(33 days)
To administer IV fluids/medication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.
The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic devices used to administer I.V. fluids/medication to a patient's vascular system via gravity control.
The provided text describes a 510(k) premarket notification for the Victus IV Administration Sets. However, it does not contain the detailed acceptance criteria, study design, or performance data that you've requested regarding device performance. The document explicitly states:
"The Victus I.V. Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards."
This indicates that testing was performed, but the results of that testing (i.e., acceptance criteria and reported performance) are not included in this document. Instead, this document is a summary for a 510(k) submission, confirming that the device is substantially equivalent to predicate devices. Substantial equivalence means it has the same intended use and similar technological characteristics, and any differences don't raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions about "the study that proves the device meets the acceptance criteria" using the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.
Here's what I can extract based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "performance and safety testing" was done, but gives no details about the sample size, type of test set, or data provenance.
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):
- Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging AI). For an IV administration set, "ground truth" would typically be established through engineering specifications, material science testing, and biological assays, not expert consensus on interpretations. No details on specific experts or their qualifications are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are typically used when multiple human experts provide opinions that need to be reconciled, such as in clinical studies evaluating diagnostic accuracy. This is not mentioned or relevant for the type of device and testing described.
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:
- No. This is not an AI device. It is a traditional medical device (IV administration set).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For this type of device, ground truth would be established by engineering specifications, material properties, biocompatibility standards, and functional performance benchmarks (e.g., flow rates, leak integrity, particulate matter, pyrogenicity). The document mentions "FDA recognised standards" were used, implying these types of criteria formed the "ground truth." Specific details are not provided.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to pre-existing devices, rather than a detailed scientific study report outlining specific performance criteria and test results. It confirms that "performance and safety testing" was conducted using "FDA recognized standards," but the specifics of those tests and their outcomes are not included in this document.
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Ko30246
| Submitted by: | Ileana YanesVictus, Inc.4918 S.W. 74 CourtMiami, FL 33155Tel: (305) 663 - 2129 ext. 102Fax: (305) 663 - 1843 | ||||
|---|---|---|---|---|---|
| Date of Summary: | January 13, 2003 | ||||
| Device Name | Victus IV Administration Sets (Model Numbers 27071 and 27072) | ||||
| Common Name | Intra Vascular Administration Set | ||||
| Classification Name | Regulation NumberClassification Name21 C.F.R §880.5440ProCode 80 FPAIntra Vascular Administration Set | Regulation Number | Classification Name | 21 C.F.R §880.5440ProCode 80 FPA | Intra Vascular Administration Set |
| Regulation Number | Classification Name | ||||
| 21 C.F.R §880.5440ProCode 80 FPA | Intra Vascular Administration Set | ||||
| Predicate Devices | BBraun/McGaw IV Administration Sets(Pre-Amendment, and as modified by K921860 and K93265),ICU Medical, Inc. standard or custom Clave® IV systems (K964435), andICU Medical, Inc. Clave® Connector (K915571; K941190; and K970855). | ||||
| Modifications | There are no modifications to the device design that affect safety andeffectiveness of the Victus I.V. Administration Sets. | ||||
| Device Description | The Victus I.V. Administration Sets are single use, sterile, non-pyrogenicdevices used to administer I.V. fluids/medication to a patient's vascularsystem via gravity control. | ||||
| Intended Use | The Victus I.V. Administration Sets provide a sterile fluid path for theintravenous administration of sterile intravenous fluid and/or intravenousmedications from and I.V. container to a patient's vascular system via acatheter venous site. It is intennded for use on patients who requirefluid/medication. | ||||
| Technologicalcharacteristics | The Victus I.V. Administration Sets have the same technologicalcharacteristics as the legally marketed predicate BBraun McGaw and ICUClave® IV Administrations Sets. | ||||
| Testing | The Victus I.V. Administration Sets have undergone performance andsafety testing to verify mechanical properties and biocompatibility usingFDA recognised standards. |
FEB 2 6 2003
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Ms. Ileana Yanes Victus, Incorporated 4918 Southwest 74th Court Miami, Florida 33155
Re: K030246
Trade/Device Name: Victus I.V. Administration Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 20, 2003 Received: January 24, 2003
Dear Ms. Yanes:
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 - Ms. Yanes
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Ruiner
Susan Runner, DDS, MA Interim 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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510(k) Number (if known)
Victus I.V. Administration Set Device Name To administer IV fluids/medication to the patient's vascular system Indications for Use through a needle-free system that aids in the elimination of needle-
stick injury.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pitrea Cucenti
(Division Sign (Division Sign-On)
Division of Anesthesiology, General Hosp Infection Control, Den
510(k) Number: K030246
Prescription Use
OR
Over-The-Counter Use_
Page of
§ 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.