(33 days)
K921860, K93265
No
The summary describes a gravity-controlled IV administration set with no mention of AI/ML, image processing, or data-driven performance metrics.
No.
The device's intended use is to administer IV fluids/medication, which is a supportive function in patient care, not directly treating a disease or condition. While essential for delivering therapeutics, the device itself is a delivery system, not a therapeutic agent or intervention.
No
The device is described as an "I.V. Administration Set" used to "administer IV fluids/medication." This function is therapeutic (delivering substances) rather than diagnostic (identifying a condition or disease).
No
The device description explicitly states it is a "single use, sterile, non-pyrogenic device" used to administer fluids, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer IV fluids/medication to the patient's vascular system." This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description reinforces the administration function, stating it's used to "administer I.V. fluids/medication."
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition. IVDs are designed to perform tests on samples to aid in diagnosis, monitoring, or screening.
This device is clearly intended for the delivery of substances into the body, which falls under the category of a therapeutic or delivery medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Victus I.V. Administration Sets provide a sterile fluid path for the intravenous administration of sterile intravenous fluid and/or intravenous medications from and I.V. container to a patient's vascular system via a catheter venous site. It is intennded for use on patients who require fluid/medication.
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.
Product codes
80 FPA, FPA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Victus I.V. Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BBraun/McGaw IV Administration Sets (Pre-Amendment, and as modified by K921860 and K93265)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ICU Medical, Inc. standard or custom Clave® IV systems (K964435), ICU Medical, Inc. Clave® Connector (K915571; K941190; and K970855)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Ko30246
| Submitted by: | Ileana Yanes
Victus, Inc.
4918 S.W. 74 Court
Miami, FL 33155
Tel: (305) 663 - 2129 ext. 102
Fax: (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 §880.5440
ProCode 80 FPAIntra Vascular Administration Set | Regulation Number | Classification Name | 21 C.F.R §880.5440
ProCode 80 FPA | Intra Vascular Administration Set |
| Regulation Number | Classification Name | | | | |
| 21 C.F.R §880.5440
ProCode 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), and
ICU Medical, Inc. Clave® Connector (K915571; K941190; and K970855). | | | | |
| Modifications | There are no modifications to the device design that affect safety and
effectiveness of the Victus I.V. Administration Sets. | | | | |
| Device Description | 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. | | | | |
| Intended Use | The Victus I.V. Administration Sets provide a sterile fluid path for the
intravenous administration of sterile intravenous fluid and/or intravenous
medications from and I.V. container to a patient's vascular system via a
catheter venous site. It is intennded for use on patients who require
fluid/medication. | | | | |
| Technological
characteristics | The Victus I.V. Administration Sets have the same technological
characteristics as the legally marketed predicate BBraun McGaw and ICU
Clave® IV Administrations Sets. | | | | |
| Testing | The Victus I.V. Administration Sets have undergone performance and
safety testing to verify mechanical properties and biocompatibility using
FDA recognised standards. | | | | |
FEB 2 6 2003
1
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.
2
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
3
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_
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