(105 days)
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No
The summary describes a basic surgical tool (bipolar electrodes) and does not mention any AI or ML capabilities, image processing, or data-driven features.
No
The device is described as a "surgical tool for cutting and coagulation." It is used for procedures like coagulation and bleeding control, which are interventions rather than therapies.
No
The document describes the device as a surgical tool used for cutting and coagulation in GYN and General Surgery procedures. This is a description of a therapeutic device, not a diagnostic one.
No
The intended use describes physical surgical tools (electrodes and cannula) used for cutting and coagulation, which are hardware devices. 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 that the ACCU-Surg Bipolar Laparoscopic Electrodes are "surgical tools for cutting and coagulation" used in surgical procedures. This describes a device used during a surgical intervention on a patient, not a device used to examine specimens outside the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Performing tests in a laboratory setting
Therefore, the ACCU-Surg Bipolar Laparoscopic Electrodes are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The ACCU-Surg Bipolar Laparoscopic Electrodes are intended to be used with the ACCU-Surg Suction / Irrigation Cannula. They are surgical tools for cutting and coagulation used for GYN and General Surgery for such procedures as coagulation of endometrium, laparoscopic myomectomy, laparoscopic leiomyoma coagulation (myolysis), bleeding control of pelvic vessels and laparoscopic (**) errors )) bacanth orgeons choice will determine the tip style used.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pelvic vessels
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is facing left and has three lines that make up its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Allen R. Howes President Transamerican Technologies International 7026 Koll Center Parkway, 207 Pleasanton, California 94566
AUG 20 1997
Re: K971677
Trade Name: ACCU-Surg Bipolar Laparoscopic Electrodes Regulatory Class: II Product Code: GEI Dated: July 23, 1997 Received: July 28, 1997
Dear Mr. Howes:
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 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 Regulation (OS) 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 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.
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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) 594-4595. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Sincerely yours,
[Image of a signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
The ACCU-Surg Bipolar Laparoscopic Electrodes are intended to be used with the ACCU-Surg Suction / Irrigation Cannula. They are surgical tools for cutting and coagulation used for GYN and General Surgery for such procedures as coagulation of endometrium, laparoscopic myomectomy, laparoscopic leiomyoma coagulation (myolysis), bleeding control of pelvic vessels and laparoscopic (**) errors )) bacanth orgeons choice will determine the tip style used.
Allen R. Howes, President
Date: May 6, 1997
Premarket Notification Number
Prescription Use
(Per 21 CFR 801.109)
scoteo
Divis