(57 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML terms or functionalities.
No
The device is described as an infusion set for subcutaneous delivery of medication, not a device that applies therapy itself. Its purpose is to facilitate the administration of medication (like insulin), which is the therapeutic agent.
No
The device is an infusion set designed for subcutaneous delivery of medication, not for diagnosing conditions.
No
The device description clearly outlines physical components like an applicator, adhesive site, cannula, needle, extension tubing, and buckle. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Cleo 90 Infusion Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of medication (including insulin) into the human body. This is a therapeutic delivery method, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system for delivering medication into the subcutaneous tissue, involving a cannula, needle, and tubing. This aligns with a drug delivery device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body. The Cleo 90 Infusion Set operates in vivo (within the living body) to deliver medication.
N/A
Intended Use / Indications for 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.
Product codes
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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.
Key Metrics
No needle sticks or injuries were reported in the evaluation by the participants.
Predicate Device(s)
Not Found
Reference Device(s)
Unomedical Comfort Set, Disetronic® UltraflexTM Set, Medtronic MiniMed Sof-Set®
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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.
3
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
4
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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