(26 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes.
The device is used for administering fluids, medications, and nutrients, which are therapeutic interventions.
No
The intended use of the device is for administering fluids, medications, and nutrients, as well as blood sampling and power injection of contrast media. These are therapeutic and access functions, not diagnostic.
No
The device description clearly describes a physical catheter with various hardware components (flexible radiopaque catheter, lumens, extension tube, suture wing, luer lock adaptor, valve, colored hubs). It also mentions in-vitro performance testing, which is typical for physical medical devices.
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 access to the central venous system for therapeutic and diagnostic purposes within the body (administering fluids, medications, nutrients, sampling blood, power injection of contrast media). This is an in vivo application, meaning it's used within a living organism.
- 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 in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting to diagnose diseases or conditions. This device is a medical device used for direct patient care and intervention.
N/A
Intended Use / Indications for 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 administrations and nutrients; the sampling of blood; and for power injection of contrast media.
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 Peripherally Inserted Catheter is a Flexible radiopaque catheter with similar technological characteristics as the predicate devices. It is available in single and multi-lumen configurations with markings along the 55cm shaft length; with extension tube(s) and suture wing for cather securement; and each lumen is differentiated by a proximally located female luer lock adaptor with valve and colored hubs that indicate lumen size.
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)
Performance testing included in-viro testing in accordance with ISO 10555-1 and ISO 10555-3; high I cromance testing morates and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K69 3366
510(k) Summary
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Nicholas Condakes Manager, Regulatory Affairs
C. Device Name
Trade Name: Common/usual name: Classification Name:
Lorraine M. Hanley Director, Global Regulatory Affairs
NMI PICC II Peripherally Inserted Central Catheter (PICC) LJS-Long Term Intravascular Therapeutic Catheter 21CFR § 880.5970, Class Il
D. Predicate Device(s)
Common/usual name: Classification Name: Classification Name: Premarket Notification: Peripherally Inserted Central Catheter (PICC) LJS-Long Term Intravascular Therapeutic Catheter 21 CFR § 880.5970, Class II K091261, K070002, K021704
E. Device Description
The proposed Peripherally Inserted Catheter is a Flexible radiopaque catheter with similar technological characteristics as the predicate devices. It is available in single and multi-lumen configurations with markings along the 55cm shaft length; with extension tube(s) and suture wing for cather securement; and each lumen is differentiated by a proximally located female luer lock adaptor with valve and colored hubs that indicate lumen size.
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 administrations and nutrients; the sampling of blood; and for power injection of contrast media.
G. Performance Data
Performance testing included in-viro testing in accordance with ISO 10555-1 and ISO 10555-3; high I cromance testing morates 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 Guidance on the CDRH Premarket Notification Review Program, 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent to the predicates.
Confidential and Proprietary to Navilyst Medical, Inc.
1
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Public Health Service
NUV 2 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Lorraine Hanley Global Director Regulatory Affairs Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752
Re: K093366
Trade/Device Name: NMI PICC II Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 28, 2009 Received: October 29, 2009
Dear Ms. Hanley:
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.
2
Page 2 - Ms. Hanley
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 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,
for
Susan Runner, 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
3
Indications for Use
510(k) Number (if Known):
19093366
Device Name:
NMI PICC II
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: And/Or
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
区
Concurrence of CDRH, Office of Device Evaluation (ODE)
1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093366
Confidential and Proprietary to Navilyst Medical, Inc.