(84 days)
Not Found
No
The summary describes a standard laparoscopic bipolar forceps device and makes no mention of AI or ML.
Yes
The device is used for laparoscopic bipolar coagulation, which is a therapeutic intervention to stop bleeding during surgery.
No
The device description states its purpose is for "laparoscopic bipolar coagulation," which is a therapeutic function to stop bleeding, not to diagnose a condition.
No
The device description clearly states it is a "laparoscopic coagulating forceps device," which is a physical hardware instrument.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "laparoscopic bipolar coagulation." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument used for coagulation during laparoscopic surgery. It interacts directly with tissue inside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Minisite* Bipolar Forceps** Device is intended for use during laparoscopic bipolar coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Minisite* Bipolar Forceps** Device is a laparoscopic coagulating forceps device that is intended to be passed down a laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the bipolar outputs of compatible electrosurgical generators.
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.
Everest Medical BiCOAG Forceps (K912544)
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.
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United States Surgical Corporation 510(k) Premarket Notification Minisite* Bipolar Forceps** Device
| IX. | 510(k)_Summary of Safety and Effectiveness |
|---|---|
| SUBMITTER: | United States Surgical Corporation |
| 150 Glover Avenue | |
| Norwalk, CT 06856 | |
| CONTACT PERSON: | Melissa Mazzoni |
| DATE PREPARED: | June 26, 1997 |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and |
| accessories | |
| COMMON NAME: | Bipolar Forceps |
| PROPRIETARY NAME: | Trademark name not yet determined |
| PREDICATE DEVICES: | Everest Medical BiCOAG Forceps (K912544) |
| DEVICE DESCRIPTION: | The Minisite* Bipolar Forceps** Device is a laparoscopic |
| coagulating forceps device that is intended to be passed | |
| down a laparoscopic cannula. Coagulation is achieved | |
| using electrosurgical energy under laparoscopic | |
| visualization. The device is intended to be used with the | |
| bipolar outputs of compatible electrosurgical generators. | |
| INTENDED USE: | The Minisite* Bipolar Forceps** Device is intended for |
| use during laparoscopic bipolar coagulation. | |
| MATERIALS: | All patient contact materials of the Minisite* Bipolar |
| Forceps** Device are evaluated for biocompatibility in | |
| accordance with ISO Standard # 10993-1. |
K97241
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, which is a traditional symbol of medicine. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Melissa Mazzoni Regulatory Affairs Associate United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
SEP 1 9 1997
Re: K972415 Trade Name: Minisite*Bipolar Forceps**Device Regulatory Class: II Product Code: GEI Dated: June 26, 1997 Received: June 27, 1997
Dear Ms. Mazzoni:
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 (QS) 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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Page 2 - Ms. Melissa Mazzoni
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,
Cynthia L. Williams, Ph.D., J.D.
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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IV. Indications For Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Minisite* Bipolar Forceps** Device
Indications For Use: The Minisite* Bipolar Forceps** Device is indicate for use in laparoscopic bipolar coagulation.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: |
(Division Sign Off,
Division of Device Evaluation
510(k) Number ________________
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