(29 days)
These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.
The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.
The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Asante Conset™ and Asante Comfort™ Subcutaneous Infusion Sets:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Asante Conset™ and Asante Comfort™) | Outcome |
|---|---|---|---|
| Flow (Occlusion) – Asante Comfort™ | Minimum 40 mL/min at 1 bar pressure | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
| Flow (Occlusion) – Asante Conset™ | Minimum 80 mL/min at 1 bar pressure | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
| Leak Test | No leaks at 0.56 bar pressure for 30 seconds | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
| Pull Test (Tubing to Asante Adapter) | Minimum 15 N | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
Note: The document states "The following verification testing was performed on the modified sets" and then lists the criteria, followed by a conclusion that the new products are "substantially equivalent." It does not explicitly provide the numerical results for the modified sets, but the substantial equivalence claim implies that the acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the verification testing (Flow, Leak, and Pull tests). The data provenance is also not specified (country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The study involves performance testing of a medical device (infusion sets) against engineering specifications, not a clinical diagnostic assessment that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study involves objective engineering measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and not provided. This is a 510(k) submission for an infusion set, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (Flow, Leak, Pull) is established by the specified acceptance criteria (e.g., minimum flow rate, no leaks, minimum pull force). These are objective engineering specifications derived from the predicate devices' performance and industry standards.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this device.
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8.0 Revised 510(K) SUMMARY Date Prepared: April 10, 2012
APR 2 0 2012
8.1 SUMMARY OF SAFETY AND EFFECTIVENESS Submitted By: John M. Lindskog President Unomedical A/S Infusion Devices Aaholmvei 1-3. Osted DK-4320 lejre, Denmark Telephone: + 45 48 16 70 00 8.2 asante conset™ and asante comfort™ Trade/Proprietary Name: Subcutaneous Infusion Sets for use with Asante
- Subcutaneous Infusion Set 8.3 Common/Usual Name
- Classification Name Intravascular Administration Set 8.4
8.5 Predicate Devices
The asante comfort™ infusion sets for use with the Asante Pearl™ Pump are substantially equivalent to the current Unomedical Comfort™(K972135) and asante conset™ infusion sets for use with the Asante Pearl™ Pump are substantially equivalent to the Unomedical Inset™ (K032854) infusion sets.
Pearl™ infusion Pumps
8.6 General Description
- 8.6.1 Asante comfort™
The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.
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8.6.2 Asante conset™
The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.
- 8.7 Intended Use
8.7.1 Indication for Use
These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.
8.7.2 Intended use
These infusion sets are intended to be used only with the Asante Pearl™ Insulin Infusion Pump.
8.8 Technological Characteristics
The asante comfort™ and asante conset™ Subcutaneous Infusion Sets have all of the same technological characteristics as the Unomedical Comfort™ and Unomedical Inset™ Infusion Sets except that a proprietary connector, uniquely compatible with the Asante Pearl™ Insulin Infusion Pump has been substituted for the female luer connector on the pump end of the set.
8.9 Performance Data
The following verification testing was performed on the modified sets:
8.9.1 Flow (Occlusion) test
| 8.9.1.1 | asante comfort™ - minimum 40 mL/min at 1 bar pressure |
|---|---|
| 8.9.1.2 | asante conset™ - minimum 80 mL/min at 1 bar pressure |
| 8.9.2 Leak test | |
| 8.9.2.1 | No Leaks at 0.56 bar pressure for 30 seconds |
| 8.9.3 Pull test |
8.9.3 Pull test
Tubing to Asante Adapter - min 15 N 8.9.3.1
8.10 Conclusion
Unomedical A/S assessed the sterilization cycle, material biocompatibility, and connector function, flow, leak and pull test results to conclude that the new product lines are substantially equivalent to products currently legally marketed in the USA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES.
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John M. Lindskog President Unomedical a/s Infusion Devices Aaholmvej 1-3, Osted 4320 Lejre Denmark
APR 2 0 2012
Re: K120872
Trade/Device Name: Asante Conset™ and Asante Comfort™ Subcutaneous Infusion Set
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular Administration Set
Regulatory Class: II
Product Code: FPA
Dated: March 9, 2012
Received: March 22, 2012
Dear Mr. Lindskog:
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.
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Page 2- Mr. Lindskog -
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bag Anthony D. Watson, B.S., M.S., M.B.A. 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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INDICATIONS FOR USE
510(k) Number:
Device Name:
Asante Consetm and Asante Comfortm Subcutaneous Infusion Sets "for" the Asante Pearl Insulin Infusion Pump
Indications for Use:
These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4/19/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 120872
§ 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.