VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072

K030246 · Victus, Inc. · FPA · Feb 26, 2003 · General Hospital

Device Facts

• Record ID: K030246
• Device Name: VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072
• Applicant: Victus, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Victus I.V. Administration Sets are single-use, sterile, non-pyrogenic devices; facilitate delivery of IV fluids/medications from container to patient vascular system via gravity control; incorporate needle-free system to mitigate needle-stick injury risk; used in clinical settings; operated by healthcare professionals; provides sterile fluid path; benefits patient by enabling controlled fluid/medication delivery while enhancing safety for clinicians.

Clinical Evidence

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

Technological Characteristics

Single-use, sterile, non-pyrogenic IV administration set; gravity-fed fluid path; needle-free connector interface; materials verified via biocompatibility testing per FDA-recognized standards.

Indications for Use

Indicated for patients requiring intravenous administration of sterile fluids or medications via a needle-free system designed to reduce needle-stick injuries.

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 (Pre-Amendment, K921860, K93265)
• ICU Medical, Inc. standard or custom Clave® IV systems (K964435)
• ICU Medical, Inc. Clave® Connector (K915571, K941190, K970855)

Submission Summary (Full Text)

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Ko30246

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| Submitted by: | Ileana Yanes<br>Victus, Inc.<br>4918 S.W. 74 Court<br>Miami, FL 33155<br>Tel: (305) 663 - 2129 ext. 102<br>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 | <table><tr><th>Regulation Number</th><th>Classification Name</th></tr><tr><td>21 C.F.R §880.5440<br/>ProCode 80 FPA</td><td>Intra Vascular Administration Set</td></tr></table> | Regulation Number | Classification Name | 21 C.F.R §880.5440<br>ProCode 80 FPA | Intra Vascular Administration Set |
| Regulation Number | Classification Name | | | | |
| 21 C.F.R §880.5440<br>ProCode 80 FPA | Intra Vascular Administration Set | | | | |
| Predicate Devices | BBraun/McGaw IV Administration Sets<br>(Pre-Amendment, and as modified by K921860 and K93265),<br>ICU Medical, Inc. standard or custom Clave® IV systems (K964435), and<br>ICU Medical, Inc. Clave® Connector (K915571; K941190; and K970855). | | | | |
| Modifications | There are no modifications to the device design that affect safety and<br>effectiveness of the Victus I.V. Administration Sets. | | | | |
| Device Description | The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic<br>devices used to administer I.V. fluids/medication to a patient's vascular<br>system via gravity control. | | | | |
| Intended Use | The Victus I.V. Administration Sets provide a sterile fluid path for the<br>intravenous administration of sterile intravenous fluid and/or intravenous<br>medications from and I.V. container to a patient's vascular system via a<br>catheter venous site. It is intennded for use on patients who require<br>fluid/medication. | | | | |
| Technological<br>characteristics | The Victus I.V. Administration Sets have the same technological<br>characteristics as the legally marketed predicate BBraun McGaw and ICU<br>Clave® IV Administrations Sets. | | | | |
| Testing | The Victus I.V. Administration Sets have undergone performance and<br>safety testing to verify mechanical properties and biocompatibility using<br>FDA recognised standards. | | | | |

FEB 2 6 2003

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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.

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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 (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 [phone]. 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 [phone] or [phone] 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

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K030246

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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