(55 days)
To administer IV fluids/medication to the patient's vascular system.
The Victus Administration Sets are single use, sterile, non-pyrogenic devices used to administer IV fluids/medication to a patient's vascular system via gravity control.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is for a physical medical device (I.V. Administration Set) and not an AI/software device, so many of the requested fields are not applicable:
Acceptance Criteria and Device Performance
| Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional | Administer IV fluids/medication to the patient's vascular system via gravity control. | Same as legally marketed predicate IV Administrations Sets. |
| Safety | Sterile | Verified through performance and safety testing. |
| Safety | Non-pyrogenic | Verified through performance and safety testing. |
| Mechanical | Mechanical properties and biocompatibility. | Verified through performance and safety testing using FDA recognized standards. |
| Equivalence | Substantially equivalent to legally marketed predicate devices. | Found substantially equivalent by FDA. |
Study Details (Relevant to K023469 - Victus IV Administration Sets)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "performance and safety testing" and "biocompatibility testing," but does not specify the sample size for these tests or the data provenance (e.g., country, retrospective/prospective). This information is typically found in detailed testing reports, which are not included in the provided 510(k) summary. -
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. This device is a physical IV administration set. Ground truth establishment by medical experts (like radiologists) is relevant for diagnostic or image-based AI devices, not for the functional testing of a physical product like this. Testing would involve engineering, microbiology, and biocompatibility specialists. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This refers to consensus methods for establishing ground truth, typically in the context of expert review of images or data for AI studies. For a physical device, testing outcomes are objective (e.g., pass/fail for sterility, flow rate, material strength). -
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 device is an IV Administration Set, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI are not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is a physical medical product, not an algorithm or AI. Standalone performance refers to the accuracy of a digital algorithm on its own. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device would be established through:- Engineering specifications and standards: Verification that the device meets defined physical, mechanical, and functional requirements (e.g., flow rates, connection integrity, material strength).
- Microbiological testing: Confirmation of sterility.
- Biocompatibility testing: Verification that materials are non-toxic and do not induce adverse biological responses, often following standards like ISO 10993.
- Comparison to predicate device: The fundamental "ground truth" for FDA clearance here is substantial equivalence to a legally marketed predicate device (BBraun-McGaw IV Administration Sets), implying that if it performs comparably to a safe and effective predicate, it too is considered safe and effective.
-
The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set. -
How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/machine learning device.
Summary of the Study:
The provided document describes a 510(k) premarket notification for the Victus IV Administration Set. The study primarily involves demonstrating substantial equivalence to existing predicate devices (BBraun-McGaw IV Administration Sets).
The evidence for this substantial equivalence is based on:
- Technological characteristics: The Victus IV Administration Sets have the "same technological characteristics" as the predicate device.
- Performance and safety testing: The device "undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards, where applicable." This testing would rigorously assess physical integrity, flow rates, sterility, material safety, and other critical performance attributes against established standards and the performance profile of the predicate device.
The FDA's decision to clear the device (K023469) signifies that they found the data presented by Victus, Inc. sufficient to demonstrate that the Victus IV Administration Set is as safe and effective as the predicate device already on the market. The specific details of the individual tests (e.g., how many units were tested for sterility, details of biocompatibility studies) are not in the provided summary but would have been part of the full 510(k) submission.
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| Submitted by: | Ileana YanesVictus, Inc.4918 S.W. 74 CourtMiami, Fl 33155Tel: (305) 663-2129 ext 102.Fax: (305) 663-1843 | DEC 1 0 2002 |
|---|---|---|
| Date of Summary | October 7, 2002 | |
| Device name | Victus IV Administration Sets (27058, 27059, 27062) | |
| Common name | Intra Vascular Administration Set | |
| Classification name | Regulation Number | Classification Name |
| 21 C.F.R §880.5440 | Intra Vascular Administration Set | |
| Predicate Devices | BBraun-McGaw IV Administration Sets (Pre-Amendment, and as modifiedby K921860 and K93265) | |
| Modifications | There are no modifications to the device design that affect safety &effectiveness of the Victus IV Administration Sets. | |
| Device Description | The Victus Administration Sets are single use, sterile, non-pyrogenicdevices used to administer IV fluids/medication to a patient's vascularsystem via gravity control. | |
| Intended Use | To administer IV fluids/medication to the patient's vascular system. | |
| Technologicalcharacteristics | The Victus IV Administration Sets have the same technologicalcharacteristics as the legally marketed predicate IV Administrations Sets. | |
| Testing | The Victus Administration Sets have undergone performance and safetytesting to verify mechanical properties and biocompatibility using FDArecognised standards, where applicable. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administrat 9200 Corporate Boulevaro Rockville MD 20850
DEC 1 0 2002
Ms. Ileana Yanes Regulatory Affairs Victus. Incorporated 4918 S.W. 74 Court Miami, Florida 33155
Re: K023469
Trade/Device Name: Victus I.V. Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 15, 2002 Received: October 16, 2002
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 (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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timothy A. Ulatowski
Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Ki2346.9
Indications for Use Statement
510(k) Number (if known)
Device Name
Victus I.V. Administration Set
Indications for Use To administer IV fluids/medication to the patient's vascular system.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED --
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-Counter Use
Patricia Currenik
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023469
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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.