(387 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical and suction device with no mention of AI or ML capabilities.
No.
The device's function is to apply electrosurgical energy for coagulation and remove fluids, which are surgical tools to facilitate procedures, not to treat a disease or condition therapeutically.
No
Explanation: The device's intended use is for surgical procedures (electrosurgical energy and fluid removal), not for identifying or investigating a disease or condition.
No
The intended use and description clearly indicate a physical device (electrosurgical energy conductor and suction apparatus) used in surgical procedures, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to apply energy to tissue and remove fluids. This is a therapeutic and procedural function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information related to image processing, AI/ML, training/test sets, performance studies with diagnostic metrics (sensitivity, specificity, etc.) further supports that this is not a diagnostic device.
IVDs are devices 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 entirely focused on the surgical procedure itself.
N/A
Intended Use / Indications for Use
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.
Product codes
GEI
Device Description
Not Found
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): 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.
Not Found
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2013
Medline Industries, Inc. Mr.Matt Clausen Sr. RA Specialist One Medline Place Mundelein, Illinois 60060-4486
K122949 Re:
Trade/Device Name: Medline Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosugical, Cutting and Coagulation and accessories Regulatory Class: Class II Product Code: GEI Dated: September 13, 2013 Received: September 24, 2013
Dear Mr. Clausen:
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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K122949
Device Name:
Medline Suction Coagulator
Indications For Use:
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
| Long H. Chen -A | Digitally signed by Long H. Chen -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Long H. Chen -A
0.9.2342.19200300.100.1.1=1300369056
Date: 2013.10.15 13:49:07 -04'00' |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Division Sign-off) | For MXM |
Division of Surgical Devices 510(k) Number K122949