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™ 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 up to a maximum of 300 psi.

Device Description

The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, peripheral intravascular catheter made from a radiopaque slender, flexible plastic, integrated extension tubing with a secondary stabilization hub system, a female luer lock and clamp, and a passive needle shielding mechanism. The design of the NovaCath™ System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. The needle is withdrawn through a septum that will seal after the needle has been withdrawn and the luer lock is closed, blood is contained within the NovaCath™ System during insertion. 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

Acceptance Criteria and Study for NovaCath™ Secure IV Catheter System

The NovaCath™ Secure IV Catheter System is cleared based on demonstrating substantial equivalence to predicate devices and meeting relevant performance, biocompatibility, and sterilization standards. No specific quantitative "acceptance criteria" for a novel performance metric are presented in the document, as the clearance is based on equivalence and adherence to established standards.

The primary "study" proving the device meets the acceptance criteria is a simulated clinical use study for its sharps injury prevention feature, in addition to extensive non-clinical and biocompatibility testing. The data predominantly supports claims of equivalence to existing devices and compliance with recognized standards for medical devices of this type.

1. Table of Acceptance Criteria and Reported Device Performance

Given that the submission is for a 510(k) clearance based on substantial equivalence and adherence to recognized standards, the "acceptance criteria" are generally framed as meeting the requirements of these standards or demonstrating performance comparable to predicate devices. There are no specific quantitative metrics provided for "reported device performance" in the way one might see in a de novo pre-market authorization for a completely novel AI diagnostic, rather, it's about confirming compliance.

Acceptance Criteria Category	Specific Acceptance Criteria (or Standard Met)	Reported Device Performance
General Device Design	Substantial equivalence to predicate devices (K032843, K971339, K051355)	The NovaCath™ System is "substantially equivalent in device description, intended use, function, principle of operation, and basic composition" to the predicate devices. Table 1 provides detailed comparisons, showing the NovaCath™ generally matches or improves upon predicate features (e.g., dual flash visualization, integrated passive sharps injury prevention, primary & secondary stabilization).
Performance Testing	ISO 10555-1: General requirements for sterile, single-use intravascular catheters	"Successfully tested to meet the applicable requirements outlined in ISO 10555-1."
	ISO 10555-5: Over-needle peripheral catheters	"Successfully tested to meet the applicable requirements outlined in ISO 10555-5."
Flow Rate	Comparable to predicate devices (e.g., BD Nexiva, BD Insyte)	For 20G: NovaCath™ reports 52.55 ml/min, which is comparable to predicate devices (BD Nexiva 20G: 45 ml/min, BD Insyte 20G: 65 ml/min).
Biocompatibility	FDA Blue Book Memorandum - #G95-1 Table 1 Initial Evaluation Test for Consideration and relevant ISO 10993 standards	"Successfully tested... to establish that the NovaCath™ Secure IV Catheter System meets the appropriate biocompatibility testing requirements." Classified as an external communicating, prolonged (24hrs to less than 30 days) circulating blood contact device.
Sterilization	ANSI/AAMI/ISO 11135-2 (Sterility Assurance Level of 10-6)	"Will be released to market with a Sterility Assurance Level of 10-6, per the requirements set forth in ANSI/AAMI/ISO 11135-2." Maximum levels of ethylene oxide and ethylene chlorohydrin residues will not exceed ISO 10993-7 limits.
Shelf-life	ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems for Medical Devices)	"Shelf-life and expiry dating meet the requirements of ASTM F1980-07," supported by real-time shelf-life data.
Sharps Injury Prevention	FDA Guidance for Medical Devices with Sharps Injury Prevention Features	A "simulated clinical use study was successfully conducted in accordance with: FDA Guidance for Medical Devices with Sharps Injury Prevention Features." The device is described as having an "integrated sharps injury prevention device (passive)" and that "Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure" and the needle-shielding feature "aids in the prevention of needlestick injuries."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" in the context of an AI/ML algorithm evaluation, as this is a medical device clearance based on engineering, performance, biocompatibility, and simulated use testing.

Simulated Clinical Use Study (Sharps Injury Prevention): The sample size for this study is not explicitly stated.
Data Provenance: The document does not specify the country of origin for the simulated clinical use study or other testing data. It is a prospective study in the sense that it was conducted specifically to support this regulatory submission, but it is a "simulated" study, not involving actual patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert-established ground truth on a test set of data. The "ground truth" for the device's performance is established by adherence to recognized engineering, biocompatibility, and safety standards, and by successful completion of simulated use testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device involving multi-reader adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and therefore no MRMC study with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's regulatory clearance is compliance with established international and national standards (e.g., ISO 10555-1, ISO 10555-5, ISO 10993, ANSI/AAMI/ISO 11135-2, ASTM F1980-07) and successful completion of simulated use testing to confirm safety features like sharps injury prevention and blood containment. For a physical device, this often involves objective measurements, material analysis, and functional tests rather than subjective expert consensus on image interpretation or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that utilizes a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that utilizes a training set.

Summary

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JUL 20 2012

TANGENT MEDICAL TECHNOLOGIES, INC. NOVACATH™ SECURE IV CATHETER SYSTEM

510(k) SUMMARY

July 11, 2012

The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:

Submitter Information: Tangent Medical Technologies, Inc. 8170 Jackson Road, STE A Ann Arbor, MI 48103

9/23/2005.

Contact Information:	Kay Fuller, RACVP, Regulatory and Clinical Affairskay @tangentmedical.com1+734-527-4060 / 1+734-846-7852
Device Name:	NovaCath™ Secure IV Catheter System
Proprietary Name:	NovaCath™Secure IV Catheter System
Common Name:	Intravascular Catheter (short-term)
Classification Name:	Catheter, intravascular, therapeutic, short-term less than 30 days
Classification Code:	FOZ
Regulation Number:	21 CFR § 880.5200
Predicate Device Equivalence:	The Tangent NovaCath™ Secure IV Catheter System issubstantially equivalent to the BD Nexiva™ Device cleared forU.S. commercialization via K032843 on 2/27/200, the BD Insyte®Catheter(s), cleared for US commercialization via K971339 on

12/24/1997 and the Retractable Technologies' VanishPoint® IV Catheter , cleared for US commercialization via K051355, on

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Device Description:

The NovaCath™ Secure IV Catheter System is inserted into the Indications for Use: 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™ System may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 gauge NovaCath™ System catheters are suitable for use with power injectors for a maximum of 300 psi.

The technological similarities between the subject NovaCath™ Secure IV Catheter System and the noted predicate devices are substantially equivalent. There are no new questions raised regarding safety or efficacy of the subject NovaCath™ Secure IV Catheter System. Table 1, below provides a summary comparison of the technological characteristics.

Comparison of Technological Characteristics:

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Table 1: Comparison Between NovaCath™ Secure IV Catheter System and Predicates

	NovaCathSecure IV Catheter System	K032843Nexiva	K971339Insyte	K051355VanishPoint
Comparison Criteria
Same Intended Use	Yes	Yes	Yes	Yes
Prescription Device (Rx Only)	Yes	Yes	Yes	Yes
Biocompatible Polyurethane Catheter	Yes	Yes	Yes	Yes
Biocompatible Materials of Fabrication	Yes	Yes	Yes	Yes
Closed System	Yes	Yes	No	No
Built-In Extension from Main Assembly	Yes, connecting tubing & reverse Y-configuration	Yes, connecting tubing & Y-configuration	No	No
Flashback Visualization	Yes, dual flash feature, allows for visualization at pre-priming & upon insertion	Yes, single, allows flash view upon insertion	Yes, single, allows flash view upon insertion	Yes, single, allows flash view upon insertion
Sharps Injury Prevention Feature	Yes, integrated sharps injury prevention device (passive)	Yes, integrated sharps injury prevention device	Yes integrated sharps injury prevention device	No, Automatic needle retraction occurs with depression of the needle housing
General Specifications	Yes, overall size is consistent w/ other IV catheter devices once extension tubing is added	Yes, overall size is slightly different than other IV catheter devices, due to Y-connector tubing & manual needle retraction	Yes, overall size is consistent w/ other IV catheter devices	Yes, overall size is consistent with other IV catheter devices
Intended anatomical location	Yes, peripheral vasculature	Yes, peripheral vasculature	Yes, peripheral vasculature	Yes, peripheral vein or artery
Distal End Configuration	Yes, Catheter & Needle consistent w/ ISO 10555-5	Yes, Catheter & Needle consistent w/ ISO 10555-5	Yes, Catheter & Needle consistent w/ ISO 10555-5	No, Hub w/ female locking luer fitting per ISO 594
Proximal End Configuration	Yes, female luer access port	Yes, female luer access port & open hub	Yes, Open hub	Yes, Tube w/ tapered tip & one outlet. No side portsUNK
Flow Rate (ml/min)	Yes,20G: 52.55 ml/min	Yes,20G 45 ml/min	Yes,20G: 65 ml/min	UNK
Mechanical	Needle retraction is manual	Needle retraction is manual	Stainless steel spring for needle retraction	Automatic needle retraction w/slight depression of the needle housing
Catheter Stabilization	Yes, primary & secondary stabilization (platform and wings) provide 360° stabilization	Yes, stabilization wings	Yes, available w/winged hub	No
EO Sterilization Method	Yes	Yes	Yes	Yes
Packaged Sterile, Single Use	Yes	Yes	Yes	Yes
Non-pyrogenic	Yes	Yes	Yes	Yes
Made without Latex Rubber?	Yes	Yes	Yes	Yes
Made without DEHP?	Yes	Yes	No	Yes
Multiple Gauge Sizes & Needle Lengths	Yes	Yes	Yes	No
For use w/ Power Injectors up to 300 psi	Yes18G,20G,22G;	Yes	Yes	No

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Summary of Device Evaluation:

The NovaCath™ Secure IV Catheter System is substantially equivalent in device description, intended use, function, principle of operation, and basic composition to the predicate devices noted herein.

The NovaCath™ Secure IV Catheter System has been designed and tested to meet the requirements of relevant FDA consensus standards, voluntary standards and FDA regulations and guidance documents applicable to the subject and predicate devices. Results of the non-clinical testing support the conclusion of substantial equivalence to the NovaCath™ Secure IV Catheter System to the predicate devices noted herein.

Performance Testing:

The NovaCath™ Secure IV Catheter System has been designed and successfully tested to meet the applicable requirements outlined in ISO 10555-1 Sterile, single use intravascular catheters - Part 1 General requirements and ISO 10555-5 Sterile, single use intravascular catheters - Part 5 Over-needle perioheral catheters.

Biocompatibility Testing:

The NovaCath™ Secure IV Catheter System is classified as an external communicating, prolonged (24hrs to less than 30 days) circulating blood contact device. The device was successfully tested per the FDA Blue Book Memorandum - #G95-1 Table 1 Initial Evaluation Test for Consideration and relevant ISO 10993 related biocompatibility standards to establish that the NovaCath™ Secure IV Catheter System meets the appropriate biocompatibility testing requirements.

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Sterilization and Shelf-life Testing:

The NovaCath™ System will be released to market with a Sterility Assurance Level of 10-6, per the requirements set forth in ANSI/AAMI/ISO 11135-2. The NovaCath™ System is intended for single use only and not intended for reuse or re-sterilization by the user. The maximum levels of residues of ethylene oxide and ethylene chlorohydrin will not exceed the limits presented in ISO 10993-7. Shelf-life and expiry dating meet the requirements of ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, which is also supported by real-time shelf -life data.

Clinical Data:

A NovaCath™ Secure IV Catheter System simulated clinical use study was successfully conducted in accordance with: FDA Guidance for Medical Devices with Sharps Injury Prevention Features.

No prospective clinical trials were conducted in support of this Traditional 510(k).

Conclusions:

Based on the information contained herein, we conclude the NovaCath™ Secure IV Catheter System is substantially equivalent to the noted legally marketed Predicate devices and is safe and effective for its intended use.

pwie Sats

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Kay Fuller, RAC Vice President, Regulatory & Clinical Affairs Tangent Medical Technologies, Incorporated 8170 Jackson Road, Suite A Ann Arbor, Michigan 48103

JUL 20 2012

Re: K120839

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: July 3, 2012 Received: July 5, 2012

Dear Ms. Fuller:

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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Page 2 - Ms. Fuller

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 1 5809 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Antony D. arar

Anthony D. Watson, B.S., M.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

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Indications for Use

510(k) Number (if known): K120839

Device Name: NovaCath™ Secure IV Catheter System

Indications for Use:

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atricia Bustos for David Chapman

Ivision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _K 120039 Page 1 of

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).