(74 days)
A137605
NOT_APPLICABLE
No
The 510(k) summary describes a standard medical device (a PICC catheter) and does not mention any AI or ML capabilities, image processing, or data sets for training or testing.
No.
The device is for prolonged intravenous administration of fluids, medication, and/or nutritional therapy, which are supportive rather than therapeutic functions.
No
This device is designed for therapeutic purposes, such as administering fluids, medication, and nutritional therapy, rather than for diagnosing medical conditions.
No
The device description clearly describes a physical catheter made of silicone with lumens, hubs, extensions, clamps, and luer connectors, which are all hardware components.
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 "long-term central venous catheterization or prolonged intravenous administration of fluids, medication, and /or when nutritional therapy is prescribed." This describes a device used for direct patient treatment and administration of substances into the body.
- Device Description: The description details a catheter designed for insertion into veins for fluid/medication delivery. This is consistent with a medical device used for therapeutic purposes, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other information. This device is designed to deliver substances into the body.
N/A
Intended Use / Indications for Use
THE MEDCOMP SILICONE Vascu-PICC™ CATHETERS ARE DESIGNED FOR LONG-TERM CENTRAL VENOUS CATHETERIZATION OR PROLONGED INTRAVENOUS ADMINISTRATION OF FLUIDS, MEDICATION, AND /OR WHEN NUTRITIONAL THERAPY IS PRESCRIBED.
THIS CATHETER MAY BE INSERTED VIA THE BASILIC OR CEPHALIC VEIN.
Product codes
LJS
Device Description
The Medcomp Silicone Vascu-PICC™ Catheters are designed for peripheral vein catheterization. The Silicone Vascu-PICC™ lumen is comprised of a soft radiopaque silicone material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration.
The catheters are available in 3F, 4F, and 5F single lumen versions, and 4F, 5F, and 6F double lumen versions. All versions are 60 cm long with depth markings in 5cm increments.
The Silicone Vascu-PICC™ Catheter product line is packaged with the necessary accessories to facilitate catheter insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basilic or cephalic vein
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)
In vitro testing was performed on the Medcomp Silicone Vascu-PICC™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3.
Biocompatibility testing on the Medcomp Silicone Vascu-PICC™ Catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
A137605
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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510(k) SUMMARY
A. Submitter Information:
B.
| Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
(215) 256-4201 Telephone
(215) 256-0818 Fax |
|-----------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Meghan J. Tintle
Regulatory Affairs Assistant |
| Date Prepared: | January 23, 2003 |
| Trade Name: | Medcomp Silicone Vascu-PICC™ |
| Common Name: | Catheter, Intravascular, Therapeutic,
Long-Term |
| Classification: | LJS |
| C.F.R. Section: | 880.5970 |
C. Predicate Device:
A137605 Cook PICC Catheters
D. Device Description:
The Medcomp Silicone Vascu-PICC™ Catheters are designed for peripheral vein catheterization. The Silicone Vascu-PICC™ lumen is comprised of a soft radiopaque silicone material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration.
The catheters are available in 3F, 4F, and 5F single lumen versions, and 4F, 5F, and 6F double lumen versions. All versions are 60 cm long with depth markings in 5cm increments.
The Silicone Vascu-PICC™ Catheter product line is packaged with the necessary accessories to facilitate catheter insertion.
ட். Intended Use:
The Medcomp Silicone Vascu-PICC™ Catheters are designed for long-term central venous catheterization or prolonged intravenous administration of fluids, medications, and/or when nutritional therapy is prescribed.
This catheter may be inserted via the basilic or cephalic vein.
F. Comparison to Predicate Device:
The Medcomp Silicone Vascu-PICC™ Catheter is substantially equivalent to the predicate device in terms of intended use, insertion method, anatomical location,
Medcomp Silicone Vascu-PICC™ Catheter Summary Page 1 of 2 APR 1 1 2003
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design, material type, performance, labeling, manufacturing process, and method of sterilization.
G. Performance Data:
In vitro testing was performed on the Medcomp Silicone Vascu-PICC™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3.
Biocompatibility testing on the Medcomp Silicone Vascu-PICC™ Catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2003
Ms. Meghan J. Tintle Regulatory Affairs Assistant MEDCOMP® 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K030270
Trade/Device Name: MEDCOMP SILICONE Vascu-PICC™ CATHETER Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: January 23, 2003 Received: January 27, 2003
Dear Ms. Tintle:
This letter corrects our substantially equivalent letter of January 23, 2003 regarding the contact name.
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 (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.
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Page 2 - Ms. Tintle
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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KO30270 510(k) Number:
Device Name: MEDCOMP SILICONE Vascu-PICC™CATHETER
Indications for use:
THE MEDCOMP SILICONE Vascu-PICC™ CATHETERS ARE DESIGNED FOR LONG-TERM CENTRAL VENOUS CATHETERIZATION OR PROLONGED INTRAVENOUS ADMINISTRATION OF FLUIDS, MEDICATION, AND /OR WHEN NUTRITIONAL THERAPY IS PRESCRIBED.
THIS CATHETER MAY BE INSERTED VIA THE BASILIC OR CEPHALIC VEIN.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR --
Over-The-Counter
(Optional Format 1-2-96)
Patricia Lucente
y. General Hospital
510(k) Number.__
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