(27 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a standard electrosurgical probe, with no mention of AI or ML capabilities.
Yes.
The device's intended use is to provide hemostasis (stopping bleeding) within the gastrointestinal tract, which is a therapeutic intervention.
No
The device is described as a "Bipolar Coagulation Probe" intended to "provide hemostasis throughout the gastrointestinal tract." Hemostasis is a therapeutic function (stopping bleeding), not a diagnostic one. While it may be used in conjunction with diagnostic procedures, its direct purpose is treatment.
No
The device description clearly outlines physical components such as a plug, luer flush hub, tubing, wire, and a ceramic tip with metal electrodes, 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 "provide hemostasis throughout the gastrointestinal tract." This describes a therapeutic intervention performed directly on the patient's tissue, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a probe designed for delivering electrical energy for coagulation, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to stop bleeding within the body, which is a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Bipolar Coagulation Probe is intended to be passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.
Product codes
KNS
Device Description
The proximal end of the Merit Bipolar Coagulation Probe consists of a plug which connects to an electrosurgical generator and a luer flush hub which connects to an irrigation source. The plug comes in one of two configurations: a single or dual bipolar plug. The tubing from the plug encases a Teflon coated wire which is united with the flushing lumen from the luer in a Y connection. A single tube with the coated wire and flushing lumen leads from the Y connection to the distal probe tip. The distal end (tip) consists of uniformly spaced metal electrodes configured in a spiral fashion on the rounded ceramic tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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)
The verification testing required by the risk analysis was completed and included the following tests: tensile, flow, leak, high frequency leakage, high frequency dielectric strength, mains frequency dielectric strength, wiring continuity, kink resistance and tip separation. Testing results met the predetermined acceptance criteria.
The results of the testing performed demonstrate the subject device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
VA AERITAEDICA
K102273
py 1 of 2
Merit Medical Systems, Inc. 1,600 Viest Merit Parkway Scuth Iopdan. Utah 54095 PHONE: 201-253-1600 FAX 801-250 14:33 :www.pepl.com
5.0 510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Primary Contact:
Date of Preparation: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4187
(801) 253-6905
Dan W. Lindsay
August 9, 2010 | SEP 07 2010 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | To be assigned
Bipolar Coagulation Probe
Unit, electrosurgical, endoscopic (with or without
accessories) | |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Merit Bipolar Coagulation Probe
Unit, electrosurgical, endoscopic (with or without
accessories)
K912129
Merit Medical Systems, Inc. | |
| Classification | Class II
21 CFR §876.4300
Gastroenterology/Urology | | |
| Intended Use | The Bipolar Coagulation Probe is intended to be passed through an
endoscope's working channel to provide hemostasis throughout the
gastrointestinal tract. | | |
| Device
Description | The proximal end of the Merit Bipolar Coagulation Probe consists of a plug
which connects to an electrosurgical generator and a luer flush hub which
connects to an irrigation source. The plug comes in one of two
configurations: a single or dual bipolar plug. The tubing from the plug
encases a Teflon coated wire which is united with the flushing lumen from
the luer in a Y connection. A single tube with the coated wire and flushing
lumen leads from the Y connection to the distal probe tip. The distal end
(tip) consists of uniformly spaced metal electrodes configured in a spiral
fashion on the rounded ceramic tip. | | |
1
| pg 2 of 2 | |
|---|---|
| Technological Characteristics | The subject device has the same technological characteristics as the predicate device. Minor design changes were made to improve aesthetics, ergonomics and manufacturability of the device. |
| Performance Testing | The verification testing required by the risk analysis was completed and included the following tests: tensile, flow, leak, high frequency leakage, high frequency dielectric strength, mains frequency dielectric strength, wiring continuity, kink resistance and tip separation. Testing results met the predetermined acceptance criteria. |
| Testing Conclusion | The results of the testing performed demonstrate the subject device is as safe, as effective, and performs as well as or better than the predicate device. |
| Summary of Substantial Equivalence | Based on the indications for use, design, and safety and performance testing, the subject Merit Bipolar Coagulation Probe meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit Bipolar Coagulation Probe manufactured by Merit Medical Systems, Inc. |
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K 102273
Pet 2 of 2
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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 eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Dan W. Lindsay Regulatory Affairs Specialist II Merit Medical Systems, Inc. 1600 West Merit Parkway SOUTH JORDAN UT 84095
SEP 0 7 2010
Re: K102273
Trade/Device Name: Merit Bipolar Coagulation Probe Regulation Number: 21 CFR8 876,4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: August 10, 2010 Received: August 11, 2010
Dear Mr. Lindsay:
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.
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 of medical device-related
3
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,
Hubert H Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
Merit Bipolar Coagulation Probe Premarket Notification 510(k)
Merit Medical Systems, Inc.
SEP 0 7 2010
Indications for Use Statement 4.0
510(k) Number (if known):
Device Name:
Indications for Use:
The Bipolar Coagulation Probe is intended to be passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
Hul
ition Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number