(85 days)
Not Found
No
The summary describes a standard bipolar electrosurgical forceps and does not mention any AI or ML components or functionalities.
Yes
The device is identified as a therapeutic device as its intended use is to "grasp, manipulate and coagulate selected tissue," which are actions aimed at treating or managing a medical condition or tissue.
No
The device is described as surgical forceps used for grasping, manipulating, and coagulating tissue with electrosurgical energy, not for diagnosing conditions.
No
The device description clearly states it is a physical forceps designed to grasp, manipulate, and coagulate tissue, requiring connection to an electrosurgical generator via a cable. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- MSD BIPOLAR Forceps Function: The description clearly states the forceps are designed to "grasp, manipulate and coagulate selected tissue." This is a surgical procedure performed on the body (in vivo) to treat or alter tissue directly.
- No Specimen Analysis: There is no mention of analyzing any specimens taken from the body. The device is used for direct surgical intervention.
Therefore, based on the provided information, the MSD BIPOLAR Forceps are a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Product codes
GEI
Device Description
The MSD BIPOLAR Forceps are intended for use in general surgical procedures. The device is connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
selected tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgical procedures
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MSD BIPOLAR Forceps 510(k) Summary June 2006
Page 1 of 1
- I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
SEP - 5 2006
- Contact: Richard W. Treharne, PhD Vice President Regulatory Affairs
II. Proprietary Trade Name: MSD BIPOLAR Forceps
- III. Classification Name: Electrosurgical Cutting and Coagulation and Accessories
- IV. Regulation Number: 878.4400
Product Code: GEI Class: Class II
V. Product Description
The MSD BIPOLAR Forceps are intended for use in general surgical procedures. The device is connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.
VII Indications
The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
VIII Substantial Equivalence
Documentation was provided which demonstrated the subject MSD BIPOLAR Forceps to be substantially equivalent to the CLARIS Non-Stick Bipolar Forceps previously cleared by the agency in K051429 (SE 07/29/05).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2006
Medtronic Sofamor Danek % Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pvramid Place Memphis, Tennessee 38132
Re: K061635
Trade/Device Name: MSD Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 11, 2006 Received: August 15, 2006
Dear Mr. Grant:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became as a get fie device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease of the enactment date of the Medical Device Amendments, or to conninered pror to rias 2017-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval approval application (PMA). and Cosmetic rear (110.) that to hevice, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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.
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 (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.
2
Page 2 - Mr. Lee Grant
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
661635
Device Name: MSD Bipolar Forceps
Indications for Use:
The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, R. Boran. and Neurological Devices
510(k) Number K011636
000005