(75 days)
These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Not Found
The provided text is a 510(k) summary for the Unomedical A/S Intuition Infusion Sets. It discusses the device's substantial equivalence to existing products and verifies that it meets specifications. However, the document does not contain the detailed information necessary to answer many of the specific questions asked about acceptance criteria and a study design, especially concerning AI/ML aspects.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product Specifications | "Verification testing confirmed the product meets their specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only states "Verification testing confirmed the product meets their specifications" but gives no details about the size or nature of the test set, nor its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. This type of device (infusion set) does not typically involve expert review for ground truth in the way medical imaging AI does. The "ground truth" for an infusion set would likely be functional performance metrics, material properties, and manufacturing tolerances, all assessed through engineering and quality control tests, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here for an infusion set.
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
No, an MRMC comparative effectiveness study was not done. This document describes an infusion set, which is a physical medical device, not an AI/ML algorithm used to assist human readers (e.g., in medical image interpretation). Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical infusion set, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for performance was product specifications. For an infusion set, this would typically involve various engineering, material science, and functional tests (e.g., fluid flow rates, strength of materials, sterility, biocompatibility, force required for insertion, leakage rates). It would not be expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic or AI devices.
8. The sample size for the training set
This information is not provided and is not applicable. This is a physical device, and the concept of a "training set" is relevant for AI/ML algorithms, not for the verification of a medical infusion set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as point 8.
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- 8.0 510(K) SUMMARY Date Prepared: May 1, 2006
K\$\alpha$61374
8.1 SUMMARY OF SAFETY AND EFFECTIVENESS John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
JUL 3 1 2006
- 8.2 Trade/Proprietary Name: Intuition Infusion Sets
- 8.3 Common/Usual Name Subcutaneous catheter Insertion and Infusion Set
- 8.4 Classification Name Intravascular Administration Set; Introducer, syringe needle
- 8.5 Classification Class: II Panel: 80 Product Code: FPA; KZH Cite: 21 CFR 880.5440; 880.6920
- 8.6 Substantial Equivalence The Intuition™ sets are substantially equivalent to the Paradigm Quick Set Infusion set (K011071), the Unomedical Pureline Comfort Subcutaneous Infusion Set (K972135), the Unomedical Inset™ Subcutaneous Infusion Sets (K032854) and the MiniMed Sil-serter™ (K010377).
- 8.7 Technological Characteristics The Intuition™ Subcutaneous Infusion Sets have the same technological characteristics of the current marketed products.
- 8.8 Performance Data Verification testing confirmed the product meets their specifications.
- 8.9 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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human profile, with three curved lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
Mr. John M. Lindskog General Manager Unomedical A/S Infusion Devices AAholmvej 1-3. Osted Roskilde, Denmark 4000
Re: K061374
Trade/Device Name: INTUITION Subcutaneous Catheter Insertion and Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 1, 2006 Received: May 17, 2006
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.
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
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K061374
1 of
INDICATIONS FOR USE
510(k) Number:
INTUITION Subcutaneous Catheter Inserter and Infusion Set Device Name:
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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Whiting, M.D. for Hatcher, Witten & Zuccon
Sign-Off
on of Anesthesiology, General Hospital Jon Control, Dental Device
Number. 100154
§ 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.