(14 days)
Not Found
No
The summary describes a physical medical device (PICC line) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used to administer fluids and withdraw blood, which are diagnostic or supportive functions rather than direct therapeutic actions to treat a disease.
No
The device description and intended use state that the device is for administering fluids and withdrawing blood specimens, which are therapeutic and collection functions, not diagnostic.
No
The device description clearly indicates it is a physical medical device (PICC line) used for central venous access, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for establishing peripheral access to the central venous system for administering fluids and withdrawing blood specimens. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic sampling purposes, not for performing tests in vitro (outside the body) on biological samples.
- Device Description: The description reiterates the same intended uses, focusing on access and administration/withdrawal.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect specific substances, or provide diagnostic information based on testing in vitro.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to diagnose diseases, monitor conditions, or screen for health issues. This device is a medical device used for accessing the vascular system for treatment and sample collection, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal. This product is effective for central venous access in adults, children and infants who require intravenous (IV) therapy.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal. This product is effective for central venous access in adults, children and infants who require intravenous (IV) therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
adults, children and infants
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)
Vaxcel™ PICC with PASV® Valve Technology have been tested and compared to the predicate device as per USP (Class VI) and ISO10993. All data demonstrate this device is biocompatible for its intended use. All of the materials of the Vaxcel™ PICC with PASV® Valve Technology have been tested against numerous chemicals routinely used in medical applications. All data demonstrate this device is chemically compatible for its intended use. The Vaxcel™ PICC with PASV® Valve Technology has been tested and compared to the predicate device. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised.
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.
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
§ 880.5970 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
Catheter Innovations®
ﺍﻟﻤﺴﺎﻋﺪﺓ
Vaxcel™ PICC with PASV® Valve Technology
6 2002 Jun
Ko21704
Telephone:
Attachment 5
Summary of Safety and Effectiveness
Catheter Innovations, Inc. Salt Lake City, Utah - 84.04
| General Provisions | Trade Name: Vaxcel™ PICC Catheter with PASV® Technology. |
|---|---|
| Name of Predicate | |
| Device | PLACEMENT-plus™ [K003642] |
| Classification | Class II |
| Performance | |
| Standards | Performance Standards have not been established by FDA under Section 514 of the |
| Food, Drug and Cosmetic Act. | |
| Intended Use and | |
| Device Description | The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing |
| peripheral access to the central venous system for administration of fluids including, | |
| but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional | |
| therapy and blood products. It is also indicated for blood specimen withdrawal. | |
| This product is effective for central venous access in adults, children and infants who | |
| require intravenous (IV) therapy. | |
| Biocompatibility | Vaxcel™ PICC with PASV® Valve Technology have been tested and compared to the |
| predicate device as per USP (Class VI) and ISO10993. All data demonstrate this | |
| device is biocompatible for its intended use. | |
| Chemical | |
| Compatibility | All of the materials of the Vaxcel™ PICC with PASV® Valve Technology have been |
| tested against numerous chemicals routinely used in medical applications. All data | |
| demonstrate this device is chemically compatible for its intended use. | |
| Summary of | |
| Substantial | |
| Equivalence | The Vaxcel™ PICC with PASV® Valve Technology has been tested and compared to |
| the predicate device. All data gathered demonstrate this device is substantially | |
| equivalent. No new issues of safety or efficacy have been raised. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with no facial details. The profiles are enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle.
Public Health Service
JUN 6 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rogers L. Richins Vice President, Technology & Regulatory Affairs Catheter Innovations, Incorporated 3598 West 1820 South Salt Lake City, Utah 84104
Re: K021704
Trade/Device Name: Vaxcel™ PICC with PASV® Value Technology Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 21, 2002 Received: May 23, 2002
Dear Mr. Richins:
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 III (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.
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.
2
Page 2 - Mr. Richins
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Gilchrist
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):
Vaxcel ™ PICC with PASV®Valve Technology Device Name:
Indications For Use:
Vaxcel ™ PICC with PASV®Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, and piotics, chemotherapy, analgesics, nutitional therapy, and blood products, and blood indicated for blood specimen withdrawal.
The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF MEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
ਦੱਖ
Over-The-Caustor Use
(Optional Formal 1-2-96)
Patricia Cusciente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________