(174 days)
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.
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).
This document pertains to the 510(k) premarket notification for a medical device, specifically an Intravenous Gravity Set, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML performance evaluation is not applicable.
The document discusses the substantial equivalence of the Cedic srl Intravenous Gravity Set to legally marketed predicate devices. The "safety and effectiveness summary" in the original document outlines the following:
1. A table of acceptance criteria and the reported device performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Solvent Bond Pull test | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Leak/Occlusion test | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Roller/Clamp functionality | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Leak test (for F 00010) | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Filter Integrity | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Retainer Adhesive Inspection | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| ISO luer test (594:172) | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Check Valve performance | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
Note: The document broadly states "All testing of the Intravenous Gravity Set indicates that the device meets or exceeds the functional requirements for the device's intended use," without specific numerical values for acceptance criteria or detailed test results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The filing focuses on substantial equivalence based on design, components, and manufacturing processes rather than a detailed clinical trial or performance study with a specified sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable as this is a medical device (intravenous gravity set) and not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The performance is assessed through various engineering and functional tests as listed above. The "ground truth" for this type of device is its ability to perform its intended mechanical and fluid delivery functions without issues like leaks, occlusions, or component failures.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
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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:
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- It has the same intended use.
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- It uses the same components.
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- The device configuration is the same.
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- The composition of the raw materials is similar if not identical.
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- 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
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
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 (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
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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
§ 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.