(15 days)
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No
The summary describes a physical medical device (extension sets) for fluid delivery and does not mention any software, algorithms, or AI/ML related terms.
No.
The device is an extension set for infusion systems, primarily used for fluid and medication delivery, and does not inherently treat or cure any medical condition on its own.
No
The device, "Medegen Pressure Rated Extension Sets," is described as being used for the delivery of fluids, medications, blood, and blood products, and for adding medication to a primary line. This clearly indicates a therapeutic or delivery function, not a diagnostic one.
No
The device description clearly indicates a physical product ("Extension Sets") used for fluid delivery, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the delivery of fluids, medications, blood, and blood products through infusion systems. This is a therapeutic or delivery function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to obtain information about a patient's health, which is the core definition of an IVD.
- No Mention of Diagnostic Tests: The description focuses on the physical function of extending an infusion line and allowing needleless medication addition, not on performing any kind of diagnostic test.
Therefore, the Medegen Pressure Rated Extension Sets are medical devices used for infusion therapy, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.
Product codes
FPA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional healthcare environment, including healthcare facilities, home care and medical transport
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in black. The bird is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medegen, Incorporated C/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street NW Buffalo, Minnesota 55313
K083472 Re:
Trade/Device Name: Pressure Rated Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 18, 2008 Received: November 24, 2008
Dear Mr. Job:
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.
DEC 0 9 2008
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.
1
Page 2 - Mr. Job
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Siyita Y. Michie Oms
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Extension Set
Indications for Use:
The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.
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)
Charles L. Cox for ADW
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Section 3-2
510(k) Number: K083472