(58 days)
Not Found
Not Found
No
The summary describes a physical medical device (catheter) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as being for "patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling," which indicates its use in the treatment or management of a medical condition.
No
Explanation: The device is a catheter for infusion therapy and blood sampling, which are therapeutic and collection procedures, not diagnostic ones.
No
The device description explicitly states it is a "Mini Polyurethane Catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "long-term vascular access for infusion therapy and/or blood sampling." This describes a device used in vivo (within the body) for delivering substances or collecting samples directly from the bloodstream.
- Device Description: The description reinforces its use for "long-term vascular access."
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. The description of this catheter does not involve any analysis or testing of specimens outside the body.
Therefore, the Mini Polyurethane Catheter is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy sampling.
Product codes
LJT
Device Description
The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Premarket Notification Mini Polyurethane Catheter
SEP 1 6 1998
I. 510(k) SUMMARY
Submitted By:
Neal E. Fearnot, President MED Institute, Incorporated West Lafayette, Indiana 47906 (765) 463-7537 July 16, 1998
Device:
| Trade Name: | Mini Polyurethane Catheter |
|---|---|
| Common/Usual Name: | Implanted Subcutaneous Intravascular Catheter |
| Proposed Classification: | Implanted Subcutaneous Intravascular Catheter |
Predicate Devices:
The Mini Polyurethane has the same intended use, design, and materials of construction as predicate catheters supplied with Vital-Port® systems manufactured by COOK Vascular™ Incorporated.
Device Description:
The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.
Substantial Equivalence:
The Mini Polyurethane Catheter will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK. Vascular™ Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
r for
1
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1998
Mr. Neal E. Fearnot President MED Institute, Incorporated A Cook Group Company P.O. Box 2402 West Lafayette, Indiana 47906
Re : K982507 Mini Polyurethane Catheter Trade Name : Regulatory Class: Unclassified Product Code: LJT July 16, 1998 Dated: Received: July 20, 1998
Dear Mr. 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or ro 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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 - Mr. Fearnot
through 542 of the Act for devices under the Electronic Chrough 542 OF the nee to: revisions, 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 described in your 31011 plemance of your device to a legally marketed predicate device results in a classification for your marketed predicate anits 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 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 Other general ** premarket notification" (21CFR 807.97). 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/dsma/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
C 0
Enclosure
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use:
The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy
sampling sampling.
(Please do NOT WRITE BELOW THIS LINE - Continue on another Page IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Labrita Crescente
(Division Sign-Off)
ivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 4982507
Prescription Use
(Per 21 CFR 801.109)
OR
Image /page/3/Picture/11 description: The image shows the text "Over-The-Counter Use" followed by a line and the number 3. Below the text, it says "(Optional Format 1-2-96)". The text is in a simple, sans-serif font and is left-aligned. The number 3 is handwritten and placed to the right of the text.