CoLign™ The Hemostasis Valve is intended to to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller.

The insertion tool facilitates introduction of the guide wire go through the hemostasis valve.

The torquer when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.

Device Description

The CoLign Hemostasis Valve is a device that can be operated with only one hand through its special "push-pull" mechanism. In the pushed-down position, the valve is open for safe insertion and removal of devices. In the pulled-up position, the valve is closed and seals smoothly round the inserted devices. Once the valve is closed, devices can still be manipulated freely. CoLign eliminates the need for adjustment of the hemostasis valve by rotating during the procedure. The CoLign Hemostasis Valve is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the CoLign Hemostasis Valve: the Standard CoLign , the CoLign 20,and the CoLign 50. The configuration of the sideport is the only difference among the three models. The sideport of the Standard CoLign ends in a male luer, while the sidearm of the CoLign 20/50 ends with a 20/50 cm extension tubing and 3-way stopcock.

AI/ML Overview

Here's an analysis of the provided text regarding the CoLign™ Hemostasis Valve, focusing on the acceptance criteria and study data:

It's important to note that the provided text is a 510(k) Premarket Notification for a medical device. This type of submission aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the "acceptance criteria" and "study" information will differ significantly from what one might expect for a novel device requiring a PMA (Premarket Approval).

The "acceptance criteria" in this context refers to the performance characteristics that the CoLign™ Hemostasis Valve needed to meet to be considered substantially equivalent to its predicate device. The "study" refers to the non-clinical performance testing conducted to demonstrate these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the acceptance criteria are largely implied by the comparison to the predicate device and the typical tests for this device type. The reported device performance is presented as meeting these criteria.

Acceptance Criteria Category	Specific Criteria / Measurement	CoLign™ Hemostasis Valve Performance (Reported)
Material Equivalence	Component materials should be identical or highly similar to predicate.	Identical materials (Poly carbonate for Valve Body, Silicone for O-ring)
Optimal Inner Lumen	7 French (2.33mm/0.092")	7 French (2.33mm/0.092")
Inner Diameter (Narrowest)	7.2F/2.4mm/0.094"	7.2F/2.4mm/0.094"
Device Diameter Range	Max: 7F/2.33MM/0.092", Min: 0.53F/0.17mm/0.007"	Max: 7F/2.33MM/0.092", Min: 0.53F/0.17mm/0.007"
Pressure Resistance (with catheter & guidewire)	8 bar	8 bar
Pressure Resistance (without device)	21 bar (predicate)	20 bar
Visual Inspection	Pouch integrity (no damage, proper seal)	Met requirements
Pouch Peel Test	Adequate seal strength for packaging	Met requirements
Leak Test (without products)	No leakage	Met requirements
Leak Test (with guide wire & hypo tube)	No leakage	Met requirements
Tensile Test	Assembly of PU tube/PC fitting integrity	Met requirements
Product Stability	Shelf life validation	Met requirements
Sterilization	Effective sterilization (ETO)	Met requirements
Biocompatibility	Hemolysis, Pyrogenicity, other ISO 10993 requirements	All tests met requirements specified in ISO 10993 (Hemolysis, Pyrogenicity)

Note on "Acceptance Criteria": For a 510(k), the primary "acceptance criterion" is often demonstrated substantial equivalence to the predicate device, which is shown by comparing technological characteristics and performance test results. Many of the reported performances are directly compared against the predicate's stated specifications or generally accepted industry standards for such devices. The "Met requirements" for tests like visual inspection or peel tests imply internal company-defined acceptance criteria based on good manufacturing practices and risk assessment.

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

Sample Size: The document does not specify the exact sample sizes for each of the performance tests (e.g., how many valves were subjected to leak testing or pressure resistance testing). It is typical for such non-clinical tests to use a statistically relevant but often small number of units (e.g., N=3 to N=10 per test) to demonstrate performance.
Data Provenance: The studies were conducted by Jilin Coronado Medical Ltd. The data is non-clinical performance test data, likely conducted in a controlled laboratory setting (in-house or third-party lab) by the manufacturer. The country of origin for the testing would be China, where the manufacturer is located. The nature of these tests makes them prospective in the sense that they were designed and executed to evaluate the new device's performance against predefined criteria.

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

This question is not applicable to this type of submission. The ground truth for the non-clinical performance tests (e.g., pressure resistance, leak testing, material composition) is established by physical measurement, chemical analysis, and engineering standards. It does not involve human expert interpretation of data like imaging studies.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where multiple human readers interpret patient data and discrepancies need to be resolved. Performance testing of a physical device against engineering specifications does not involve such human "readings" or adjudication. The results are typically quantitative measurements or qualitative observations that conform to a standard.

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

This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks (e.g., radiology). The CoLign™ Hemostasis Valve is a physical medical device (hemostatic valve), not an AI-powered diagnostic tool. Therefore, no MRMC study was performed or is relevant here.

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

This question is not applicable. This device is a physical, mechanical medical device. It does not involve any algorithm or AI component, so the concept of "standalone algorithm performance" is irrelevant.

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

The "ground truth" for the non-clinical performance tests is based on established engineering standards, material specifications, and validated test methods. For example:
- Pressure Resistance: Ground truth is a measured pressure, compared against a specified bar value.
- Biocompatibility: Ground truth is determined by compliance with ISO 10993 standards, involving quantitative and qualitative lab tests (e.g., cell culture assays for cytotoxicity, chemical analyses for extractables).
- Leak Test: Ground truth is the absence of fluid leakage under defined conditions.
- Material Composition: Ground truth is the chemical identity of the materials (e.g., polycarbonate, silicone) as confirmed by material testing.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train machine learning models. As established, this device is a physical medical component and does not involve AI or machine learning.

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

This question is not applicable for the same reason as point 8. There is no training set for a device of this type.

Summary

{0}------------------------------------------------

1 Submitter

Jilin Coronado Medical Ltd. 9 South-west Circle Road, Fengman Economic Development Zone Jilin City. China Tel: 86-432-63529555 Establishment Registration Number: 3009718176

Official contact: Ms Tianya Ma, Regulatory Affairs Tel: 86-432-63529555 ext 610 Fax: 86-432-63528222 Email: tyma@coronadomed.com

2 Device

AUG 2 8 2013

Trade name:	CoLign™ Hemostasis Valve
Common Name:	Hemostatic Valve
Classification Name:	Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting
Classification:	Class II
Regulation Number:	870.4290
Product code:	DTL

3 Predicate Device

The predicate devices is used to determine the substantial equivalence between the CoLign Hemostasis Valve and the EasyPass" Y-connector Hemostatic Valve marketed by Millimed A/S( # K042060)

4 Device Description

5 Intended Use

{1}------------------------------------------------

CoLign™ Hemostasis Valve is intended to to maintain hemostasis during the The introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller.

The insertion tool facilitates introduction of the guide wire through the hemostasis valve.

The torque when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.

6 Comparisons of Technological Characteristics

Comparing CoLign Hemostasis Valve with the predicate devices, it has shown that the technological characteristics of the CoLign Hemostasis Valve such as materials used, performance, and sterilization are identical or substantially equivalent to the currently marketed predicate device method.

General Information	CoLign™	EasyPass™
Manufacturer	Jilin Coronado Medical Ltd	Millimed A/S
Intended Use	CoLign Hemostatic Valve isintended to maintain hemostasisduring the introduction, use andwithdrawal of diagnostic andinterventional devices that have anouter diameter of 7 French orsmaller.	Same
Operational Principle	Pull-push valve with one-handoperation	Pull-push valve opener enablessingle handed control
Sterilization Method	ETO	ETO
Sub-component functiondesign	CoLign™	EasyPass™
Y-hub	Main body of the product	Same
Bridge valve	Holding the silicone valve in place	Similar Design
Hemositatic valvesandwich	Maintain sealing with or withoutproducts inserted through the valve	Similar Design
Valve opener	Mechanic opening of the siliconevalve, by pushing a hollow tubethrough the valve	Same
Extension-tube	Functions as an extension of theproduct to be connected withadditional accessories	Same

{2}------------------------------------------------

3-Way Stopcock	Enabling joining of accessories tothe distal end of the PU-tube	Same
Introducer Needle(Accessory)	Ensure a safe passage of productthrough the silicone valve	Same
Torquer Device(Accessory)	Ensure better handling of guidewires	Same
Specification comparison	CoLign™	Eas Pass™
Optimal inner lumen	7 French(2.33mm/0.092")	7 French(2.33mm/0.092")
Inner diameter ofnarrowest portion	7.2F/2.4mm/0.094"	7.2F/2.4mm/0.094"
Diameter of device toinserted	Maximum7F/2.33MM/0.092"Minimum0.53F/0.17mm/0.007"	Maximum7F/2.33MM/0.092"Minimum0.53F/0.17mm/0.007"
Pressure resistance withcatheter and guidewire	8bar	8bar
Pressure resistancewithout device	20bar	21bar
Component material	CoLign™	EasyPass™
Valve Body	Poly carbonate	Poly carbonate
O-ring	Silicone	Silicone

7 Performance Data

The results of the performance testing have demonstrated of the CoLign™ Hemostasis Valve.

Visual Inspection for Pouch Integrity .
Pouch Peel Test .
Leak Test without products inserted .
Leak test with guide wire and hypo tube inserted .
Pressure Resistance Test .
. Tensile test on assembly of PU tube/PC fitting
Product Stability (Shelf Life) .
Product Sterilization .
Biocompatibility Testing (all the test met the requirements specified in ISO 10993) .
- Hemolysis -
- Pyrogenicity ।
8 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests supports the substantial equivalence between CoLign Hemostasis Valve and the predicate device mentioned immediately above.

{3}------------------------------------------------

の Conclusion

It can be concluded that the CoLign Hemostasis Valve has demonstrated the substantial equivalence to the predicate devices with respect to intended use, technological characteristics.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is made up of three curved lines that represent the wings and body of the bird.

· Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

August 28, 2013

Jilin Coronado Medical, Ltd. Ms. Nicole Ma Regulatory Specialist 9 South-west Ring Road Fengman Economic Development Zone Jilin City, China 132016

Re: K131124

Trade/Device Name: CoLign Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II Product Code: DTL Dated: May 27, 2013 Received: June 03, 2013

Dear Ms. Ma:

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. However, we remind you 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.

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

{5}------------------------------------------------

Page 2 - Ms. Nicole Ma

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

M. A. Ellison

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

Enclosure

{6}------------------------------------------------

Annex 1- Indication for Use Statement

Ki31124 510(k) Number (if known): ___ Device

Name: CoLign™ Hemostasis Valve

The insertion tool facilitates introduction of the guide wire go through the hemostasis valve.

The torquer when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) 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)

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.