INTUITION INFUSION SETS

K061374 · Unomedical A/S · FPA · Jul 31, 2006 · General Hospital

Device Facts

• Record ID: K061374
• Device Name: INTUITION INFUSION SETS
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Device Story

The Intuition Subcutaneous Catheter Insertion and Infusion Set is a device used to deliver fluids from a reservoir into the subcutaneous tissue. It functions as an interface between an external fluid source and the patient's body. The device is intended for use in clinical or home settings to facilitate subcutaneous infusion. It is operated by patients or healthcare providers to establish a fluid pathway. The device design is consistent with established infusion set technology, ensuring compatibility with standard fluid reservoirs.

Clinical Evidence

Bench testing only. Verification testing confirmed the product meets its specifications.

Technological Characteristics

Subcutaneous catheter insertion and infusion set. Mechanical device for fluid administration. No electronic components, software, or energy source.

Indications for Use

Indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

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

• Paradigm Quick Set Infusion set (K011071)
• Unomedical Pureline Comfort Subcutaneous Infusion Set (K972135)
• Unomedical Inset™ Subcutaneous Infusion Sets (K032854)
• MiniMed Sil-serter™ (K010377)

Submission Summary (Full Text)

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- 8.0 510(K) SUMMARY Date Prepared: May 1, 2006
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8.1 SUMMARY OF SAFETY AND EFFECTIVENESS John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark

JUL 3 1 2006

- 8.2 Trade/Proprietary Name: Intuition Infusion Sets
- 8.3 Common/Usual Name Subcutaneous catheter Insertion and Infusion Set
- 8.4 Classification Name Intravascular Administration Set; Introducer, syringe needle
- 8.5 Classification Class: II Panel: 80 Product Code: FPA; KZH Cite: 21 CFR 880.5440; 880.6920
- 8.6 Substantial Equivalence The Intuition™ sets are substantially equivalent to the Paradigm Quick Set Infusion set (K011071), the Unomedical Pureline Comfort Subcutaneous Infusion Set (K972135), the Unomedical Inset™ Subcutaneous Infusion Sets (K032854) and the MiniMed Sil-serter™ (K010377).
- 8.7 Technological Characteristics The Intuition™ Subcutaneous Infusion Sets have the same technological characteristics of the current marketed products.
- 8.8 Performance Data Verification testing confirmed the product meets their specifications.
- 8.9 Conclusion Unomedical A/S concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

Mr. John M. Lindskog General Manager Unomedical A/S Infusion Devices AAholmvej 1-3. Osted Roskilde, Denmark 4000

Re: K061374

Trade/Device Name: INTUITION Subcutaneous Catheter Insertion and Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 1, 2006 Received: May 17, 2006

Dear Mr. Lindskog:

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 – Mr. Lindskog

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]. 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/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D 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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K061374
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## INDICATIONS FOR USE

510(k) Number:

INTUITION Subcutaneous Catheter Inserter and Infusion Set Device Name:

Indications For Use:

These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Whiting, M.D. for Hatcher, Witten & Zuccon
Sign-Off

on of Anesthesiology, General Hospital Jon Control, Dental Device

Number. 100154