(73 days)
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Not Found
No
The summary describes a standard central venous access catheter and does not mention any AI or ML components or functionalities.
Yes
The device is used for the infusion of substances and withdrawal of blood samples, which are therapeutic interventions.
No
The device description indicates its use for long-term central venous access for procedures like infusions and blood withdrawal, not for diagnosing medical conditions.
No
The device description clearly identifies it as a physical catheter, which is a hardware component, not software.
Based on the provided information, the Medcomp H-Cath Central Venous Access Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device being used for direct access to the central venous system for infusion and blood withdrawal. This is a procedure performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description is of a catheter, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are typically used in laboratories or point-of-care settings to analyze samples. This device is clearly intended for direct patient care involving insertion into the circulatory system.
N/A
Intended Use / Indications for Use
The Medcomp H-Cath Central Venous Access Catheter is designed for long-term central venous access. It can be used for total parenters nutrition (TPN), infusion of I.V. liquids, blood, blood products and drugs. It can also be used for rep withdrawal of blood samples.
Product codes
INIS
Device Description
Medcomp H-Cath Triple Lumen Central Venous Access Catheter
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Central Venous
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)
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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
Not Found
§ 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
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design of three curved shapes that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1998
Ms. Jeanne M. Cush Technical Submissions Coordinator Medical Components, Incorporated 1499 Delp Drive Harleysville, Pennsylvania 19438
K983412 Re : Medcomp H-Cath Triple Lumen Central Venous Trade Name : Access Catheter Unclassified Regulatory Class : Product Code: Inis September 28, 1998 Dated: September 28, 1998 Received:
Dear Ms. Cush:
We have reviewed your Section 510(k) notification of intent to we have reviewed your boosed above and we have determined the market the device felly equivalent (for the indications for use stated in the enclosure) to devices marketed in interestate commerce prior to May 28, 1976, the enactment date of the Commerce proof ovendments, or to devices that have been Medical Device Amendically, with the provisions of the Federal Food, Drug, 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 Include requiremanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
into either class II If your device is classified (see above) (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be auffect to back us your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ rederal Negalvalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (SMP inspections, the Food and Drug Administration (PDA) will Failure to comply with the GMP verify such assumptions. regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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.
1
Page 2 - Ms. Cush
This letter will allow you to begin marketing your device as the FDA This letter will allow you to begin mailoung your maintenen. The FDA
described in your 510(k) premarket notification. The FDA described in your 510(k) premarker notificacion: - books of the same of across of substantial equivalence of your device of or your and marketed predicate device results in a crassission and the parket.
device and thus, permits your device to proceed to the market.
at you desire specific advice for your device on our labeling
If you desire app Box 801 and additionally 809.10 for in If you desire specific advice for your active of the or in
regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of ritro diagnostic devices ( 1) 594-4692. Additionally, for questions on
Compliance at (301) 594-4692. Additionally, for questions on Compliance at (301) 594-4692. Additionarity, 2004-2001
the promotion and advertising of your device, please not Also, please note the promotion and advertising on 594-4639.
the Office of Compliance at (301) 594-4639.
The Office of compliance at (301) 594-4639. the regulation entification" (21 CFR 807) . . Oteferences to Other general premarket notification" (21 CFR 807.97). "Other on your con information on your responsibilities and in the more and at its toll-free number (800) 638-204) or (301) 443-6597 at
at its toll-free number (800) 638-204) or (301) 443-6597 at . ol its toll-free number (800) 638-2041 of (301) 415-2011 11:41
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Director of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
2
1 Page 1 র্প্ত
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _Medcomp H-Cath Triple Lumen Central Venous Access Catheter
Indications for Use:
The Medcomp H-Cath Central Venous Access Catheter is designed for long-term The Medcomp H-Cath Central venusal for total parenters nutrition (TPN), infusion
central venous access. It can be used for total parenters nutrition (TPN), infusion central venous access. It can be used for total parentered in the mail of the mail of repeated
of I.V. liquids, blood, blood products and drugs. It can also be used for rep withdrawal of blood samples.
(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
Peterea Aucenbe
(Division Sign-Off)
(Optional Format 1-2-96)
510(k) Number K983412
sion of Dental, Infection Control.
General Hospital Devices
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