(100 days)
No
The device description and performance studies focus on mechanical aspects and fluid delivery, with no mention of AI/ML terms or functionalities.
No.
The device administers fluids/medication but does not directly treat a condition or disease.
No
This device is for administering IV fluids/medication, not for diagnosing conditions.
No
The device description clearly outlines physical components like sets, filters, valves, and connectors, and the performance studies mention mechanical testing, indicating it is a hardware device.
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 a patient's vascular system." This describes a device used for treatment or delivery of substances into the body, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a system for delivering fluids and filtering them during administration. It focuses on the physical process of delivery and safety features like needle-free access. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
In summary, the Victus I.V. Administration and Extension Sets are devices used for the delivery of fluids into the body, which falls under the category of medical devices used for treatment or administration, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
To administer IV fluids/medication to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
80 FPA
Device Description
The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system via a catheter venous site
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 IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance.
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.
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.
K832952, K061115, K002689, K952810, K884370, K894954, K021395, K896333, K011336, K964435, K970855, K052722, K932165, K896292, K973107
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
| 5. 510(K) Summary or 510(K) Statement | |||||
|---|---|---|---|---|---|
| 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: | October 13, 2009 | ||||
| Device Name | (1) Victus Intravascular (I. V.) Administration Sets (with 0.22 µ Filter and/or Flow Regulator) and (2) Victus I.V. Extension Sets (with 0.22 µ Filter and/or Flow Regulator) | ||||
| Common Name | Intravascular Administration Set | ||||
| Classification Name | Regulation NumberClassification Name21 C.F.R §880.5440 | ||||
| ProCode 80 FPAIntravascular Administration Set | Regulation Number | Classification Name | 21 C.F.R §880.5440 | ||
| ProCode 80 FPA | Intravascular Administration Set | ||||
| Regulation Number | Classification Name | ||||
| 21 C.F.R §880.5440 | |||||
| ProCode 80 FPA | Intravascular Administration Set | ||||
| Predicate Devices | Victus IV Administration Sets (K023469; K030246) | ||||
| Millipore/NP Medical IVEX Filter (K832952)* | |||||
| GVS SPA Flow Regulator (K061115)* | |||||
| Halkey-Roberts (Robertsite Needleless Injection Site: (K002689)* | |||||
| Leventon S.A. Administration Set and Extension Set with Flow Regulator with and without "Y" Connector or Needleless Access Connector (K952810) | |||||
| Churchill Medical Systems Extension Set with 0.22μ & 1.2μ filter (K884370), (K894954), and (K021395), and Administration Set (K896333) and (K011336) | |||||
| ICU Medical, Inc. Administration Set and Extension Set with Needle-Free straight connector and Needle-Free Injection Site (K964435) and (K970855) | |||||
| Hospira, Inc. Microbore Extension Set (K052722) | |||||
| McGAW, Inc. (B.Braun Medical) Administration Set (K932165) | |||||
| Kendall McGAW Laboratories, Inc. Administration Set with 1.2µ filter (K896292) | |||||
| AMSINO INTL., INC. Administration Set with Flow regulator (K973107) | |||||
| *Note: Components manufactured by these companies will be used in the manufacture of the VICTUS I.V. Administration Sets and VICTUS I.V. Extension Sets. |
JAN 2 7 2010
•
and the state of the state Carlos Concession
1
tended
This submission provides information on the following chances and additions to its IV Administration Set product line:
(1) substitutes a Flow Regulator (GVS SPA; K061115) for the Roller Clamp component in this system for specific applications (Note: The Roller Clamp will continue to be used in some versions of this system);
(2) replaces the PVC tubing (non DEHP) with PVC tubing (non-DEHP) in a systems; and
(3) substitutes Halkey-Roberts Needle-Free connector for the CLAVE® connector: and
(4) adds a Filter (typically 0.22u) to some configurations of the IV Administration Set and Extension Sets; (other filter sizes such as 1.2u may be used); and
(5) adds check valve in some configurations.
In addition, the I. V. Extension Set (with Minibore tubing with/without Filter Flow Regulator, Needle-Free straight connector and Standard (latex free) or Needle-Free Injection Site) will be marketed as an accessory for use with other I. V. Administration Sets.
None of the additions/substitutions to the device design affect safety and effectiveness of the Victus IV Administration Sets and Extension Sets.
The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.
To administer IV fluids/medication to a patient's vascular system.
The device may include a needle-free valve injection site/connector which eliminates the use of needles to access the set during IV administration and aids in the prevention of needlestick injuries.
When included, the purpose of the filter is for filtering solution (I.V. Solution and/or Nutritional fluid) during intravascular administration.
2
The IV Extension Sets & IV Sets have the same technological characteristics As the legally marketed predicate Churchill Medical Systems Extension Sets with 0.22u and 1.2u filter (K884370), (K894954) and Administration Set (K896333) and (K011336), Hospira, Inc. Microbore Extension Set (K052722), Leventon S.A. Administration Set and Extension Set with Flow Regulator (K952810), McGAW, Inc. Administration Set with 1.2u filter (K932165), Kendall McGAW Laboratories, Inc. Administration Set with 1.2u filter (K896292), ICU Medical Extension Sets with Needle-Free straight connector (K964435) and (K970855) and AMSINO INTL, Inc. Administration Set with Flow Regulator (K973107). This system incorporates PVC tubing that does not contain DEHP. The Flow Regulator that will be incorporated will be supplied by GVS SPA and is cleared under K061115.
The Technological characteristics of the Victus Sets are substantiallyequivalent to the referenced predicates.
The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance.
Contract Manufacturer and Contract Sterilizer:
Plásticos y Materias Primas S.A. de C.V. (PyMPSA),
Juan de la Barrera No. 3609-2
Alamo Industrial 44700 Guadalajara, Jal. Mexico.
Establishment Registration Number: 9710643
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ileana Yanes Manager of Regulatory Affairs and Quality Assurance Victus, Incorporated 4918 Southwest 74th Court Miami, Florida 33155
JAN 2 7 2010
Re: K093271
Trade/Device Name: VICTUS Intravascular (IV) Administration Sets VICTUS Intravascular (IV) Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA
Dated: January 19, 2010
Received: January 21, 2010
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 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K093271
Device Name: YICTUS Intravascular (IV) Administration Sets and
VICTUS Intravascular (IV) Extension Sets
Indications for Use:
To administer IV fluids/medication to a patient's vascular system.
Prescription Use _ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles B
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K09327/
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