(108 days)
Not Found
No
The summary describes a subcutaneous infusion set, a mechanical device for fluid delivery, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as an "infusion set" used for "infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir." This primarily functions as a delivery mechanism for substances, rather than directly treating a disease or condition itself. Therapeutic devices are typically defined by their active role in providing treatment or managing medical conditions. While essential for certain therapies, it's a delivery system, not a therapeutic device on its own.
No
Explanation: The device is an infusion set for delivering fluids into the body, not for diagnosing medical conditions. Its intended use is described as "infusion of fluids into the body below the surface of the skin."
No
The device description explicitly states "Subcutaneous Infusion Sets," which are physical hardware components used for fluid delivery. The summary does not mention any software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The provided description clearly states the device is an "Infusion Set" used for "infusion of fluids into the body below the surface of the skin." This is a device used within the body for delivering substances, not for testing samples taken from the body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, based on the provided information, this device is a medical device used for infusion, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Product codes
FPA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin
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
Verification testing confirmed the product meets their specifications.
Key Metrics
Not Found
Predicate Device(s)
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.
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SEP - 1 2005
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8.0 510(K) SUMMARY Date Prepared: March 18, 2005
- SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 Submitted By: John M. Lindskog General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
- 8.2 Trade/Proprietary Name: Comfort™ and Inset™ Subcutaneous Infusion Sets For Use with the Abbot Pump
- 8.3 Common/Usual Name Subcutaneous Infusion Set
- 8.4 Classification Name Intravascular Administration Set
8.5 Substantial Equivalence
The Comfort™ and Inset™ Subcutaneous Infusion Sets for use with the Abbott Pump are substantially equivalent to the Unomedical Comfort™ (K972135) and Inset® (K032854) sets.
Technological Characteristics 8.6
The Comfort™ and Inset™ Subcutaneous Infusion Sets for use with the Abbott Pump have the same technological characteristics of the current marketed products.
8.7 Performance Data
Verification testing confirmed the product meets their specifications.
8.8 Conclusion
Unomedical A/S concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of a human figure. The figure is composed of three abstract profiles facing right, with flowing lines suggesting movement or energy. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John M. Lindskog General Manager Unomedical A/S, Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, DENMARK
Re: K051264
Trade/Device Name: Comfort TM and Inset™ Subcutaneous Infusiou Sets For Use with the Abbot Pump Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: August 4, 2005 Received: August 10, 2005
SEP - 1 2005
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.
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.
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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); 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/industry/support/index.html.
Sincerely yours.
Suette Y. Micham Davis
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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Indications for Use
Business Unit Infusion Devices
510(k) Number (if known): K051264
Device Name: COMFORT and INSET Subcutaneous Infusion Sets for Use With the Abbott Pump
Indications For Use: These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Prescription Use (Part 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)
image
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number _ Kus 1264
Page 1 of
Unomedical a/s Aholmvej 1-3, Osted 4000 Roskilde Denmark
Tel +45 4816 7000 Fax +45 4642 7865 E-mail buid@unomedical.com www.unomedical.com
CVR No. 64 15 33 15