(146 days)
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No
The summary describes a standard medical catheter and does not mention any AI or ML capabilities.
No
The device is a catheter used for administering medications and solutions, not for treating a disease or condition itself.
No
The device is described as a catheter for IV administration, delivering medications and solutions, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a "sterile, disposable, single lumen catheter," which is a physical hardware component.
Based on the provided information, the GuardianPICC™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "I.V. administration" of various substances directly into the body. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description reinforces its function as a catheter for I.V. administration.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVD devices are designed to perform tests on samples taken from the body.
The GuardianPICC™ is a medical device used for delivering substances into the body, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hurritional concernis inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.
Product codes
LJS
Device Description
The GuardianPICC™ is a sterile, disposable, single lumen catheter.
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
large central veins of the body
Indicated Patient Age Range
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Intended User / Care Setting
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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
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§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
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 AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2005
Ms. Sandra Winkler President Marian Medical, Incorporated 319 Westport Drive Louisville, Kentucky 40207
- 100
Re: K050542
Trade/Device Name: GuardianPICC™ Percutaneous Central Venous Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 14, 2005 Received: July 18, 2005
Dear Ms. Winkler:
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 Cc ntrols) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 w 1) vice 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 - Ms. Winkler
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 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
2
Indications for Use Statement:
510(K) Number: K-050542 GuardianPICC™ Percutaneous Central Venous Catheter Device Name:
Indications For Use:
The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hurritional concernis inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.
Prescription Use Yes (Part 2:1 CFR 801 Subpart) 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)
Shula H. Murphy, D.O., H.D. Watson 7/26/05
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K050542
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