CLEO 90 INFUSION SET

K042172 · Smiths Medical MD, Inc. · FPA · Oct 7, 2004 · General Hospital

Device Facts

• Record ID: K042172
• Device Name: CLEO 90 INFUSION SET
• Applicant: Smiths Medical MD, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cleo 90 Infusion Set is designed for subcutaneous infusion of medication (including insulin) only. The set is not intended for intravenous (IV) infusion or to infuse blood or blood products.

Device Story

Cleo 90 Infusion Set; subcutaneous infusion device for medication/insulin delivery. Components: applicator with adhesive site, cannula, needle, and separate extension tubing with buckle. Operation: user places needle/cannula into subcutaneous tissue; applicator automatically retracts needle into housing post-insertion to prevent sharps injury; buckle attaches extension tubing to site for infusion. Used in clinical or home settings by patients, caregivers, or healthcare providers. Benefits: provides secure, protected needle insertion for continuous subcutaneous medication delivery.

Clinical Evidence

No human clinical studies performed. Safety and effectiveness of the needle protection feature evaluated via simulated clinical use study involving patients, caregivers, and healthcare providers per FDA guidance. Results confirmed needle protection operated as intended with zero needle sticks or injuries reported. Bench testing confirmed device functionality and material biocompatibility.

Technological Characteristics

Subcutaneous infusion set with flexible cannula and needle. Features automatic needle retraction mechanism for sharps injury prevention. Includes adhesive patch for site securement and standard luer connection. Materials are biocompatible. Non-electronic, mechanical device.

Indications for Use

Indicated for subcutaneous infusion of medication, including insulin, in patients requiring such therapy. Not for IV use or blood/blood product infusion.

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

• Unomedical Comfort Set
• Disetronic Ultraflex Set
• Medtronic MiniMed Sof-Set

Submission Summary (Full Text)

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K042172

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Cleo™ 90 Infusion Set August 10, 2004

| Date | OCT 7 - 2004 |
|------|--------------|
|------|--------------|

# GENERAL INFORMATION

Applicant's Name and Address: Smiths Medical MD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 Contact Person: David H. Short Director Regulatory and Clinical Affairs Common/Usual Name: Subcutaneous Infusion Set Proprietary Name: Cleo™ 90 Infusion Set Equivalence Device Comparison: Unomedical Comfort Set, Disetronic® UltraflexTM Set; and the Medtronic MiniMed Sof-Set®

### II. DEVICE DESCRIPTION

The Cleo™ 90 Infusion Set consists of an applicator that contains an adhesive site with cannula and needle and separate extension tubing set with buckle. The infusion set has a standard luer connection. After insertion of the needle and cannula into the subcutaneous tissue, the applicator automatically retracts the needle into the applicator housing providing needle protection. The infusion set buckle attaches to the site allowing infusion of medication through the extension tubing.

### III. INTENDED USE OF THE DEVICE

The Cleo 90 Infusion Set is designed for subcutaneous infusion of medication (including insulin) only. The set is not intended for intravenous (IV) infusion or to infuse blood or blood products.

### IV. DEVICE COMPARISON

The Cleo 90 Infusion Set was compared to the following similar products: Unomedical, Comfort Set; Disetronic®, Ultraflex™ Set; and the Medtronic MiniMed, Sof-Set®. The Cleo 90 Infusion Set is substantially equivalent to these products by having the identical indication for use, a site with flexible oatheter and needle for insertion into the subcutaneous tissue and a separate extension tubing with buckle for attachment to the site. The Unomedical Comfort Set utilizes a rigid needle rather than a flexible cannula. All sets have an addesive patch that secures the catheter or needle to the skin following placement. The

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Cleo™ 90 Infusion Set August 10, 2004

Unomedical Comfort Set and Medtronic MiniMed Sof-Set have detachable extension sets, where as the Disetronic, Ultraflex Set has an integral extension set. For those devices with a flexible cannula, the needle is removed prior to infusion. The Cleo 90 Infusion Set incorporates a needle protection feature that retracts the needle automatically following insertion of the needle and cannula. The needle may also be retracted automatically by the user as well.

#### V. SUMMARY OF STUDIES

### A. Functional Testing

In-vitro functional testing of the Cleo 90 Infusion Set was conducted. Biocompatibility testing was performed on the materials of the Cleo 90 Infusion Set.

### B. Clinical Studies

Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the Cleo 90 Infusion Set.

To evaluate the safety and effectiveness of the needle protection feature of the Cleo 90 Infusion Set, a simulated clinical use evaluation was conducted in accordance with the "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA", December 31, 2002. Individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set, parents or guardians of patients who insert an infusion set on behalf of a patient, and health care providers who instruct patients and caregivers on the use of infusion pumps and infusion sets. This evaluation determined the needle protection feature operated as intended and no needle sticks or injuries were reported in the evaluation by the participants.

### C. Conclusions Drawn from the Studies

The results of the testing conducted indicate the Cleo 90 Infusion Set functioned according to specifications and the materials used in the device are biocompatible. Based on these results, the product is considered acceptable for human use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

Mr. David H. Short Director Regulatory and Clinical Affairs Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re: K042172

Trade/Device Name: Cleo 90 Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 10, 2004 Received: August 11, 2004

Dear Mr. Short:

We have reviewed your Section 510(k) premarket notification of intent to market the device we fire 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 the readeral 1 600 may, therefore, market the device, subject to the general appental 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 (1 vir 1) vice 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. Short

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. or the Not of myly 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/dsma/dsmamain.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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K04272

# Indications for Use

510(k) Number (if known): K042172

Cleo 90 Infusion Set Device Name:

Indications For Use:

The Cleo 90 Infusion Set is designed for subcutaneous infusion of medication (including insulin) only. The set is not intended for incation (Inforacing in or to infuse blood or blood products

Prescription Use _ X (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)

Nicola Hubbard for Anthony Watson

ision Sic ivision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number Ko421 72

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