(114 days)
No
The summary describes a standard intravascular catheter with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are related to physical device standards and biological evaluation, not algorithmic performance.
Yes
The device is used for intravenous therapy, administration of fluids, medications, and nutrients, central venous pressure monitoring, and power injection of contrast media, all of which are therapeutic purposes.
No
The device is an intravascular catheter used for therapy, administration, and sampling, not for diagnosing a condition. While it mentions central venous pressure monitoring, this is a measurement and not a diagnostic interpretation of medical conditions.
No
The device description clearly outlines physical components like lumens, luer lock adapters, extension tubes, clamps, and a suture wing, indicating it is a hardware device.
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 for direct access to the central venous system for administering substances, sampling blood from the body, and monitoring pressure. This is a direct interaction with the patient's circulatory system, not the examination of specimens outside the body.
- Device Description: The description details a catheter designed for insertion into a blood vessel. This aligns with an in vivo (within the living body) device, not an in vitro device.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any processes typically associated with in vitro diagnostics.
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 monitoring purposes.
N/A
Intended Use / Indications for Use
The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.
Product codes
LJS
Device Description
The NMI IC has an open ended lumen with proximally located luer lock adapters(s), extension tube(s) with clamp(s) and suture wing for catheter securement; available in single and multi-lumen with burnif(s) and the reverse tapered shaft to aid in staunching bleeding at the insertion site. The comingulations, when a revelod with depth indicators along its length. The lumens are differentiated by proximally located colored clamps and luer adapter(s) marked with lumen size. Maximum power injection flow rates are indicated on the clamp(s). The proposed NMI IC will be offered in kits with other legally marketed products.
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 NMI IC was assessed in accordance with the following FDA guidance document and international standards:
- EN ISO 10555-1:1996, AMD 1: 1999, AMD 2: 2004, Sterile, Single use intravascular catheters . Part 1: General Requirements
- EN ISO 10555-3:1997 COR 2002, Sterile, Single-Use Intravascular Catheters Part 3: Central . Venous Catheters
- FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-. Term Intravascular Catheters dated March 16, 1995"
- IEC 60601-2-34:2000-10- Medical Electrical Eguipment Part 2-34: Particular Requirements for . ICC 00001-2-54.2000-10 Theated Bloomed. By Invasive Blood Pressure Monitoring Equipment
- A AMI TIR 9: 1992- Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring .
- A AMI/ANSI/ISO 10993-1: 2003, Biological evaluation of medical devices Part 1: Evaluation . and testing
Key Metrics
Not Found
Predicate Device(s)
K070002, K003839, K070996, K051991, K051991, K061179, K081113
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/0 description: The image shows the logo for Navilyst Medical. The logo consists of a circular graphic on the left and the text "Navilyst Medical" on the right. The word "Navilyst" is on the top line and the word "Medical" is on the bottom line.
K101326
Date prepared: August 20, 2010
SEP
2 2010
- A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact Nicholas Condakes Manager, Regulatory Affairs 508-658-7931
C. Device Name Trade Name: Common/Usual name: Classification Name:
Classification Panel:
.
-
D. Predicate Device(s) Trade Name: Common/Usual name: Classification Name: Premarket Notification(s): Classification Panel:
Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945 -
NMI IC Intravascular Catheter Short and Long-Term Intravascular Catheter 21CFR §880.5970, Class II General Hospital
510(k) SUMMARY 21 CFR 807.92
Navilyst Medical, Inc. Xcela Power Injectable PICC Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K070002 General Hospital Navilyst Medical, Inc. Central Venous Catheter Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K003839 General Hospital Bard Power PICC Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K070996, K051991 General Hospital Bard PowerLine Central Venous Catheter Intravascular Catheter
Short and Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K051991
General Hospital
1
Bard PowerHickman™ Catheter
Intravascular Catheter
Short and Long-Term Intravascular Catheter; 21CFR 5880.5970, Class II K061179
General Hospital
Cook Spectrum and Spectrum Glide Central Venous Catheters Intravascular Catheter; 21CFR §880.5200, Class II K081113
General Hospital
Device Description E.
The NMI IC has an open ended lumen with proximally located luer lock adapters(s), extension tube(s) with clamp(s) and suture wing for catheter securement; available in single and multi-lumen with burnif(s) and the reverse tapered shaft to aid in staunching bleeding at the insertion site. The comingulations, when a revelod with depth indicators along its length. The lumens are differentiated by proximally located colored clamps and luer adapter(s) marked with lumen size. Maximum power injection flow rates are indicated on the clamp(s). The proposed NMI IC will be offered in kits with other legally marketed products.
F. Intended Use
The NMI IC is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, venous system for maravelleds therapy, and any for central venous pressure monitoring, and for power injection of contrast media.
G. Technology Characteristics
The proposed device has similar materials, design and components and technological characteristics as predicate intravascular catheters.
H. Performance Data
The NMI IC was assessed in accordance with the following FDA guidance document and international standards:
- EN ISO 10555-1:1996, AMD 1: 1999, AMD 2: 2004, Sterile, Single use intravascular catheters . Part 1: General Requirements
- EN ISO 10555-3:1997 COR 2002, Sterile, Single-Use Intravascular Catheters Part 3: Central . Venous Catheters
- FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-. Term Intravascular Catheters dated March 16, 1995"
- IEC 60601-2-34:2000-10- Medical Electrical Eguipment Part 2-34: Particular Requirements for . ICC 00001-2-54.2000-10 Theated Bloomed. By Invasive Blood Pressure Monitoring Equipment
- A AMI TIR 9: 1992- Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring .
- A AMI/ANSI/ISO 10993-1: 2003, Biological evaluation of medical devices Part 1: Evaluation . and testing
I. Conclusion
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 predicate devices
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Nicholas Condakes Regulatory Affairs Manager Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752
2 2010 SEP
Re: K101326
Trade/Device Name: NMI Intravascular Catheter (IC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 11, 2010 Received: August 13, 2010
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 (the 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 Devices mark 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. Please note: CDRH, not evaluate information related to contract liability warranties. We remind you, for rever, that device labeling must be truthful and not misleading.
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 affection 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. Condakes
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 to: tegli (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Wh for.
Anthony D. Watson, B.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Abbreviated 510(k) NMI IC 07-May-2010
Indications for Use
510(k) Number (if Known): K101326
Device Name: .
NMI Intravascular Catheter (IC)
Indications for Use:
The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.
Prescription Use (21 CFR 801 Subpart D)
ని And/Or AND/OR Over-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)
Richard C. Unger 8/31/10
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101326