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 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.

AI/ML Overview

The Cleo™ 90 Infusion Set is a medical device designed for subcutaneous infusion of medication, including insulin. The manufacturer conducted functional testing and a simulated clinical use evaluation to support its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Device functions according to specifications	In-vitro functional testing indicated the Cleo™ 90 Infusion Set functioned according to specifications.
Materials used are biocompatible	Biocompatibility testing confirmed the materials used in the device are biocompatible.
Needle protection feature operates as intended	A simulated clinical use evaluation concluded the needle protection feature operated as intended.
No needle sticks or injuries reported during use	No needle sticks or injuries were reported by participants in the simulated clinical use evaluation.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the exact sample size for the simulated clinical use evaluation. It mentions "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."
Data Provenance: The study was a simulated clinical use evaluation, implying it was conducted specifically for this device's validation. The country of origin is not explicitly stated, but the submission is to the US FDA, suggesting the study was likely conducted in the US or under US regulatory standards. It was a prospective evaluation tailored to assess the needle protection feature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of "experts" in the traditional sense for establishing ground truth regarding device performance during the simulated clinical use evaluation. Instead, the evaluation involved users of infusion sets (patients, parents/guardians, healthcare providers) who assessed the functionality and safety of the needle protection feature. Their reported experiences (or lack thereof, regarding needle sticks) served as the "ground truth" for the performance of the needle protection feature.
Their qualifications are described by their roles: "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."

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method in the context of multiple independent assessments being reconciled. The simulated clinical use evaluation appears to have collected direct feedback and observations from individual participants regarding the operation of the needle protection feature and the occurrence of any needle sticks or injuries. The report simply states that "no needle sticks or injuries were reported in the evaluation by the participants," suggesting a summation of individual reports rather than a formal adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The studies described are functional testing and a simulated clinical use evaluation focused on the device's performance, particularly its needle protection feature. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

The concept of "standalone" performance typically applies to AI algorithms. This device is a physical medical device (an infusion set), not an algorithm. Therefore, the concept of a standalone study in this context is not applicable. The functional testing assessed the device's inherent mechanical and material properties.

7. Type of Ground Truth Used:

For the functional testing, the ground truth was based on device specifications and biocompatibility standards.
For the simulated clinical use evaluation, the ground truth for the needle protection feature's performance and safety was established by user feedback and reported outcomes (no reported needle sticks or injuries). This could be considered a form of "user reported safety/effectiveness data."

8. Sample Size for the Training Set:

The document does not mention a "training set" as this device is a physical hardware product, not a machine learning model. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established:

As there was no "training set" for a machine learning model, this question is not applicable.

Summary

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K042172

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

Date	OCT 7 - 2004
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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

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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

Page 1 of __ 1 __

Regulation Number and Section

§ 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.