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.

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: 20G with 1.25" Catheter Length and 24G with 0.56" Catheter Length are being added to the existing four (4) models cleared in K120839: 18G with 1.25" Catheter Length, 20G with 1.00" Catheter Length, 22G with 1.00" Catheter Length, and 24G with 0.75" Catheter Length.

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.

AI/ML Overview

The document describes the NovaCath™ Secure IV Catheter System, and this submission is a "Special 510(k): Device Modification" to add two new models (20G x 1.25" and 24G x 0.56" catheters) to an existing cleared device (K120839). Therefore, the study focuses on demonstrating that these new models perform substantially equivalently to the predicate device and meet relevant performance standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the typical format of a clinical study or performance goals. Instead, it details specific tests performed for the modified devices and the consensus standards they adhere to. The "reported device performance" is implied by the successful completion of these tests.

Acceptance Criteria (Proxy) / Test Performed	Reported Device Performance (Implied)	Relevant Standard
20G x 1.25" Catheter (New Model)
Power Injection Test for Flow Rate and Device Pressure (up to 300 psi)	Device performs acceptably under power injection conditions and meets flow rate/pressure requirements.	ISO 10555-1:2013
Flow Rate Test	Achieved a flow rate of 40 ml/min. (Note: Predicate 20G flow rate was 46 ml/min, showing a slight decrease but still deemed substantially equivalent).	ISO 10555-1:2013
24G x 0.56" Catheter (New Model)
Flow Rate Test	Achieved a flow rate of 14 ml/min. (Matches predicate 24G flow rate of 14 ml/min).	ISO 10555-1:2013
Test Access to the Sharp in Safe Mode (for Modified Housing/“Slider” Component)	The device's needle-shielding feature functions correctly, preventing access to the sharp in safe mode.	ISO 23908:2011

Note on "Acceptance Criteria": The document refers to compliance with ISO standards. For example, "Power Injection Test for Flow Rate and Device Pressure" would have specific acceptance criteria defined within ISO 10555-1:2013 regarding maximum pressure tolerance and flow rate. The document states these tests were "completed," implying successful adherence to these criteria. The flow rates are explicitly mentioned for specific gauges.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of catheters tested for flow rate or power injection).
Data Provenance: The data comes from design verification tests conducted by Tangent Medical Technologies, Inc. This is a retrospective analysis of the device's performance based on internal testing protocols as part of a 510(k) submission for device modification. The country of origin of the data is implicitly the USA, where the company is based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document describes engineering and design verification tests against established ISO standards. This type of testing typically relies on standard measurement techniques and equipment rather than expert consensus on a "ground truth" derived from patient data. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not applicable to these specific performance tests. The "ground truth" here is the adherence to the technical specifications outlined in the ISO standards.

4. Adjudication Method for the Test Set

As the tests are engineering/design verification, an adjudication method (like 2+1 or 3+1) is not applicable. The results are typically objectively measured against pre-defined engineering specifications and ISO standard requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done and is not relevant for this type of device modification submission. This study focuses on the physical and functional performance of an intravascular catheter, not on interpretative diagnostic accuracy requiring human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical device (catheter system), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is adherence to recognized international consensus standards for intravascular catheters (ISO 10555-1:2013 and ISO 23908:2011) and pre-defined engineering specifications established by the manufacturer. These standards dictate acceptable parameters for flow rates, pressure resistance, and sharps protection.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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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.

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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)

K160374

Device Name NovaCathTM Secure IV Catheter System

Indications for Use (Describe)

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.

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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 OwnerInformation:	Tangent Medical Technologies, Inc.8170 Jackson Rd. STE AAnn Arbor, MI 48103
ContactInformation:	Greg LastQuality Systems and Regulatory Affairs ManagerGreg@tangentmedical.comTel: 734-527-4051Fax: 734-253-2043
Device Name:	NovaCath™ Secure IV Catheter System
ProprietaryName:	NovaCath™ Secure IV Catheter System
Common Name:	Intravascular Catheter (short-term, less than 30 days, therapeutic)
ClassificationName:	Intravascular Catheter
ClassificationCode:	FOZ
RegulationNumber:	21 CFR §880.5200
PredicateDevice:	NovaCath™ Secure IV Catheter System (K120839)
DeviceDescription:	The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter. TheNovaCath™ currently has four commercially available models. This special 510(k) addstwo 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:

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 NeedleRetraction	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/minYes, 24G: 14 ml/min	Yes, 20G: 46 ml/minYes, 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 to300 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 FlowRate 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" CatheterModified Housing("Slider") Component	Test Access to the Sharp inSafe Mode	ISO 23908:2011

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Conclusions: The NovaCath™ Secure IV Catheter System as described in this Special 510(k) has been found to perform in the substantial equivalent manner as the predicate device.

Regulation Number and Section

§ 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).