F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK

K042129 · Cedic S.R.L. · FPA · Jan 27, 2005 · General Hospital

Device Facts

• Record ID: K042129
• Device Name: F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK
• Applicant: Cedic S.R.L.
• Product Code: FPA · General Hospital
• Decision Date: Jan 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Non-DEHP tubing set for gravity-fed IV fluid administration; connects IV fluid container to indwelling catheter. Components include spike, drip chamber with 15um disk filter, roller clamp, latex-free flash bulb injection site, and male luer slip or lock connector. Drip chamber filter removes gross particles; vent filter provides 3u aerosol microbial barrier. Used in clinical settings by healthcare providers to facilitate fluid delivery. Device is sterile, single-use, and disposable.

Clinical Evidence

Bench testing only. Tests included Solvent Bond Pull (STM 001), Leak/Occlusion (STM 012), Roller/Clamp functionality (STM 002), Leak test (STM 011), Filter Integrity (STM 006), Retainer Adhesive Inspection (STM 003), ISO luer test (594:172), and Check Valve performance.

Technological Characteristics

Non-DEHP tubing set; 15um disk filter; 3u aerosol microbial barrier vent filter; latex-free flash bulb; male luer slip or lock connector. Sterilized per ISO 11135. ISO 594:172 luer standard compliance.

Indications for Use

Indicated for IV fluid administration via connection between IV fluid container and indwelling catheter.

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

• Venusa Ltd (K843692)

Submission Summary (Full Text)

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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.
- 2. It uses the same components.
- 3. The device configuration is the same.
- 4. The composition of the raw materials is similar if not identical.
- 5. 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: [phone] fax: [phone]

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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.

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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 [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.

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

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## 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