(68 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or any related concepts in the provided text.
No
The device is described as a hemostatic valve used to maintain hemostasis, facilitate guide wire introduction, and manipulate the guide wire. Its function is to support diagnostic and interventional procedures by managing blood flow and device insertion, rather than directly treating a disease or condition.
No
The device is described as a hemostatic valve intended to maintain hemostasis during the use of diagnostic and interventional devices, facilitating the introduction and withdrawal of such devices. It does not perform any diagnostic function itself.
No
The device description clearly outlines physical components (y-connector body, rotating luer lock, sidearm, hemostasis valve, valve opener cap, passage tube) and their mechanical function, indicating it is a hardware device.
Based on the provided information, the EasyPass™ US Y-connector Hemostatic Valve is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices within the body. This describes a device used in vivo (within a living organism) during medical procedures, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description details a mechanical device with a valve and connectors designed for use in a procedural setting, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the EasyPass™ US Y-connector Hemostatic Valve is a medical device used in interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.
The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.
The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.
Product codes
DTL
Device Description
The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.
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
The results of the performance testing demonstrated the safety and effectiveness of the EasyPass™ US Y-connector Hemostatic Valve.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2004
10-2
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Millimed A/S |
|---|---|
| Submitter's Address: | Langebjerg 2 |
| DK-4000 Roskilde | |
| Denmark | |
| Telephone: | +45 4676 1420 |
| Fax: | +45 4676 1970 |
| Contact Person: | Jannie Funch, Quality Manager |
| Date Prepared: | July 30, 2004 |
| Device Trade Name: | EasyPass™ US Y-connector Hemostatic Valve |
| Device Common Name: | Hemostasis Device |
| Device Classification Name: | Cardiovascular Surgical Devices |
Device Classification: Class II
Summary of Substantial Equivalence:
The EasyPass Y-connector Hemostatic Valve is substantially equivalent to Guidant Corporation's Copilot Bleedback Control Valve (K991102)
Device Description:
The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.
Intended Use:
The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.
1
The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.
20f2
The torquer, inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.
Technological Characteristics:
Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device.
Performance Data:
The results of the performance testing demonstrated the safety and effectiveness of the EasyPass™ US Y-connector Hemostatic Valve.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
OCT 6 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Millimed A/S c/o Ms. Jannie Funch Quality Manager Langebjerg 2 DK-4000 Roskilde Denmark
K042060 Re:
EasyPass™ US Y-connector hemostatic Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: July 30, 2004 Received: July 30, 2004
Dear Ms. Funch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regars comment date of the Medical Device Amendments, or to commerce proof to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices mat have been receised in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercerore, market the Act include requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (Socure) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FRA Inay be subject to sable additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
3
Page 2 - Ms. Jannie Funch
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ввиташов
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | EasyPass™ US Y-connector Hemostatic Valve |
| Indications for Use | The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller. |
| The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter. | |
| The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire. | |
| Prescription Use | X |
| OR Over-The-Counter Use | |
| (Per 21 CFR 801.109) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K042060 |