(315 days)
To Administer IV Fluids/medications to the patient's vascular system.
To administer IV Fluids into a patient's vascular system
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.
The provided text describes the 510(k) summary for the PENTADEFLU IV Administration Sets, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with acceptance criteria and comparative effectiveness studies as might be seen for novel therapeutic devices or AI-powered diagnostics.
Therefore, the information requested, such as acceptance criteria based on performance metrics, sample sizes for test and training sets, expert adjudication methods, MRMC studies, and ground truth establishment, is generally not present or applicable in the context of this 510(k) summary. The summary focuses on engineering and biocompatibility testing, along with demonstrating similarity to a predicate device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Properties | Verified | "subjected to performance and safety testing to verify mechanical properties and functioning" - Specific numerical criteria and results are not provided in this summary. |
| Functioning | Verified | "subjected to performance and safety testing to verify mechanical properties and functioning" - Specific functional criteria and results are not provided in this summary. |
| Biocompatibility | Verified | "biocompatibility... using FDA recognized Standards, where applicable" - Specific tests and results are not provided. |
| Sterility | Verified | "sterility... using FDA recognized Standards, where applicable" - Specific tests and results are not provided. |
| Design | No modifications affect safety/effectiveness | "There are no modifications to the device design that affect safety and effectiveness of the PENTADEFLU IV Administration Sets" compared to the predicate. |
| Technological Characteristics | Same as predicate device | "The PENTADEFLU IV Administration Sets have the same technological characteristics as the legally marketed predicative IV Administration Sets." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This 510(k) summary does not describe a "test set" in the context of an AI/ML algorithm or diagnostic accuracy study. The testing mentioned refers to engineering, performance, biocompatibility, and sterility testing of the physical device. The provenance of samples for these tests (e.g., manufacturing batches) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts during a diagnostic accuracy study is not relevant to this device's 510(k) submission.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods are relevant for diagnostic studies, not for the type of device described here.
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 / Not Provided. This device is an IV administration set, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a physical medical administration set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided directly in this format. For a physical device like an IV set, "ground truth" would refer to its adherence to engineering specifications, biocompatibility standards, and sterility requirements as verified by standardized testing methods and regulatory guidelines (e.g., ISO standards, FDA regulations for IV sets). This isn't "ground truth" in the diagnostic sense.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no "training set."
Summary of the Study:
The "study" described in the 510(k) summary for the PENTADEFLU IV Administration Sets is a series of performance and safety tests conducted to demonstrate the device's conformance to established standards and its substantial equivalence to a legally marketed predicate device (Victus IV Administration Sets, K023469).
The key aspects of the study are:
- Type of Study: Bench testing for mechanical properties, functioning, biocompatibility, and sterility. There are no clinical trials or human subject studies described for this 510(k).
- Purpose: To verify that the device meets safety and performance requirements for its intended use and is substantially equivalent to the predicate device.
- Methodology: Testing was conducted "using FDA recognized Standards, where applicable." The specific standards are not listed in this summary, but they would typically include ISO standards for medical devices, specifically those pertaining to IV administration sets (e.g., ISO 8536 series), as well as biocompatibility standards (e.g., ISO 10993 series) and sterility validation.
- No specific acceptance criteria values (e.g., tensile strength, flow rate tolerances) or numerical performance results are included in this high-level summary. The statement merely indicates that such testing was performed and verified.
- Comparison to Predicate: The submission asserts that the device has "the same technological characteristics" as the predicate and that "no modifications to the device design that affect safety and effectiveness" have been made. This forms the primary basis for the substantial equivalence determination.
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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 ServidoriGeneral ManagerPENTAFERTE S.p.ALoc. Nocelia Statale 26264012 Campli (Teramo), ItalyTel: 011 39 0532 778811Fax: 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 andeffectiveness of the PENTADEFLU IV Administration Sets |
| Device Description | The PENTADEFLU IV Administration Setsare Single Use, Sterile, Non-Pyrogenic devices used to administer IVfluids/medications to a patient's vascular system via gravity control. |
| Intended Use: | To Administer IV Fluids/medications to the patient'svascular system. |
| Technological | The PENTADEFLU IV Administration Sets have the sametechnological characteristics as the legally marketed predicative IVAdministration Sets. |
| Testing: | The PENTADEFLU IV Administration Sets have beensubjected to performance and safety testing to verifymechanical properties and functioning, as well asbiocompatibility and sterility, using FDA recognizedStandards, where applicable |
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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 (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
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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)
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Anton V. Inc.
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§ 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.