(22 days)
The Subcutaneous Infusion Sets with Indwelling Catheters Indications for Use: are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.
Click-On Infusion Set Cover
The provided text is a 510(k) summary for a medical device called the "Click-On Infusion Set Cover." This document is focused on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would.
Based on the provided document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Met specifications | "Physical testing confirmed the covers met their specifications." |
- Note: The specific "specifications" for the Click-On Infusion Set Cover are not detailed in this document. The document states that the addition of the cover is "only cosmetic" and "does not change the technological characteristics of the current product." This suggests the specifications likely relate to basic physical integrity, fit, and compatibility with the existing infusion sets, rather than clinical performance metrics.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document only mentions "Physical testing."
- Data Provenance: Not specified, but given it's "physical testing" of the device itself, it would be laboratory-based and likely conducted by Unomedical A/S. It is a prospective test of the device, not a study involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable in the context of this device and report. The testing described is physical product testing, not a clinical study requiring expert-established ground truth for diagnosis/assessment.
4. Adjudication Method for the Test Set
- This question is not applicable. There is no ground truth adjudication process described for physical product testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers evaluate cases with and without AI assistance. The Click-On Infusion Set Cover is a physical accessory to an infusion set and not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- This question is not applicable in the traditional sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" here would be the physical specifications and functional requirements of the device (e.g., fit, durability, material integrity), which were assessed through "physical testing."
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.
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APR - 1 2004
8.0 510(K) SUMMARY Date Prepared: February 26, 2004
- SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
| 8.2 | Trade/Proprietary Name: Click-On Infusion Set Cover | |
|---|---|---|
| 8.3 | Common/Usual Name: | Infusion Set Cover |
| 8.4 | Classification Name: | Intravascular AdministrationSet Accessory |
8.5 Substantial Equivalence
The additional Click-on Covers Marketed with the Comfort Subcutaneous Infusion sets are substantially equivalent to the currently marketed Comfort Subcutaneous Infusion sets.
Intended Use 8 6
The Intended Use for the device has not changed. The Unomedical Comfort™ Subcutaneous Infusion Sets with Indwelling Catheters continue to be intended for the infusion and/or injection of fluids into the body below the surface of the skin. The addition of the Click-on Infusion set cover is only cosmetic.
Technological Characteristics 8.7
This modification does not change the technological characteristics of the current product.
Performance Data 8.8
Physical testing confirmed the covers met their specifications.
8.9 Conclusion
Unomedical A/S concludes based on the information presented that the modified product is 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Unomedical A/S Mr. John M. Lindskog General Manager Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
Re: K040633
Trade/Device Name: Click-on™ Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 5, 2004 Received: March 10, 2004
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 vour 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) 594-5618. 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 yours,
Clue Le
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
| 510(k) Number: | K040633 |
|---|---|
| Device Name: | Click-on™ |
The Subcutaneous Infusion Sets with Indwelling Catheters Indications for Use: are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Irene Lawrence for Adec 4/1/04
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
K 040633 510(k) Number ..
... . . . . . . . . . .
ﺳﮯ Prescription Use
or
Over-the-Counter Use __________
(Per 21 CFR 801.109)
§ 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.