(28 days)
Not Found
None
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use describes a standard IV access system.
Yes
The device is used for repeated I.V. access for injection and drug therapy, which are therapeutic interventions.
No
The device, the Celsite® System, is described as providing repeated I.V. access for injections, drug therapy, and blood sampling. This indicates it is a therapeutic or access device, not one that identifies or characterizes a disease or condition.
No
The provided text describes a "Celsite® System" intended for repeated I.V. access, injection, drug therapy, and blood sampling. This functionality strongly suggests a physical device (like an implanted port or catheter system) rather than a software-only solution. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, the Celsite® System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for repeated I.V. access for injection, drug therapy, and/or blood sampling. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes in vivo (within the living body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are performed in vitro (outside the living body).
The Celsite® System's function is to provide access to the bloodstream within the patient, which is an in vivo application, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Celsite® System is recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.
Product codes
LJT
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
0
Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2000
Ms. Valerie A. Lewis Requlatory Affairs Specialist B. Braun & McGaw B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, PA 18103
Re: K994111 Trade Name: Celsite® Models ST401L and ST405L Class: Unclassified Product Code: LJT Dated: December 17, 1999 Received: December 20, 1999
Dear Ms. Lewis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
1
Page 2 - Ms. Lewis
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaj.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K994111
Device Name: Celsite® Dual Venous Access System
Indications For Use:
The Celsite® System is recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.
(Please Do Not Write Below This Line – Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Valarie Curnock
(Division Sign Off)
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