(22 days)
Not Found
No
The summary describes a mechanical valve for vascular procedures and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is described as being used during "intravascular therapeutic procedures," indicating it plays a role in treatment rather than just diagnosis.
No
Explanation: The device is described as a hemostasis valve used during therapeutic procedures (PTA and other intravascular procedures) to provide access and maintain hemostasis, not to diagnose a condition.
No
The device description clearly states it is a "Dual Seal Hemostasis Valve with an integral introducer," which are physical hardware components used in medical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures. This indicates a device used in vivo (within the body) for a therapeutic purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description of a "Dual Seal Hemostasis Valve with an integral introducer" aligns with a device used to manage bleeding and facilitate access during a medical procedure performed on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the MBA Hemostasis Valve is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MBA Hemostasis Valves are designed for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures that utilize a guiding catheter.
Product codes
DTL
Device Description
The MBA™ is a Dual Seal Hemostasis Valve with an integral introducer
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Attachment 4
510(k) Summary
SAFETY AND EFFECTIVENESS SUMMARY
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted by Name/Address: | Chester McCoy
Regulatory Affairs Engineer
Merit Medical Systems, Inc.
1600 West Merit Parkway |
|----------------------------|--------------------------------------------------------------------------------------------------------|
| | South Jordan, UT 84095
(801) 253-1600 ext. 404
(801) 253-1684 fax |
| Contact Person: | Same as above |
| Date Summary Prepared: | September 9, 1999 |
| Device Name: | MBA Hemostasis Valves |
| Common Name: | Hemostasis Valves |
| Trade Name: | MBA |
| Classification (if known): | Cardiopulmonary bypass adaptor, stopcock,
manifold, or fitting (74DTL) Class II |
| Predicate Device: | Passage™ Hemostasis Valve (K925419) |
1
| Device Description: | The MBA™ is a Dual Seal Hemostasis Valve with an integral introducer |
|---|---|
| Performance | |
| Standards: | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use: | The MBA Hemostasis Valves are designed for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures that utilize a guiding catheter. |
| Device Use: | During angioplasty and other interventional procedures, the patient's vasculature is accessed through a peripheral artery. To control bleed-back from the artery, a hemostasis valve is attached to the external female luer of a guiding catheter. This device is typically 'y' shaped with a female luer and a manual hemostasis valve. The female port is attached to a manifold system to allow for contrast injections and pressure monitoring, while the hemostasis valve allows controlled direct arterial access when using a guide wire and/or interventional therapy devices. |
| Biocompatibility: | All materials used in the MBA Hemostasis Valves are biocompatible. |
| Summary of | |
| Substantial | |
| Equivalence: | The Merit MBA Hemostasis Valves are substantially equivalent to the previously cleared Merit Passage Hemostasis Valves. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 1999
Mr. Chester McCoy Requlatory Affairs Engineer Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re : K993057
Trade Name: MBA™ Hemostasis Valves Regulatory Class: II Product Code: DTL Dated: September 9, 1999 Received: September 13, 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 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). 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 (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 Requlation (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 assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
3
Page 2 - Mr. Chester McCoy
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.
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) 594-4586. 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 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,
Thomas J. Callahon
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
| Indications for Use Statement | |
|---|---|
| 510(k) Number (if Known) | |
| Device Name | MBA TM Hemostasis Valves |
| Indications for Use | The MBA Hemostasis Valves are designed for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures that utilize a guiding catheter. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Kyy 510(k) Number
Prescription Use
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OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________