(358 days)
Not Found
Not Found
No
The summary describes a mechanical valve for controlling fluid flow and blood loss during vascular access procedures. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is a hemostasis valve used to control blood loss and fluid flow during vascular access, which is a supportive function during a medical procedure, not a therapeutic treatment for a disease or condition itself.
No
This device is a hemostasis valve used to control blood and fluid flow and provide a seal during vascular access procedures. Its function is to manage fluid, not to diagnose a condition or disease.
No
The device description clearly describes a physical hemostasis valve, which is a hardware component used in medical procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IN-LINE Hemostasis Valve is a mechanical device used to control blood flow and maintain a seal during vascular procedures. It interacts directly with the vascular system in vivo (within the living body), not with samples in vitro (outside the living body).
- Intended Use: The intended use clearly describes its function within the vascular system during procedures involving catheters and guide wires.
- Device Description: The description focuses on its mechanical function and configuration for controlling fluid flow within the vascular system.
There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
A hemostasis valve is a device which is used to control the amount of blood loss or fluid 801-253-1600 flow while permitting vasculature access. An "in-line" hemostasis valve is a device used to control fluid which is geometrically configured in a single straight path. The inner lumen does not have additional or intersecting fluid paths.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
Products have been tested to substantiate Merit's claim that the hemostasis provides a leak-proof seal around angioplasty catheters and guide wires.
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.
Merit Y-adaptor with hemostasis valve
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol followed by the word "MERIT" in bold, black letters. The word "MEDICAL" is written to the right of "MERIT" in an outlined font.
MAR 1 5 2000
510(k) SUMMARY This summary was prepared on March 19, 1999
| Submitter's name: | Chester McCoy, RA
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095
P(801) 253-1600 ext. 404
F(801) 253-1684 | MERIT MEDICAL
SYSTEMS, INC.
1600 WEST
MERIT PARKWAY
SOUTH JORDAN, |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Contact Person: | Same as above | |
| Name of device: | IN-LINE Hemostasis Valve (Passage | |
| Common name: | Hemostasis Valve | |
| Classification name: | Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting
(74DTL) | |
| Predicate device: | Merit Y-adaptor with hemostasis valve | |
PRODUCT DESCRIPTION
A hemostasis valve is a device which is used to control the amount of blood loss or fluid 801-253-1600 flow while permitting vasculature access. An "in-line" hemostasis valve is a device used to control fluid which is geometrically configured in a single straight path. The inner lumen does not have additional or intersecting fluid paths. FAX 801-253-1651
UTAH 84095
INTENDED USE
The Merit IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.
SUBSTANTIAL EQUIVALENCE STATEMENT
The IN-LINE Hemostasis Valve is manufactured from plastics that have a history of safe blood contact use. Products have been tested to substantiate Merit's claim that the hemostasis provides a leak-proof seal around angioplasty catheters and guide wires. The IN-LINE Hemostasis Valve's intended use is similar to the predicate device's intended use.
Therefore, Merit Medical Systems, Inc. believes this product is substantially equivalent to the predicate device and that its introduction into interstate commerce will not raise new questions of safety or efficacy.
1
Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
Mr. Chester McCoy Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re: K990975 Merit IN-LINE™ Hemostasis Valve Requlatory Class: II (two) Product Code: DYB Dated: December 15, 1999 Received: December 16, 1999
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Chester McCoy
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Chistopher Alan for.
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
| 510(k) Number (if Known) | K990975 |
|---|---|
| Device Name | INspector™ Hemostasis Valve |
| Indications for Use | The IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires. |
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