VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062

K023469 · Victus, Inc. · FPA · Dec 10, 2002 · General Hospital

Device Facts

• Record ID: K023469
• Device Name: VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
• Applicant: Victus, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To administer IV fluids/medication to the patient's vascular system.

Device Story

Victus IV Administration Sets are single-use, sterile, non-pyrogenic devices designed for gravity-controlled delivery of intravenous fluids or medications. The device connects a fluid source to a patient's vascular access site. It is intended for clinical use by healthcare professionals. The device functions as a conduit for fluid therapy, facilitating the administration of prescribed treatments to patients. No complex electronics, software, or automated processing are involved.

Clinical Evidence

Bench testing only. Performance and safety testing were conducted to verify mechanical properties and biocompatibility using FDA-recognized standards.

Technological Characteristics

Single-use, sterile, non-pyrogenic IV administration set. Gravity-fed fluid delivery system. Materials and design are equivalent to predicate devices. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring administration of IV fluids or medication into the vascular system.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BBraun-McGaw IV Administration Sets (K921860, K93265)

Submission Summary (Full Text)

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K023469

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| Submitted by: | Ileana Yanes<br>Victus, Inc.<br>4918 S.W. 74 Court<br>Miami, Fl 33155<br>Tel: [phone] ext 102.<br>Fax: [phone] | DEC 1 0 2002 |
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| 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<br>by K921860 and K93265) | |
| Modifications | There are no modifications to the device design that affect safety &<br>effectiveness of the Victus IV Administration Sets. | |
| Device Description | The Victus Administration Sets are single use, sterile, non-pyrogenic<br>devices used to administer IV fluids/medication to a patient's vascular<br>system via gravity control. | |
| Intended Use | To administer IV fluids/medication to the patient's vascular system. | |
| Technological<br>characteristics | The Victus IV Administration Sets have the same technological<br>characteristics as the legally marketed predicate IV Administrations Sets. | |
| Testing | The Victus Administration Sets have undergone performance and safety<br>testing to verify mechanical properties and biocompatibility using FDA<br>recognised 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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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