(55 days)
K921860, K93265
K921860,K93265
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
No.
The device is used for administering fluids/medication, which is a delivery mechanism, not a therapeutic action itself. The therapy comes from the medication, not the administration set.
No
The device is described as administering IV fluids/medication, which is a treatment or delivery function, not a diagnostic one.
No
The device description clearly states it is a physical device ("single use, sterile, non-pyrogenic devices") used to administer IV fluids, and the performance studies mention testing of "mechanical properties and biocompatibility." This indicates a hardware component.
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 describes a device used on the patient for therapeutic purposes (delivering fluids/medication), not a device used with patient samples (like blood, urine, etc.) to diagnose or monitor a condition.
- Device Description: The description reinforces this by stating the device is used "to administer IV fluids/medication to a patient's vascular system via gravity control." This is a delivery mechanism, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for administering substances into the body.
N/A
Intended Use / Indications for Use
To administer IV fluids/medication to the patient's vascular system.
Product codes
FPA
Device Description
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.
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 Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards, where applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BBraun-McGaw IV Administration Sets (Pre-Amendment, and as modified by K921860 and K93265)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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| Submitted by: | Ileana Yanes
Victus, Inc.
4918 S.W. 74 Court
Miami, Fl 33155
Tel: (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 modified
by 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-pyrogenic
devices used to administer IV fluids/medication to a patient's vascular
system via gravity control. | |
| Intended Use | To administer IV fluids/medication to the patient's vascular system. | |
| Technological
characteristics | The Victus IV Administration Sets have the same technological
characteristics as the legally marketed predicate IV Administrations Sets. | |
| Testing | The Victus Administration Sets have undergone performance and safety
testing to verify mechanical properties and biocompatibility using FDA
recognised standards, where applicable. | |
.
1
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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