srl Intravenous Gravity set performance tests include Solvent Bond Pull test (STM 001). Leak/Occlusion test (STM 012), Roller/Clamp functionality (STM 002), Leak test (for S 00010) (STM 011), Filter Integrity (STM 006), Retainer Adhesive Inspection (STM 003), ISO luer test (594:172), Check Valve performance. All testing of the Intravenous Gravity Set indicates that the device meets or exceeds the functional requirements for the device's intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K843692

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Cedic

JAN 2 7 2005

510(K) K042129: Intravenous Gravity Set with male luer slip (Cedic code F 00010) Intravenous Gravity Set with male luer lock (Cedic code F 00027)

Safety and Effectiveness Summary

27 January, 2005

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Trade Name - Cedic srl. Intravenous Gravity Set Common Name -- Intravenous Gravity set Classification Name - Intravascular Administration Set

The Cedic srl Intravenous Gravity Set is a universal non-DEHP tubing set that allows IV solutions to be infused into the patient in conjunction with an indwelling catheter. The drip chamber fiker precludes passage of gross particle potentially generated during spiking of the IV solution container. The vent filter is 3u aerosol microbial barrier . The device consists of a spike, drip chamber with disk filter (15 um approx.), roller clamp, latex free flash bulb injection site, and male luer slip connector (Cedie product code: F 00010) or male luer lock connector (Cedic product code: F 00027). The components and the processes used to manufacture these Intravenous Gravity sets are substantially equivalent to like products currently legally marketed by Venusa Ltd, under K843692. The Cedic srl Intravenous Gravity set will be packaged in PE bags and sterilized per ISO 11135 guidelines.

The Cedic srl Intravenous Gravity Set is similar to the above named predicate devices in following ways:

    1. It has the same intended use.
    1. It uses the same components.
    1. The device configuration is the same.
    1. The composition of the raw materials is similar if not identical.
    1. The processes used to manufacture the devices are similar if not identical.

Cedic srl Intravenous Gravity set performance tests include Solvent Bond Pull test (STM 001). Leak/Occlusion test (STM 012), Roller/Clamp functionality (STM 002), Leak test (for S 00010) (STM 011), Filter Integrity (STM 006), Retainer Adhesive Inspection (STM 003), ISO luer test (594:172), Check Valve performance. All testing of the Intravenous Gravity Set indicates that the device meets or exceeds the functional requirements for the device's intended use.

Based on the fact that Cedic srl Intravenous Gravity Set utilizes similar and equivalent designs. components, manufacturing processes as currently marketed products, the Cedie srl Intravenous Gravity Set is safe and effective when used as intended.

Sincerely.

Giancarlo Gagliardoni

Le srl, Via Liberazione 63/9. 20068 Peschiera Borromeo (MI), Italia Tel: 0039-02-55300174 fax: 0039-02-55301487

Page I of I

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Public Health Service

JAN 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Giancarlo Gagliardoni General Manager Cedic S.R.L. Via Liberazione 63/9 Peschiera Borromeo, 20068 ITALY

Re: K042129

Trade/Device Name: Intravenous Gravity Set with Male Luer Slip (Cedic Code F00010) and Intravenous Gravity Set with Male Luer Lock (Cedic Code F00027) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 28, 2004 Received: December 30, 2004

Dear Mr. Gagliardoni:

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. Gagliardoni

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 (OS) 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.

Chiu, Lin, Ph.D.

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: K042129

Device Name: Intravenous Gravity Set with Male Luer Slip (Cedic code F00010) and Intravenous Gravity Set with Male Luer lock (Cedic code F00027)

Indications For Use:

The Cedic srl Intravenous Gravity Set is used for IV fluid administration. This device serves as a connection between the IV fluid container and an indwelling catheter.

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Anthony Vams

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

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510(k) Number_KO4