(28 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter, with no mention of AI or ML technologies.
No.
The device facilitates the administration of therapies but is not itself a therapeutic device; it is a catheter used for IV access.
No
The device is a catheter for administering IV therapy, not for diagnosing medical conditions.
No
The device description clearly details physical components made of barium impregnated silicone elastomer, including catheters, guidewires, fixation hubs, extension lines, and clamps. This indicates a hardware-based medical device, not a software-only one.
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 administering IV therapy (hyperalimentation, antibiotics, chemotherapy, etc.) directly to patients. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details a catheter designed for insertion into a patient's veins for fluid delivery. This aligns with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.
Product codes (comma separated list FDA assigned to the subject device)
ris, LJS
Device Description
The Lifecath S peripherally inserted central catheters and midline catheters are fabricated of barium impregnated silicone elastomer. The catheters are supplied with a guidewire to aid in insertion. The 60 cm PICC is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. The 20 cm midline catheter is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. Both catheters have a fixation hub and an extravascular extension line. The catheters are marked every centimeter from the hub to the proximal tip. The fixation hub is marked with the catheter French size, and the extension lines are marked with the gauge size. A clamp is attached to each extension line, and is marked with the priming volume.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility data demonstrates that the materials used are nonirritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices. Risk Assessment was conducted in compliance with ISO 14971.
Biocompatibility testing, performance testing and risk assessment Conclusion: demonstrate that the Lifecath S is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use.
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.
Vascu-PICC (K030270), Lifevac-PICC (K903648 and K983544), Lifecath PICC PUR (K993442)
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
Page 1 of 2
K062425
VYGON CORPORATION
2495 General Armistead Avenue Norristown, PA 19403-3685
(800) 544-4907 (610) 630-3350 Fax (610) 630-3835
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)
SEP 15 2006
Date of Preparation: August 14, 2006
Applicant:
Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403
Courtney Smith, Regulatory Affairs Manager
Contact Individual:
Trade Name: Lifecath S
Common Name: Lifecath PICC
Regulation Number: 880.5970
Product Code: ris
Classification Name: Percutaneous, implanted, long-term intravascular catheter
610-539-9300 Ext. 110
Classification: Class II
Predicate Device Name: Vascu-PICC (K030270) Lifevac-PICC (K903648 and K983544) Lifecath PICC PUR (K993442)
Device Description: The Lifecath S peripherally inserted central catheters and midline catheters are fabricated of barium impregnated silicone elastomer. The catheters are supplied with a guidewire to aid in insertion. The 60 cm PICC is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. The 20 cm midline catheter is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. Both catheters have a fixation hub and an extravascular extension line. The catheters are marked every centimeter from the hub to the proximal tip. The fixation hub is marked with the catheter French size,
1
Page 2 of 2
K062425
and the extension lines are marked with the gauge size. A clamp is attached to each extension line, and is marked with the priming volume.
The Vygon LIFECATH S PICC and Midline catheters are intended for use Intended Use: in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.
Technology Characteristics: The Lifecath S PICC and Midline catheters are composed of silicone and substantially equivalent to the predicate devices.
Summary of Design Control Activities:
Biocompatibility data demonstrates that the materials used are nonirritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices. Risk Assessment was conducted in compliance with ISO 14971.
Biocompatibility testing, performance testing and risk assessment Conclusion: demonstrate that the Lifecath S is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use.
Courtney Smith 8/14/06
Courtney Smith Regulatory Affairs Manager
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403
Re: K062425
Trade/Device Name: Lifecath S PICC and Midline Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 17, 2006 Reccived: August 18, 2006
Dear Ms. Smith:
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 Eederal Register.
3
Page 2 - Ms. Smith
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 your 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Ling, Ph.D.
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
Enclosure
4
Indications for Use
510(k) Number (if known): K 062125
PICC AND MIDLINE CATHE TER Lifecath S Device Name:
Indications For Use:
The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chater ver
. 1 Sign-Off) on of Anesthesiology, General Hospital, on Control, Dental Devices
: Number. K467425
Page 1 of