(30 days)
Not Found
No
The summary describes a physical catheter and its intended use, with no mention of software, algorithms, or data processing that would indicate AI/ML technology. The performance studies focus on physical and material standards.
Yes
The device is described as a long-term catheter intended for central venous access via peripheral insertion in neonates, infants, and children, used for administering fluids, medication, and nutritional therapy, which are all therapeutic interventions.
No
The device is described as a long-term catheter for central venous access in neonates, infants, and children, used for administering fluids, medication, and nutritional therapy. Its function is therapeutic delivery, not diagnosis.
No
The device description clearly indicates it is a physical catheter made of polyurethane with associated hardware components like a hub, suture wing, clamp, and luer connector. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "central venous access via peripheral insertion in neonates, infants, and children" for the "administration of fluids, medication, and nutritional therapy." This describes a device used in vivo (within the body) for therapeutic purposes.
- Device Description: The description details a catheter designed for insertion into a vein, made of polyurethane, with a lumen, hub, clamp, and luer connector. These are all components of a device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, and are used with biological samples like blood, urine, or tissue.
Therefore, the 1.9F Vascu-PICC® is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
- Designed for peripheral vein catherization .
- Comprised of a polyurethane material .
- The lumen is connected to the extensions by a hub with a suture wing for . placement.
- A clamp is provided on the extension tube to prevent air/fluid communication. .
- A female luer connector provides the connection for intravenous administration. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous access via peripheral insertion
Indicated Patient Age Range
neonates, infants, and children
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)
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the 1.9F Vascu-PICC® were previously cleared for similar applications by Medcomp, Inc.
Performance testing of the 1.9F Vascu-PICC® was conducted in accordance with the following international standards:
- ISO 10555-1: 1997: Sterile Single Use-Intravascular Catheters, General ® Requirements
- ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and ● Certain Other Medical Equipment - Part 2: Lock Fittings
Subject product testing has vielded acceptable safety and performance outcomes.
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 1.9F Vascu-PICC® is substantially equivalent to the cited predicate device.
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
510(k) Summary
1.9F Vascu-PICC® Summary of Safety and Effectiveness Prepared May 15, 2009
General Information
Submitter:
JUN 17 2009
MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 Phone: (215) 256-4201 Fax: (215) 256-9191
| Contact: | Susan Pileggi |
|---|---|
| Regulatory Specialist |
| Device Trade Name: | 1.9F Vascu-PICC® |
|---|---|
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Catheter, Intravascular, Therapeutic, Long-Term |
| Greater then 30 Days | |
| CFR Reference: | 21 CFG 880.5970, Class II |
| Classification Panel: | General Hospital |
Predicate Device:
| Device Trade Name: | 1.9F Vascu-PICC™ |
|---|---|
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS-Catheter, Intravascular, Therapeutic, Long- |
| Term Greater then 30 Days | |
| CFR Reference: | 21 CFR 880.5970, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K061986, concurrence date August 15, 2006 |
Performance Standards: Performance standards have not been established by FDA under section 514 of the Federal Food, Drug, and Cosmetic Act.
Indications for Use: The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.
Device Description:
- Designed for peripheral vein catherization .
- Comprised of a polyurethane material .
- The lumen is connected to the extensions by a hub with a suture wing for . placement.
- A clamp is provided on the extension tube to prevent air/fluid communication. .
- A female luer connector provides the connection for intravenous administration. .
1
1091464
Safety and Performance Tests
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the 1.9F Vascu-PICC® were previously cleared for similar applications by Medcomp, Inc.
Performance testing of the 1.9F Vascu-PICC® was conducted in accordance with the following international standards:
- ISO 10555-1: 1997: Sterile Single Use-Intravascular Catheters, General � Requirements
- ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and ● Certain Other Medical Equipment - Part 2: Lock Fittings
Subject product testing has vielded acceptable safety and performance outcomes.
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 1.9F Vascu-PICC® is substantially equivalent to the cited predicate device.
Summary of Substantial Equivalence
Based on the indications for use and safety and performance testing, the 1.9F Vascu-PICC® meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use to the predicate device.
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
JUN 1 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Pileggi Regulatory Specialist MedCOMP 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K091466
Trade/Device Name: 1.9F Vascu-PICC® Regulation Number: 21 CFR 880.5970 . Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 15, 2009 Received: May 18, 2009
Dear Ms. Pileggi:
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 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.
3
Page 2- Ms. Pileggi
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony O. Arthur for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Device Name: 1.9F Vascu-PICC®
Indications for Use:
The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.
Prescription Use X Over-The-Counter Use Prescription Ose (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K091466
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