(213 days)
Not Found
Not Found
No
The summary describes a standard PICC catheter and does not mention any AI or ML components or functionalities.
No.
The device is a PICC catheter system used for prolonged intravenous administration of fluids, medications, and nutritional therapy, which are supportive treatments, not therapeutic interventions by the device itself.
No
The device is a PICC catheter system, which is used for prolonged intravenous administration of fluids, medications, and/or nutritional therapy. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states the device is a physical catheter made from polyurethane material, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for administering fluids, medications, and nutritional therapy directly into the bloodstream via a catheter inserted into a vein. This is a therapeutic and access device, not a diagnostic one.
- Device Description: The description details a physical catheter made of polyurethane with markings and clamps. This aligns with a medical device used for access and delivery, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This PICC catheter is used to deliver substances into the body.
N/A
Intended Use / Indications for Use
The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, which are used to determine the exact catheter trim length. The PICC catheter is offered with or without plastic clamps on the proximal extension tubes.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K9805266'. The characters are written in a dark color, possibly black ink, against a light background. The style of writing is somewhat rough, giving it a hand-drawn appearance.
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
| Owner Operator Submitting Boston Scientific Corporation | |
|---|---|
| this Premarket Notification: One Boston Scientific Place | |
| Natick, MA 01757 | |
| (508) 650.9174 | |
| Contact Person: | Wanda M. Carpinella |
| Regulatory Affairs Department | |
| Device Generic Name: | Peripherally Inserted Central Catheter |
| Device Classification: | 80 FOZ, Intravascular Catheter |
B. INDICATIONS FOR USE
The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.
C. DESCRIPTIVE CHARACTERISTICS
The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, which are used to determine the exact catheter trim length. The PICC catheter is offered with or without plastic clamps on the proximal extension tubes.
D. SUBSTANTIAL EQUIVALENCE
The subject PICC catheter has been shown to be substantially equivalent to the PICC catheter offered by Cook Inc. and Luther Medical.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
The PICC catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.
F. CONCLUSION
Based on the information presented, Boston Scientific Corporation believes that the PICC catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed PICC catheters.
1
Public Health Service
SEP 1 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Wanda M. Carpinella Project Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K980566 Vaxess Peripherally Inserted Central Trade Name: Catheter Regulatory Class: II Product Code: FOZ Dated: July 21, 1998 Received: July 23, 1998
Dear Ms. Carpinella:
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 leqally 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). 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 aqainst 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. ਸੋ 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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
Paqe 2 - Ms. Carpinella
through 542 of the Act for devices under the Electronic Product 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 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" (21CFR 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.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Dutman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices __ _ _ Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
14980566 New Application
Device Name:
Peripherally Inserted Central Catheter
The PICC catheter system is designed for use when Indications for Use: indications for 800.
central venous catheterization or prolonged intravenous administration of fluids, Central verious catherenzation of profession in the mariety of insertion sites may medications, and/or harmond the patient involved and the catheter size selected. While be utilized, dopending apon the pay be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for used voin: Eoodtion of the alstarssary and assurance of a continued, uncompromised vascular access.
(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluaiton (ODE)
(Division Sign-Off) 75 . 1 Division of Deneral Infection Control, and General Hospital Devices 510(k) Number K 9 8 0
Prescription Use
(Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)