(156 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of an insulin infusion set, with no mention of AI or ML capabilities.
Yes
The device is an infusion set used with insulin pumps for continuous subcutaneous insulin infusion, which is a therapeutic treatment for diabetes.
No
This device is an infusion set designed to deliver insulin, not to diagnose a condition. It is a delivery mechanism, not a diagnostic tool.
No
The device description clearly details physical components like cannulas, tubing sets, connectors, and adhesive tape, indicating it is a hardware medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "continuous subcutaneous insulin infusion by patients or caregivers in the home environment." This describes a device used for delivering medication directly into the body, not for testing samples outside of the body to diagnose or monitor a condition.
- Device Description: The description details components like cannulas, tubing sets, and connectors designed for subcutaneous infusion. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and functional aspects of the infusion set, such as water ingress, dry out time, and air flow through the membrane. These are relevant to the safe and effective delivery of insulin, not to the analytical performance of an IVD.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
All of the Subcutaneous Insulin Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. Each set design has two main components provided for each device. The first is a subcutaneous indwelling Cannula component and the second is a tubing set component. For all sets, the connection of the indwelling cannula to the tubing set is made using a proprietary plastic "click-lock" connector system that enables the disconnection.
The Cannula component has an adhesive backed fixation tape that is attached directly to the patient's skin over the injection site. The cannula is sometimes provided separately from, and sometimes provided pre-attached to the tubinq, but in all cases is able to be detached from the tubing to temporarily discontinue the infusion or to replace the cannula independent of the tubing. Some of the cannulas are stainless steel needles and others are soft catheters that are inserted with stainless steel insertion needles that are then removed and discarded. All except the Mio® are manually inserted into the subcutaneous tissue. The Mio® is provided integrated in an automated inserter.
The second main component of the set is the tubing set. The infusion set tubing for all sets, except for the QuickSet, are comprised of a co-extruded tube with a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient that punctures and penetrates a septum in the cannula connector, creating an aseptic fluid path to the user and that enables the connection and disconnection. The QuickSet tubing connects and disconnects with a snap on connection to the cannula component. The sets are offered in different lengths of tubing. As these sets are specifically designed only to be used with the commercially available MiniMed Paradigm Insulin Infusion pumps which use a MiniMed Paradigm medication reservoir with a proprietary pump reservoir connection, all of these sets terminate at the proximal end with the P-Cap connector. The P-Cap connector has a stainless steel needle that punctures and penetrates the insulin cartridge, creating an aseptic fluid path to the user. The P-Cap also attaches to the pump housing creating a water tight interface between the pump housing and the P-Cap, precluding water ingress into the pump through the cartridge reservoir chamber. Once sealed onto the pump, the hydrophobic membrane in the P-Cap enables pressure equalization between the inside of the pump (external to the drug reservoir) and the external environment under all ambient pressure conditions. This venting mechanism is designed to allow equalization of a pressure differential created by an altitude change between sea level and 10,000 feet air within 10 minutes, will withstand 8 feet of water for 30 minutes, and have a dry out time of 10 minutes or less.
All of the subject sets are identical to the predicate sets in design, materials, manufacture, user interface, labeling, indications for use and intended use except for the material of the P-Cap Membrane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients or caregivers in the home environment.
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)
The following verification testing was performed to confirm proper function of the P-Cap. All samples passed the tests:
- Water Ingress and Dry out Time Test: The P-Cap components were tested for leakage to ensure they provided an effective barrier to the transmission of moisture into the pump cartridge. They were attached to a sealed pump cartridge chamber and subjected to pressure equal to submersion in 8 feet of water for 30 minutes. Then the cartridge chamber was checked for the presence of any moisture. The wet Components were then tested to ensure that they dried out within 10 minutes.
- Dry and Wet Flow Test: Air was passed through the membrane at a constant pressure and the flow through the membrane is measure to ensure that they enabled a minimum of 5 SCCM flow which had been determined as the minimum air flow which will allow equalization of the pressure to ambient in the cartridge chamber. The device was tested both when dry and when wet to simulate if insulin leaked into the connector during filling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011071, K041545, K002138, K032854
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design featuring a series of overlapping human profiles, creating a sense of unity and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2016
Unomedical A/S Ms. Cindie Vandfeldt Regulatory Affairs Specialist Aaholmvej 1-3, Osted Roskilde, DK-4320 DENMARK
Re: K160648 Trade/Device Name: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 28, 2016 Received: June 30, 2016
Dear Ms. Vandfeldt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160648
Device Name
MiniMed Quick-Set®; MiniMed Sure-T®; MiniMed Silhouette®; MiniMed Mio®
Indications for Use (Describe)
These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
"510(K) SUMMARY"
Submitted by/Contact Person: John M. Lindskog
General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
- 45 46 42 78 10 (CET 0800-1700) Telephone:
Fax:
E-mail: JML@unomedical.com Date Prepared: February 20, 2016
- 1.0 Trade/Proprietary Names:
- MiniMed Quick-Set® 1.1
- 1.2 MiniMed Sure-T®
- MiniMed Silhouette® 1.3
- 1.4 MiniMed Mio®
- 2.0 Subcutaneous Insulin Infusion Set Common/Usual Name
- 3.0 Classification Name: Intravascular Administration Set
Classification: Class: II Panel: 80 Product Code: FPA Cite: 21 CFR 880.5440
4.0 Purpose of Submission
To market sets in which the membrane material of the proprietary Medtronic P-Cap Connector was upgraded to enhance the ability of the membrane to remain gas permeable and retain venting capability when wet.
5.0 Substantial Equivalence
The subject devices are substantially equivalent to the Subcutaneous Insulin Infusion Sets cleared under the following 510(k)s:
- K011071- Medtronic Quick-Set® Paradigm® Subcutaneous 5.1 Insulin Infusion Set
- K041545 Contact Detach (Marketed as Medtronic Sure-T® 5.2 Paradigm® Subcutaneous Insulin Infusion Set)
- 5.3 K002138 Medtronic Silhouette® Paradigm® Subcutaneous Insulin Infusion Set
- 5.4 K032854 - Unomedical Monica Infusion Set - (Marketed as Medtronic Mio® Subcutaneous Infusion Insulin Set)
4
6.0 Device Description
General Description 6.1
All of the Subcutaneous Insulin Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. Each set design has two main components provided for each device. The first is a subcutaneous indwelling Cannula component and the second is a tubing set component. For all sets, the connection of the indwelling cannula to the tubing set is made using a proprietary plastic "click-lock" connector system that enables the disconnection.
The Cannula component has an adhesive backed fixation tape that is attached directly to the patient's skin over the injection site. The cannula is sometimes provided separately from, and sometimes provided pre-attached to the tubinq, but in all cases is able to be detached from the tubing to temporarily discontinue the infusion or to replace the cannula independent of the tubing. Some of the cannulas are stainless steel needles and others are soft catheters that are inserted with stainless steel insertion needles that are then removed and discarded. All except the Mio® are manually inserted into the subcutaneous tissue. The Mio® is provided integrated in an automated inserter.
The second main component of the set is the tubing set. The infusion set tubing for all sets, except for the QuickSet, are comprised of a co-extruded tube with a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient that punctures and penetrates a septum in the cannula connector, creating an aseptic fluid path to the user and that enables the connection and disconnection. The QuickSet tubing connects and disconnects with a snap on connection to the cannula component. The sets are offered in different lengths of tubing. As these sets are specifically designed only to be used with the commercially available MiniMed Paradigm Insulin Infusion pumps which use a MiniMed Paradigm medication reservoir with a proprietary pump reservoir connection, all of these sets terminate at the proximal end with the P-Cap connector. The P-Cap connector has a stainless steel needle that punctures and penetrates the insulin cartridge, creating an aseptic fluid path to the user. The P-Cap also attaches to the pump housing creating a water tight interface between the pump housing and the P-Cap, precluding water ingress into the pump through the cartridge reservoir chamber. Once sealed onto the pump, the hydrophobic membrane in the P-Cap enables pressure equalization between the inside of the pump (external to the drug reservoir) and the external environment under all ambient pressure conditions. This venting mechanism is designed to allow equalization of a pressure differential created by an altitude change between sea level and 10,000 feet air within 10 minutes, will withstand 8 feet of water for 30 minutes, and have a dry out time of 10 minutes or less.
All of the subject sets are identical to the predicate sets in design, materials, manufacture, user interface, labeling, indications for use and intended use
5
except for the material of the P-Cap Membrane.
- 7.0 Indication for Use
These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
These Indications for Use have been updated to more accurately reflect that these pumps have always been intended for use with Medtronic Insulin Infusion pumps.
- 8.0 Intended Use The Intended Use has not been modified.
- 9.0 Technological Characteristics
The overall technological characteristics of the Subcutaneous Infusion Sets have not changed. It performs all of the same functions in exactly the same manner as the predicate devices. The only change was to the material used for the gas permeable membrane that enables the pressure to equilibrate between the cartridge and the ambient environment, which was changed to ensure the flow of air is not adversely impacted when the membrane becomes wet. The use of a gas permeable membrane to enable equilibration of pressure between the cartridge and the ambient environment has always been a technological characteristic. This change of materials only ensures reliable performance is instances where the membrane become wet.
- 10.0 Performance and Safety Data
Three (3) different lots of POREX membrane (P/N D6014672-009) were used to produce three (3) different PQ lots of the PCAP assemblies (P/N D7004363-029). All samples were sterilized three (3) times using reqular production sterilization process, then subjected to several preconditioning steps, including aging.
The following verification testing was performed to confirm proper function of the P-Cap. All samples passed the tests.
Water Ingress and Dry out Time Test
The P-Cap components were tested for leakage to ensure they provided an effective barrier to the transmission of moisture into the pump cartridge. They were attached to a sealed pump cartridge chamber and subjected to pressure equal to submersion in 8 feet of water for 30 minutes. Then the cartridge chamber was checked for the presence of any moisture. The wet Components were then tested to ensure that they dried out within 10 minutes.
Dry and Wet Flow Test
Air was passed through the membrane at a constant pressure and the flow through the membrane is measure to ensure that they enabled a minimum
6
of 5 SCCM flow which had been determined as the minimum air flow which will allow equalization of the pressure to ambient in the cartridge chamber. The device was tested both when dry and when wet to simulate if insulin leaked into the connector during filling.
11.0 Conclusion
Unomedical A/S confirmed that the devices passed all testing and concluded that the Subcutaneous Infusion Sets are substantially equivalent to products the predicate devices.