(50 days)
Not Found
No
The summary describes a subcutaneous infusion set, a mechanical device for delivering medication. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on verification testing against specifications, not AI/ML model performance metrics.
Yes
The device is used for the "subcutaneous infusion of medication, including insulin," which directly treats a medical condition.
No
The device is described as being for "the subcutaneous infusion of medication," which indicates a therapeutic rather than a diagnostic purpose. It delivers medication, it does not identify or investigate medical conditions.
No
The summary describes a device for subcutaneous infusion of medication, which is a hardware-based function. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of medication. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- Mentions image processing, AI, DNN, or ML: These are often associated with advanced diagnostic techniques, and their absence further supports the conclusion.
- Input Imaging Modality: "Not Applicable" confirms it doesn't use imaging for diagnosis.
- Anatomical Site: "subcutaneous" refers to the location of infusion, not where a diagnostic sample is taken.
- Performance Studies: The summary mentions "Verification testing confirmed the product meets their specifications," which is typical for a medical device ensuring proper function, not for evaluating diagnostic accuracy.
- Predicate Devices: The predicate devices listed (infusion sets) are also therapeutic devices, not IVDs.
In summary, the device's function is to deliver medication into the body, which is a therapeutic action, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.
Product codes
80FPA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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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510(K) SUMMARY 8.0 Date Prepared: January 25 2007
APR - 4 2007
- SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvei 1-3, Osted DK-4000 Roskilde, Denmark
- Paradigm Quick-Set® Il and Quick-8.2 Trade/Proprietary Name: Set® II Subcutaneous Infusion Sets
- Subcutaneous Infusion Set 8.3 Common/Usual Name
Classification Name 8.4
Intravascular Administration Set
8.5 Substantial Equivalence
The Paradigm Quick-Set® II sets are substantially equivalent to the current Paradigm Quick-Set® (K011071) sets. The Quick-Set® II sets are substantially equivalent to the current Quick-Set® (K991759) sets.
- Classification 8.6
Class: II Panel: 80 Product Code: 80FPA Cite: 21 CFR 880.5440
Technological Characteristics 8.7
The Quick-Set® I Infusion Sets have the same technological characteristics as 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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.
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
APR - 4 2007
Re: K070430
Trade/Device Name: Paradigm Ouick-Set® II and Ouick-Set II® Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 25, 2007 Received: February 14, 2007
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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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Indications for Use
K070430 510(k) Number:
Paradigm Quick-Set® II and Quick-Set® II
Indications For Use:
Device Name:
These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.
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)
C
cion of Anesthesiology, General Hospital, ാഥാ Control, Dental Devices
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:.2(k) Number: K470434