(43 days)
Not Found
No
The summary describes a physical catheter device and its performance testing against established standards. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
A therapeutic device is one that performs a medical intervention, treatment, or therapy. This device, a catheter, is used for access to the central venous system for intravenous therapy and power injection of contrast media, and for blood sampling and infusions. While it facilitates therapy, it does not, in itself, perform a therapeutic action.
No
The device description clearly states its purpose is for "peripheral access to the central venous system for intravenous therapy and power injection of contrast media," indicating a therapeutic and interventional role rather than a diagnostic one.
No
The device description clearly outlines physical components made of polyurethane, including a catheter, lumen, hub, extensions, clamps, and a luer connector. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for providing peripheral access to the central venous system for intravenous therapy, power injection of contrast media, blood sampling, infusions, or therapies. This involves direct interaction with the patient's circulatory system for treatment and access, not for examining specimens in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into a vein. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples.
Therefore, the PRO-PICC ® C catheter is a medical device used for therapeutic and access purposes in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PRO-PICC ® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
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.
- Clamps are provided on the extension tubes to prevent air/fluid communication. .
- . A female luer connector provides the connection for intravenous administration.
- Maximum recommended pressure limit setting 300 psi.
- Maximum indicated power injection flow rate 5cc/sec.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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 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 PRO-PICC® were previously cleared for similar applications by Medcomp, Inc.
Performance testing of the PRO-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 yielded acceptable safety and performance outcomes.
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the PRO -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
SEP 16 2009
510(k) Summary PRO-PICC ® C Summary of Safety and Effectiveness Prepared June 27, 2009
General Information:
Submitter:
MEDCOMP® 1499 Delo Drive Harlevsville, PA 19438 Phone: (215) 256-4201 Fax: (215) 256-9191
Contact:
Jean Callow Regulatory Specialist
Device Trade Name: PRO-PICC ® CT 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 Device:
Device Trade Name: Common Name: Classification Name:
CFR Reference: Classification Panel: Premarket Notification: PRO-PICC-%CT Peripherally Inserted Central Catheter (PICC) LJS -Catheter, Intravascular, Therapeutic, Long-Term Greater than 30 Days 21 CFR 880.5970, Class II General Hospital K081904, concurrence date September 23, 2008
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 PRO-PICC @ °T catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
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.
- Clamps are provided on the extension tubes to prevent air/fluid communication. .
- . A female luer connector provides the connection for intravenous administration.
Medcomp The PRO-PICC ๑ ° ° 510(k) Summary Page 1 of 2
1
- Maximum recommended pressure limit setting 300 psi.
- Maximum indicated power injection flow rate 5cc/sec.
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 PRO-PICC® were previously cleared for similar applications by Medcomp, Inc.
Performance testing of the PRO-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 yielded acceptable safety and performance outcomes.
The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the PRO -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 PRO-PICC % CT 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
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.
SEP 1 6 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K092347
Trade/Device Name: PRO-PICC®" Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 30, 2009 Received: August 17, 2009
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.
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. Callow
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,
Anthony D., Avatar for
Susan Runher, D.D.S., M.A. Acting 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): | K092347 |
|---|---|
| --------------------------- | --------- |
PRO-PICC ® CT Device Name:
Indications for Use: -
The PRO-PICC ® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
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)
(Division Sign-Off)
(Division Sign-Q#ff Division of Anesthesiology, General Hospital infection Control, Dental Devices
Page 1 of 1
510(k) Number: K092347