(30 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of an IV catheter system, with no mention of AI or ML technologies.
Yes
The "Device Description" explicitly states, "The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter."
No
The device is described as a "short-term, therapeutic, IV catheter" used for administering fluids, monitoring blood pressure, and sampling blood. While blood sampling is mentioned, its primary function and description do not indicate that it analyzes or interprets data to diagnose medical conditions, but rather facilitates the collection of samples or direct measurement of pressure, which are then used by other diagnostic tools or methods.
No
The device description clearly outlines physical components such as an over-the-needle catheter, extension tubing, luer lock, clamp, and a passive safety needle shielding mechanism. The performance studies also describe physical tests like flow rate and access to the sharp in safe mode.
Based on the provided text, the NovaCath™ Secure IV Catheter System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into the patient's vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids. These are all procedures performed on the patient, not on a sample of bodily fluid or tissue outside the body for diagnostic purposes.
- Device Description: The description details a catheter system designed for direct patient access to the vascular system. It focuses on features related to insertion, safety, and fluid management within the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples, detect substances, or provide diagnostic information based on in vitro testing.
Therefore, the NovaCath™ Secure IV Catheter System is a therapeutic and access device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter. The NovaCath™ currently has four commercially available models. This special 510(k) adds two additional models of different catheter lengths to the existing gauge size portfolio.
Two (2) additional models:
Gauge: 20G, Catheter Length: 1.25"
Gauge: 24G, Catheter Length: 0.56"
Are being added to the existing four (4) models cleared in K120839:
Gauge: 18G, Catheter Length: 1.25"
Gauge: 20G, Catheter Length: 1.00"
Gauge: 22G, Catheter Length: 1.00"
Gauge: 24G, Catheter Length: 0.75"
The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, radiopaque intravascular catheter, integrated extension tubing with a secondary stabilization hub, a female luer lock and clamp, and a passive safety needle shielding mechanism. The design of the NovaCath™ Secure IV Catheter System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. Blood is contained within the device after needle withdrawl by a self-sealing septum and luer lock, which is provided with a one-time use vent plug. The clamp on the extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or other end cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral Vasculature
Indicated Patient Age Range
The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure.
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)
The device was developed and tested in accordance with released company procedures on design control (per 21 CFR 820.30) and risk analysis (per ISO 14971:2009). The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) per released procedures.
Design verification tests completed:
- 20Gx1.25" Catheter: Power Injection Test for Flow Rate and Device Pressure (Consensus Standard: ISO 10555-1:2013)
- 20Gx1.25" Catheter: Flow Rate Test (Consensus Standard: ISO 10555-1:2013)
- 24G x0.56" Catheter: Flow Rate Test (Consensus Standard: ISO 10555-1:2013)
- 24G x0.56" Catheter Modified Housing ("Slider") Component: Test Access to the Sharp in Safe Mode (Consensus Standard: ISO 23908:2011)
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.
NovaCath™ Secure IV Catheter System (K120839)
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
Mr. Greg Last Ouality Systems and Regulatory Affairs Manager Tangent Medical Technologies. Incorporated 8170 Jackson Road, Suite A Ann Arbor, Michigan 48103
Re: K160374
Trade/Device Name: NovaCath™ Secure IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 8, 2016 Received: February 10, 2016
Dear Mr. Last:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 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.
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name NovaCathTM Secure IV Catheter System
Indications for Use (Describe)
The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Special 510(k): Device Modification 510(k) Summary Tangent Medical Technologies, Inc. NovaCath Secure IV Catheter System
| Submission Date: | February 8, 2016 |
|---|---|
| Submission Owner | |
| Information: | Tangent Medical Technologies, Inc. |
| 8170 Jackson Rd. STE A | |
| Ann Arbor, MI 48103 | |
| Contact | |
| Information: | Greg Last |
| Quality Systems and Regulatory Affairs Manager | |
| Greg@tangentmedical.com | |
| Tel: 734-527-4051 | |
| Fax: 734-253-2043 | |
| Device Name: | NovaCath™ Secure IV Catheter System |
| Proprietary | |
| Name: | NovaCath™ Secure IV Catheter System |
| Common Name: | Intravascular Catheter (short-term, less than 30 days, therapeutic) |
| Classification | |
| Name: | Intravascular Catheter |
| Classification | |
| Code: | FOZ |
| Regulation | |
| Number: | 21 CFR §880.5200 |
| Predicate | |
| Device: | NovaCath™ Secure IV Catheter System (K120839) |
| Device | |
| Description: | The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter. The |
| NovaCath™ currently has four commercially available models. This special 510(k) adds | |
| two additional models of different catheter lengths to the existing gauge size portfolio. | |
| Two (2) additional models: |
| Gauge | 20G | 24G |
|---|---|---|
| Catheter Length | 1.25" | 0.56" |
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| Gauge | 18G | 20G | 22G | 24G |
|---|---|---|---|---|
| Catheter Length | 1.25" | 1.00" | 1.00" | 0.75" |
Are being added to the existing four (4) models cleared in K120839:
The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, radiopaque intravascular catheter, integrated extension tubing with a secondary stabilization hub, a female luer lock and clamp, and a passive safety needle shielding mechanism. The design of the NovaCath™ Secure IV Catheter System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. Blood is contained within the device after needle withdrawl by a self-sealing septum and luer lock, which is provided with a one-time use vent plug. The clamp on the extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or other end cap.
Intended Use: The intended use of the device is identical to the predicate device.
The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi.
Comparison of The intended use of the device and the technological characteristics of the device are Technological unchanged from the predicate device. The two models being added to the NovaCath™ Characteristics: product line per this special 510(k) use the same technology and materials as the four commercially available models. The differences are in the needle length, catheter length, and housing sizes.
The table below provides a comparison summary of the technological characteristics between the subject and predicate device.
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| Substantial Equivalence Comparison | ||
|---|---|---|
| Comparison Criteria | Subject Device | |
| (NovaCath 201250 & 240560) | Predicate Device | |
| (NovaCath K120839) | ||
| Same Intended Use | Yes | Yes |
| Prescription Device (Rx Only) | Yes | Yes |
| Biocompatible Polyurethane Catheter | Yes | Yes |
| Biocompatible Materials of Fabrication | Yes | Yes |
| Closed System | Yes | Yes |
| Built-In Extension from Main Assembly | Yes | Yes |
| Flashback Visualization | Yes | Yes |
| Sharps Injury Prevention Feature | Yes, Passive Integrated | Yes, Passive Integrated |
| Mechanical | Yes, Manual Needle | |
| Retraction | Yes, Manual Needle Retraction | |
| Intended Anatomical Location | Yes, Peripheral Vasculature | Yes, Peripheral Vasculature |
| Distal End Configuration | Yes, Meets ISO 10555-5 | Yes, Meets ISO 10555-5 |
| Proximal End Configuration | Yes, Female Luer Access Port | Yes, Femal Luer Access Port |
| Flow Rate (ml/min) | Yes, 20G: 40 ml/min | |
| Yes, 24G: 14 ml/min | Yes, 20G: 46 ml/min | |
| Yes, 24G: 14 ml/min | ||
| Catheter Stabilization | Yes, Primary and Secondary | Yes, Primary and Secondary |
| EO Sterilization Method | Yes | Yes |
| Packaged Sterile, Single Use | Yes | Yes |
| Non-Pyrogenic | Yes | Yes |
| Made without Latex Rubber | Yes | Yes |
| Made without DEHP | Yes | Yes |
| For Use with Power Injections up to | ||
| 300 psi | Yes, 20G; | |
| 24G Contraindicated | Yes, 18G, 20G, 22G; | |
| 24G Contraindicated |
The device was developed and tested in accordance with released company procedures Summary of on design control (per 21 CFR 820.30) and risk analysis (per ISO 14971:2009). A Device declaration of conformity to design controls is located within the 510(k). Evaluation:
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) per released procedures. The design verification tests completed are as follows:
| Modification | Test Performed | Consensus Standard |
|---|---|---|
| 20Gx1.25" Catheter | Power Injection Test for Flow | |
| Rate and Device Pressure | ISO 10555-1:2013 | |
| 20Gx1.25" Catheter | Flow Rate Test | ISO 10555-1:2013 |
| 24G x0.56" Catheter | Flow Rate Test | ISO 10555-1:2013 |
| 24G x0.56" Catheter | ||
| Modified Housing | ||
| ("Slider") Component | Test Access to the Sharp in | |
| Safe Mode | ISO 23908:2011 |
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