(21 days)
No
The summary describes a physical catheter and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a long-term catheter intended for central venous access for the administration of fluids, medication, and nutritional therapy, which are all therapeutic interventions.
No
The device is described as a long-term catheter for central venous access and administration of fluids, medication, and nutritional therapy, with no indication of diagnostic function.
No
The device description clearly outlines physical components made of polyurethane and stainless steel, 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 clearly states the device is for "central venous access via peripheral insertion in neonates, infants, and children" for "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, which is an in vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to test samples like blood, urine, or tissue outside the body to diagnose or monitor medical conditions. This device is used inside the body for treatment.
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
LJS
Device Description
The Medcomp 1.9F Vascu-PICC™ catheter is designed for peripheral vein catheterization. The 1.9F Vascu-PICC™is 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. The twisted wire stylet is made of stainless steel with a nylon and high density polyethylene handle. The stylet aids in insertion of the catheter.
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)
In vitro testing was performed on the Medcomp 1.9F Vascu-PICC™ to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3. Testing includes gravity flow, air leakage, liquid leakage, tensile strength, elongation, air priming volume.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Biocompatibility testing on the same materials that are included in the 1.9F Vascu-PICC™ were completed on K974236, Medcomp Duo-Flow Soft Line Catheter and K003682, Medcomp Z Cath. These tests demonstrate that the materials used in the 1.9F Vascu-PICC™ meet the requirements of ISO 10993 for a permanent contact device. Biocompatibility testing on the stainless steel with silicone coating of the stylet was completed by the vendor and is enclosed in this submission. These tests demonstrate that the stylet meets requirements of ISO 10993 for a limited externally communicating device with indirect blood path. The handle of the stylet has no patient contact and therefore biocompatibility testing is unnecessary.
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.
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
Local 986
1 of 2
510(k) SUMMARY
A. Submitter Information:
Submitter:
AUG - 3 2006
MEDCOMP® 1499 Delo Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Susan Motzer July 12, 2006
1.9F Vascu-PICC™
Than 30 Days
ાજરી
Catheter, Intravascular,
Contact: Date Prepared:
- B. Trade Name: Common Name:
Classification: C.F.R. Section:
C. Predicate Device: 880.5970 K993052 Vygon 2F Epicutaneo
Therapeutic, Long-Term Greater
PUR Catheter
D. Device Description:
The Medcomp 1.9F Vascu-PICC™ catheter is designed for peripheral vein catheterization. The 1.9F Vascu-PICC™is 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. The twisted wire stylet is made of stainless steel with a nylon and high density polyethylene handle. The stylet aids in insertion of the catheter.
E. Intended 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.
F. Comparison to Predicate Device:
The Medcomp 1.9F Vascu-PICC™ is substantially equivalent to the Vygon 2F Epicutaneo Catheter in terms of intended use, insertion method, anatomical location, performance and method of sterilization.
Medcomp 1.9F Vascu-PICC™ 510(k) Summary Page 1 of 2
1
Kael984
2012
G. Performance Data:
In vitro testing was performed on the Medcomp 1.9F Vascu-PICC™ to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3. Testing includes gravity flow, air leakage, liquid leakage, tensile strength, elongation, air priming volume.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Biocompatibility testing on the same materials that are included in the 1.9F Vascu-PICC™ were completed on K974236, Medcomp Duo-Flow Soft Line Catheter and K003682, Medcomp Z Cath. These tests demonstrate that the materials used in the 1.9F Vascu-PICC™ meet the requirements of ISO 10993 for a permanent contact device. Biocompatibility testing on the stainless steel with silicone coating of the stylet was completed by the vendor and is enclosed in this submission. These tests demonstrate that the stylet meets requirements of ISO 10993 for a limited externally communicating device with indirect blood path. The handle of the stylet has no patient contact and therefore biocompatibility testing is unnecessary.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2006
Ms. Susan Motzer Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K061986
Trade/Device Name: 1.9F Vasu-PICCTM Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 13, 2006 Received: July 13, 2006
Dcar Ms. Motzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device rcferenced 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 Eederal Register.
3
Page 2 - Ms. Motzer
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); 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
1 of 1
Indications for Use
510(k) Number (if known):
Device Name: 1.9F Vascu-PICCTM
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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Clues
ംസ Sign-Off) ്ഥാ of Anesthesiology, General Hospital, I. Haction Control, Dental Devices 540(k) Number:
Page 1 of 1