The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French.

The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter.

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

Device Description

The E-Pass is a unique one-hand operated, "push-pull" hemostatic valve system. It consists of two pieces of silicone hemostasis valve. The quick open-close valve reduces the patient blood loss significantly during endovascular procedures. In the push forward position the valves is 100% open for safe insertion and removal of devices. In the pulled back position the valve is 100% closed and seals smoothly around the inserted devices. Once the valve is closed, devices can still be manipulated freely. E-Pass eliminates the need for rotating hemostatic valve adjustments during the procedure. The E-Pass hemostatic valve system is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the E-Pass: the standard E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only difference among the three models. The sideport of the standard E-Pass ends in a female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.

AI/ML Overview

The provided text describes a 510(k) summary for the E-Pass™ Hemostasis Valve. However, it does not include detailed acceptance criteria or a comprehensive study report with specific performance metrics to fill a table and address all the requested points.

The document states:

"The results of the performance testing demonstrated the safety and effectiveness of the E-Pass TM Hemostatic Valve."
"Performance testing mainly includes the following tests: Visual Inspection for Pouch Integrity, Pouch Peel Test, E-Pass Visual Inspection, Leak Test without products inserted, E-Pass Alarm pressure leak rate, Tensile test on assembly of Extention tube/Y-hub."

This lists the types of tests performed but does not provide the acceptance criteria or reported results for these tests. Therefore, I cannot construct the requested table or answer many of the specific questions.

Here's what can be inferred or stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Visual Inspection for Pouch Integrity	Not specified in the provided text. (Typically involves absence of tears, punctures, proper seals, etc.)	"demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test).
Pouch Peel Test	Not specified in the provided text. (Typically involves peel strength within a defined range).	"demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test).
E-Pass Visual Inspection	Not specified in the provided text. (Typically involves absence of defects, proper assembly, correct labeling).	"demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test).
Leak Test without products inserted	Not specified in the provided text. (Typically involves a maximum allowable leak rate under specified pressure).	"demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test).
E-Pass Alarm pressure leak rate	Not specified in the provided text. (Typically involves a maximum allowable leak rate at alarm pressure conditions).	"demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test).
Tensile test on assembly of Extension tube/Y-hub	Not specified in the provided text. (Typically involves a minimum tensile strength or force required to cause separation).	"demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test).
Overall Conclusion	The device is considered "substantially equivalent" to the predicate device based on comparison of technological characteristics such as materials, performance characteristics, and sterilization. The performance testing "demonstrated the safety and effectiveness."	The device was cleared by the FDA, indicating it met the requirements for substantial equivalence. No specific quantitative performance data is provided in the summary.

Missing Information:

The provided 510(k) summary is very high-level and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific quantitative results typically found in full test reports. This type of detail is usually in the appendices or a more comprehensive submission, not in the summary document provided.

Therefore, for the remaining points, most answers are "Not specified" or "Not applicable" based solely on the provided text.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., retrospective or prospective, country of origin). This involves physical testing of the device, not clinical data that would typically have country of origin.

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

Not applicable. This device is a hemostatic valve, and the testing described consists of engineering/physical performance tests (e.g., leak tests, tensile tests, visual inspections), not clinical studies requiring expert image interpretation or ground truth establishment in a diagnostic sense.

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

Not applicable. As above, this is physical performance testing, not a diagnostic study requiring adjudication of expert interpretations.

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 device is a hemostatic valve, not an AI-powered diagnostic tool.

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

Not applicable. This device is a hemostatic valve, not an algorithm or AI system.

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

Not applicable. The "ground truth" for this device's performance would be the specifications and requirements for mechanical and sealing integrity, based on engineering standards and design validation.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable. As above.

Summary

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K113148
pg 1 of 2

FEB 2 8 2012

510 (k) summary

5. 1 Submitter

Synexmed (Shenzhen) company limited B-11/F, ZTY Building, Taohua Road, Futian Free Trade Zone Shenzhen, 518038, China Tel: (86 755) 8358 0375 Establishment Registration Number: 3008388400

Official contact: Mr. Yongwei Chien, CEO Tel: (86 755) 8358 0375 ext 808 Fax: (86 755) 8359 1037 E-mail: echien@synexmed.com

5.2 Device

Trade name:	E-PassTM
Classification Name:	Cardiopulmonary Bypass Adaptor, Stopcock, Manifold orFitting
Classification:	Class II
Common Name:	Hemostatic Valve
Regulation Number:	870.4290

5.3 Predicate Device

The predicate devices used to determine substantial equivalence for the EasyPass Y-connector Hemostatic Valve marketed by Millimed A/S (#K042060).

5.4 Device Description

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E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only The sideport of the standard E-Pass ends in a difference among the three models. female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.

5.5 Intended Use

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

The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter.

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

5.6 Comparison of Characteristics

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, and sterilization are identical or substantially equivalent to the currently marketed predicate devices.

5.7 Performance Data

The results of the performance testing demonstrated the safety and effectiveness of the E-Pass TM Hemostatic Valve.

Performance testing mainly includes the following tests:

Visual Inspection for Pouch Integrity
Pouch Peel Test �
E-Pass Visual Inspection .
Leak Test without products inserted
E-Pass Alarm pressure leak rate
Tensile test on assembly of Extention tube/Y-hub

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a simple, abstract style, and the text is in a sans-serif font.

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

FEB 2 8 2012

Synexmed Shenzhen Company Limited c/o Ms. Ada Ho Regulatory Assistant B-11/F, ZTY Bldg, Taohua Road, Futian Free Trade Zone Shenzhen, Guangdong 518038 China

Re: K113148

Trade/Device Name: E-Pass™ Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL, DQX Dated: October 8, 2011 Received: October 24, 2011

Dear Ms. Ho:

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. Ada Ho

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 (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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. G. Allehenne

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

Enclosure

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Indications for Use

510(k) Number (if known):_K113148

Device Name:E-Pass™

Indications For Use:

The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French.

The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter.

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Hillieman

(Division Sign-Off) Division of Cardiovascular Devices

113148 510(k) Number

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.