(234 days)
Not Found
Not Found
No
The device description and intended use describe a simple mechanical aid, with no mention of software, data processing, or any terms related to AI/ML.
No.
The device facilitates the location and stabilization of a port body for access, rather than directly treating a condition or restoring a function.
No
The device is described as an aid for locating and stabilizing a port body for infusion access, not for diagnosing a medical condition.
No
The device description explicitly states it is an "open-ringed plastic disk," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Vital-Port® Infusion Pal™ is a physical device (a plastic disk) used externally on the skin surface to help locate and stabilize a port body for accessing a vascular access system. It does not analyze any biological samples or provide diagnostic information.
The device's function is purely mechanical and procedural, assisting in the physical process of accessing a medical port. This falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.
Product codes
LJT, LBJ
Device Description
The Vital-Port® Infusion Pal™ is an open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body for accessing Vital-Port® Vascular Access Systems. The Vital-Port® Infusion Pal™ is placed on the skin surface on the area overlying the port septum. The device is supplied sterile and intended for onetime use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
NOV 17 1997
510(K) SUMMARY G.
Submitted By:
Neal E. Fearnot, Ph.D., E.E. President MED Institute, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (765) 463-7537 March 27, 1997
Device:
| Trade Name: | Vital-Port® Infusion Pal™ |
|---|---|
| Common/Usual Name: | Locating Ring, Port Stabilizer |
| Proposed Classification Name: | Vein Stabilizer 21CFR §880.6980 (80LBJ) |
| with intended use specific to implanted | |
| subcutaneous intravascular catheters (80LJT) |
Predicate Devices:
The Vital-Port® Infusion Pal™ is similar to predicate vein stabilizers that are currently marketed in terms of technological characteristics and the same intended use of facilitating location and stabilization for vessel access. The Vital-Port® Infusion Pal™ is used with totally implantable vascular access systems for indirect vessel access.
Device Description:
The Vital-Port® Infusion Pal™ is an open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body for accessing Vital-Port® Vascular Access Systems. The Vital-Port® Infusion Pal™ is placed on the skin surface on the area overlying the port septum. The device is supplied sterile and intended for onetime use.
Substantial Equivalence:
The Vital-Port® Infusion Pal™ will be manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated. This device is similar with respect to indications for use and technology to predicate devices in terms of section 510(k) substantial equivalency.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling three human profiles facing right, stacked on top of each other. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1997
Neal E. Fearnot, Ph.D.,E.E. ·President Med Institute, Incorporated P.O. Box 2402 West Lafayette, Indiana 47906
Re : K971140 Vital-Port Infusion Pal Trade Name: Requlatory Class: Unclassified Product Code: LJT Dated: October 10, 1997 October 14, 1997 Received:
Dear Dr. Fearnot:
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, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Dr. Fearnot
through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 encregulation chercica, "Hibblanding by suremo" of everal 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Tim A. Hukari
A. Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
。 が
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Page __ 1_ of ___
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
. Device Name:________________ VITAL-PORT® INFUSION PALTM
Indications For Use:
The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Valeraci Crescenti.
I. Intention Co. arel Ho ander : 510(k) Number
Prescription Use (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)