The Flush Connector consists of a main lumen body with a hemostasis valve at one end and a rotating male luer at the other end. In addition, the body has a side arm lumen with attached extension tube and female luer fitting. The haemostatic valve is designed to seal around a guide wire, stiffening wire, or other devices: and the side arm tubing is provided for fluid administration and flushing. The rotating male luer is designed to a female luer such as on a catheter. The proposed Flush Connector may be provided as a stand alone device or may be provided in a kit configuration with other legally marketed devices as a convenience to the user.

AI/ML Overview

The provided text is a 510(k) summary for the Navilyst Medical Flush Connector. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics typically found in clinical trials or software validation studies.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, and ground truth establishment for a diagnostic AI/ML device is not directly available in this type of regulatory submission.

This document describes a physical medical device (Flush Connector) and its performance evaluation is done through a series of bench tests and biocompatibility assessments against established standards, not through clinical studies involving human readers or AI.

However, I can extract the relevant information from the document regarding the performance evaluation that was conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria/Standard	Reported Device Performance
Functional Testing	ISO 594-2 (Luer fittings)	Assessed in accordance with this standard. (Specific quantitative results for leak, flex, pull strength are not provided in the summary, but implied by compliance.)
	EN ISO 11070 (Sterile intravascular catheters)	Assessed in accordance with this standard. (Specific quantitative results for leak, flex, pull strength are not provided in the summary, but implied by compliance.)
	EN ISO 8536-9 (Infusion equipment)	Assessed in accordance with this standard. (Specific quantitative results for leak, flex, pull strength are not provided in the summary, but implied by compliance.)
	Various Functional Evaluations	Included evaluation for air and hydrodynamic leak, luer bond flex and pull strength, valve detachment, collar rotation, securement, and interface with ancillary devices. (Specific quantitative results are not provided, but the statement implies successful completion of these tests.)
Biocompatibility	ANSI/AAMI/ISO 10993 (Biological evaluation of medical devices)	Assessed for Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Injection, Pyrogenicity, Hemolysis, Complement Activation, and Thromboplastin. (Specific quantitative results or pass/fail decisions are not provided, but implied by compliance.)
	ASTM F750 (Cytotoxicity)	Assessed in accordance with this standard.
	USP 29<88>, USP 31 NF26 <88>, USP (31) <661> (Biological tests)	Assessed in accordance with these standards.
Sterilization & Packaging	AAMI/ANSI/ISO 10993-7 (Ethylene oxide sterilization residuals)	Assessed in accordance with this standard.
	AAMI/ANSI/ISO 11135-1 (Ethylene oxide sterilization validation)	Assessed in accordance with this standard.
	AAMI/ANSI/ISO 11138-1 (Biological indicators)	Assessed in accordance with this standard.
	AAMI/ANSI/ISO 11737-1 (Microbiological methods)	Assessed in accordance with this standard.
	AAMI ST72 (Bacterial endotoxins)	Assessed in accordance with this standard.
	EN 556-1 (Sterilization of medical devices)	Assessed in accordance with this standard.
	ANIS/AAMI/ISO 11607 Part 1&2 (Packaging)	Assessed in accordance with this standard.
	ASTM F1980 (Accelerated aging of sterile barrier systems)	Assessed in accordance with this standard.
	F88 (Seal strength)	Assessed in accordance with this standard.
	F1929 (Seal integrity)	Assessed in accordance with this standard.
	F1886 (Microbial barrier properties)	Assessed in accordance with this standard.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes for each test mentioned (e.g., how many Flush Connectors were tested for leak, or how many iterations of a biocompatibility test were performed).
The data provenance is not specified in terms of country of origin, but these are typically laboratory bench tests performed by the manufacturer or contracted labs. The tests are "retrospective" in the sense that they are performed on manufactured devices for regulatory submission, rather than prospective clinical data collection.

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

This information is not applicable to the type of device and testing described. The "ground truth" for a physical device's performance is determined by adherence to established engineering and material science standards, not by expert consensus on interpretations.

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

This concept is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) where disagreement can occur. Bench tests provide objective pass/fail results or quantitative measurements that are typically not subject to such adjudication.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical component, not an AI/ML diagnostic tool or software.

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

No, a standalone algorithm performance evaluation was not done. This device has no AI/ML component.

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

The "ground truth" for this device's performance derives from established international and national standards (e.g., ISO, EN, ASTM, USP) for medical device functionality, materials, sterilization, and biocompatibility. Compliance with these standards serves as the "ground truth" that the device is safe and effective for its intended use as a physical connector.

8. The sample size for the training set:

This is not applicable. The device is not an AI/ML model and therefore does not have a "training set."

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

This is not applicable. The device is not an AI/ML model and therefore does not have a "training set" or a ground truth established for it in that context.

Summary

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K09/634

MAR - 1 2010

Marhorough MA 017

v.navilystmedical.com

510(k) Summary

A. Sponsor

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

B. Contact

Lori Fitton Regulatory Affairs Specialist 508-658-7938

Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945

C. Device Name

Trade name: Common/usual name: Classification Name:

Flush Connector Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting DTL - Cardiovascular 21 CFR 870.4290, Class II

D. Predicate Device(s)

Trade Name: Common/usual name: Classification Name: Premarket Notification:

GateWay™ Plus Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting DTL - Cardiovascular21 CFR 870.4290, Class II Boston Scientific Corporation previously Scimed Life Systems, Inc. Scimed Gateway Plus, K951089

E. Device Description

F. Intended Use

The Flush Connector is indicated for providing hemostasis around catheters, guidewires, and other devices during general intravascular procedures.

G. Performance Evaluation

The proposed flush connector was assessed in accordance with various FDA recognized Standards and voluntary industry standards including: ISO 594-2, EN ISO 11070, EN ISO 8536-9. Testing included evaluation for air and hydrodynamic leak, luer bond flex and pull strength, valve detachment, collar rotation, securement and interface with ancillary devices. ANSI/AAMI/ISO 10993 Cytotoxicity, Sensitization, Intracutaneous Irritation. Acute Systemic Injection, Pyrogenicity, Hemolysis, Complement Activation, and Thromboplastin. ASTM F750, USP 29<88>, USP 31 NF26 <88> and USP (31) <661>; A AMI/ANSI/ISO 10993-7, A AMI/ANSI/ISO 11135-1, AAMI/ANSI/ISO 11138-1, AAMI/ANSI/ISO 11737-1, AAMI ST72, EN 556-1; ANIS/AAMI/ISO 11607 Part 1&2, ASTM F1980, F88, F1929, and F1886.

H. Substantial Equivalence

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.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare and medicine.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Navilyst Medical Incorporated c/o Ms. Lorraine Hanley Director Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752

MAR - 1 2010

Re: K091634

Trade/Device Name: Flush Connector Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II (two) Product Code: DTL Dated: January 8, 2010 Received: January 11, 2010

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. 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.

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Page 2 - Ms. Lorraine Hanley

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.

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 (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 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,

Nume R.V. din

Image /page/2/Picture/8 description: The image shows a handwritten symbol that appears to be a combination of letters or a stylized signature. The symbol consists of a curved line resembling a 'C' or a crescent shape at the top, connected to a line that crosses diagonally downwards, similar to the letter 'X'. The overall impression is that of a unique, possibly personal, mark or initial.

Bram Zuckerman, MD Division Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if Known):	K091634
Device Name:	Flush Connector
Indications for Use:	The Flush Connector is indicated for providing hemostasis around catheters, guidewires and other devices during general intravascular procedures.

Prescription Use	X	AND/OR	Over-The-Counter Use ______
(21 CFR 801 Subpart D)	(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)

Dina D. Vicker

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_2016 24

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.