(127 days)
Not Found
No
The device description and performance testing focus on mechanical function and hemostasis, with no mention of AI or ML.
No.
The device is a hemostatic valve system intended to maintain hemostasis during interventional procedures by preventing blood loss, rather than directly treating a medical condition or disease.
No
The E-Pass is described as a hemostatic valve system intended to maintain hemostasis during the introduction and withdrawal of diagnostic and interventional devices, not as a device that performs diagnosis itself.
No
The device description clearly outlines a physical, mechanical hemostatic valve system with components like silicone valves, a push-pull mechanism, and a sideport. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for maintaining hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices. This describes a function performed on the patient during a medical procedure, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a mechanical valve system designed to control blood flow during a procedure. This is consistent with a medical device used in vivo, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents or assay components
The device is a tool used during a medical procedure to manage blood loss, which falls under the category of a medical device used in vivo.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DTL, DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
The results of the performance testing demonstrated the safety and effectiveness of the E-Pass TM Hemostatic Valve.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 or |
| Fitting | |
| 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
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
1
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.
3
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
2
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.
3
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