(13 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and in-vitro performance of a standard PICC line, with no mention of AI or ML capabilities.
Yes
The device is described as "Peripherally Inserted Central Catheter (PICC)" and its intended use is for "intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media," which aligns with the definition of a therapeutic device.
No
The device is a peripherally inserted central catheter (PICC) used for administering fluids, medications, and nutrients, sampling blood, and power injection of contrast media. Its purpose is therapeutic and facilitative, not to diagnose a condition.
No
The device description clearly describes a physical catheter with lumens, hubs, and a safety valve, 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 clearly describes a device used for direct patient care (peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Performance Studies: The performance studies mentioned are related to the physical properties and safety of the catheter for insertion and use within the body (in-vitro testing according to ISO 10555-3, high pressure injection flow rates, valve integrity, and biocompatibility). These are not studies related to analyzing samples outside the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device is used inside the body for therapeutic and diagnostic access.
N/A
Intended Use / Indications for Use
For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
Product codes
LJS
Device Description
The proposed PICC has similar technological characteristics as the predicate devices. It is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.
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
Performance testing included in-virro testing in accordance with ISO 10555-3; high pressure injection flow rates; and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for Navilyst Medical. The logo consists of a stylized globe on the left, followed by the company name "Navilyst" in a sans-serif font. Below "Navilyst" is the word "Medical" in a smaller, italicized font. The overall design is simple and professional.
MAY 12 2009
26 Forest Street Marlborough, MA 01752 Tel 508.658.7990
510(k) Summary
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Nicholas Condakes Manager, Regulatory Affairs or 508-658-7931
Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945
C. Device Name
| Tradename: | To be determined |
|---|---|
| Common/usual name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Long term intravascular catheter |
| 21 CFR 880.5970, Class II |
D. Predicate Device(s)
Peripherally Inserted Central Catheter (PICC) Common/usual name: Classification Name: LJS- Long term intravascular catheter, 21 CFR 880.5970, Class II Premarket Notification(s): K070002, K021704
E. Device Description
The proposed PICC has similar technological characteristics as the predicate devices. lt is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.
F. Intended Use
The proposed device is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
G. Performance Data
Performance testing included in-virro testing in accordance with ISO 10555-3; high pressure injection flow rates; and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1.
H. Substantial Equivalence
Based on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicates.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
MAY 12 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Nicholas Condakes Regulatory Affairs Manager Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752
Re: K091261
Trade/Device Name: Undetermined Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 28, 2009 Received: April 29, 2009
Dear Mr. Condakes:
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.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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
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Page 2- Mr. Condakes
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 (Scctions 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Antony O, me for
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if Known):
Device Name:
To be determined
Indications For Use: For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR Over-The-Counter Use_
(21 CFR 801 Subpart D) (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)
Light Illusions for ABC LCDR Colburn 05/10/2009
(Division Sign-Off)
Division of Anesthesionogy, General Hospital Infection Control, Dential Devices
510(k) Number: