(28 days)
Not Found
No
The summary describes a standard electrosurgical forceps and does not mention any AI or ML capabilities.
No
The device is described as an electrosurgical instrument used for coagulation, grasping, dissection, and vessel sealing during surgical procedures, which are interventional actions rather than therapeutic ones aimed at treating a disease or condition itself.
No
The device is described as an electrosurgical instrument intended for coagulation, grasping, dissection, and vessel sealing, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states "Electrosurgical Instruments," which are hardware devices used in surgery. The intended use also describes mechanical actions and sealing of vessels, indicating a physical device. There is no mention of software as the primary or sole component.
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 "electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels... during the performance of open general surgical procedures." This describes a device used on the patient during surgery, not a device used to test samples outside the body (in vitro).
- Device Description: It's described as "Electrosurgical Instruments," which are used directly on tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely procedural and therapeutic during surgery.
N/A
Intended Use / Indications for Use
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagalation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
Product codes
GEI
Device Description
Electrosurgical cutting and coagulation device and accessories
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)
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
Gyrus Medical Inc. Open Forceps ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification Summary of Safety and Effectiveness August 4, 2006
AUG 1 0 2006 510(k) Summary of Safety and Effectiveness ACMI Corporation Gyrus Medical Inc. Open Forceps
General Information
Manufacturer:
Gyrus Medical Inc. 6655 Wedgwood Rd. Maple Grove, MN 55311-3602
Establishment Registration Number:
510(k) Submitter:
MMMM
2183680
ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104
. .
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
3003790304
Terrence E. Sullivan Director, Regulatory Affairs
Gyrus Medical Open Forceps
Electrosurgical Instruments
August 4, 2006
Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400), Class II General and Plastic Surgery Panel
Generic/Common Name:
Predicate Device
Trade Name:
Gyrus Medical Open Forceps
Intended Uses
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagalation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
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 eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2006
ACMI Corporation % Mr. Terrence E. Sullivan Director, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104
Re: K061975
Trade/Device Name: Gyrus Medical Inc. Open Forceps Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 28, 2006 Received: August 1, 2006
Dear Mr. Sullivan:
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.
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. Terrence E. Sullivan
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,
Hubert Remer
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Gyrus Medical Inc. Open Forceps ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Special 510(k) Notification -Statement of Intended Use August 4, 2006
Device Name: Gyrus Medical Inc. Open Forceps
510(k) Number:
061975
Indications for use:
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ X __
OR Over-the-Counter Use: _
(Per 21 CFR 801.109)
Hulbert Leeman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061975