(77 days)
Not Found
No
The summary describes a standard medical catheter and does not mention any AI or ML components or functionalities.
No.
The device is indicated for administration of fluids, medication, and nutritional therapy, which are not therapeutic actions in themselves, but rather methods of delivering therapeutic substances. The catheter itself does not treat or cure a disease.
No
Explanation: The device is indicated for central venous access for administration of fluids, medication, and nutritional therapy, which are treatment-oriented functions, not diagnostic ones.
No
The device description clearly outlines physical components made of polyurethane, including a lumen, hub, suture wing, clamps, and luer connectors, 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 is for accessing the central venous system for administering fluids, medication, and nutritional therapy. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details a catheter designed for insertion into a vein for delivery purposes. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
The device is a medical device used for patient treatment and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripherally 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 o
- The lumen is connected to the extensions by a hub with a suture wing for ◆ placement.
- Clamps are provided on the extension tube to prevent air/fluid communication. 0
- Female luer connectors provide the connection for intravenous administration. 0
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system 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.
Performance testing of the 2.6F 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 a Certain Other Medical Equipment - Part 2: Lock Fittings
Subject product testing has yielded acceptable safety and performance outcomes.
Risk Management of the subject device was conducted in accordance with an internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices. The analysis did not identify any new types or safety or efficacy questions for the proposed device.
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 2.6F 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
DEC 2 1 2010
510(k) Summary 2.6F Vascu-PICC®
Summary of Safety and Effectiveness Prepared October 1, 2010
General Information
| Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
Phone: (215) 256-4201
Fax: (215) 256-9191 |
|-----------------------|-------------------------------------------------------------------------------------------------------|
| Contact: | Jean Callow
Regulatory Specialist |
| Device Trade Name: | 2.6F Vascu-PICC® |
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Catheter, Intravascular, Therapeutic, Long-Term
Greater than 30 Days |
| CFR Reference: | 21 CFG 880.5970, Class II |
| Classification Panel: | General Hospital |
Predicate Devices:
| Device Trade Name: | 1.9F Vascu-PICC® |
|---|---|
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS-Catheter, Intravascular, Therapeutic, Long-Term Greater than 30 Days |
| CFR Reference: | 21 CFR 880.5970, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K091466 |
Indications for Use: The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripherally 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 o
- The lumen is connected to the extensions by a hub with a suture wing for ◆ placement.
- Clamps are provided on the extension tube to prevent air/fluid communication. 0
- Female luer connectors provide the connection for intravenous administration. 0
Safety and Performance Tests
Medcomp 2.6F Vascu-PICC® 510(k) Summary Page 1 of 2
1
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.
Performance testing of the 2.6F 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 a Certain Other Medical Equipment - Part 2: Lock Fittings
Subject product testing has vielded acceptable safety and performance outcomes.
Risk Management of the subject device was conducted in accordance with an internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices. The analysis did not identify any new types or safety or efficacy questions for the proposed device.
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 2.6F 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 2.6F 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.
5-2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national affiliation. The logo is simple, using a black and white color scheme.
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville Pennsylvania 19438
DEC 2 1 2010
Re: K102966 Trade/Device Name: 2.6F Vascu-PICC® Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 1, 2010 Received: December 2, 2010
Dear Ms. Callow:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 -- Ms Callow
Enclosure .
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/CentersOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
fas
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, İnfection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
4
Indications for Use
DEC 2 1 2010
510(k) Number (if known): Kl 0296 6
Device Name: 2.6F Vascu-PICC®
Indications for Use:
The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system 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 (21 CFR 801 Subpart C (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)
Rild C. Chay 12/20
(Division Sign-Off)
Page 1 of 1
rDivision Olgh Only rection Control, Dental Devices
10(k) Number: K102966