(69 days)
Not Found
No
The summary describes a standard implantable port and catheter system for drug administration and blood sampling, with no mention of AI, ML, image processing, or any related technologies.
No.
The device facilitates the administration of drugs and fluids, but it does not directly treat a disease or medical condition.
No.
Explanation: The device is an implantable port and catheter system for administering drugs and fluids, and for blood sampling or transfusions, none of which are diagnostic functions.
No
The device description clearly states it is an "implantable port and catheter system," which are hardware components.
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 administration of drugs, parenteral nutrition, blood sampling, and transfusions directly into the patient's bloodstream. This is a therapeutic and access function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The device is described as an "implantable port and catheter system" for "safe, repeated access to the patient's bloodstream." This aligns with a device used for direct patient intervention and access, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes.
Therefore, the Aesculap Celsite®/Celsite® Concept™ Access Ports are a medical device used for patient access and administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The Celsite®/ Celsite® Concept™ Access Ports are an implantable port and catheter system which allows safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical testing results of the subject device showed to be similar in performance to the previously cleared Aesculap® Access Ports with similar indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K902401, K952548, K954297, K962230, K993024, K032557, K992697, K932840
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.
Not Found
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).
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.
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Kolo1424
Page 1 of 1
510(k) SUMMARY (as required by 21 CFR 807.92) в.
Celsite®/Celsite® Concept™ Access Ports May 3, 2006
JUL 3 1 2006
| COMPANY: | Aesculap®, Inc. |
|---|---|
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: | 2916714 |
- Lisa M. Boyle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
Celsite®/Celsite® Concept™ Access Ports TRADE NAME:
Port & Catheter, Implanted, Subcutaneous, Intravascular COMMON NAME:
CLASSIFICATION NAME: Port & Catheter, Implanted, Subcutaneous, Intravascular 880.5965 REGULATION NUMBER: LJT PRODUCT CODE:
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Celsite®/ Celsite® Concept™ Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deitec Inc., PORT-A-CATH® II (K032557, K992697, K932840).
DEVICE DESCRIPTION
The Celsite®/ Celsite® Concept™ Access Ports are an implantable port and catheter system which allows safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
INDICATIONS FOR USE
The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The Aesculap Celsite®/ Celsite® Concept™ Access Ports is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing results of the subject device showed to be similar in performance to the previously cleared Aesculap® Access Ports with similar indications.
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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 stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
Ms. Lisa Boyle Regulatory Affairs Specialist Aesculap®, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K061424
Trade/Device Name: Celsite®/Cclsite® Concept™ Access Ports Regulation Number: 880.5965 Regulation Name: Subcutaneous. Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: Mav 22, 2006 Received: May23, 2006
Dear Ms. Boyle:
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 Hi (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 - Ms. Boyle
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.
Chi-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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Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number:_j/061424
Device Name:
Indications for Use:
The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.
| Prescription Use | X | and/or Over-the-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
Ad. D. Peranio 7/31/2006
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