(108 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.
Comfort™ and Inset™ Subcutaneous Infusion Sets For Use with the Abbot Pump
Based on the provided documents, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product meets its specifications | Verification testing confirmed the product meets its specifications. |
| Substantial Equivalence to Predicate Devices (Unomedical Comfort K972135 and Inset K032854) | The new products are substantially equivalent to products currently legally marketed in the USA. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Verification testing confirmed the product meets their specifications." However, it does not specify the sample size used for this testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).
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. The submission is for a medical device (subcutaneous infusion set), not an AI/imaging device requiring expert ground truth establishment in the typical sense. The "ground truth" here would be the device's adherence to its mechanical/performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or performance assessment, which is not the primary focus for a physical 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
An MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools or imaging devices, not for a subcutaneous infusion set.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device (infusion set), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for the performance data would be the engineering specifications and functional requirements of the infusion set. The verification testing would have assessed these against objective measurements (e.g., fluid flow rate, connection integrity, material strength, biocompatibility, etc.). The document does not explicitly state the specific types of ground truth used, but it implies adherence to design and performance specifications.
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical medical device like an infusion set. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
{0}------------------------------------------------
SEP - 1 2005
page 1 of 1
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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the text "K051264" written in a handwritten style above the word "Unomedica" in a bold, sans-serif font. The handwritten text appears to be a code or identifier, while "Unomedica" likely represents a company or brand name. The contrast between the two fonts creates a visual hierarchy, with the handwritten text appearing more informal and the company name more professional.
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
§ 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.