(122 days)
No
The description focuses on the physical characteristics and functional performance of a peripherally inserted central venous catheter (PICC) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a peripherally inserted central venous catheter (PICC), which is used for infusion or injection therapy, delivering substances to affect the body for medical purposes.
No
The device description clearly states its purpose is for "repeated venous access for infusion or injection therapy" and allows for "contrast media studies." It functions as a delivery system rather than a tool for diagnosis.
No
The device description clearly describes a physical catheter made of radiopaque polyurethane tubing, which is a hardware component.
Based on the provided text, the Power-V PICC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device for providing venous access for infusion or injection therapy directly into the patient's central venous system. This is a therapeutic and diagnostic procedure performed in vivo (within the living body).
- Device Description: The description details a catheter designed for insertion into 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 used to perform tests in vitro (outside the living body) on samples taken from a patient. The Power-V PICC is a medical device used in vivo for direct patient treatment and access.
N/A
Intended Use / Indications for Use
The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.
Product codes
LJS
Device Description
The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted pcriphcrally. Each Power-V PICC has a kink resistant, reverse tapered catheter design. The Power-V PICC is indicated for dwell times greater than 30 days. The Power-V PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 cc/sec with a maximum power injection pressure of 300 psi (scc Appendix B). The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations (scc Appendix C).
The Power-V PICC is illustrated in the drawings at the end of this section. The Power-V PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. All catheters are 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with luer lock fittings for access attachment.
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
The Power-V met all functional requirements and specifications.
Key Metrics
Not Found
Predicate Device(s)
K033853, K051102, K062579, K033389
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.”
0
510(k) Summary
General Information
Classification: Class II
Trade Name: V-Cath Poly PICC
NOV - 5 2007
Submitter: HDC, Corporation. 628 Gibraltar Court Milpitas, CA 95035, USA
Earl Smart QA Tel # (408) 942-7340
Device Identification
Contact:
- A. Common Name: Power-V PICC
- B. Classification Name: Percutaneous Implant, long-term intravascular catheter
- C. Regulation Number: 880.5970
- D. Panel: General Hospital
- E. Product Code: LJS
- F. Class: Class II
Predicate Devices
V-Cath Poly PICC from HDC Corporation, K033853 OMNIPICC P.I. from RITA Medical Systems, Inc., K051102 OMNIPICC P.I. from RITA Medical Systems, Inc., K062579 PowerPICC Catheter, Bard Access Systems, Inc., K033389
Device Description
The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted pcriphcrally. Each Power-V PICC has a kink resistant, reverse tapered catheter design. The Power-V PICC is indicated for dwell times greater than 30 days. The Power-V PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 cc/sec with a maximum power injection pressure of 300 psi (scc Appendix B). The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations (scc Appendix C).
The Power-V PICC is illustrated in the drawings at the end of this section. The Power-V PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. All catheters are 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with luer lock fittings for access attachment.
1
Intended Use
The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.
Biocompatibility
Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE . The device is identical to the previously approved device OMNIPICC P.I. from RITA Medical Systems and made by Health Line International Corporation. The device is now made for HDC Corporation by Health Line International Corporation.
Device Performance/Product Testing
The Power-V met all functional requirements and specifications.
Technology Characteristics
The Power-V is equivalent technologically to the devices mentioned under predicate devices above.
Substantial Equivalence
The design, methods of manufacturing, and materials used in the Power-V device are substantially equivalent to the predicate devices.
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 caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the caduceus symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2007
Mr. Earl Smart Quality Assurance HDC Corporation 628 Gibraltar Court Milpitas, California 95035
Re: K071875
Trade/Device Name: V-Cath (Polyurethane) Power PICC (Power -V) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 3, 2007 Received: October 5, 2007
Dear Mr. Smart:
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 Federal Register.
3
Page 2 - Mr. Smart
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D. fa
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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K071875
1 of 1
Indications For Use
510 (K) NUMBER:
Device Name:
Indications For Use:
V-Cath (Polyurethane) Power PICC (Power-V)
The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OROver-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign-Off
livision of Anestheslology, General fection Control, Dental Devices
510(k) Number: KD 71875
K071875 HDC Corporation Dated: July 12, 2007
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