(84 days)
Not Found
Not Found
No
The summary describes a standard infusion set and does not mention any AI or ML components or functionalities.
Yes
The device is used to administer insulin, a treatment for diabetes, making it a therapeutic device.
No
Explanation: The device, Ultraflex™, is described as an infusion set for administering insulin, which is a therapeutic function, not a diagnostic one. It is used to deliver a substance, not to detect or analyze a medical condition.
No
The device description clearly states it is a physical infusion set with a soft cannula and adhesive, designed to interface with insulin pumps. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of insulin. This is a therapeutic delivery of a substance into the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as an infusion set for delivering insulin. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver a treatment (insulin) directly into the body.
N/A
Intended Use / Indications for Use
Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
Product codes
FPA
Device Description
The Ultratlex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
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
patients with insulin dependent diabetes mellitus.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the modified Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the Ultraflex Infusion Set is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Ko33892
510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. and the same of the same of the same of the same of the same of the same and the season of the season of the season of the season of the season of the season of the season of Submitted by: 1) Submitter Disetronic Medical Systems AG name, address, Kirchbergstrasse 190, Postfach contact CH-3401 Burgdorf, Switzerland United States Contact Person: Scott Thiel Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250 317-521-3362 scott.thiel(@roche.com Date Prepared: December 12, 2003 Proprietary name: Ultraflex Infusion Set 2) Device name Common name: subcutaneous infusion set Classification name: intravascular administration sct Product Code: FPA We claim substantial equivalence to the current legally marketed version of the 3) Predicate same device. device and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co The Ultratlex is a disconnectable infusion set with soft cannula perpendicular 4) Device to the adhesive, for transfusion of insulin into the subcutaneous tissue. The Description unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus. Ultraflex™ is an infusion set for the subcutancous infusion of insulin 5) Intended use administered with microdosage insulin pumps.
MAR - 9 2004
Continued on next page
1
510(k) Summary, Continued
- Data demonstrating substantial equivalence
Testing of the modified Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the Ultraflex Infusion Set is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird, with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Disetronic Medical System AG C/O Mr. Scott Thiel Regulatory Affairs/Diabetes Specialist Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250
Re: K033892
Trade/Device Name: Ultraflex Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA. Dated: December 12, 2003 Received: December 16, 2003
Dear Mr. Thiel:
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.
3
Page 2 -Mr. Thiel
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 (301) 594-4618. 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 vours.
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
Indications for Use Statement
510(k) Number (if known): Device Name: Ultraflex Infusion Set
Indications for Use:
Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
William M. Burdick Sr
Arsene Nareau
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: A2252wmB