(71 days)
No
The summary describes a purely mechanical valve with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The description indicates the device, a hemostasis valve, is intended to maintain a fluid-tight seal around other medical devices, not to directly treat a medical condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended to maintain a fluid-tight seal around interventional and diagnostic devices, rather than performing a diagnostic function itself.
No
The device description explicitly lists physical components like a polycarbonate body, silicone valve, and Luer lock connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain a fluid-tight seal around interventional and diagnostic devices during use." This describes a function related to the delivery or access of other medical devices within the body, not the examination of specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description details the physical components of a valve designed for sealing, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
The device appears to be an accessory used in conjunction with other medical devices during procedures, rather than a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Hemostasis Valve is intended to maintain a fluid-tight seal around interventional and diagnostic devices during use.
Product codes
DTL
Device Description
The Hemostasis Valve is a valve consisting of a clear polycarbonate body, silicone valve, polyacetal actuation lever, and polycarbonate and EPDM o-ring rotating male Luer lock connector and female Luer lock.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Merit Passage® Hemostasis Valve (K925419)
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.
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SECTION 5: 510(k) SUMMARY
NOV 2 0 2007
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
| CONTACT: | Shirley Hyink |
|---|---|
| DATE PREPARED: | September 7, 2007 |
| TRADE OR PROPRIETARY NAME: | Hemostasis Valve |
| CLASSIFICATION NAME: | Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting |
| 21CFR 870.4290 | |
| PREDICATE DEVICE: | Merit Passage® Hemostasis Valve (K925419) |
DEVICE DESCRIPTION: The Hemostasis Valve is a valve consisting of a clear polycarbonate body, silicone valve, polyacetal actuation lever, and polycarbonate and EPDM o-ring rotating male Luer lock connector and female Luer lock.
Image /page/0/Picture/5 description: The image shows a detailed technical drawing of a mechanical device, possibly a type of valve or actuator. The device features a cylindrical body with various attachments and levers. The drawing style suggests it is a blueprint or schematic, emphasizing the mechanical components and their arrangement.
INTENDED USE: The Hemostasis Valve is intended to maintain a fluid-tight seal around interventional and diagnostic devices during use.
TECHNOLOGICAL CHARACTERISTICS: The Hemostasis Valve and the predicate device Passage are similar in design and technology. All of the component materials found in the Hemostasis Valve have been used in legally marketed Merit devices and were found safe for their intended use.
The prior use of component materials of the Hemostasis Valve in legally marketed devices, a similar indication for use, the performance data provided, and the biocompatibility statement support the safety and effectiveness of this hemostasis valve for the indicated use.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird, with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2007
Merit Medical Systems, Inc. c/o Ms. Shirley Hyink Manager, Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095
Re: K072556 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: September 7, 2007 Received: September 10, 2007
Dear Ms. Hyink:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Shirley Hyink
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uma R. lochner
\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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SECTION 4: INDICATIONS FOR USE
KOZ2556 510(k) Number (if known):
Device Name: Hemostasis Valve
Indications for Use:
The Hemostasis Valve is indicated to maintain a fluid-tight seal around interventional and diagnostic devices during use.
Prescription Use X (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)
suma R. Jaimes
(Division Sign-Off) (Division of Cardiovascular Devices
310(k) Number K072556
Premarket Notification
Hemostasis Valve
Merit Medical Systems, Inc.
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